Trial Outcomes & Findings for MSB11022 in Moderate to Severe Chronic Plaque Psoriasis (NCT NCT02660580)

NCT ID: NCT02660580

Last Updated: 2023-12-27

Results Overview

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI-75 response is defined as the percentage of participants who achieved at least a 75% improvement in PASI score from Baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 443 participants
• Primary outcome timeframe: Week 16
• Results posted on: 2023-12-27

Participant Flow

Participants were randomized to either MSB11022 or EU-Humira in Core Treatment Period till Week 16. Participants who achieved PASI50 at Week 16 entered Extension Period where participants in MSB11022 were continued to receive MSB11022 & participants in EU-Humira were re-randomized to receive either MSB11022 or EU-Humira for additional 37 weeks.

Participant milestones

Measure	MSB11022 (Core Treatment Period) Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	EU-Humira Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Core Treatment Period (Week 1 to 16) STARTED	222	221	0	0	0
Core Treatment Period (Week 1 to 16) Treated	221	220	0	0	0
Core Treatment Period (Week 1 to 16) COMPLETED	213	202	0	0	0
Core Treatment Period (Week 1 to 16) NOT COMPLETED	9	19	0	0	0
Extended Treatment Period(Week 16 to 52) STARTED	0	0	213	101	101
Extended Treatment Period(Week 16 to 52) COMPLETED	0	0	195	90	90
Extended Treatment Period(Week 16 to 52) NOT COMPLETED	0	0	18	11	11

Reasons for withdrawal

Measure	MSB11022 (Core Treatment Period) Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	EU-Humira Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Core Treatment Period (Week 1 to 16) Randomized, not treated	1	1	0	0	0
Core Treatment Period (Week 1 to 16) Protocol Violation	3	1	0	0	0
Core Treatment Period (Week 1 to 16) Other un-specified	1	0	0	0	0
Core Treatment Period (Week 1 to 16) Lack of Efficacy	0	2	0	0	0
Core Treatment Period (Week 1 to 16) Adverse Event	2	9	0	0	0
Core Treatment Period (Week 1 to 16) Withdrawal by Subject	1	4	0	0	0
Core Treatment Period (Week 1 to 16) Lost to Follow-up	1	2	0	0	0
Extended Treatment Period(Week 16 to 52) Protocol Violation	0	0	2	0	1
Extended Treatment Period(Week 16 to 52) Other un-specified	0	0	1	0	1
Extended Treatment Period(Week 16 to 52) Lack of Efficacy	0	0	4	2	2
Extended Treatment Period(Week 16 to 52) Adverse Event	0	0	8	6	4
Extended Treatment Period(Week 16 to 52) Withdrawal by Subject	0	0	3	2	2
Extended Treatment Period(Week 16 to 52) Lost to Follow-up	0	0	0	1	1

Baseline Characteristics

MSB11022 in Moderate to Severe Chronic Plaque Psoriasis

Baseline characteristics by cohort

Measure	MSB11022 (Core Treatment Period) n=222 Participants Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	EU-Humira n=221 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	Total n=443 Participants Total of all reporting groups
Age, Continuous	44.5 years STANDARD_DEVIATION 12.8 • n=93 Participants	42.7 years STANDARD_DEVIATION 12.0 • n=4 Participants	43.6 years STANDARD_DEVIATION 12.5 • n=27 Participants
Sex: Female, Male Female	75 Participants n=93 Participants	73 Participants n=4 Participants	148 Participants n=27 Participants
Sex: Female, Male Male	147 Participants n=93 Participants	148 Participants n=4 Participants	295 Participants n=27 Participants
Race White	205 Participants n=93 Participants	200 Participants n=4 Participants	405 Participants n=27 Participants
Race Black or African American	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race Asian	5 Participants n=93 Participants	9 Participants n=4 Participants	14 Participants n=27 Participants
Race American Indian or Alaska Native	10 Participants n=93 Participants	8 Participants n=4 Participants	18 Participants n=27 Participants
Race Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race Other	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race Missing/Not collected at this site	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity Hispanic or Latino	23 Participants n=93 Participants	23 Participants n=4 Participants	46 Participants n=27 Participants
Ethnicity Not Hispanic or Latino	199 Participants n=93 Participants	196 Participants n=4 Participants	395 Participants n=27 Participants
Ethnicity Missing	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants

PRIMARY outcome

Timeframe: Week 16

Population: The per-protocol (PP) Analysis Set included all randomized and treated participants who did not have any major protocol deviations during the Core Treatment Period with respect to factors likely to affect the efficacy of treatment.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI-75 response is defined as the percentage of participants who achieved at least a 75% improvement in PASI score from Baseline.

Outcome measures

Measure	EU-Humira n=191 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=203 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI 75) at Week 16	91.6 Percentage of Participants	89.7 Percentage of Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 of Core Treatment Period), Week 16

Population: The PP Analysis set was used.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Percent change from Baseline in PASI score was reported.

Outcome measures

Measure	EU-Humira n=191 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=203 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Percent Change From Baseline in PASI at Week 16	-91.7 Percent change Standard Deviation 9.9 • Interval 9.9 to	-90.6 Percent change Standard Deviation 11.3 • Interval 11.3 to	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: PP analysis set was used.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI 50, 90 and 100 response rate at Week 16 is measured as the percentage of participants who achieved at least 50, 90 and 100% improvement from baseline PASI score at Week 16.

Outcome measures

Measure	EU-Humira n=191 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=203 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16 PASI 50	100.0 Percentage of Participants	100.0 Percentage of Participants	—	—	—
Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16 PASI 90	66.0 Percentage of Participants	64.0 Percentage of Participants	—	—	—
Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16 PASI 100	37.2 Percentage of Participants	33.0 Percentage of Participants	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: The Extended Treatment Period (ETP)-PP Analysis Set included participants who were in PP Analysis Set \& were re-randomized \& received treatment in Extended Treatment Period. Here "Number of participants analyzed" signifies those who were evaluable for this outcome measure.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI response rate at Week 24 is measured as the percentage of participants who achieved at least 50, 75, 90 and 100% improvement from baseline PASI at Week 24.

Outcome measures

Measure	EU-Humira n=94 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=200 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=92 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 PASI 50	98.9 Percentage of Participants	100.0 Percentage of Participants	100.0 Percentage of Participants	—	—
Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 PASI 90	78.7 Percentage of Participants	74.0 Percentage of Participants	80.4 Percentage of Participants	—	—
Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 PASI 75	88.3 Percentage of Participants	92.5 Percentage of Participants	94.6 Percentage of Participants	—	—
Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 PASI 100	37.2 Percentage of Participants	42.5 Percentage of Participants	35.9 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Week 52

Population: The ETP-PP Analysis Set was used. Here "Number of participants analyzed" signifies those who were evaluable for this outcome measure.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI response rate at Week 52 is measured as the percentage of participants who achieved at least 50, 75, 90 and 100% improvement from baseline PASI at Week 52.

Outcome measures

Measure	EU-Humira n=85 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=186 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=87 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 PASI 50	100.0 Percentage of Participants	97.8 Percentage of Participants	100.0 Percentage of Participants	—	—
Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 PASI 75	92.9 Percentage of Participants	90.9 Percentage of Participants	93.1 Percentage of Participants	—	—
Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 PASI 90	78.8 Percentage of Participants	76.3 Percentage of Participants	85.1 Percentage of Participants	—	—
Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 PASI 100	54.1 Percentage of Participants	53.8 Percentage of Participants	57.5 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 of Extended Treatment Period), Weeks 24 and 52

Population: The ETP-PP analysis set was used. Here "Number analyzed" Signifies those participants who were evaluable for this outcome measure at specified time points.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity.

Outcome measures

Measure	EU-Humira n=95 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=203 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=96 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Percent Change From Baseline in PASI at Week 24 and 52 Week 24	-91.3 Percent change Standard Deviation 12.7	-92.9 Percent change Standard Deviation 9.9	-94.2 Percent change Standard Deviation 8.2	—	—
Percent Change From Baseline in PASI at Week 24 and 52 Week 52	-93.9 Percent change Standard Deviation 9.6	-92.8 Percent change Standard Deviation 13.6	-94.8 Percent change Standard Deviation 9.7	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 of Core Treatment Period), Week 16

Population: PP Analysis set was used. Number of participants with PGA response of Clear or Almost clear at Week 16 were presented.

PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates Clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates Mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates Moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates Severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).

Outcome measures

Measure	EU-Humira n=191 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=203 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 16 Baseline: Moderate; Week 16: Almost clear	59 Participants	76 Participants	—	—	—
Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 16 Baseline: Severe; Week 16: Clear	20 Participants	16 Participants	—	—	—
Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 16 Baseline: Moderate; Week 16: Clear	51 Participants	52 Participants	—	—	—
Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 16 Baseline: Severe; Week 16: Almost clear	26 Participants	27 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 of Extended Treatment Period), Week 24 and 52

Population: ETP-PP Analysis set was used. Here "Number analyzed" indicates number of participants who were evaluable for this outcome measure at specified category. Number of participants with PGA response of Clear or Almost clear at Week 24 and 52 were presented.

PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).

Outcome measures

Measure	EU-Humira n=95 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=203 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=96 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 24 and 52 Baseline: Moderate; Week 24: Clear	25 Participants	69 Participants	25 Participants	—	—
Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 24 and 52 Baseline: Severe; Week 24: Almost Clear	14 Participants	27 Participants	13 Participants	—	—
Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 24 and 52 Baseline: Moderate; Week 52: Clear	29 Participants	74 Participants	34 Participants	—	—
Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 24 and 52 Baseline: Severe; Week 52: Almost Clear	6 Participants	15 Participants	6 Participants	—	—
Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 24 and 52 Baseline: Moderate; Week 24: AlmostClear	24 Participants	52 Participants	31 Participants	—	—
Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 24 and 52 Baseline: Severe; Week 24: Clear	11 Participants	18 Participants	9 Participants	—	—
Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 24 and 52 Baseline: Moderate; Week 52: AlmostClear	13 Participants	40 Participants	16 Participants	—	—
Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 24 and 52 Baseline: Severe; Week 52: Clear	17 Participants	29 Participants	16 Participants	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 of Core Treatment Period) up to Month 4

Population: PP analysis set was used.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 50% improvement in PASI from baseline was measured.

Outcome measures

Measure	EU-Humira n=191 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=203 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Time to Achieve PASI 50	1.6 Months Full Range 0.2 • Interval 0.2 to 3.5	1.6 Months Full Range 0.2 • Interval 0.2 to 3.7	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 of Core Treatment Period) up to Month 4

Population: PP analysis set was used.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 75% improvement in PASI from baseline was measured.

Outcome measures

Measure	EU-Humira n=191 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=203 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Time to Achieve PASI 75	1.7 Months Full Range 0.7 • Interval 0.7 to 3.7	2.5 Months Full Range 0.2 • Interval 0.2 to 3.5	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 of Core Treatment Period) up to Month 4

Population: PP analysis set was used.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 90% improvement in PASI from baseline was measured.

Outcome measures

Measure	EU-Humira n=191 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=203 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Time to Achieve PASI 90	2.6 Months Full Range 1.4 • Interval 1.4 to 3.7	3.4 Months Full Range 0.7 • Interval 0.7 to 3.5	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 of Core Treatment Period) up to Month 13.5

Population: ETP-PP analysis set was used.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 100% improvement in PASI from baseline was measured.

Outcome measures

Measure	EU-Humira n=95 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=203 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=96 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Time to Achieve PASI 100	7.2 Month Interval 1.6 to 11.8	7.2 Month Interval 0.7 to 11.8	8.9 Month Interval 1.6 to 11.8	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 of Core Treatment Period), Week 16

Population: PP Analysis set was used. Only categories for which participants recorded a PGA response were included below.

PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).

Outcome measures

Measure	EU-Humira n=191 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=203 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 Baseline- Moderate; Week 16- Moderate	1 Participants	2 Participants	—	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 Baseline- Severe; Week 16- Mild	16 Participants	12 Participants	—	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 Baseline- Moderate; Week 16- Clear	51 Participants	52 Participants	—	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 Baseline- Moderate; Week 16- Almost Clear	59 Participants	76 Participants	—	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 Baseline- Moderate; Week 16- Mild	17 Participants	16 Participants	—	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 Baseline- Severe; Week 16- Clear	20 Participants	16 Participants	—	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 Baseline- Severe; Week 16- Almost Clear	26 Participants	27 Participants	—	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 Baseline- Severe; Week 16- Moderate	1 Participants	2 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 of Extended Treatment Period), Week 24

Population: ETP-PP Analysis set was used. Only categories for which participants recorded a PGA response were included below. Here "Number of participants analyzed" signifies those who were evaluable for this outcome measure.

PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).

Outcome measures

Measure	EU-Humira n=94 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=200 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=92 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 Baseline- Severe; Week 24- Mild	6 Participants	9 Participants	6 Participants	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 Baseline- Moderate; Week 24- Clear	25 Participants	69 Participants	25 Participants	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 Baseline- Moderate; Week 24- Almost Clear	24 Participants	52 Participants	31 Participants	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 Baseline- Moderate; Week 24- Mild	10 Participants	21 Participants	7 Participants	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 Baseline- Moderate; Week 24- Moderate	2 Participants	2 Participants	0 Participants	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 Baseline- Severe; Week 24- Clear	11 Participants	18 Participants	9 Participants	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 Baseline- Severe; Week 24- Almost Clear	14 Participants	27 Participants	13 Participants	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 Baseline- Severe; Week 24- Moderate	1 Participants	2 Participants	1 Participants	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 Baseline- Severe; Week 24- Severe	1 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 of Extended Treatment Period), Week 52

Population: ETP-PP Analysis set was used. Here "Number of participants analyzed" signifies those who were evaluable for this outcome measure. Only categories for which participants recorded a PGA response were included below.

PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).

Outcome measures

Measure	EU-Humira n=85 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=188 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=87 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 Baseline- Moderate; Week 52- Moderate	0 Participants	4 Participants	4 Participants	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 Baseline- Moderate; Week 52- Missing	0 Participants	1 Participants	0 Participants	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 Baseline- Severe; Week 52- Moderate	2 Participants	3 Participants	2 Participants	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 Baseline- Moderate; Week 52- Clear	29 Participants	74 Participants	34 Participants	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 Baseline- Moderate; Week 52- Almost Clear	13 Participants	40 Participants	16 Participants	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 Baseline- Moderate; Week 52- Mild	11 Participants	17 Participants	6 Participants	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 Baseline- Severe; Week 52- Clear	17 Participants	29 Participants	16 Participants	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 Baseline- Severe; Week 52- Almost Clear	6 Participants	15 Participants	6 Participants	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 Baseline- Severe; Week 52- Mild	7 Participants	3 Participants	3 Participants	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 Baseline- Severe; Week 52- Severe	0 Participants	1 Participants	0 Participants	—	—
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 Baseline- Severe; Week 52- Missing	0 Participants	1 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 of Core Treatment Period) up to Week 16

Population: Safety (SAF) Analysis Set included all randomized participants who received at least 1 dose of MSB11022 or EU-Humira. Participants in SAF were analyzed according to actual treatment received initially during the relevant treatment period.

Adverse event(AE) was defined as any untoward medical occurrence in participants which does not necessarily have causal relationship with treatment. AE was any unfavorable and unintended sign(including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event(SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Term TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs.

Outcome measures

Measure	EU-Humira n=220 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=221 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16 Participants with TEAEs	117 Participants	114 Participants	—	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16 Participants with Serious TEAEs	6 Participants	8 Participants	—	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16 Participants with TEAEs of special interest	3 Participants	2 Participants	—	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16 Participants with TEAEs Leading to Death	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1 of Extended Treatment Period) up to Week 54

Population: ETP-SAF Analysis Set was used. Participants were analyzed according to actual treatment received initially during the relevant treatment period.

Adverse event(AE) was defined as any untoward medical occurrence in participants which does not necessarily have causal relationship with treatment. AE was any unfavorable and unintended sign(including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event(SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Term TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs.

Outcome measures

Measure	EU-Humira n=101 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=213 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=101 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54 Participants with TEAEs	65 Participants	142 Participants	63 Participants	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54 Participants with Serious TEAEs	3 Participants	12 Participants	4 Participants	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54 Participants with TEAEs of special interest	1 Participants	10 Participants	4 Participants	—	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54 Participants with TEAEs Leading to Death	1 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54

Population: Safety Analysis Set (SAF) was used for up to Week 16. The ETP-SAF was used in Extended Treatment Period.

Based on categories of low, normal, or high according to the laboratory normal ranges, there were no clinically meaningful differences across the treatment groups in the numbers of participants with shifts in Laboratory parameters including hematology, chemistry and urinalysis from normal at Core Baseline to either low or high during the overall treatment period. Clinical meaningful was determined by the investigator.

Outcome measures

Measure	EU-Humira n=213 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=221 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=220 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira n=101 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 n=101 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Number of Participants With Clinically Meaningful Differences in Laboratory Values	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 16

Population: Safety analysis set was used.

Number of participants ANA and anti-ds DNA values were reported. For ANA, positivity is defined as any participants with ANA titer greater than (>) 1:160 and negativity is defined as ANA titer less than (<) 1:160. For anti-ds DNA, positivity is defined as any participants with adsDNA > 15 units per milliliter (U/mL), intermediate category is defined as value between 10 U/mL to 15 U/mL and negativity is defined as adsDNA < 10 U/mL.

Outcome measures

Measure	EU-Humira n=220 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=221 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16 Participants with Negative ANA values	190 Participants	205 Participants	—	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16 Participants with Positive ANA values	10 Participants	6 Participants	—	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16 Participants with Negative anti-ds DNA values	186 Participants	201 Participants	—	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16 Participants with Intermediate anti-ds DNA values	5 Participants	4 Participants	—	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16 Participants with Positive anti-ds DNA values	6 Participants	4 Participants	—	—	—

SECONDARY outcome

Timeframe: Week 24, 32, 40 and 52

Population: ETP-SAF included all re-randomized participants who received at least 1 dose of MSB11022 or EU-approved Humira in ETP. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure \& "Number analyzed" signifies those participants who were evaluable for this outcome measure for specified categories.

