Trial Outcomes & Findings for A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis (NCT NCT03230292)

Results Overview

TEAEs were events that had a start date on or after the first administration of study treatment in PS0018 until the last received dose of investigational medicinal product (IMP) +140 days \[which covered the 20-week Safety Follow-Up (SFU) Visit\]. The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64)

Results posted on

2022-07-22

Participant Flow

The study started to enroll patients in July 2017 and concluded in March 2019.

Participant Flow refers to the Safety Set.

Participant milestones

Participant milestones
Measure	BKZ All Participants Participants received bimekizumab (BKZ) 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously (sc) during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's Psoriasis Area and Severity Index (PASI) response was greater than or equal to (\>=) 50% to less than (\<) 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator.
Overall Study STARTED	43
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	BKZ All Participants Participants received bimekizumab (BKZ) 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously (sc) during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's Psoriasis Area and Severity Index (PASI) response was greater than or equal to (\>=) 50% to less than (\<) 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator.
Overall Study Adverse Event	1
Overall Study Protocol Violation	1
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BKZ All Participants n=43 Participants Participants received bimekizumab (BKZ) 160 milligrams (mg) every 4 weeks (Q4W) subcutaneously (sc) during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320 mg Q4W if the participant's Psoriasis Area and Severity Index (PASI) response was greater than or equal to (\>=) 50% to less than (\<) 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	45.0 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized White	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64)

Population: The Safety Set consisted of all participants who received at least 1 dose of the study medication in PS0018.

TEAEs were events that had a start date on or after the first administration of study treatment in PS0018 until the last received dose of investigational medicinal product (IMP) +140 days \[which covered the 20-week Safety Follow-Up (SFU) Visit\]. The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Incidence of Treatment Emergent Adverse Event (TEAE) Adjusted by Duration of Participant Exposure to Treatment	76.00 no. of new events per 100 subject-years Interval 53.8 to 104.3

SECONDARY outcome

Timeframe: From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64)

Population: The Pharmacokinetics Per-Protocol Set consisted of all enrolled participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration postdose in PS0018. Here, 'number analyzed' signifies participants who were evaluable at specified time points.

Plasma concentration of Bimekizumab was expressed in micrograms per milliliter (μg/mL). Values Below Limit of Quantification (BLQ) were replaced by value of Lower Limit of Quantification (LLOQ) divided by 2 (=0.075 μg/mL) in calculations of Means and Coefficient of Variations (CVs). Means and CVs were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Plasma Concentration of Bimekizumab During the Study Follow-up	0.310 μg/mL Geometric Coefficient of Variation 164.8
Plasma Concentration of Bimekizumab During the Study PS0018 Week 0	NA μg/mL Geometric Coefficient of Variation NA Participants had no prior BKZ treatment and thus no BKZ levels at Baseline.
Plasma Concentration of Bimekizumab During the Study Week 4	5.309 μg/mL Geometric Coefficient of Variation 47.8
Plasma Concentration of Bimekizumab During the Study Week 8	7.304 μg/mL Geometric Coefficient of Variation 60.7
Plasma Concentration of Bimekizumab During the Study Week 12	7.994 μg/mL Geometric Coefficient of Variation 53.9
Plasma Concentration of Bimekizumab During the Study Week 16	8.700 μg/mL Geometric Coefficient of Variation 53.7
Plasma Concentration of Bimekizumab During the Study Week 28	9.285 μg/mL Geometric Coefficient of Variation 49.7
Plasma Concentration of Bimekizumab During the Study Week 40	9.238 μg/mL Geometric Coefficient of Variation 51.3
Plasma Concentration of Bimekizumab During the Study Week 48/ Withdrawal	9.056 μg/mL Geometric Coefficient of Variation 52.5

SECONDARY outcome

Timeframe: Baseline of study PS0016 [NCT03025542]

Population: The Safety Set consisted of all participants who received at least 1 dose of the study medication in PS0018.

For a given visit / time point, an Anti-BKZ status of positive was concluded for any participant with an anti-drug antibody (ADA) level that was above cut point (ACP) and CP at that visit/ time point. A participant was classified as overall positive if at least one PS0018 measurement is ACP and CP (this included participants who had negative results at PS0016 Baseline). Percentages were based on the number of participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants With Positive Anti-bimekizumab (BZK) Antibody Levels Prior to Study Treatment	2.3 percentage of participants

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Safety Set consisted of all participants who received at least 1 dose of the study medication in PS0018. The number of participants analyzed reflects participants with a non-missing measurement.

