Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (NCT NCT03370133)
NCT ID: NCT03370133
Last Updated: 2025-12-23
Results Overview
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
567 participants
Primary outcome timeframe
Week 16
Results posted on
2025-12-23
Participant Flow
This study started to enroll participants in December 2017 and concluded in December 2019.
The study included a 2-5 week Screening Period, a 16-week Initial Period and a 36-week Maintenance Period. After the Maintenance Period participants either enrolled in an open-label study or had a SFU Visit 20 weeks after their final dose (including those withdrawn from IMP). Participant Flow refers to the Randomized Set and Maintenance Set.
Participant milestones
| Measure |
Placebo/Bimekizumab 320 mg Q4W
After the 16-week Initial Treatment Period (Initial Period) participants initially randomized to placebo received bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period (Maintenance Period).
|
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period.
|
Ustekinumab/Ustekinumab
After the 16-week Initial Treatment Period participants initially randomized to ustekinumab 45 mg or 90 mg (depending on participant weight) continued to receive ustekinumab during the 36-week Maintenance Treatment Period.
|
Placebo
Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52.
|
Bimekizumab (BKZ) 320 Milligrams (mg) Q4W
Participants received bimekizumab 320 mg Q4W for 52 weeks.
|
Ustekinumab (Uste)
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding.
|
|---|---|---|---|---|---|---|
|
Initial Treatment Period (WK 16)
STARTED
|
0
|
0
|
0
|
83
|
321
|
163
|
|
Initial Treatment Period (WK 16)
COMPLETED
|
0
|
0
|
0
|
74
|
306
|
157
|
|
Initial Treatment Period (WK 16)
NOT COMPLETED
|
0
|
0
|
0
|
9
|
15
|
6
|
|
Maintenance Treatment Period (WK 52)
STARTED
|
74
|
306
|
157
|
0
|
0
|
0
|
|
Maintenance Treatment Period (WK 52)
COMPLETED
|
69
|
283
|
141
|
0
|
0
|
0
|
|
Maintenance Treatment Period (WK 52)
NOT COMPLETED
|
5
|
23
|
16
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo/Bimekizumab 320 mg Q4W
After the 16-week Initial Treatment Period (Initial Period) participants initially randomized to placebo received bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period (Maintenance Period).
|
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period.
|
Ustekinumab/Ustekinumab
After the 16-week Initial Treatment Period participants initially randomized to ustekinumab 45 mg or 90 mg (depending on participant weight) continued to receive ustekinumab during the 36-week Maintenance Treatment Period.
|
Placebo
Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52.
|
Bimekizumab (BKZ) 320 Milligrams (mg) Q4W
Participants received bimekizumab 320 mg Q4W for 52 weeks.
|
Ustekinumab (Uste)
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding.
|
|---|---|---|---|---|---|---|
|
Initial Treatment Period (WK 16)
Adverse Event
|
0
|
0
|
0
|
5
|
5
|
2
|
|
Initial Treatment Period (WK 16)
Death
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Initial Treatment Period (WK 16)
Lack of Efficacy
|
0
|
0
|
0
|
2
|
1
|
0
|
|
Initial Treatment Period (WK 16)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Initial Treatment Period (WK 16)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Initial Treatment Period (WK 16)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
2
|
1
|
|
Initial Treatment Period (WK 16)
Non-compliance
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Initial Treatment Period (WK 16)
Site closed
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Maintenance Treatment Period (WK 52)
Adverse Event
|
3
|
12
|
4
|
0
|
0
|
0
|
|
Maintenance Treatment Period (WK 52)
Lack of Efficacy
|
0
|
1
|
4
|
0
|
0
|
0
|
|
Maintenance Treatment Period (WK 52)
Protocol Violation
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Maintenance Treatment Period (WK 52)
Lost to Follow-up
|
0
|
4
|
3
|
0
|
0
|
0
|
|
Maintenance Treatment Period (WK 52)
Withdrawal by Subject
|
1
|
4
|
4
|
0
|
0
|
0
|
|
Maintenance Treatment Period (WK 52)
Non-compliance
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Maintenance Treatment Period (WK 52)
Consent Withdrawn for IMP Not Procedures
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo
n=83 Participants
Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52.
|
Bimekizumab (BKZ) 320 Milligrams (mg) Q4W
n=321 Participants
Participants received bimekizumab 320 mg Q4W for 52 weeks.
|
Ustekinumab (Uste)
n=163 Participants
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding.