Number of participants ANA and anti-ds DNA values were reported. For ANA, positivity is defined as any participants with ANA titer greater than (>) 1:160 and negativity is defined as ANA titer less than (<) 1:160. For anti-ds DNA, positivity is defined as any participants with adsDNA > 15 units per milliliter (U/mL), intermediate category is defined as value between 10 U/mL to 15 U/mL and negativity is defined as adsDNA < 10 U/mL.

Outcome measures

Measure	EU-Humira n=101 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=213 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=101 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 24: Negative ANA	89 Participants	188 Participants	92 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 24: Positive ANA	5 Participants	13 Participants	5 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 40: Negative anti-dsDNA	86 Participants	179 Participants	84 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 32: Positive anti-dsDNA	3 Participants	8 Participants	5 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 24: Intermediate anti-dsDNA	3 Participants	3 Participants	1 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 32: Positive ANA	3 Participants	13 Participants	7 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 52: Negative ANA	84 Participants	185 Participants	79 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 32: Negative ANA	85 Participants	186 Participants	88 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 40: Negative ANA	85 Participants	178 Participants	85 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 40: Positive ANA	6 Participants	18 Participants	7 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 52: Positive ANA	3 Participants	8 Participants	8 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 24: Negative anti-dsDNA	89 Participants	191 Participants	88 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 32: Negative anti-dsDNA	83 Participants	184 Participants	86 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 52: Negative anti-dsDNA	81 Participants	173 Participants	79 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 24: Positive anti-dsDNA	3 Participants	8 Participants	5 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 40: Positive anti-dsDNA	3 Participants	10 Participants	7 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 52: Positive anti-dsDNA	2 Participants	11 Participants	7 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 32: Intermediate anti-dsDNA	2 Participants	7 Participants	2 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 40: Intermediate anti-dsDNA	2 Participants	7 Participants	1 Participants	—	—
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 Week 52: Intermediate anti-dsDNA	4 Participants	8 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54

Population: Safety analysis set was used for Core Treatment Period. ETP-SAF was used for Extended Treatment Period.

Number of participants with clinically meaningful abnormalities in vital signs were reported. Clinical meaningful was determined by the investigator.

Outcome measures

Measure	EU-Humira n=213 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=221 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=220 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira n=101 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 n=101 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Number of Participants With Clinically Meaningful Differences in Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54

Population: Safety analysis set was used for Core Treatment Period. ETP-SAF was used for Extended Treatment Period.

Number of participants with clinically significant abnormalities in 12-ECG were reported. Clinical significance was determined by the investigator.

Outcome measures

Measure	EU-Humira n=213 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=221 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=220 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira n=101 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 n=101 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Number of Participants With Clinically Significant Abnormalities in 12-Electrocardiogram (12-ECG)	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Weeks 16

Population: PP analysis set was used.

The DLQI is a 10-item validated quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI measures how much participant's skin problems has affected his life. Responses range from 0=Not at all to 3=Very much. The DLQI total score is the sum of individual 10 items and could range from 0 to 30 (higher score indicated greater negative impact on life).

Outcome measures

Measure	EU-Humira n=191 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=203 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Dermatology Life Quality Index (DLQI) at Week 16	2.5 Units on a scale Standard Deviation 3.7 • Interval 3.7 to	2.4 Units on a scale Standard Deviation 3.2 • Interval 3.2 to	—	—	—

SECONDARY outcome

Timeframe: Week 24 and 52

Population: ETP-PP analysis set was used. Here "Number analyzed" signifies number of participants who were evaluable for this outcome measure at specified category.

The DLQI is a 10-item validated quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI measures how much participant's skin problems has affected his life. Responses range from 0=Not at all to 3=Very much. The DLQI total score is the sum of individual 10 items and could range from 0 to 30 (higher score indicated greater negative impact on life).

Outcome measures

Measure	EU-Humira n=95 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=203 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=96 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Dermatology Life Quality Index (DLQI) at Week 24 and 52 Week 24	2.3 Units on a scale Standard Deviation 4.0	2.5 Units on a scale Standard Deviation 4.1	2.3 Units on a scale Standard Deviation 3.9	—	—
Dermatology Life Quality Index (DLQI) at Week 24 and 52 Week 52	2.1 Units on a scale Standard Deviation 3.5	3.0 Units on a scale Standard Deviation 4.7	2.7 Units on a scale Standard Deviation 4.0	—	—

SECONDARY outcome

Timeframe: Week 16

Population: PP analysis set was used. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The responses are converted into a single index value, with scores ranging from -0.594 to 1 (a higher score indicates better health state).