For a given visit / time point, an Anti-BKZ status of positive was concluded for any participant with an anti-drug antibody (ADA) level that was above cut point (ACP) and CP at that visit/ time point. A participant was classified as overall positive if at least one PS0018 measurement is ACP and CP (this included participants who had negative results at PS0016 Baseline). Percentages were based on the number of participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=39 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants With Overall Positive Anti-bimekizumab (BZK) Antibody Levels Following Study Treatment	25.6 percentage of participants

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and had a valid efficacy measurement for PASI at Baseline of PS0018.

The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed the average redness, thickness, and scaliness of lesions in each body area (each on a 5 - point scale); 0 = none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. The PASI50 responses were based on at least 50% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study PS0018 Week 0	60.5 percentage of participants Interval 45.6 to 73.6
Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 4	95.3 percentage of participants Interval 84.5 to 98.7
Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 8	95.3 percentage of participants Interval 84.5 to 98.7
Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 12	95.3 percentage of participants Interval 84.5 to 98.7
Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 16	97.7 percentage of participants Interval 87.9 to 99.6
Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 20	95.3 percentage of participants Interval 84.5 to 98.7
Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 24	93.0 percentage of participants Interval 81.4 to 97.6
Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 28	93.0 percentage of participants Interval 81.4 to 97.6
Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 32	90.7 percentage of participants Interval 78.4 to 96.3
Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 36	90.7 percentage of participants Interval 78.4 to 96.3
Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 40	88.4 percentage of participants Interval 75.5 to 94.9
Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 44	90.7 percentage of participants Interval 78.4 to 96.3
Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 48/ Withdrawal	88.4 percentage of participants Interval 75.5 to 94.9
Percentage of Participants Achieving a 50% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Follow-Up	79.1 percentage of participants Interval 64.8 to 88.6

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and had a valid efficacy measurement for PASI at Baseline of PS0018.

The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed the average redness, thickness, and scaliness of lesions in each body area (each on a 5 - point scale); 0 = none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. The PASI75 responses were based on at least 75% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study PS0018 Week 0	44.2 percentage of participants Interval 30.4 to 58.9
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 4	88.4 percentage of participants Interval 75.5 to 94.9
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 8	95.3 percentage of participants Interval 84.5 to 98.7
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 12	90.7 percentage of participants Interval 78.4 to 96.3
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 16	93.0 percentage of participants Interval 81.4 to 97.6
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 20	90.7 percentage of participants Interval 78.4 to 96.3
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 24	90.7 percentage of participants Interval 78.4 to 96.3
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 28	88.4 percentage of participants Interval 75.5 to 94.9
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 32	90.7 percentage of participants Interval 78.4 to 96.3
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 36	90.7 percentage of participants Interval 78.4 to 96.3
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 40	86.0 percentage of participants Interval 72.7 to 93.4
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 44	90.7 percentage of participants Interval 78.4 to 96.3
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 48/ Withdrawal	86.0 percentage of participants Interval 72.7 to 93.4
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Follow-Up	65.1 percentage of participants Interval 50.2 to 77.6

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and had a valid efficacy measurement for PASI at Baseline of PS0018.

The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed the average redness, thickness, and scaliness of lesions in each body area (each on a 5 - point scale); 0 = none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. The PASI90 responses were based on at least 90% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study PS0018 Week 0	20.9 percentage of participants Interval 11.4 to 35.2
Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 4	53.5 percentage of participants Interval 38.9 to 67.5
Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 8	79.1 percentage of participants Interval 64.8 to 88.6
Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 12	79.1 percentage of participants Interval 64.8 to 88.6
Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 16	86.0 percentage of participants Interval 72.7 to 93.4
Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 20	79.1 percentage of participants Interval 64.8 to 88.6
Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 24	79.1 percentage of participants Interval 64.8 to 88.6
Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 28	81.4 percentage of participants Interval 67.4 to 90.3
Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 32	81.4 percentage of participants Interval 67.4 to 90.3
Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 36	86.0 percentage of participants Interval 72.7 to 93.4
Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 40	76.7 percentage of participants Interval 62.3 to 86.8
Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 44	86.0 percentage of participants Interval 72.7 to 93.4
Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 48/ Withdrawal	79.1 percentage of participants Interval 64.8 to 88.6
Percentage of Participants Achieving a 90% or Higher Improvement in Psoriasis Area and Severity Index (PASI) During the Study Follow-Up	58.1 percentage of participants Interval 43.3 to 71.6

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and had a valid efficacy measurement for PASI at Baseline of PS0018.