|
Total Title
n=567 Participants
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=68 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=219 Participants
|
3 Participants
n=219 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
73 Participants
n=68 Participants
|
285 Participants
n=4 Participants
|
144 Participants
n=219 Participants
|
502 Participants
n=219 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=68 Participants
|
34 Participants
n=4 Participants
|
18 Participants
n=219 Participants
|
62 Participants
n=219 Participants
|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 13.6 • n=68 Participants
|
45.2 years
STANDARD_DEVIATION 14.0 • n=4 Participants
|
46.0 years
STANDARD_DEVIATION 13.6 • n=219 Participants
|
46.1 years
STANDARD_DEVIATION 13.9 • n=219 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=68 Participants
|
92 Participants
n=4 Participants
|
46 Participants
n=219 Participants
|
161 Participants
n=219 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=68 Participants
|
229 Participants
n=4 Participants
|
117 Participants
n=219 Participants
|
406 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan native
|
0 Participants
n=68 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=219 Participants
|
2 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 Participants
n=68 Participants
|
71 Participants
n=4 Participants
|
36 Participants
n=219 Participants
|
127 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=68 Participants
|
9 Participants
n=4 Participants
|
3 Participants
n=219 Participants
|
12 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
White
|
63 Participants
n=68 Participants
|
237 Participants
n=4 Participants
|
120 Participants
n=219 Participants
|
420 Participants
n=219 Participants
|
|
Race/Ethnicity, Customized
Other/mixed
|
0 Participants
n=68 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=219 Participants
|
6 Participants
n=219 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: The Randomized Set (RS) consisted of all randomized study participants.
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=321 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
n=163 Participants
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=83 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
|
85.0 percentage of participants
|
49.7 percentage of participants
|
4.8 percentage of participants
|
PRIMARY outcome
Timeframe: Week 16Population: The Randomized Set (RS) consisted of all randomized study participants.
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear \[0\] or almost clear \[1\] with at least a two-category improvement from Baseline at Week 16.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=321 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
n=163 Participants
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=83 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Percentage of Participants With an Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 16
|
84.1 percentage of participants
|
53.4 percentage of participants
|
4.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: The Randomized Set (RS) consisted of all randomized study participants.
The PASI100 response assessments are based on a 100% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=321 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
n=163 Participants
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=83 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Percentage of Participants With a PASI100 Response at Week 16
|
58.6 percentage of participants
|
20.9 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: The Randomized Set (RS) consisted of all randomized study participants.
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear \[0\] with at least a two-category improvement from Baseline at Week 16.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=321 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
n=163 Participants
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=83 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Percentage of Participants With an IGA 0 Response at Week 16
|
58.6 percentage of participants
|
22.1 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: The Randomized Set (RS) consisted of all randomized study participants.
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=321 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
n=163 Participants
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=83 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Percentage of Participants With a PASI75 Response at Week 4
|
76.9 percentage of participants
|
15.3 percentage of participants
|
2.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score at or above the 1.98 response threshold.
As Patient-Reported-Outcome (PRO) measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD pain item was assessed daily on a numeric rating scale (NRS) from 0 (no pain) to 10 (very severe pain). PSD score for pain at a given visit was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in pain score higher than the prespecified 1.98 response threshold at Week 16. The endpoint was characterized as percentage of participants with PSD pain response.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=229 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
n=107 Participants
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=54 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16
|
77.3 percentage of participants
|
68.2 percentage of participants
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score at or above the 2.39 response threshold.
A PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD itch item was assessed daily on a NRS from 0 (no itch) to 10 (very severe itch). PSD score for itch was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in itch score higher than the prespecified 2.39 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD itch response.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=244 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
n=117 Participants
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=61 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16
|
76.6 percentage of participants
|
65.8 percentage of participants
|
13.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score at or above the 2.86 response threshold.
As PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD scaling item was assessed daily on a NRS from 0 (no scaling) to 10 (very severe scaling). PSD score for scaling was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in scaling score higher than the prespecified 2.86 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD scaling response.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=246 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
n=116 Participants
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=63 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16
|
78.5 percentage of participants
|
59.5 percentage of participants
|
12.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score of at least 2.
Only participants with scalp involvement at Baseline completed the scalp IGA. Participants with scalp involvement at Baseline were defined as those with a scalp IGA score \>0 at Baseline. Scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe). Scalp IGA 0/1 response at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=285 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
n=146 Participants
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=72 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Percentage of Participants With a Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) >=2 at Baseline
|
84.2 percentage of participants
|
70.5 percentage of participants
|
15.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: The Randomized Set (RS) consisted of all randomized study participants.
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=321 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
n=163 Participants
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=83 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Percentage of Participants With a PASI90 Response at Week 12
|
85.0 percentage of participants
|
43.6 percentage of participants
|
2.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: The Randomized Set (RS) consisted of all randomized study participants. Placebo was only provided up to Week 16 and was not included in this analysis.
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=163 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=321 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Percentage of Participants With a PASI90 Response at Week 52
|
55.8 percentage of participants
|
—
|
81.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: The Randomized Set (RS) consisted of all randomized study participants.
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear \[0\] or almost clear \[1\] with at least a two-category improvement from Baseline at Week 12.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=321 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
n=163 Participants
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=83 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 12
|
81.9 percentage of participants
|
52.1 percentage of participants
|
4.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: The Randomized Set (RS) consisted of all randomized study participants. Placebo was only provided up to Week 16 and was not included in this analysis.
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear \[0\] or almost clear \[1\] with at least a two-category improvement from Baseline at Week 52.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=163 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=321 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 52
|
60.7 percentage of participants
|
—
|
78.2 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)Population: The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the Adverse Event (AE) being considered. If a participant had no events, the total time at risk was used.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=321 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
n=163 Participants
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=83 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
|
287.26 no. of new events per 100 subject-years
Interval 246.93 to 332.29
|
247.62 no. of new events per 100 subject-years
Interval 197.23 to 306.96
|
238.41 no. of new events per 100 subject-years
Interval 169.53 to 325.91
|
SECONDARY outcome
Timeframe: From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)Population: The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=321 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
n=163 Participants
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=83 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
|
5.06 no. of new events per 100 subject-years
Interval 1.64 to 11.8
|
10.14 no. of new events per 100 subject-years
Interval 3.29 to 23.66
|
7.97 no. of new events per 100 subject-years
Interval 0.97 to 28.8
|
SECONDARY outcome
Timeframe: From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)Population: The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=321 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
n=163 Participants
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=83 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
|
6.08 no. of new events per 100 subject-years
Interval 2.23 to 13.24
|
5.99 no. of new events per 100 subject-years
Interval 1.24 to 17.52
|
24.39 no. of new events per 100 subject-years
Interval 8.95 to 53.09
|
SECONDARY outcome
Timeframe: From Week 16 to Safety Follow-Up (up to 52 weeks duration)Population: The Maintenance Set (MS) consisted of all study participants who had received at least 1 dose of active IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period.
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the Adverse Event (AE) being considered. If a participant had no events, the total time at risk was used.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=306 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
n=157 Participants
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=74 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
|
127.84 no. of new events per 100 subject-years
Interval 111.58 to 145.81
|
111.24 no. of new events per 100 subject-years
Interval 90.8 to 134.91
|
149.35 no. of new events per 100 subject-years
Interval 114.24 to 191.85
|
SECONDARY outcome
Timeframe: From Week 16 to Safety Follow-Up (up to 52 weeks duration)Population: The Maintenance Set (MS) consisted of all study participants who had received at least 1 dose of active IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period.
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=306 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
n=157 Participants
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=74 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
|
6.19 no. of new events per 100 subject-years
Interval 3.3 to 10.58
|
7.46 no. of new events per 100 subject-years
Interval 3.22 to 14.7
|
9.88 no. of new events per 100 subject-years
Interval 3.21 to 23.05
|
SECONDARY outcome
Timeframe: From Week 16 to Safety Follow-Up (up to 52 weeks duration)Population: The Maintenance Set (MS) consisted of all study participants who had received at least 1 dose of active IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period.
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Outcome measures
| Measure |
Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS)
n=306 Participants
After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the MS.
|
Ustekinumab (SS)
n=157 Participants
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.
|
Placebo (SS)
n=74 Participants
Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS).
|
|---|---|---|---|
|
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
|
5.72 no. of new events per 100 subject-years
Interval 2.95 to 9.99
|
3.71 no. of new events per 100 subject-years
Interval 1.01 to 9.51
|
5.91 no. of new events per 100 subject-years
Interval 1.22 to 17.27
|
Adverse Events
Placebo Initial Period (SS)
Serious events: 2 serious events
Other events: 17 other events
Deaths: 1 deaths
Bimekizumab 320 mg Q4W Initial Period (SS)
Serious events: 5 serious events
Other events: 87 other events
Deaths: 1 deaths
Ustekinumab Initial Period (SS)
Serious events: 5 serious events
Other events: 37 other events
Deaths: 1 deaths
Any Bimekizumab 320 mg Q4W (AMS)
Serious events: 24 serious events
Other events: 192 other events
Deaths: 2 deaths
Any Ustekinumab (AMS)
Serious events: 13 serious events
Other events: 73 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo Initial Period (SS)
n=83 participants at risk
During the 16-week Initial Treatment Period participants received placebo. Participants formed the Safety Set (SS).
|
Bimekizumab 320 mg Q4W Initial Period (SS)
n=321 participants at risk
During the 16-week Initial Treatment Period participants received bimekizumab 320 mg Q4W. Participants formed the SS.
|
Ustekinumab Initial Period (SS)
n=163 participants at risk
During the 16-week Initial Treatment Period participants received ustekinumab 45 mg or 90 mg (depending on participants weight). Participants formed the SS.
|
Any Bimekizumab 320 mg Q4W (AMS)
n=395 participants at risk
This arm consisted of all participants who received bimekizumab 320 mg Q4W at any time in the study (up to Week 52). It also includes the participants that switched from placebo to bimekizumab 320 mg Q4W after the 16-week Initial Treatment Period. Participants formed the SS.
|
Any Ustekinumab (AMS)
n=163 participants at risk
This arm consisted of all participants who received ustekinumab 45 mg or 90 mg (depending on participants weight) at any time in the study (up to Week 52). Participants formed the SS.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.31%
1/321 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.51%
2/395 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.31%
1/321 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.51%
2/395 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Eye disorders
Macular hole
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.31%
1/321 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
General disorders
Death
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Infections and infestations
Wound infection
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Infections and infestations
Otitis externa
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Infections and infestations
Infective tenosynovitis
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Infections and infestations
Subglottic laryngitis
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Injury, poisoning and procedural complications
Heart injury
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Injury, poisoning and procedural complications
Tendon injury
|
1.2%
1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
1.2%
1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Investigations
Liver function test increased
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Investigations
False positive tuberculosis test
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.31%
1/321 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.31%
1/321 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
1.2%
1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.31%
1/321 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Nervous system disorders
Brain injury
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/395 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Nervous system disorders
Vocal cord paresis
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Pregnancy, puerperium and perinatal conditions
Haemorrhage in pregnancy
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Surgical and medical procedures
Metabolic surgery
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/321 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.25%
1/395 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
Other adverse events
| Measure |
Placebo Initial Period (SS)
n=83 participants at risk
During the 16-week Initial Treatment Period participants received placebo. Participants formed the Safety Set (SS).
|
Bimekizumab 320 mg Q4W Initial Period (SS)
n=321 participants at risk
During the 16-week Initial Treatment Period participants received bimekizumab 320 mg Q4W. Participants formed the SS.
|
Ustekinumab Initial Period (SS)
n=163 participants at risk
During the 16-week Initial Treatment Period participants received ustekinumab 45 mg or 90 mg (depending on participants weight). Participants formed the SS.
|
Any Bimekizumab 320 mg Q4W (AMS)
n=395 participants at risk
This arm consisted of all participants who received bimekizumab 320 mg Q4W at any time in the study (up to Week 52). It also includes the participants that switched from placebo to bimekizumab 320 mg Q4W after the 16-week Initial Treatment Period. Participants formed the SS.
|
Any Ustekinumab (AMS)
n=163 participants at risk
This arm consisted of all participants who received ustekinumab 45 mg or 90 mg (depending on participants weight) at any time in the study (up to Week 52). Participants formed the SS.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.4%
7/83 • Number of events 8 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
9.3%
30/321 • Number of events 35 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
8.6%
14/163 • Number of events 15 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
21.8%
86/395 • Number of events 121 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
22.1%
36/163 • Number of events 53 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
8.7%
28/321 • Number of events 30 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.00%
0/163 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
15.2%
60/395 • Number of events 98 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
2/83 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
2.8%
9/321 • Number of events 9 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
3.1%
5/163 • Number of events 6 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
9.1%
36/395 • Number of events 48 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
11.0%
18/163 • Number of events 22 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Infections and infestations
Urinary tract infection
|
6.0%
5/83 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
1.9%
6/321 • Number of events 6 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.61%
1/163 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
3.0%
12/395 • Number of events 14 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
3.7%
6/163 • Number of events 7 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
2/83 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.93%
3/321 • Number of events 3 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
2.5%
4/163 • Number of events 4 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
2.5%
10/395 • Number of events 10 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
5.5%
9/163 • Number of events 10 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Nervous system disorders
Headache
|
0.00%
0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
3.4%
11/321 • Number of events 11 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
4.3%
7/163 • Number of events 10 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
4.1%
16/395 • Number of events 17 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
6.1%
10/163 • Number of events 14 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
6.0%
5/83 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
0.93%
3/321 • Number of events 4 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
1.2%
2/163 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
2.3%
9/395 • Number of events 11 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
1.2%
2/163 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
|
Vascular disorders
Hypertension
|
1.2%
1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
2.2%
7/321 • Number of events 7 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
3.1%
5/163 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
3.5%
14/395 • Number of events 14 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
|
6.1%
10/163 • Number of events 11 • Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60