Trial Outcomes & Findings for Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis (NCT NCT02696031)

Last Updated: 2022-04-29

Results Overview

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

555 participants

Primary outcome timeframe

Week 16

Results posted on

2022-04-29

Participant Flow

A total of 1583 patients were screened for this study, of which 555 patients (35.1%) were randomized. Overall, 1028 patients (64.9%) discontinued prior to screening phase completion, most due to screen failure (1000 patients, 63.2%).

Participant milestones

Participant milestones
Measure	Secukinumab, Load, Core Phase AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase Placebo s.c., Core Phase	AIN457 150 mg Extension Phase AIN457 150 mg Core Phase Responders who were rerandomized at week 104 to the 150 mg in the Extension phase (from Week 104 to week 208).	AIN457 300 mg Extension Phase AIN457 150 mg Core Phase Responders who were rerandomized at week 104 to the 300 mg in the Extension phase (from Week 104 to week 208).	AIN457 300 mg Open Label Extension Phase AIN457 150 mg Open Label Core Phase Non-Responders who were assigned at week 104 to the 300 mg Open Label in the Extension phase (from Week 104 to week 208).
Up to Week 24 STARTED	185	184	186	0	0	0
Up to Week 24 COMPLETED	175	177	175	0	0	0
Up to Week 24 NOT COMPLETED	10	7	11	0	0	0
Up to Week 52 STARTED	185	184	186	0	0	0
Up to Week 52 COMPLETED	156	165	160	0	0	0
Up to Week 52 NOT COMPLETED	29	19	26	0	0	0
Up to Week 104 STARTED	185	184	186	0	0	0
Up to Week 104 COMPLETED	146	143	149	0	0	0
Up to Week 104 NOT COMPLETED	39	41	37	0	0	0
Extension Phase From wk 104 to wk 208 STARTED	0	0	0	147	147	78
Extension Phase From wk 104 to wk 208 COMPLETED	0	0	0	137	132	72
Extension Phase From wk 104 to wk 208 NOT COMPLETED	0	0	0	10	15	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Secukinumab, Load, Core Phase AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase Placebo s.c., Core Phase	AIN457 150 mg Extension Phase AIN457 150 mg Core Phase Responders who were rerandomized at week 104 to the 150 mg in the Extension phase (from Week 104 to week 208).	AIN457 300 mg Extension Phase AIN457 150 mg Core Phase Responders who were rerandomized at week 104 to the 300 mg in the Extension phase (from Week 104 to week 208).	AIN457 300 mg Open Label Extension Phase AIN457 150 mg Open Label Core Phase Non-Responders who were assigned at week 104 to the 300 mg Open Label in the Extension phase (from Week 104 to week 208).
Up to Week 24 Adverse Event	2	4	2	0	0	0
Up to Week 24 Lack of Efficacy	2	1	2	0	0	0
Up to Week 24 Lost to Follow-up	0	1	1	0	0	0
Up to Week 24 Physician Decision	1	0	1	0	0	0
Up to Week 24 Protocol Violation	1	0	0	0	0	0
Up to Week 24 Withdrawal by Subject	4	1	5	0	0	0
Up to Week 52 Adverse Event	4	5	3	0	0	0
Up to Week 52 Lack of Efficacy	10	7	11	0	0	0
Up to Week 52 Lost to Follow-up	1	1	1	0	0	0
Up to Week 52 Physician Decision	1	1	2	0	0	0
Up to Week 52 Pregnancy	0	2	0	0	0	0
Up to Week 52 Protocol Violation	1	0	0	0	0	0
Up to Week 52 Withdrawal by Subject	12	3	9	0	0	0
Up to Week 104 Pregnancy	0	2	1	0	0	0
Up to Week 104 Withdrawal by Subject	15	10	16	0	0	0
Up to Week 104 Protocol Violation	1	0	0	0	0	0
Up to Week 104 Physician Decision	1	2	3	0	0	0
Up to Week 104 Lost to Follow-up	2	3	1	0	0	0
Up to Week 104 Lack of Efficacy	13	12	11	0	0	0
Up to Week 104 Adverse Event	7	11	5	0	0	0
Up to Week 104 Pt completed wk 52. Withdrawal by subject at wk 52.	0	1	0	0	0	0
Extension Phase From wk 104 to wk 208 Withdrawal by Subject	0	0	0	6	8	2
Extension Phase From wk 104 to wk 208 Physician Decision	0	0	0	1	1	0
Extension Phase From wk 104 to wk 208 Non-compliance with study treatment	0	0	0	1	0	0
Extension Phase From wk 104 to wk 208 Lost to Follow-up	0	0	0	0	1	0
Extension Phase From wk 104 to wk 208 Lack of Efficacy	0	0	0	1	1	3
Extension Phase From wk 104 to wk 208 Adverse Event	0	0	0	1	4	1

Baseline Characteristics

Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Secukinumab, Load, Core Phase n=185 Participants AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase n=184 Participants AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase n=186 Participants Placebo s.c., Core Phase	Total n=555 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	183 Participants n=5 Participants	180 Participants n=7 Participants	183 Participants n=5 Participants	546 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Age, Continuous	39.1 Years STANDARD_DEVIATION 11.45 • n=5 Participants	39.8 Years STANDARD_DEVIATION 11.68 • n=7 Participants	39.3 Years STANDARD_DEVIATION 11.47 • n=5 Participants	39.4 Years STANDARD_DEVIATION 11.52 • n=4 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	100 Participants n=7 Participants	95 Participants n=5 Participants	300 Participants n=4 Participants
Sex: Female, Male Male	80 Participants n=5 Participants	84 Participants n=7 Participants	91 Participants n=5 Participants	255 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	24 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	165 Participants n=5 Participants	162 Participants n=7 Participants	161 Participants n=5 Participants	488 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	14 Participants n=7 Participants	18 Participants n=5 Participants	43 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	23 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized White	176 Participants n=5 Participants	165 Participants n=7 Participants	167 Participants n=5 Participants	508 Participants n=4 Participants
Race/Ethnicity, Customized Other	5 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	19 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Subset of TNF naive patients

Outcome measures

Outcome measures
Measure	Secukinumab, Load, Core Phase n=164 Participants AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase n=166 Participants AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase n=171 Participants Placebo s.c., Core Phase
The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response at Week 16	68 Participants	70 Participants	50 Participants

PRIMARY outcome

Timeframe: Week 52

Population: Subset of TNF naive patients

Outcome measures

Outcome measures
Measure	Secukinumab, Load, Core Phase n=164 Participants AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase n=166 Participants AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase n=171 Participants Placebo s.c., Core Phase
The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 52	58 Participants	66 Participants	34 Participants

SECONDARY outcome

Timeframe: Week 16 and week 52

Population: Full Analysis Set (FAS)

Outcome measures

Outcome measures
Measure	Secukinumab, Load, Core Phase n=185 Participants AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase n=184 Participants AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase n=186 Participants Placebo s.c., Core Phase
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response week 16	74 Participants	75 Participants	52 Participants
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response week 52	62 Participants	70 Participants	36 Participants

SECONDARY outcome

Timeframe: Week 16

Population: Full Analysis Set (FAS)

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). ASAS 20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the VAS signifies higher severity.

Outcome measures

Outcome measures
Measure	Secukinumab, Load, Core Phase n=185 Participants AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase n=184 Participants AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase n=186 Participants Placebo s.c., Core Phase
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 20 Response	105 Participants	107 Participants	85 Participants

SECONDARY outcome

Timeframe: Week 16

Population: Full Analysis Set (FAS)

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains. A higher score on the VAS signifies higher severity.

Outcome measures

Outcome measures
Measure	Secukinumab, Load, Core Phase n=185 Participants AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase n=184 Participants AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase n=186 Participants Placebo s.c., Core Phase
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response	74 Participants	66 Participants	44 Participants

SECONDARY outcome

Timeframe: Week 16

Population: Full Analysis Set (FAS)

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 10. A higher score on the VAS signifies higher severity.

Outcome measures

Outcome measures
Measure	Secukinumab, Load, Core Phase n=185 Participants AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase n=184 Participants AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase n=186 Participants Placebo s.c., Core Phase
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society Partial Remission (ASAS PR)	40 Participants	39 Participants	13 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full Analysis Set (FAS)

The Bath Ankylosing Spondylitis Functional Index (BASFI) is a set of 10 questions designed to determine the degree of functional limitation in those subjects with AS. The ten questions were chosen with a major input from subjects with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the subjects' ability to cope with everyday life. A 100 mm visual analog scale (VAS) is used to answer the questions. The mean of the ten questions gives the BASFI score - a value between 0 and 10. (0 being no problem and 10 being the worst problem, captured as a continuous visual analog scale (VAS)). A higher score on the VAS signifies higher severity.

Outcome measures

Outcome measures
Measure	Secukinumab, Load, Core Phase n=181 Participants AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase n=177 Participants AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase n=177 Participants Placebo s.c., Core Phase
Change in Bath Ankylosing Spondylitis Functional Index (BASFI)	-1.75 Index Standard Error 0.202	-1.64 Index Standard Error 0.204	-1.01 Index Standard Error 0.206

SECONDARY outcome

Timeframe: Week 16 and 52

Population: Full Analysis set (FAS)

The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of AS. The BASDAI 50 is defined as an improvement of at least 50% in the BASDAI compared to baseline. A higher score on the VAS signifies higher severity.

Outcome measures

Outcome measures
Measure	Secukinumab, Load, Core Phase n=185 Participants AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase n=184 Participants AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase n=186 Participants Placebo s.c., Core Phase
The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response week 52	57 Participants	65 Participants	37 Participants
The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response week 16	69 Participants	69 Participants	39 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full Analysis Set (FAS)

The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a validated assessment tool using 1 through 10 scales (1 indicating "no problem" and 10 indicating " worst problem"), to characterize six clinical domains (fatigue, spinal pain, joint pain/selling, localized tenderness, morning stiffness duration, morning stiffness severity) pertaining to five major symptoms of Ankylosing Spondylitis (AS). The computed final BASDAI score is a value between 0 and 10 with a higher score indicating worse disease. A higher score on the VAS signifies higher severity.

Outcome measures

Outcome measures
Measure	Secukinumab, Load, Core Phase n=181 Participants AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase n=177 Participants AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase n=177 Participants Placebo s.c., Core Phase
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	-2.35 scores on a scale Standard Error 0.201	-2.43 scores on a scale Standard Error 0.203	-1.46 scores on a scale Standard Error 0.205

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full Analysis Set (FAS)

The Ankylosing Spondylitis Quality of Life scores (ASQoL) is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each "yes" response and no points for each "no" response resulting in overall scores that range from 0 (least severity) to 18 (highest severity). As such, lower score indicate better quality of life. Items include an assessment of mobility/energy, self-care and mood/emotion. The recall period is "at the moment," and the measure requires approximately 6 minutes to complete.

Outcome measures

Outcome measures
Measure	Secukinumab, Load, Core Phase n=181 Participants AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase n=176 Participants AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase n=177 Participants Placebo s.c., Core Phase
Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 16	-3.45 Scores on a scale Standard Error 0.408	-3.62 Scores on a scale Standard Error 0.414	-1.84 Scores on a scale Standard Error 0.421

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: Full Analysis Set (FAS).

Outcome measures

Outcome measures
Measure	Secukinumab, Load, Core Phase n=83 Participants AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase n=88 Participants AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase n=54 Participants Placebo s.c., Core Phase
Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 52	-7.1 Scores on a scale Standard Deviation 4.77	-7.6 Scores on a scale Standard Deviation 5.38	-6.4 Scores on a scale Standard Deviation 4.64

SECONDARY outcome

Timeframe: Week 52

Population: Full Analysis Set (FAS)

Ankylosing Spondylitis Disease Activity Score (ASDAS) - C-reactive protein (CRP) inactive disease criteria are defined as a value below 1.3. Higher score indicates worse symptoms. The formula is: ASDAS-CRP = 0.121 x total back pain + 0.110 x patient global + 0.073 x peripheral pain/swelling + 0.058 x duration of morning stiffness + 0.579 x ln(hsCRP +1)

Outcome measures

Outcome measures
Measure	Secukinumab, Load, Core Phase n=185 Participants AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase n=184 Participants AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase n=186 Participants Placebo s.c., Core Phase
The Number and Percentage of Patients Who Achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease	29 Participants	44 Participants	19 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

High sensitivity C-reactive protein is measured as a marker of inflammation from blood samples during the study.

Outcome measures

Outcome measures
Measure	Secukinumab, Load, Core Phase n=180 Participants AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase n=176 Participants AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase n=175 Participants Placebo s.c., Core Phase
Change in High Sensitivity C-reactive Protein	0.64 ratio Standard Error 1.078	0.64 ratio Standard Error 1.079	0.91 ratio Standard Error 1.080

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full Analysis Set (FAS)

The Short Form-36 Physical Component Summary (SF-36 PCS) is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of eight subscales (domains) that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role- Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed. The eight domains are based on a scale from 0-100 while PCS and MCS are norm-based scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of functioning. A positive change from baseline score indicates an improvement.

Outcome measures

Outcome measures
Measure	Secukinumab, Load, Core Phase n=182 Participants AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase n=176 Participants AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase n=178 Participants Placebo s.c., Core Phase
Change in Short Form-36 Physical Component Summary (SF-36 PCS)	5.71 Scores on a Scale Standard Error 0.683	5.57 Scores on a Scale Standard Error 0.694	2.93 Scores on a Scale Standard Error 0.705

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full Analysis Set

Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a maximum score of 24.

Outcome measures

Outcome measures
Measure	Secukinumab, Load, Core Phase n=180 Participants AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase n=177 Participants AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase n=174 Participants Placebo s.c., Core Phase
Change in Sacroiliac Joint Edema - Week 16	-1.68 Scores on a Scale Standard Error 0.24	-1.03 Scores on a Scale Standard Error 0.18	-0.39 Scores on a Scale Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: Full Analysis Set where intercurrent event = no.

Outcome measures

Outcome measures
Measure	Secukinumab, Load, Core Phase n=81 Participants AIN457 150 mg s.c. load, Core Phase	Secukinumab, No Load, Core Phase n=87 Participants AIN457 150 mg s.c. no load, Core Phase	Placebo, Core Phase n=53 Participants Placebo s.c., Core Phase
Change in Sacroiliac Joint Edema - Week 52	-2.9 Scores on a scale Standard Deviation 4.54	-1.9 Scores on a scale Standard Deviation 3.40	-0.1 Scores on a scale Standard Deviation 1.97

Adverse Events

Any AIN457 150 mg, in Core Phase and Extension Phase

Serious events: 48 serious events

Other events: 320 other events

Deaths: 0 deaths

Any AIN457 300 mg in Extension Phase

Serious events: 11 serious events

Other events: 74 other events

Deaths: 0 deaths

Any AIN457, In Core Phase and Extension Phase

Serious events: 58 serious events

Other events: 335 other events

Deaths: 0 deaths

Placebo, Core Phase

Serious events: 8 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Any AIN457 150 mg, in Core Phase and Extension Phase n=543 participants at risk Includes patients originally randomized to AIN457 150 mg (Load and No Load) at baseline and placebo patients switched to AIN457 150 mg before or at W52 (AEs occurring after the switch) who either were re-randomized (Core Phase Responders) to AIN457 150 mg at W104 or did not participate in the Extension Phase.	Any AIN457 300 mg in Extension Phase n=254 participants at risk Includes patients re-randomized (Core Phase Responders) or re-assigned (Core Phase Non-Responders) to AIN457 300 mg at W104 (Extension Phase) and patients re-randomized (Core Phase Responders) to AIN457 150 mg at W104 who up-titrated to AIN457 300 mg (only AEs occurring after up-titration).	Any AIN457, In Core Phase and Extension Phase n=543 participants at risk Includes patients randomized or switched (AEs occurring after the switch) to AIN457 150 mg (Load and No Load) who either were re-randomized (Core Phase Responders) to AIN457 150 mg or AIN457 300 mg at W104 or did not participate in the Extension Phase.	Placebo, Core Phase n=186 participants at risk Includes patients originally randomized to Placebo (AEs until the time of a switch to AIN457 150 mg)
Gastrointestinal disorders Diarrhoea	10.1% 55/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	2.4% 6/254 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	11.2% 61/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	5.4% 10/186 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.
Infections and infestations Bronchitis	4.2% 23/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	2.4% 6/254 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	5.2% 28/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	1.1% 2/186 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.
Infections and infestations Nasopharyngitis	25.2% 137/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	13.0% 33/254 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	26.9% 146/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	17.2% 32/186 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.
Infections and infestations Pharyngitis	5.0% 27/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	2.0% 5/254 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	5.7% 31/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	0.54% 1/186 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.
Infections and infestations Sinusitis	5.5% 30/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	2.0% 5/254 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	6.3% 34/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	1.6% 3/186 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.
Infections and infestations Upper respiratory tract infection	12.0% 65/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	6.3% 16/254 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	14.2% 77/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	7.0% 13/186 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.
Infections and infestations Urinary tract infection	7.0% 38/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	3.5% 9/254 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	7.7% 42/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	2.2% 4/186 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.
Musculoskeletal and connective tissue disorders Arthralgia	7.9% 43/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	2.4% 6/254 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	8.8% 48/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	4.8% 9/186 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.
Musculoskeletal and connective tissue disorders Back pain	6.6% 36/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	1.2% 3/254 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	7.0% 38/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	1.6% 3/186 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.
Nervous system disorders Headache	11.2% 61/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	2.8% 7/254 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	12.0% 65/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	4.8% 9/186 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.
Vascular disorders Hypertension	5.3% 29/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	2.0% 5/254 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	6.3% 34/543 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.	1.6% 3/186 • Adverse events are reported from first dose of study treatment until end of study treatment plus 12 wks post-treatment, up to a maximum timeframe of 1520 days (approx. 4.2 years). Safety results summarize long term data for all patients for the entire period of their study participation, which, for the majority of pts, combines the core phase and the extension phase (not all pts participated in the extension). The table is presented by dose group, AIN457 150 mg and AIN457 300 mg and placebo. Any exposure to AIN457 in the core phase is presented as Any AIN457 150 mg, regardless if patients were initially assigned to Load or No Load. Considering the total length of exposure to AIN457 150 mg, the effect of initial loading regimen during the first 4 weeks of treatment is considered negligible. Pts. may have switched from placebo to 150 mg or from 150 mg to 300 mg during the course of the study. Therefore, some pts are counted in more than 1 dose group, depending on the AE timing.

Additional Information

Study Director

Novartis Pharma AG

Phone: 1-888-669-6682

Email: [email protected]

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. Publications from a single-site are postponed until publication of the pooled clinical trial data (i.e., data from all sites) or disclosure of trial results in their entirety
Publication restrictions are in place

Restriction type: OTHER