Trial Outcomes & Findings for A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis (NCT NCT03010527)

Last Updated: 2022-10-18

Results Overview

Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of PS0011 investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of PS0011 study medication. The exposure adjusted incidence rate (EAIR) is defined as the number of subjects (n) with a specific AE adjusted for the exposure and was scaled to 100 subject-years: where the numerator is the total number of subjects experiencing the AE and the denominator is the total time at risk scaled to 100 subject-years; that is, the total summation of individual subject-years at risk up to the first occurrence of the AE for subjects with that AE, and the total subject-years at risk for those subjects not experiencing that AE, divided by 100.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

217 participants

Primary outcome timeframe

From Baseline until Safety Follow-Up Visit (up to Week 64)

Results posted on

2022-10-18

Participant Flow

The study started to enroll participants in December 2016 and concluded in September 2018. Among the 217 participants in PS0011, no participants were assigned to receive placebo.

Participant Flow refers to the Full Analysis Set (FAS), which consisted of all enrolled participants who received at least 1 dose of the investigational medicinal product (IMP) and had a valid measurement of the primary efficacy variable at Baseline of PS0011.

Participant milestones

Participant milestones
Measure	Bimekizumab 64 mg Q4W Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011.	Bimekizumab 160 mg Q4W Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011.	Bimekizumab 320 mg Q4W Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010.
Overall Study STARTED	15	111	91
Overall Study COMPLETED	15	92	75
Overall Study NOT COMPLETED	0	19	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Bimekizumab 160 mg Q4W Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011.	Bimekizumab 320 mg Q4W Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010.
Overall Study Death	0	1
Overall Study Adverse Event	4	2
Overall Study Protocol Violation	1	0
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	3	4
Overall Study WITHDRAWAL CRITERIA #9	4	6
Overall Study WITHDRAWAL CRITERIA #12	4	2
Overall Study PDILI and WITHDRAWAL CRITERIA #9	1	0

Baseline Characteristics

A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bimekizumab 64 mg Q4W n=15 Participants Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011.	Bimekizumab 160 mg Q4W n=111 Participants Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011.	Bimekizumab 320 mg Q4W n=91 Participants Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010.	Total Title n=217 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	105 Participants n=7 Participants	77 Participants n=5 Participants	196 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants	18 Participants n=4 Participants
Age, Continuous	44.5 years STANDARD_DEVIATION 14.7 • n=5 Participants	44.5 years STANDARD_DEVIATION 12.8 • n=7 Participants	43.5 years STANDARD_DEVIATION 14.7 • n=5 Participants	44.1 years STANDARD_DEVIATION 13.7 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	40 Participants n=7 Participants	31 Participants n=5 Participants	77 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	71 Participants n=7 Participants	60 Participants n=5 Participants	140 Participants n=4 Participants
Race/Ethnicity, Customized American Indian /Alaskan native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized White	13 Participants n=5 Participants	99 Participants n=7 Participants	83 Participants n=5 Participants	195 Participants n=4 Participants

PRIMARY outcome

Timeframe: From Baseline until Safety Follow-Up Visit (up to Week 64)

Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication in PS0011.

Outcome measures

Outcome measures
Measure	Bimekizumab 64 mg Q4W (SS) n=15 Participants Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the Safety Set (SS).	Bimekizumab 160 mg Q4W (SS) n=111 Participants Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the SS.	Bimekizumab 320 mg Q4W (SS) n=91 Participants Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010. Participants who received at least one dose of the IMP formed the SS.	Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS) Participants who achieved PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Placebo/Bimekizumab 160 mg Q4W/NR (FAS) Participants who did not achieve PASI90 response at Week 12 and received placebo Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.	Bimekizumab 64 mg Q4W/Bimekizumab 160 mg Q4W/NR (FAS) Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.	Bimekizumab 160 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS) Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS) Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS) Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.
Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment	110.68 no. of new events per 100 subject-years Interval 53.08 to 203.55	225.26 no. of new events per 100 subject-years Interval 182.88 to 274.53	206.82 no. of new events per 100 subject-years Interval 162.95 to 258.86	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Baseline during the Treatment Period (up to Week 48)

Population: The Full Analysis Set (FAS) consisted of all enrolled participants who received at least 1 dose of the study medication in PS0011 and had a valid efficacy measurement for Psoriasis Area and Severity Index (PASI) at Baseline of PS0011.

The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. It 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). The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. PASI90 response is defined to be equal to 1 if the percentage improvement from Baseline in the PASI scores is 90% or greater and 0 if the percentage improvement from Baseline is less than 90%. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.

Outcome measures

Outcome measures
Measure	Bimekizumab 64 mg Q4W (SS) n=15 Participants Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the Safety Set (SS).	Bimekizumab 160 mg Q4W (SS) n=55 Participants Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the SS.	Bimekizumab 320 mg Q4W (SS) n=33 Participants Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010. Participants who received at least one dose of the IMP formed the SS.	Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS) n=30 Participants Participants who achieved PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Placebo/Bimekizumab 160 mg Q4W/NR (FAS) n=37 Participants Participants who did not achieve PASI90 response at Week 12 and received placebo Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.	Bimekizumab 64 mg Q4W/Bimekizumab 160 mg Q4W/NR (FAS) n=19 Participants Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.	Bimekizumab 160 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS) n=14 Participants Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS) n=6 Participants Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS) n=8 Participants Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.
Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time Week 8	100 percentage of participants	96.4 percentage of participants	100 percentage of participants	100 percentage of participants	67.6 percentage of participants	73.7 percentage of participants	57.1 percentage of participants	83.3 percentage of participants	50.0 percentage of participants
Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time Week 12	100 percentage of participants	96.4 percentage of participants	100 percentage of participants	96.7 percentage of participants	81.1 percentage of participants	78.9 percentage of participants	64.3 percentage of participants	100 percentage of participants	62.5 percentage of participants
Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time Week 16	100 percentage of participants	92.7 percentage of participants	100 percentage of participants	96.7 percentage of participants	83.8 percentage of participants	78.9 percentage of participants	64.3 percentage of participants	100 percentage of participants	62.5 percentage of participants
Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time Week 20	100 percentage of participants	89.1 percentage of participants	93.9 percentage of participants	96.7 percentage of participants	89.2 percentage of participants	84.2 percentage of participants	78.6 percentage of participants	83.3 percentage of participants	62.5 percentage of participants
Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time Week 24	100 percentage of participants	85.5 percentage of participants	97.0 percentage of participants	96.7 percentage of participants	83.8 percentage of participants	78.9 percentage of participants	71.4 percentage of participants	83.3 percentage of participants	75.0 percentage of participants
Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time Week 28	93.3 percentage of participants	90.9 percentage of participants	97.0 percentage of participants	96.7 percentage of participants	91.9 percentage of participants	84.2 percentage of participants	71.4 percentage of participants	83.3 percentage of participants	50.0 percentage of participants
Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time Week 32	100 percentage of participants	89.1 percentage of participants	97.0 percentage of participants	93.3 percentage of participants	91.9 percentage of participants	73.7 percentage of participants	71.4 percentage of participants	83.3 percentage of participants	50.0 percentage of participants
Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time Week 36	100 percentage of participants	85.5 percentage of participants	97.0 percentage of participants	93.3 percentage of participants	91.9 percentage of participants	73.7 percentage of participants	71.4 percentage of participants	66.7 percentage of participants	50.0 percentage of participants
Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time Week 40	100 percentage of participants	83.6 percentage of participants	87.9 percentage of participants	86.7 percentage of participants	89.2 percentage of participants	78.9 percentage of participants	71.4 percentage of participants	83.3 percentage of participants	50.0 percentage of participants
Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time Week 44	100 percentage of participants	81.8 percentage of participants	87.9 percentage of participants	86.7 percentage of participants	89.2 percentage of participants	78.9 percentage of participants	71.4 percentage of participants	83.3 percentage of participants	50.0 percentage of participants
Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time Week 48	100 percentage of participants	80.0 percentage of participants	87.9 percentage of participants	86.7 percentage of participants	91.9 percentage of participants	68.4 percentage of participants	71.4 percentage of participants	66.7 percentage of participants	50.0 percentage of participants
Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time Week 4	100 percentage of participants	100 percentage of participants	97.0 percentage of participants	100 percentage of participants	45.9 percentage of participants	42.1 percentage of participants	42.9 percentage of participants	66.7 percentage of participants	50.0 percentage of participants
Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time PS0011 Baseline	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: From Baseline during the Treatment Period (up to Week 48)

Population: The FAS consisted of all enrolled participants who received at least 1 dose of the study medication in PS0011 and had a valid efficacy measurement for PASI at Baseline of PS0011.

The Investigator's Global Assessment (IGA) measures the overall 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 is defined as clear (0) or almost clear (1) with at least a two category improvement from Baseline. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.

Outcome measures

Outcome measures
Measure	Bimekizumab 64 mg Q4W (SS) n=15 Participants Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the Safety Set (SS).	Bimekizumab 160 mg Q4W (SS) n=55 Participants Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the SS.	Bimekizumab 320 mg Q4W (SS) n=33 Participants Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010. Participants who received at least one dose of the IMP formed the SS.	Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS) n=30 Participants Participants who achieved PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Placebo/Bimekizumab 160 mg Q4W/NR (FAS) n=37 Participants Participants who did not achieve PASI90 response at Week 12 and received placebo Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.	Bimekizumab 64 mg Q4W/Bimekizumab 160 mg Q4W/NR (FAS) n=19 Participants Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.	Bimekizumab 160 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS) n=14 Participants Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS) n=6 Participants Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS) n=8 Participants Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.
Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time Week 12	100 percentage of participants	92.7 percentage of participants	97.0 percentage of participants	96.7 percentage of participants	81.1 percentage of participants	89.5 percentage of participants	64.3 percentage of participants	83.3 percentage of participants	62.5 percentage of participants
Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time PS0011 Baseline	100 percentage of participants	96.4 percentage of participants	100 percentage of participants	100 percentage of participants	5.4 percentage of participants	10.5 percentage of participants	35.7 percentage of participants	50.0 percentage of participants	25.0 percentage of participants
Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time Week 4	100 percentage of participants	98.2 percentage of participants	97.0 percentage of participants	100 percentage of participants	56.8 percentage of participants	57.9 percentage of participants	42.9 percentage of participants	66.7 percentage of participants	62.5 percentage of participants
Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time Week 8	100 percentage of participants	96.4 percentage of participants	97.0 percentage of participants	100 percentage of participants	75.7 percentage of participants	84.2 percentage of participants	57.1 percentage of participants	83.3 percentage of participants	62.5 percentage of participants
Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time Week 16	100 percentage of participants	90.9 percentage of participants	97.0 percentage of participants	96.7 percentage of participants	83.8 percentage of participants	78.9 percentage of participants	57.1 percentage of participants	66.7 percentage of participants	62.5 percentage of participants
Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time Week 20	100 percentage of participants	85.5 percentage of participants	93.9 percentage of participants	96.7 percentage of participants	89.2 percentage of participants	84.2 percentage of participants	71.4 percentage of participants	66.7 percentage of participants	75.0 percentage of participants
Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time Week 24	100 percentage of participants	81.8 percentage of participants	97.0 percentage of participants	93.3 percentage of participants	83.8 percentage of participants	84.2 percentage of participants	64.3 percentage of participants	83.3 percentage of participants	62.5 percentage of participants
Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time Week 28	93.3 percentage of participants	89.1 percentage of participants	97.0 percentage of participants	93.3 percentage of participants	86.5 percentage of participants	84.2 percentage of participants	71.4 percentage of participants	66.7 percentage of participants	62.5 percentage of participants
Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time Week 32	100 percentage of participants	85.5 percentage of participants	93.9 percentage of participants	93.3 percentage of participants	89.2 percentage of participants	78.9 percentage of participants	71.4 percentage of participants	66.7 percentage of participants	50.0 percentage of participants
Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time Week 36	100 percentage of participants	81.8 percentage of participants	90.9 percentage of participants	93.3 percentage of participants	86.5 percentage of participants	78.9 percentage of participants	71.4 percentage of participants	66.7 percentage of participants	37.5 percentage of participants
Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time Week 40	100 percentage of participants	83.6 percentage of participants	87.9 percentage of participants	86.7 percentage of participants	86.5 percentage of participants	78.9 percentage of participants	71.4 percentage of participants	66.7 percentage of participants	50.0 percentage of participants
Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time Week 44	100 percentage of participants	81.8 percentage of participants	87.9 percentage of participants	86.7 percentage of participants	83.8 percentage of participants	78.9 percentage of participants	71.4 percentage of participants	66.7 percentage of participants	50.0 percentage of participants
Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time Week 48	100 percentage of participants	78.2 percentage of participants	87.9 percentage of participants	86.7 percentage of participants	89.2 percentage of participants	68.4 percentage of participants	71.4 percentage of participants	66.7 percentage of participants	62.5 percentage of participants

Adverse Events

Bimekizumab 64 mg Q4W (SS)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Bimekizumab 160 mg Q4W (SS)

Serious events: 7 serious events

Other events: 56 other events

Deaths: 0 deaths

Bimekizumab 320 mg Q4W (SS)

Serious events: 7 serious events

Other events: 51 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

UCB

Cares

Phone: 001 844 599 2273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Bimekizumab 64 mg Q4W (SS) n=15 participants at risk Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the Safety Set (SS).	Bimekizumab 160 mg Q4W (SS) n=111 participants at risk Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the SS.	Bimekizumab 320 mg Q4W (SS) n=91 participants at risk Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010. Participants who received at least one dose of the IMP formed the SS.
Renal and urinary disorders Nephrolithiasis	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.90% 1/111 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Renal and urinary disorders Ureterolithiasis	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.90% 1/111 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Renal and urinary disorders Renal colic	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.90% 1/111 • Number of events 2 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Reproductive system and breast disorders Uterine cervix stenosis	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.90% 1/111 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	1.1% 1/91 • Number of events 2 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	1.1% 1/91 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Surgical and medical procedures Abortion induced	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	1.1% 1/91 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Vascular disorders Circulatory collapse	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	1.1% 1/91 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Vascular disorders Hypovolaemic shock	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	1.1% 1/91 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Investigations Hepatic enzyme increased	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.90% 1/111 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.90% 1/111 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Nervous system disorders Carpal tunnel syndrome	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	1.1% 1/91 • Number of events 2 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Renal and urinary disorders IgA nephropathy	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.90% 1/111 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
General disorders Non-cardiac chest pain	6.7% 1/15 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Infections and infestations Otitis externa bacterial	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	1.1% 1/91 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	1.1% 1/91 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	1.1% 1/91 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Infections and infestations Staphylococcal abscess	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.90% 1/111 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Cardiac disorders Cardiac failure	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.90% 1/111 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Eye disorders Cataract	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	1.1% 1/91 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)

Measure	Bimekizumab 64 mg Q4W (SS) n=15 participants at risk Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the Safety Set (SS).	Bimekizumab 160 mg Q4W (SS) n=111 participants at risk Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the SS.	Bimekizumab 320 mg Q4W (SS) n=91 participants at risk Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010. Participants who received at least one dose of the IMP formed the SS.
Ear and labyrinth disorders External ear inflammation	6.7% 1/15 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	1.1% 1/91 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Gastrointestinal disorders Diarrhoea	6.7% 1/15 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	1.1% 1/91 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Gastrointestinal disorders Flatulence	6.7% 1/15 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Hepatobiliary disorders Non-alcoholic fatty liver	6.7% 1/15 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.90% 1/111 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Infections and infestations Oral candidiasis	6.7% 1/15 • Number of events 2 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	11.7% 13/111 • Number of events 17 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	16.5% 15/91 • Number of events 19 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Infections and infestations Skin candida	6.7% 1/15 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Infections and infestations Angular cheilitis	6.7% 1/15 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	1.8% 2/111 • Number of events 3 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Infections and infestations Gingivitis	6.7% 1/15 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Infections and infestations Vulvovaginal mycotic infection	6.7% 1/15 • Number of events 2 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.90% 1/111 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Infections and infestations Nasopharyngitis	13.3% 2/15 • Number of events 4 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	13.5% 15/111 • Number of events 20 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	12.1% 11/91 • Number of events 14 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Infections and infestations Upper respiratory tract infection	6.7% 1/15 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	9.0% 10/111 • Number of events 12 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	9.9% 9/91 • Number of events 12 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Infections and infestations Pharyngitis	6.7% 1/15 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.90% 1/111 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	3.3% 3/91 • Number of events 3 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Infections and infestations Urinary tract infection	13.3% 2/15 • Number of events 3 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.90% 1/111 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	1.1% 1/91 • Number of events 2 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Infections and infestations Respiratory tract infection viral	6.7% 1/15 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.90% 1/111 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	1.1% 1/91 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Injury, poisoning and procedural complications Joint injury	6.7% 1/15 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Injury, poisoning and procedural complications Procedural pain	6.7% 1/15 • Number of events 2 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Investigations Gamma-glutamyl-transferase increased	6.7% 1/15 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	3.6% 4/111 • Number of events 6 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	3.3% 3/91 • Number of events 4 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Metabolism and nutrition disorders Hyperphagia	6.7% 1/15 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	2.7% 3/111 • Number of events 4 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	6.6% 6/91 • Number of events 7 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumour	6.7% 1/15 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/91 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/15 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	5.4% 6/111 • Number of events 6 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	6.6% 6/91 • Number of events 8 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Skin and subcutaneous tissue disorders Dermatitis contact	6.7% 1/15 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	4.5% 5/111 • Number of events 6 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	3.3% 3/91 • Number of events 3 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	6.7% 1/15 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	2.7% 3/111 • Number of events 4 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	2.2% 2/91 • Number of events 2 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Skin and subcutaneous tissue disorders Pruritus generalised	6.7% 1/15 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	0.00% 0/111 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	1.1% 1/91 • Number of events 1 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Skin and subcutaneous tissue disorders Psoriasis	13.3% 2/15 • Number of events 2 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	4.5% 5/111 • Number of events 6 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	5.5% 5/91 • Number of events 5 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Vascular disorders Hypertension	13.3% 2/15 • Number of events 2 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	7.2% 8/111 • Number of events 10 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)	4.4% 4/91 • Number of events 4 • From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)