The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The degree of involvement is estimated across 4 body areas; head, upper limbs, trunk, and lower limbs and then transferred into a grade. The Investigator assessed the average redness, thickness, and scaliness of lesions in each body area (each on a 5 - point scale); 0 = none, 1 = slight, 2 = moderate, 3 = marked, and 4 = very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. The PASI100 responses were based on 100% improvement in the PASI score at the Baseline of PS0016. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study PS0018 Week 0	4.7 percentage of participants Interval 1.3 to 15.5
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 4	23.3 percentage of participants Interval 13.2 to 37.7
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 8	37.2 percentage of participants Interval 24.4 to 52.1
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 12	46.5 percentage of participants Interval 32.5 to 61.1
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 16	39.5 percentage of participants Interval 26.4 to 54.4
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 20	48.8 percentage of participants Interval 34.6 to 63.2
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 24	41.9 percentage of participants Interval 28.4 to 56.7
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 28	46.5 percentage of participants Interval 32.5 to 61.1
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 32	41.9 percentage of participants Interval 28.4 to 56.7
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 36	41.9 percentage of participants Interval 28.4 to 56.7
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 40	46.5 percentage of participants Interval 32.5 to 61.1
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 44	46.5 percentage of participants Interval 32.5 to 61.1
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study Week 48/ Withdrawal	46.5 percentage of participants Interval 32.5 to 61.1
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI) During the Study Follow-Up	18.6 percentage of participants Interval 9.7 to 32.6

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0=Clear to 4=Severe. The response was defined as clear \[0\] or almost clear \[1\] with at least 2 category improvement from PS0016 Baseline. Clear was defined as no signs of PSO; post-inflammatory hyperpigmentation may be present. Almost clear was defined as no thickening; normal to pink coloration; no to minimal focal scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants With Investigator´s Global Assessment (IGA) Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) During the Study PS0018 Week 0	18.6 percentage of participants Interval 9.7 to 32.6
Percentage of Participants With Investigator´s Global Assessment (IGA) Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) During the Study Week 4	62.8 percentage of participants Interval 47.9 to 75.6
Percentage of Participants With Investigator´s Global Assessment (IGA) Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) During the Study Week 8	79.1 percentage of participants Interval 64.8 to 88.6
Percentage of Participants With Investigator´s Global Assessment (IGA) Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) During the Study Week 12	79.1 percentage of participants Interval 64.8 to 88.6
Percentage of Participants With Investigator´s Global Assessment (IGA) Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) During the Study Week 16	81.4 percentage of participants Interval 67.4 to 90.3
Percentage of Participants With Investigator´s Global Assessment (IGA) Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) During the Study Week 20	79.1 percentage of participants Interval 64.8 to 88.6
Percentage of Participants With Investigator´s Global Assessment (IGA) Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) During the Study Week 24	76.7 percentage of participants Interval 62.3 to 86.8
Percentage of Participants With Investigator´s Global Assessment (IGA) Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) During the Study Week 28	79.1 percentage of participants Interval 64.8 to 88.6
Percentage of Participants With Investigator´s Global Assessment (IGA) Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) During the Study Week 32	86.0 percentage of participants Interval 72.7 to 93.4
Percentage of Participants With Investigator´s Global Assessment (IGA) Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) During the Study Week 36	81.4 percentage of participants Interval 67.4 to 90.3
Percentage of Participants With Investigator´s Global Assessment (IGA) Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) During the Study Week 40	79.1 percentage of participants Interval 64.8 to 88.6
Percentage of Participants With Investigator´s Global Assessment (IGA) Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) During the Study Week 44	83.7 percentage of participants Interval 70.0 to 91.9
Percentage of Participants With Investigator´s Global Assessment (IGA) Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) During the Study Week 48/ Withdrawal	79.1 percentage of participants Interval 64.8 to 88.6
Percentage of Participants With Investigator´s Global Assessment (IGA) Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) During the Study Follow-Up	51.2 percentage of participants Interval 36.8 to 65.4

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

The total PASI score ranges from 0 to 72 with a reduction from PS0016 Baseline indicating improvement. Missing data was imputed using Last observation carried forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study PS0018 Week 0	-11.21 score on a scale Standard Deviation 9.13
Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 4	-16.79 score on a scale Standard Deviation 6.72
Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 8	-18.12 score on a scale Standard Deviation 7.41
Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 12	-18.70 score on a scale Standard Deviation 7.89
Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 16	-19.01 score on a scale Standard Deviation 8.70
Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 20	-18.91 score on a scale Standard Deviation 8.70
Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 24	-19.08 score on a scale Standard Deviation 8.66
Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 28	-19.13 score on a scale Standard Deviation 8.79
Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 32	-19.30 score on a scale Standard Deviation 8.66
Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 36	-19.27 score on a scale Standard Deviation 8.68
Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 40	-19.22 score on a scale Standard Deviation 8.82
Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 44	-19.32 score on a scale Standard Deviation 8.68
Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 48/ Withdrawal	-19.20 score on a scale Standard Deviation 8.76
Mean Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Follow-up	-15.93 score on a scale Standard Deviation 9.29

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

A negative percentage change from PS0016 baseline indicated improvement in Total PASI score. The total PASI score ranges from 0 to 72 with a reduction from PS0016 Baseline indicating improvement. Missing data was imputed using Last Observation Carried Forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study PS0018 Week 0	-56.45 percentage change Standard Deviation 38.26
Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 4	-87.71 percentage change Standard Deviation 15.52
Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 8	-93.28 percentage change Standard Deviation 12.13
Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 12	-94.50 percentage change Standard Deviation 8.22
Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 16	-95.15 percentage change Standard Deviation 8.43
Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 20	-94.84 percentage change Standard Deviation 9.02
Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 24	-95.69 percentage change Standard Deviation 6.77
Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 28	-95.72 percentage change Standard Deviation 7.35
Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 32	-96.85 percentage change Standard Deviation 4.81
Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 36	-96.66 percentage change Standard Deviation 4.88
Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 40	-96.13 percentage change Standard Deviation 6.38
Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 44	-96.98 percentage change Standard Deviation 4.14
Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Week 48/ Withdrawal	-96.10 percentage change Standard Deviation 7.45
Mean Percentage Change From PS0016 [NCT03025542] Baseline in PASI Score During the Study Follow-Up	-81.98 percentage change Standard Deviation 25.45

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Clear IGA was defined as no signs of PSO; post-inflammatory hyperpigmentation may be present. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study PS0018 Week 0	4.7 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 4	23.3 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 8	37.2 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 12	44.2 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 16	34.9 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 20	41.9 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 24	37.2 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 28	39.5 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 32	37.2 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 36	37.2 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 40	37.2 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 44	37.2 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 48/ Withdrawal	39.5 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Follow-Up	18.6 percentage of participants

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Almost clear was defined as no thickening; normal to pink coloration; no to minimal focal scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study PS0018 Week 0	11.6 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 4	37.2 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 8	32.6 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 12	23.3 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 16	37.2 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 20	23.3 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 24	30.2 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 28	30.2 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 32	37.2 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 36	30.2 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 40	27.9 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 44	32.6 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 48/ Withdrawal	25.6 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Follow-Up	30.2 percentage of participants

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Mild was defined as just detectable to mild thickening; pink to light red coloration; predominately fine scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study PS0018 Week 0	25.6 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 4	18.6 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 8	14.0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 12	11.6 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 16	9.3 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 20	14.0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 24	9.3 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 28	7.0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 32	2.3 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 36	9.3 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 40	9.3 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 44	2.3 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 48/ Withdrawal	7.0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Follow-Up	11.6 percentage of participants

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 36	0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study PS0018 Week 0	25.6 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 4	4.7 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 8	0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 12	2.3 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 16	2.3 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 20	2.3 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 24	2.3 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 28	2.3 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 32	0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 40	2.3 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 44	4.7 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 48/ Withdrawal	4.7 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Follow-Up	11.6 percentage of participants

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Moderate IGA was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Severe was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study PS0018 Week 0	16.3 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 4	0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 8	0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 12	0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 16	0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 20	0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 24	0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 28	0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 32	0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 36	0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 40	0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 44	0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 48/ Withdrawal	0 percentage of participants
Percentage of Participants Who Shifted From Moderate Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Follow-Up	4.7 percentage of participants

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Clear was defined as no signs of PSO; post-inflammatory hyperpigmentation may be present. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study PS0018 Week 0	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 4	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 8	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 12	2.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 16	4.7 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 20	7.0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 24	4.7 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 28	7.0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 32	4.7 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 36	7.0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 40	11.6 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 44	9.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Week 48/ Withdrawal	9.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Clear IGA Score During the Study Follow-Up	0 percentage of participants

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Almost clear was defined as no thickening; normal to pink coloration; no to minimal focal scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study PS0018 Week 0	2.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 4	2.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 8	9.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 12	9.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 16	4.7 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 20	7.0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 24	4.7 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 28	2.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 32	7.0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 36	7.0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 40	2.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 44	4.7 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Week 48/ Withdrawal	4.7 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Almost Clear IGA Score During the Study Follow-Up	2.3 percentage of participants

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Mild was defined as just detectable to mild thickening; pink to light red coloration; predominately fine scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study PS0018 Week 0	2.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 4	9.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 8	2.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 12	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 16	4.7 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 20	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 24	4.7 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 28	4.7 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 32	2.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 36	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 40	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 44	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Week 48/ Withdrawal	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Mild IGA Score During the Study Follow-Up	7.0 percentage of participants

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Moderate was defined as clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study PS0018 Week 0	2.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 4	2.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 8	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 12	2.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 16	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 20	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 24	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 28	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 32	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 36	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 40	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 44	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Week 48/ Withdrawal	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Moderate IGA Score During the Study Follow-Up	2.3 percentage of participants

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

A static IGA for Psoriasis (PSO) was used to assess disease severity in all study participants during the study. IGA is a 5 point scale ranging from 0 = Clear to 4 = Severe. Severe IGA was defined as severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study PS0018 Week 0	9.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 4	2.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 8	2.3 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 12	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 16	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 20	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 24	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 28	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 32	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 36	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 40	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 44	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Week 48/ Withdrawal	0 percentage of participants
Percentage of Participants Who Shifted From Severe Investigator´s Global Assessment (IGA) Score at PS0016 [NCT03025542] Baseline to Severe IGA Score During the Study Follow-Up	2.3 percentage of participants

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

The BSA palm method was used for the evaluation of BSA as follows: Body surface area estimation used the palm (study participant's flat hand and thumb together, fingers included) as representing around 1% of the total BSA. Missing data was imputed using Last Observation Carried forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study PS0016 Baseline	25.8 percentage of BSA Standard Deviation 17.5
Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study PS0018 Week 0	8.6 percentage of BSA Standard Deviation 10.7
Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 4	5.2 percentage of BSA Standard Deviation 12.6
Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 8	3.0 percentage of BSA Standard Deviation 10.9
Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 12	2.0 percentage of BSA Standard Deviation 4.8
Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 16	1.0 percentage of BSA Standard Deviation 1.6
Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 20	1.2 percentage of BSA Standard Deviation 2.2
Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 24	1.2 percentage of BSA Standard Deviation 1.9
Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 28	0.9 percentage of BSA Standard Deviation 1.6
Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 32	0.8 percentage of BSA Standard Deviation 1.1
Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 36	0.7 percentage of BSA Standard Deviation 1.1
Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 40	0.8 percentage of BSA Standard Deviation 1.2
Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 44	0.7 percentage of BSA Standard Deviation 1.0
Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 48/ Withdrawal	0.7 percentage of BSA Standard Deviation 1.2
Mean Percentage in the Body Surface Area (BSA) Affected by Psoriasis During the Study Follow-Up	4.8 percentage of BSA Standard Deviation 13.0

SECONDARY outcome

Timeframe: From Baseline of study PS0016 [NCT03025542] until Safety Follow Up Visit (up to Week 64) of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

The percentage BSA (0 to 100%) affected by PSO was listed by PS0016 randomized treatment, by study participant and visit including the percentage change from PS0016 Baseline. The BSA palm method was used for the evaluation of BSA as follows: Body surface area estimation used the palm (study participant's flat hand and thumb together, fingers included) as representing around 1% of the total BSA. Missing data was imputed using Last observation carried forward (LOCF) at all visits. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study PS0018 Week 0	-61.0 percentage change Standard Deviation 41.5
Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 4	-83.0 percentage change Standard Deviation 23.7
Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 8	-91.1 percentage change Standard Deviation 15.9
Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 12	-92.9 percentage change Standard Deviation 10.9
Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 16	-95.5 percentage change Standard Deviation 7.4
Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 20	-94.4 percentage change Standard Deviation 9.1
Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 24	-94.8 percentage change Standard Deviation 7.8
Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 28	-95.4 percentage change Standard Deviation 8.7
Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 32	-96.1 percentage change Standard Deviation 6.7
Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 36	-96.5 percentage change Standard Deviation 5.7
Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 40	-95.8 percentage change Standard Deviation 8.5
Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 44	-96.3 percentage change Standard Deviation 6.2
Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study Week 48/ Withdrawal	-95.6 percentage change Standard Deviation 10.0
Mean Percentage Change From PS0016 [NCT03025542] Baseline in the Body Surface Area (BSA) Affected by Psoriasis During the Study Follow-Up	-81.5 percentage change Standard Deviation 33.9

SECONDARY outcome

Timeframe: Week 0, 12, 24, 36, and 48 of study PS0018, Relative to Baseline of study PS0016 [NCT03025542]

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

HADS-A score is the sum of the 7 individual scores in the anxiety domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal whereas a score of 15 and above was considered severe. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Score During the Study PS0018 Week 0	-1.5 score on a scale Standard Deviation 2.3
Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Score During the Study Week 12	-2.0 score on a scale Standard Deviation 1.8
Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Score During the Study Week 24	-2.0 score on a scale Standard Deviation 2.4
Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Score During the Study Week 36	-2.0 score on a scale Standard Deviation 2.4
Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Score During the Study Week 48/ Withdrawal	-1.5 score on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Week 0, 12, 24, 36, and 48 of study PS0018, Relative to Baseline of study PS0016 [NCT03025542]

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018.

HADS-D score is the sum of the 7 individual scores in the depression domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal whereas a score of 15 and above was considered severe. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Score During the Study Week 12	-0.8 score on a scale Standard Deviation 2.1
Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Score During the Study Week 24	-1.0 score on a scale Standard Deviation 1.7
Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Score During the Study Week 36	-1.1 score on a scale Standard Deviation 1.7
Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Score During the Study Week 48/ Withdrawal	-1.0 score on a scale Standard Deviation 1.8
Mean Change From PS0016 [NCT03025542] Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Score During the Study PS0018 Week 0	-1.0 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline of study PS0016 [NCT03025542], Week 0, 12, 24, 36, and 48 of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018. Here, 'number analyzed' signifies participants who were evaluable at specified time points.

HADS-A score is the sum of the 7 individual scores in the anxiety domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal. Percentages were based on the number of participants with a non-missing measurement at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants With Scores Below 8 in HADS-A (Participants With Normal Scores) During the Study PS0016 Baseline	83.7 percentage of participants
Percentage of Participants With Scores Below 8 in HADS-A (Participants With Normal Scores) During the Study PS0018 Week 0	88.4 percentage of participants
Percentage of Participants With Scores Below 8 in HADS-A (Participants With Normal Scores) During the Study Week 12	95.2 percentage of participants
Percentage of Participants With Scores Below 8 in HADS-A (Participants With Normal Scores) During the Study Week 24	90.5 percentage of participants
Percentage of Participants With Scores Below 8 in HADS-A (Participants With Normal Scores) During the Study Week 36	89.7 percentage of participants
Percentage of Participants With Scores Below 8 in HADS-A (Participants With Normal Scores) During the Study Week 48/ Withdrawal	87.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline of study PS0016 [NCT03025542], Week 0, 12, 24, 36, and 48 of study PS0018

Population: The Full Analysis Set consisted of all enrolled participants who received at least 1 dose of the study medication and have a valid efficacy measurement for PASI at Baseline of PS0018. Here, 'number analyzed' signifies participants who were evaluable at specified time points.

HADS-D score is the sum of the 7 individual scores in the depression domain and ranges from 0 to 21 with higher scores indicating worse state. A score below 8 was considered normal. Percentages were based on the number of participants with a non-missing measurement at the visit. Baseline was defined as the last available value prior to the first injection of study medication in the PS0016 study.