Outcome measures

Measure	EU-Humira n=179 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=189 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 16	0.9 Units on a scale Standard Deviation 0.1 • Interval 0.1 to	0.9 Units on a scale Standard Deviation 0.1 • Interval 0.1 to	—	—	—

SECONDARY outcome

Timeframe: Week 24 and 52

Population: ETP-PP analysis set was used. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category.

The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The responses are converted into a single index value, with scores ranging from -0.594 to 1 (a higher score indicates better health state).

Outcome measures

Measure	EU-Humira n=95 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=203 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=96 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52 Week 24	0.9 Units on a scale Standard Deviation 0.1	0.8 Units on a scale Standard Deviation 0.1	0.9 Units on a scale Standard Deviation 0.1	—	—
European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52 Week 52	0.9 Units on a scale Standard Deviation 0.1	0.9 Units on a scale Standard Deviation 0.1	0.8 Units on a scale Standard Deviation 0.1	—	—

SECONDARY outcome

Timeframe: Week 16

Population: PP analysis set was used. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level on a visual analog scale, where the participant was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state.

Outcome measures

Measure	EU-Humira n=179 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=189 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on Visual Analogue Scale (VAS) Score at Week 16	83.1 Units on a scale Standard Deviation 15.0 • Interval 15.0 to	81.9 Units on a scale Standard Deviation 13.9 • Interval 13.9 to	—	—	—

SECONDARY outcome

Timeframe: Week 24 and 52

Population: ETP-PP analysis set was used. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category.

The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level on a visual analog scale, where the participant was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state.

Outcome measures

Measure	EU-Humira n=95 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=203 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=96 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52 Week 52	85.1 Units on a scale Standard Deviation 13.2	83.5 Units on a scale Standard Deviation 15.5	82.1 Units on a scale Standard Deviation 16.1	—	—
European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52 Week 24	84.2 Units on a scale Standard Deviation 13.7	83.2 Units on a scale Standard Deviation 14.2	84.3 Units on a scale Standard Deviation 13.9	—	—

SECONDARY outcome

Timeframe: Week 16

Population: PP analysis set was used. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Outcome measures

Measure	EU-Humira n=21 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=19 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 16	0.3 Units on a scale Standard Deviation 0.4 • Interval 0.4 to	0.3 Units on a scale Standard Deviation 0.4 • Interval 0.4 to	—	—	—

SECONDARY outcome

Timeframe: Week 24 and 52

Population: ETP-PP analysis set was used. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category.

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Outcome measures

Measure	EU-Humira n=95 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=203 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=96 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52 Week 24	0.2 Units on a scale Standard Deviation 0.5	0.3 Units on a scale Standard Deviation 0.4	0.4 Units on a scale Standard Deviation 0.3	—	—
Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52 Week 52	0.1 Units on a scale Standard Deviation 0.2	0.3 Units on a scale Standard Deviation 0.4	0.5 Units on a scale Standard Deviation 0.3	—	—

SECONDARY outcome

Timeframe: Week 16

Population: PP analysis set was used. Here "Number of participants analyzed" signifies participants who were evaluable for this outcome measure at specified category.

Patient global assessment for joints was measured on a 100 millimeter (mm) VAS scale, where 0 = no pain and 100 = worst possible pain.

Outcome measures

Measure	EU-Humira n=21 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=19 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 16	24.6 millimeter (mm) Standard Deviation 24.3 • Interval 24.3 to	26.9 millimeter (mm) Standard Deviation 28.3 • Interval 28.3 to	—	—	—

SECONDARY outcome

Timeframe: Week 24 and 52

Population: ETP-PP analysis set was used. Here "Number analyzed" signifies participants who were evaluable for this outcome measure at specified category.

Patient global assessment for joints was measured on a 100 millimeter (mm) VAS scale, where 0 = no pain and 100 = worst possible pain.

Outcome measures

Measure	EU-Humira n=95 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=203 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=96 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52 Week 24	20.6 mm Standard Deviation 27.1	29.7 mm Standard Deviation 25.3	24.9 mm Standard Deviation 20.5	—	—
Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52 Week 52	14.7 mm Standard Deviation 16.5	25.0 mm Standard Deviation 20.3	29.5 mm Standard Deviation 19.6	—	—

SECONDARY outcome

Timeframe: Week 16

Population: SAF analysis set was used. Here "Number of participants analyzed" signifies those who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category.

Number of participants with treatment emergent Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab were reported from baseline to week 16. Data was collected using validated bioanalytical method.

Outcome measures

Measure	EU-Humira n=202 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=213 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 16 Participants with Neutralizing Abs	70 Participants	70 Participants	—	—	—
Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 16 Participants with ADAs	179 Participants	186 Participants	—	—	—

SECONDARY outcome

Timeframe: Week 24, 32, 40 and 52

Population: ETP-SAF analysis set was used. Here "Number analyzed" signifies participants who were evaluable for this outcome measure at specified category.

