Trial Outcomes & Findings for A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis (NCT NCT03355573)

Last Updated: 2024-11-21

Results Overview

An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

255 participants

Primary outcome timeframe

From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)

Results posted on

2024-11-21

Participant Flow

The study started to enroll study participants in November 2017 and concluded in October 2022. Participants who completed AS0008 (NCT02963506) participated in this study.

The Participant Flow refers to the Safety Set.

Participant milestones

Participant milestones
Measure	Bimekizumab Participants received bimekizumab 160 milligrams (mg) every 4 weeks (Q4W) up to 4 years.
Overall Study STARTED	255
Overall Study COMPLETED	202
Overall Study NOT COMPLETED	53

Reasons for withdrawal

Reasons for withdrawal
Measure	Bimekizumab Participants received bimekizumab 160 milligrams (mg) every 4 weeks (Q4W) up to 4 years.
Overall Study Withdrew consent due to refused treatment to AE latent tuberculosis	1
Overall Study Sponsor's decision	1
Overall Study Participant withdrew consent due to AEs	1
Overall Study PI's decision	2
Overall Study Withdrawal by Subject	23
Overall Study Lost to Follow-up	4
Overall Study Lack of Efficacy	2
Overall Study Adverse Event, non-fatal	17
Overall Study Adverse Event, serious fatal	2

Baseline Characteristics

A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bimekizumab n=255 Participants Participants received Bimekizumab 160 mg Q4W up to 4 years.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	245 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	41.8 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	217 Participants n=5 Participants
Race/Ethnicity, Customized White	253 Participants n=5 Participants
Race/Ethnicity, Customized Other/Mixed	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	254 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)

Population: The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.

Outcome measures

Outcome measures
Measure	Bimekizumab n=255 Participants Participants received Bimekizumab 160 mg Q4W up to 4 years.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study	92.9 percentage of participants

PRIMARY outcome

Timeframe: From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)

Population: The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.

A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 1) Results in death 2) Is life-threatening 3) Requires in participant hospitalisation or prolongation of existing hospitalisation 4) Is a congenital anomaly or birth defect 5) Is an infection that requires treatment with parenteral antibiotics 6) Other important medical events which based on medical or scientific judgement may jeopardise the participants, or may require medical or surgical intervention to prevent any of the above.

Outcome measures

Outcome measures
Measure	Bimekizumab n=255 Participants Participants received Bimekizumab 160 mg Q4W up to 4 years.
Percentage of Participants With Serious Adverse Event (SAE) During the Study	18.0 percentage of participants

SECONDARY outcome

Timeframe: From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)

Population: The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.

Outcome measures

Outcome measures
Measure	Bimekizumab n=255 Participants Participants received Bimekizumab 160 mg Q4W up to 4 years.
Percentage of Participants Who Withdrew Due to an Treatment-emergent Adverse Event (TEAE) During the Study	6.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline of AS0008, Week 48 (AS0009)

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the IMP and had a valid measurement for at least 1 efficacy variable at AS0009 study entry. Both Non-responder imputation and observed case analysis (imputation methods) have been reported in this outcome measure. Here, Number analyzed signifies those participants evaluable at specified categories.

The ASAS40 response was defined as relative improvements of at least 40% and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA) (score ranged from 0 (not active) to 10 (very active), Pain assessment (total spinal pain NRS score) (assessed on a scale of 0 (no pain) to 10 (severe pain)), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)) (score ranged from 0 (easy) to 10 (impossible)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) (score ranged from 0 (none) to 10 (very severe) and no worsening at all in the remaining domain. Participants for whom ASAS could not be derived due to missing data were counted as non-responders.

Outcome measures

Outcome measures
Measure	Bimekizumab n=249 Participants Participants received Bimekizumab 160 mg Q4W up to 4 years.
Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 48 Calculated Relative to Baseline of AS0008 Non-responder imputation	67.1 percentage of participants
Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 48 Calculated Relative to Baseline of AS0008 Observed case	70.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline of AS0008, Week 48 (AS0009)

The ASAS20 response was defined as relative improvements of at least 20% and absolute improvement of at least 1 unit on a 0 to 10 NRS, where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: PGADA (score ranged from 0 (not active) to 10 (very active), Pain assessment (total spinal pain NRS score) (assessed on a scale of 0 (no pain) to 10 (severe pain)), Function (BASFI) (score ranged from 0 (easy) to 10 (impossible)), Inflammation (mean of BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) (score ranged from 0 (none) to 10 (very severe) and no worsening at all in the remaining domain. Participants for whom ASAS could not be derived due to missing data were counted as non-responders.

Outcome measures

Outcome measures
Measure	Bimekizumab n=249 Participants Participants received Bimekizumab 160 mg Q4W up to 4 years.
Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 48 Calculated Relative to Baseline of AS0008 Non-responder imputation	79.9 percentage of participants
Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 48 Calculated Relative to Baseline of AS0008 Observed case	84.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline of AS0008, Week 48 (AS0009)

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the IMP and had a valid measurement for at least 1 efficacy variable at AS0009 study entry.

BASDAI is a validated self-reported instrument, which consisted of 6 questions to measure the disease activity of ankylosing spondylitis (AS) from the participant's perspective. It measured the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration). Each question was rated using a numerical rating scale from 0 (none) to 10 (very severe), higher score=high disease activity. The BASDAI score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions 1 to 4. This score was then divided by 5. The total BASDAI score was ranged from 0=none to 10= very severe, where higher score indicated high disease activity. A negative value indicated improvement and a positive value indicated worsening.

Outcome measures

Outcome measures
Measure	Bimekizumab n=249 Participants Participants received Bimekizumab 160 mg Q4W up to 4 years.
Change From Baseline of AS0008 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score to Week 48	-3.79 scores on a scale Standard Error 0.13

Adverse Events

Bimekizumab

Serious events: 46 serious events

Other events: 176 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Bimekizumab n=255 participants at risk Participants received Bimekizumab 160 mg Q4W up to 4 years.
Cardiac disorders Coronary artery disease	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Cardiac disorders Coronary artery stenosis	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Cardiac disorders Cardiac failure	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Cardiac disorders Cardio-respiratory arrest	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Ear and labyrinth disorders Endolymphatic hydrops	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Gastrointestinal disorders Colitis ulcerative	0.78% 2/255 • Number of events 2 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Gastrointestinal disorders Crohn's disease	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Gastrointestinal disorders Inguinal hernia	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Gastrointestinal disorders Umbilical hernia	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Hepatobiliary disorders Cholelithiasis	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Hepatobiliary disorders Hepatotoxicity	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Infections and infestations Perirectal abscess	0.78% 2/255 • Number of events 2 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Infections and infestations Abdominal wall abscess	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Infections and infestations Gastroenteritis bacterial	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Infections and infestations Empyema	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Infections and infestations Post procedural infection	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Infections and infestations Pneumonia	1.2% 3/255 • Number of events 3 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Infections and infestations Bronchitis	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Infections and infestations Peritonsillar abscess	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Infections and infestations Urinary tract infection	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Infections and infestations Corona virus infection	1.2% 3/255 • Number of events 3 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Injury, poisoning and procedural complications Meniscus injury	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Injury, poisoning and procedural complications Humerus fracture	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Injury, poisoning and procedural complications Tibia fracture	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Injury, poisoning and procedural complications Periprosthetic fracture	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Injury, poisoning and procedural complications Road traffic accident	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Injury, poisoning and procedural complications Skull fracture	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Injury, poisoning and procedural complications Post procedural haematuria	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Musculoskeletal and connective tissue disorders Bursitis	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Musculoskeletal and connective tissue disorders Fracture delayed union	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Musculoskeletal and connective tissue disorders Joint instability	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.78% 2/255 • Number of events 2 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Musculoskeletal and connective tissue disorders Spinal instability	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Musculoskeletal and connective tissue disorders Tendonitis	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testicular seminoma (pure)	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Nervous system disorders Cerebrovascular accident	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Nervous system disorders Carpal tunnel syndrome	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Psychiatric disorders Bipolar disorder	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Psychiatric disorders Mental disorder	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Psychiatric disorders Suicidal ideation	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Renal and urinary disorders Calculus urinary	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.78% 2/255 • Number of events 2 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Reproductive system and breast disorders Female genital tract fistula	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Skin and subcutaneous tissue disorders Psoriasis	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Vascular disorders Subclavian steal syndrome	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Vascular disorders Varicose vein	0.39% 1/255 • Number of events 1 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.

Other adverse events

Other adverse events
Measure	Bimekizumab n=255 participants at risk Participants received Bimekizumab 160 mg Q4W up to 4 years.
Infections and infestations Oral candidiasis	6.7% 17/255 • Number of events 21 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Infections and infestations Bronchitis	8.2% 21/255 • Number of events 23 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Infections and infestations Nasopharyngitis	18.0% 46/255 • Number of events 65 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Infections and infestations Upper respiratory tract infection	12.9% 33/255 • Number of events 48 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Infections and infestations Pharyngitis	7.1% 18/255 • Number of events 24 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Infections and infestations Sinusitis	5.9% 15/255 • Number of events 17 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Infections and infestations Tonsillitis	5.9% 15/255 • Number of events 21 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Infections and infestations Corona virus infection	11.8% 30/255 • Number of events 33 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Investigations Alanine aminotransferase increased	7.5% 19/255 • Number of events 26 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Investigations Aspartate aminotransferase increased	5.1% 13/255 • Number of events 17 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Metabolism and nutrition disorders Hypercholesterolaemia	6.3% 16/255 • Number of events 17 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 15/255 • Number of events 17 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Nervous system disorders Headache	5.1% 13/255 • Number of events 16 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Skin and subcutaneous tissue disorders Psoriasis	5.1% 13/255 • Number of events 16 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.
Vascular disorders Hypertension	5.5% 14/255 • Number of events 16 • From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224) Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration. The Safety Set consisted of all participants in the enrolled set who received at least one dose of study medication in AS0009.

Additional Information

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Principal investigator is a sponsor employee
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Restriction type: GT60