Outcome measures

Outcome measures
Measure	BKZ All Participants (SS) n=43 Participants Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Percentage of Participants With Scores Below 8 in HADS-D (Participants With Normal Scores) During the Study PS0016 Baseline	93.0 percentage of participants
Percentage of Participants With Scores Below 8 in HADS-D (Participants With Normal Scores) During the Study PS0018 Week 0	97.7 percentage of participants
Percentage of Participants With Scores Below 8 in HADS-D (Participants With Normal Scores) During the Study Week 12	95.2 percentage of participants
Percentage of Participants With Scores Below 8 in HADS-D (Participants With Normal Scores) During the Study Week 24	97.6 percentage of participants
Percentage of Participants With Scores Below 8 in HADS-D (Participants With Normal Scores) During the Study Week 36	94.9 percentage of participants
Percentage of Participants With Scores Below 8 in HADS-D (Participants With Normal Scores) During the Study Week 48/ Withdrawal	97.4 percentage of participants

Adverse Events

BKZ All Participants (SS)

Serious events: 3 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BKZ All Participants (SS) n=43 participants at risk Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Cardiac disorders Acute myocardial infarction	2.3% 1/43 • Number of events 1 • Adverse events were collected from the PS0018 Baseline until the Safety Follow-Up Visit [20 weeks after the last dose (up to Week 64)]
Injury, poisoning and procedural complications Anaemia postoperative	2.3% 1/43 • Number of events 1 • Adverse events were collected from the PS0018 Baseline until the Safety Follow-Up Visit [20 weeks after the last dose (up to Week 64)]
Nervous system disorders Syncope	2.3% 1/43 • Number of events 1 • Adverse events were collected from the PS0018 Baseline until the Safety Follow-Up Visit [20 weeks after the last dose (up to Week 64)]

Other adverse events

Other adverse events
Measure	BKZ All Participants (SS) n=43 participants at risk Participants received BKZ 160 mg Q4W sc during the 48-week Open Label Treatment Period. The Investigator could increase the dose to BKZ 320mg Q4W if the participant's PASI response was \>= 50% to \< 75% reduction from the Baseline of PS0016 at Week 12 or later. If the participant's disease was adequately controlled on BKZ 320 mg Q4W, they could return to BKZ 160 mg Q4W at the discretion of the Investigator. Participants formed the Safety Set (SS).
Infections and infestations Upper respiratory tract infection	18.6% 8/43 • Number of events 12 • Adverse events were collected from the PS0018 Baseline until the Safety Follow-Up Visit [20 weeks after the last dose (up to Week 64)]
Infections and infestations Nasopharyngitis	16.3% 7/43 • Number of events 10 • Adverse events were collected from the PS0018 Baseline until the Safety Follow-Up Visit [20 weeks after the last dose (up to Week 64)]
Infections and infestations Viral upper respiratory tract infection	11.6% 5/43 • Number of events 6 • Adverse events were collected from the PS0018 Baseline until the Safety Follow-Up Visit [20 weeks after the last dose (up to Week 64)]
Infections and infestations Oral candidiasis	9.3% 4/43 • Number of events 6 • Adverse events were collected from the PS0018 Baseline until the Safety Follow-Up Visit [20 weeks after the last dose (up to Week 64)]
Infections and infestations Pharyngitis	7.0% 3/43 • Number of events 3 • Adverse events were collected from the PS0018 Baseline until the Safety Follow-Up Visit [20 weeks after the last dose (up to Week 64)]
Infections and infestations Staphylococcal pharyngitis	7.0% 3/43 • Number of events 3 • Adverse events were collected from the PS0018 Baseline until the Safety Follow-Up Visit [20 weeks after the last dose (up to Week 64)]
Investigations Gamma-glutamyltransferase increased	11.6% 5/43 • Number of events 7 • Adverse events were collected from the PS0018 Baseline until the Safety Follow-Up Visit [20 weeks after the last dose (up to Week 64)]
Investigations Alanine aminotransferase increased	9.3% 4/43 • Number of events 5 • Adverse events were collected from the PS0018 Baseline until the Safety Follow-Up Visit [20 weeks after the last dose (up to Week 64)]

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