Number of participants With positive treatment emergent Anti-Drug Antibodies (ADAs) and positive Neutralizing Antibodies (NAbs) to Adalimumab were reported. Data was collected using validated bioanalytical method.

Outcome measures

Measure	EU-Humira n=101 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=213 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=101 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 Week 40: ADAs	72 Participants	161 Participants	80 Participants	—	—
Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 Week 24: ADAs	89 Participants	185 Participants	90 Participants	—	—
Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 Week 32: ADAs	78 Participants	170 Participants	85 Participants	—	—
Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 Week 52: ADAs	68 Participants	162 Participants	77 Participants	—	—
Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 Week 24: NAb	42 Participants	78 Participants	39 Participants	—	—
Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 Week 32: NAb	30 Participants	67 Participants	32 Participants	—	—
Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 Week 40: NAb	29 Participants	70 Participants	28 Participants	—	—
Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 Week 52: NAb	29 Participants	63 Participants	30 Participants	—	—

SECONDARY outcome

Timeframe: Week 16

Population: SAF analysis set was used. Here "Number of Participants analyzed" signifies those who were evaluable for this outcome measure.

Anti-Drug Antibodies (ADAs) Titers for adalimumab at week 16 was reported. Data was collected using validated bioanalytical method.

Outcome measures

Measure	EU-Humira n=202 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=213 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 16	8.0 Titers Full Range 1 • Interval 1.0 to 1024.0	8.0 Titers Full Range 1 • Interval 1.0 to 2048.0	—	—	—

SECONDARY outcome

Timeframe: Week 24, 32, 40 and 52

Population: ETP-SAF analysis set was used. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified category.

Anti-Drug Antibodies (ADAs) Titers for adalimumab at Week 24, 32, 40 and 50 was reported. Data was collected using validated bioanalytical method.

Outcome measures

Measure	EU-Humira n=101 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=213 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=101 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 Week 32	16.0 Titers Interval 1.0 to 8192.0	16.0 Titers Interval 1.0 to 1024.0	16.0 Titers Interval 1.0 to 16384.0	—	—
Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 Week 40	16.0 Titers Interval 1.0 to 8192.0	16.0 Titers Interval 1.0 to 8192.0	16.0 Titers Interval 1.0 to 16384.0	—	—
Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 Week 24	16.0 Titers Interval 1.0 to 4096.0	16.0 Titers Interval 1.0 to 4096.0	16.0 Titers Interval 1.0 to 4096.0	—	—
Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 Week 52	16.0 Titers Interval 1.0 to 4096.0	8.0 Titers Interval 1.0 to 4096.0	8.0 Titers Interval 1.0 to 4096.0	—	—

SECONDARY outcome

Timeframe: Week 16

Population: The Pharmacokinetic (PK) Analysis Set included all participants in the SAF who also had at least 1 measurable post-dose concentration. Here "Number of Participants analyzed" signifies those who were evaluable for this outcome measure.

Observed serum concentrations at week 16 were reported.

Outcome measures

Measure	EU-Humira n=170 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=192 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Observed Serum Concentration at Week 16	6410 Nanogram per milliliter (ng/mL) Standard Deviation 4152 • Interval 4152.0 to	6990 Nanogram per milliliter (ng/mL) Standard Deviation 4504 • Interval 4504.0 to	—	—	—

SECONDARY outcome

Timeframe: Week 24 and 52

Population: The ETP-PK analysis included all participants in ETP SAF who had at least 1 measurable post-dose concentration in ETP, without any important protocol deviations that could have impacted quality of PK data during ETP. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

Observed serum concentrations at week 24 and 52 were reported.

Outcome measures

Measure	EU-Humira n=87 Participants Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=198 Participants Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/MSB11022 n=92 Participants Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Observed Serum Concentration at Week 24 and 52 Week 24	5870 ng/mL Standard Deviation 4516	6240 ng/mL Standard Deviation 4569	6430 ng/mL Standard Deviation 4610	—	—
Observed Serum Concentration at Week 24 and 52 Week 52	5930 ng/mL Standard Deviation 4529	6910 ng/mL Standard Deviation 5750	6600 ng/mL Standard Deviation 5394	—	—

Adverse Events

MSB11022 (Core Treatment Period)

Serious events: 8 serious events

Other events: 30 other events

Deaths: 0 deaths

EU-Humira

Serious events: 6 serious events

Other events: 34 other events

Deaths: 0 deaths

MSB11022 (Extended Treatment Period)

Serious events: 12 serious events

Other events: 59 other events

Deaths: 0 deaths

EU-Humira/EU-Humira

Serious events: 3 serious events

Other events: 32 other events

Deaths: 1 deaths

EU-Humira/MSB11022

Serious events: 4 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	MSB11022 (Core Treatment Period) n=221 participants at risk Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	EU-Humira n=220 participants at risk Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=213 participants at risk Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira n=101 participants at risk Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 n=101 participants at risk Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Blood and lymphatic system disorders Neutropenia	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.45% 1/220 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Cardiac disorders Acute myocardial infarction	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.47% 1/213 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Cardiac disorders Atrial Fibrillation	0.45% 1/221 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.47% 1/213 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Cardiac disorders Cardiac failure	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	2.0% 2/101 • Number of events 2 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Cardiac disorders Cardiomyopathy	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.47% 1/213 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Cardiac disorders Coronary artery stenosis	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.47% 1/213 • Number of events 2 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Cardiac disorders Hypertensive cardiomyopathy	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.99% 1/101 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Cardiac disorders Mitral valve incompetence	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.99% 1/101 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Cardiac disorders Myocardial infarction	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.99% 1/101 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Eye disorders Conjunctival cyst	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.99% 1/101 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Gastrointestinal disorders Inguinal hernia	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.47% 1/213 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
General disorders Hernia	0.45% 1/221 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Hepatobiliary disorders Cholecystitis chronic	0.45% 1/221 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Immune system disorders Anaphylactic shock	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.45% 1/220 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Infections and infestations Appendicitis	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.99% 1/101 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Infections and infestations Arthritis bacterial	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.45% 1/220 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Infections and infestations Peritonsillar abscess	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.47% 1/213 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Infections and infestations Pneumonia	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.99% 1/101 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Infections and infestations Respiratory tract infection viral	0.45% 1/221 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Infections and infestations Sinusitis	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.47% 1/213 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Infections and infestations Staphylococcal abscess	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.99% 1/101 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.47% 1/213 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Injury, poisoning and procedural complications Ankle fracture	0.45% 1/221 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.47% 1/213 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.47% 1/213 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Investigations Hepatic enzyme increased	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.45% 1/220 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Investigations Liver function test increased	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.45% 1/220 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.47% 1/213 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.47% 1/213 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Musculoskeletal and connective tissue disorders Osteonecrosis	0.45% 1/221 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.45% 1/220 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Nervous system disorders Brain oedema	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.99% 1/101 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Nervous system disorders Cerebral haematoma	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.99% 1/101 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Renal and urinary disorders Acute kidney injury	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.47% 1/213 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Skin and subcutaneous tissue disorders Erythema multiforme	0.45% 1/221 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Skin and subcutaneous tissue disorders Hypersensitivity vasculitis	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.47% 1/213 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Vascular disorders Hypertension	0.45% 1/221 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/213 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Vascular disorders Vascular compression	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.47% 1/213 • Number of events 1 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/101 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54

Other adverse events

Measure	MSB11022 (Core Treatment Period) n=221 participants at risk Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	EU-Humira n=220 participants at risk Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.	MSB11022 (Extended Treatment Period) n=213 participants at risk Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.	EU-Humira/EU-Humira n=101 participants at risk Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.	EU-Humira/MSB11022 n=101 participants at risk Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
General disorders Injection site erythema	5.0% 11/221 • Number of events 18 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	5.9% 13/220 • Number of events 19 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	4.2% 9/213 • Number of events 19 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	5.0% 5/101 • Number of events 25 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	5.9% 6/101 • Number of events 31 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
General disorders Injection site pain	5.0% 11/221 • Number of events 52 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	5.0% 11/220 • Number of events 28 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	5.6% 12/213 • Number of events 54 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	4.0% 4/101 • Number of events 4 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	5.0% 5/101 • Number of events 18 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Infections and infestations Nasopharyngitis	5.9% 13/221 • Number of events 13 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	6.8% 15/220 • Number of events 16 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	14.6% 31/213 • Number of events 36 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	11.9% 12/101 • Number of events 14 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	15.8% 16/101 • Number of events 16 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Infections and infestations Upper respiratory tract infection	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	5.2% 11/213 • Number of events 15 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	5.0% 5/101 • Number of events 7 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	4.0% 4/101 • Number of events 4 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/221 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	0.00% 0/220 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	5.2% 11/213 • Number of events 12 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	9.9% 10/101 • Number of events 11 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54	3.0% 3/101 • Number of events 3 • Core Treatment period: Baseline up to Week 16; Extended Treatment Period: Baseline up to Week 54

Additional Information

Eugenia Kunina, senior clinical development manager

Fresenius Kabi SwissBioSim GmbH

Phone: +41791093376

Email: clinical.development@fresenius-kabi.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER