Trial Outcomes & Findings for 16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis (NCT NCT01358175)

NCT ID: NCT01358175

Last Updated: 2017-03-09

Results Overview

ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 371 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2017-03-09

Participant Flow

Participant milestones

Measure	Secukinumab 10 mg/kg i.v. / 75 mg s.c. Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Secukinumab 10 mg/kg i.v. / 150 mg s.c. Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Placebo Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Overall Study STARTED	124	125	122
Overall Study COMPLETED	103	97	90
Overall Study NOT COMPLETED	21	28	32

Reasons for withdrawal

Measure	Secukinumab 10 mg/kg i.v. / 75 mg s.c. Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Secukinumab 10 mg/kg i.v. / 150 mg s.c. Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Placebo Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Overall Study Death	1	0	1
Overall Study Withdrawal by Subject	9	5	10
Overall Study Technical issues	0	1	0
Overall Study Pregnancy	0	1	0
Overall Study Physician Decision	1	0	0
Overall Study Non Compliance with Study Treatment	0	1	1
Overall Study Lost to Follow-up	1	1	3
Overall Study Lack of Efficacy	3	8	6
Overall Study Adverse Event	6	11	11

Baseline Characteristics

16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis

Baseline characteristics by cohort

Measure	Secukinumab 10 mg/kg i.v. / 75 mg s.c. n=124 Participants Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Secukinumab 10 mg/kg i.v. / 150 mg s.c. n=125 Participants Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Placebo n=122 Participants Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12	Total n=371 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	117 Participants n=5 Participants	122 Participants n=7 Participants	115 Participants n=5 Participants	354 Participants n=4 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	41 Participants n=7 Participants	37 Participants n=5 Participants	114 Participants n=4 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	84 Participants n=7 Participants	85 Participants n=5 Participants	257 Participants n=4 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: FAS comprised all patients who were randomized and to whom study treatment had been assigned. The efficacy analyses are based on the FAS.

ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.

Outcome measures

Measure	Secukinumab 10 mg/kg i.v. / 75 mg s.c. n=124 Participants Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Secukinumab 10 mg/kg i.v. / 150 mg s.c. n=125 Participants Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Placebo n=122 Participants Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response	59.7 % responders	60.8 % responders	28.7 % responders

SECONDARY outcome

Timeframe: 16 weeks

Population: FAS comprised all patients who were randomized and to whom study treatment had been assigned. The efficacy analyses are based on the FAS.

ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 40 is used to assess the efficacy of at least one dose of secukinumab against placebo.

Outcome measures

Measure	Secukinumab 10 mg/kg i.v. / 75 mg s.c. n=124 Participants Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Secukinumab 10 mg/kg i.v. / 150 mg s.c. n=125 Participants Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Placebo n=122 Participants Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Assessment of Responders for the SpondyloArthritis International Society ASAS 40 Response	33.1 % responders	41.6 % responders	13.1 % responders

SECONDARY outcome

Timeframe: Base line and Week 16

Population: FAS. Analysis was done on the log(e) ratio of the treatment value vs. baseline value to normalize the distribution of the hsCRP at each visit. LS Mean, SE, 95% CI and p-value are from mixed-effect model repeated measures (MMRM) with treatment, visit, TNF-alpha inhibitor status as factors, log(e) baseline and weight as covariates.

The change from baseline in hsCRP is expressed as a ratio of post-baseline to baseline values. With the ratio normalized to 1.0 at baseline, ratios less than 1.0 represent decreased postbaseline values, whereas ratios greater than 1.0 represent increased post-baseline values.

Outcome measures

Measure	Secukinumab 10 mg/kg i.v. / 75 mg s.c. n=124 Participants Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Secukinumab 10 mg/kg i.v. / 150 mg s.c. n=125 Participants Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Placebo n=122 Participants Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Change From Baseline in Serum hsCRP	0.45 ratio Standard Error 1.092	0.4 ratio Standard Error 1.090	0.97 ratio Standard Error 1.095

SECONDARY outcome

Timeframe: 16 weeks

ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevent to AS and no worsening in the remaining domain. In this study, ASAS 5/6 is used to assess the efficacy of at least one dose of secukinumab against placebo.

Outcome measures

Measure	Secukinumab 10 mg/kg i.v. / 75 mg s.c. n=124 Participants Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Secukinumab 10 mg/kg i.v. / 150 mg s.c. n=125 Participants Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Placebo n=122 Participants Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Assessment of Responders for the SpondyloArthritis International Society ASAS 5/6 Response	45.2 % responders	48.8 % responders	13.1 % responders

SECONDARY outcome

Timeframe: Baseline and 16 weeks

BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating " worst problem"), to characterize six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI is used to assess the efficacy of at least one dose of secukinumab verus placebo. To give each symptom equal weighting, the mean (average) of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score. Scores of 4 or greater suggest suboptimal control of disease, and patients with scores of 4 or greater are usually good candidates for either a change in their medical therapy or for enrollment in clinical trials evaluating new drug therapies directed at Ankylosing Spondylitis.

Outcome measures

Measure	Secukinumab 10 mg/kg i.v. / 75 mg s.c. n=124 Participants Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Secukinumab 10 mg/kg i.v. / 150 mg s.c. n=125 Participants Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Placebo n=122 Participants Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index / BASDAI	-2.34 units on scale Standard Error 0.175	-2.32 units on scale Standard Error 0.172	-0.59 units on scale Standard Error 0.180

SECONDARY outcome

Timeframe: baseline, 16 weeks

SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both phyically and emotionally based. Two overall summary scores, the Phyical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.

Outcome measures

Measure	Secukinumab 10 mg/kg i.v. / 75 mg s.c. n=124 Participants Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Secukinumab 10 mg/kg i.v. / 150 mg s.c. n=125 Participants Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Placebo n=122 Participants Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Change From Baseline in Physical Function Component of the Short-form Health Survey / SF-36 PCS	5.64 units on a scale Standard Error 0.595	5.57 units on a scale Standard Error 0.586	0.96 units on a scale Standard Error 0.612

SECONDARY outcome

Timeframe: baseline and 16 weeks

ASQoL is an 18 item questionnaire that assesses disease-specific quality of life (QoL), consisting of statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). In this study, ASQoL is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.

Outcome measures

Measure	Secukinumab 10 mg/kg i.v. / 75 mg s.c. n=124 Participants Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Secukinumab 10 mg/kg i.v. / 150 mg s.c. n=125 Participants Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Placebo n=122 Participants Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire / ASQoL	-3.61 units on a scale Standard Error 0.424	-3.58 units on a scale Standard Error 0.420	-1.04 units on a scale Standard Error 0.437

SECONDARY outcome

Timeframe: 16 weeks

ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10. In this study ASAS partial remission is used to assess the efficacy of at least one dose of secukinumab versus placebo.ASAS partial remission was defined as a VAS score of less than 2 units in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.

Outcome measures

Measure	Secukinumab 10 mg/kg i.v. / 75 mg s.c. n=124 Participants Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Secukinumab 10 mg/kg i.v. / 150 mg s.c. n=125 Participants Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Placebo n=122 Participants Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Assessment of Responders for ASAS Partial Remission	16.1 % responders	15.2 % responders	3.3 % responders

Adverse Events

Secukinumab 10mg/kg -75 mg

Serious events: 16 serious events

Other events: 88 other events

Deaths: 0 deaths

Secukinumab 10mg/kg -150 mg

Serious events: 13 serious events

Other events: 100 other events

Deaths: 0 deaths

Placebo Secukinumab

Serious events: 5 serious events

Other events: 52 other events

Deaths: 0 deaths

Placebo Non-Resp Secukinumab 75 mg

Serious events: 5 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo Non-Resp Secukinumab 150 mg

Serious events: 8 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo Resp Secukinumab 75 mg

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo Resp Secukinumab 150 mg

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Secukinumab 10mg/kg -75 mg n=124 participants at risk Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Secukinumab 10mg/kg -150 mg n=125 participants at risk Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Placebo Secukinumab n=122 participants at risk Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 up to end of Study	Placebo Non-Resp Secukinumab 75 mg n=39 participants at risk Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 16 to Secukinumab 75 mg	Placebo Non-Resp Secukinumab 150 mg n=38 participants at risk Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 16 to Secukinumab 150 mg	Placebo Resp Secukinumab 75 mg n=17 participants at risk Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 24 to Secukinumab 75 mg	Placebo Resp Secukinumab 150 mg n=18 participants at risk Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 24 to Secukinumab 150 mg
Cardiac disorders Cardiac failure	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Cardiac disorders Coronary artery stenosis	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Cardiac disorders Myocardial infarction	1.6% 2/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Ear and labyrinth disorders Vertigo	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Endocrine disorders Hyperparathyroidism	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Eye disorders Cataract	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Eye disorders Uveitis	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Colitis	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Diarrhoea	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Epigastric discomfort	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Gastritis	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Hiatus hernia	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Lumbar hernia	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Pancreatitis	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Pancreatitis acute	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
General disorders Adverse drug reaction	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
General disorders Application site pain	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
General disorders Chest discomfort	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
General disorders Pyrexia	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Hepatobiliary disorders Cholelithiasis	1.6% 2/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Hepatobiliary disorders Hepatitis toxic	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Hepatobiliary disorders Hepatosplenomegaly	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Appendicitis	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Helicobacter gastritis	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Pneumonia	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Pyelonephritis acute	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Tonsillitis	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Injury, poisoning and procedural complications Cartilage injury	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Injury, poisoning and procedural complications Upper limb fracture	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Injury, poisoning and procedural complications Dislocation of vertebra	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Injury, poisoning and procedural complications Injury	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Injury, poisoning and procedural complications Laceration	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Injury, poisoning and procedural complications Postoperative thrombosis	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Injury, poisoning and procedural complications Rib fracture	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.3% 2/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Blood and lymphatic system disorders Abdominal lymphadenopathy	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Blood and lymphatic system disorders Anaemia	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Blood and lymphatic system disorders Pancytopenia	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Nervous system disorders Brain oedema	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Nervous system disorders Cerebrovascular accident	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Nervous system disorders Hemiparesis	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Nervous system disorders Trigeminal neuralgia	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Nervous system disorders Vocal cord paresis	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Pregnancy, puerperium and perinatal conditions Abortion incomplete	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Psychiatric disorders Completed suicide	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Psychiatric disorders Depression	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Renal and urinary disorders Renal colic	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Vascular disorders Peripheral venous disease	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Vascular disorders Varicose vein	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures

Other adverse events

Measure	Secukinumab 10mg/kg -75 mg n=124 participants at risk Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Secukinumab 10mg/kg -150 mg n=125 participants at risk Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Placebo Secukinumab n=122 participants at risk Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 up to end of Study	Placebo Non-Resp Secukinumab 75 mg n=39 participants at risk Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 16 to Secukinumab 75 mg	Placebo Non-Resp Secukinumab 150 mg n=38 participants at risk Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 16 to Secukinumab 150 mg	Placebo Resp Secukinumab 75 mg n=17 participants at risk Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 24 to Secukinumab 75 mg	Placebo Resp Secukinumab 150 mg n=18 participants at risk Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 24 to Secukinumab 150 mg
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	1.6% 2/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	4.8% 6/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	3.3% 4/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	11.8% 2/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Blood and lymphatic system disorders Leukopenia	8.1% 10/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	6.4% 8/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Blood and lymphatic system disorders Lymphadenopathy	3.2% 4/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.4% 3/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.1% 2/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Blood and lymphatic system disorders Lymphopenia	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Cardiac disorders Bradycardia	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Cardiac disorders Bundle branch block right	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Ear and labyrinth disorders Vertigo	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.1% 2/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Eye disorders Iritis	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Eye disorders Uveitis	3.2% 4/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	3.2% 4/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	16.7% 3/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Abdominal pain	2.4% 3/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	6.4% 8/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Abdominal pain upper	7.3% 9/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 7/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Aphthous stomatitis	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.4% 3/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Crohn's disease	2.4% 3/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Dental caries	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Diarrhoea	12.9% 16/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	16.8% 21/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.7% 7/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	10.3% 4/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	7.9% 3/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	11.8% 2/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Gastric ulcer	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Gastritis	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Gastrooesophageal reflux disease	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Irritable bowel syndrome	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Mouth ulceration	6.5% 8/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	4.0% 5/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.5% 3/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	11.1% 2/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Nausea	5.6% 7/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	6.4% 8/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.1% 2/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Gastrointestinal disorders Tongue ulceration	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.4% 3/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
General disorders Fatigue	4.0% 5/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.4% 3/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
General disorders Pyrexia	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	10.5% 4/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations VARICELLA ZOSTER VIRUS INFECTION	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Acute tonsillitis	2.4% 3/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Bronchitis	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	4.8% 6/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.3% 2/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	11.1% 2/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Infection parasitic	2.4% 3/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Influenza	5.6% 7/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	9.6% 12/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	10.3% 4/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	10.5% 4/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	11.8% 2/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Nasopharyngitis	20.2% 25/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	27.2% 34/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	7.4% 9/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	17.9% 7/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	15.8% 6/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	17.6% 3/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	22.2% 4/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Oral herpes	1.6% 2/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	4.8% 6/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.3% 2/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Paronychia	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Pharyngitis	8.1% 10/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	14.4% 18/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.1% 2/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	11.1% 2/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Rhinitis	3.2% 4/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	6.4% 8/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	7.9% 3/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Sinusitis	3.2% 4/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	4.0% 5/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.5% 3/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.3% 2/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Tooth abscess	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Tooth infection	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Upper respiratory tract infection	13.7% 17/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	7.2% 9/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.1% 2/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	15.8% 6/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	11.8% 2/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	11.1% 2/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Urinary tract infection	1.6% 2/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 7/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Infections and infestations Viral upper respiratory tract infection	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Injury, poisoning and procedural complications Arthropod bite	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.1% 2/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Injury, poisoning and procedural complications Fall	3.2% 4/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.4% 3/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Injury, poisoning and procedural complications Wound	2.4% 3/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	4.0% 5/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Investigations Blood cholesterol increased	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.3% 2/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Investigations Gamma-glutamyltransferase increased	1.6% 2/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Investigations Low density lipoprotein increased	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.4% 3/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.3% 2/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Investigations Osteoprotegerin decreased	1.6% 2/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	3.2% 4/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.3% 2/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Metabolism and nutrition disorders Dyslipidaemia	12.1% 15/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	10.4% 13/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	4.9% 6/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Musculoskeletal and connective tissue disorders Arthralgia	6.5% 8/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	8.8% 11/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	3.3% 4/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	7.7% 3/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.3% 2/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Musculoskeletal and connective tissue disorders Back pain	4.8% 6/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	8.8% 11/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Musculoskeletal and connective tissue disorders Bone pain	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Musculoskeletal and connective tissue disorders Bursitis	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.3% 2/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.6% 2/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.1% 2/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Musculoskeletal and connective tissue disorders Neck pain	2.4% 3/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.1% 2/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Musculoskeletal and connective tissue disorders Osteoarthritis	1.6% 2/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.4% 3/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	7.9% 3/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Musculoskeletal and connective tissue disorders Pain in extremity	2.4% 3/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	3.2% 4/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.1% 2/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Musculoskeletal and connective tissue disorders Spinal pain	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Musculoskeletal and connective tissue disorders Tendonitis	3.2% 4/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Nervous system disorders Dizziness	4.0% 5/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	4.8% 6/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	3.3% 4/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Nervous system disorders Headache	14.5% 18/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	14.4% 18/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.7% 7/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.1% 2/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.3% 2/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	11.1% 2/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Nervous system disorders Paraesthesia	1.6% 2/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	4.0% 5/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Nervous system disorders Tremor	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Psychiatric disorders Anxiety	2.4% 3/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.1% 2/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Psychiatric disorders Insomnia	2.4% 3/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	3.2% 4/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Reproductive system and breast disorders Benign prostatic hyperplasia	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Reproductive system and breast disorders Ovarian cyst	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Respiratory, thoracic and mediastinal disorders Cough	5.6% 7/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 7/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.1% 2/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.3% 2/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.1% 10/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	8.8% 11/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	4.9% 6/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	7.7% 3/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	10.5% 4/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	4.0% 5/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Skin and subcutaneous tissue disorders Eczema	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.80% 1/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Skin and subcutaneous tissue disorders Erythema	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.3% 2/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Skin and subcutaneous tissue disorders Nail dystrophy	0.00% 0/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Skin and subcutaneous tissue disorders Pruritus	1.6% 2/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	4.8% 6/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.82% 1/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Skin and subcutaneous tissue disorders Rash	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	4.0% 5/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	11.1% 2/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Skin and subcutaneous tissue disorders Urticaria	0.81% 1/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	1.6% 2/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.3% 2/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
Vascular disorders Hypertension	4.8% 6/124 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	3.2% 4/125 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	0.00% 0/122 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/39 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	2.6% 1/38 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.9% 1/17 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures	5.6% 1/18 • Baseline to week 104 Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures

Additional Information

Clinical Disclosure Office

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER