Trial Outcomes & Findings for Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP) (NCT NCT02533375)

NCT ID: NCT02533375

Last Updated: 2019-01-14

Results Overview

Clinical Response was defined as reduction of the Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) relative to baseline (Day 1), according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical Response was defined as the improvement (reduction) of total skin score of at least 1 point (if the participant's baseline total skin score was 3); improvement (reduction) at least 2 points (if the participant's baseline total skin score was 4-9); or remission if the total skin score was 0.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 10 participants
• Primary outcome timeframe: Baseline and Week 16
• Results posted on: 2019-01-14

Participant Flow

The Full Analysis Set (FAS) included all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment.

Participant milestones

Measure	Participants Receiving Adalimumab 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Overall Study STARTED	10
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Participants Receiving Adalimumab 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Overall Study Lack of Efficacy	3
Overall Study Adverse Event	2

Baseline Characteristics

Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)

Baseline characteristics by cohort

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Age, Continuous	49.8 years STANDARD_DEVIATION 13.26 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Generalized Pustular Psoriasis (GPP) Duration	10.6 years STANDARD_DEVIATION 12.59 • n=5 Participants
Prior GPP Therapy Psoralen and ultraviolet A light (PUVA)	1 Participants n=5 Participants
Prior GPP Therapy Narrow-band ultraviolet B light (UVB)	2 Participants n=5 Participants
Prior GPP Therapy Granulocyte and Monocyte Absorbent Apheresis (GMA)	2 Participants n=5 Participants
Prior GPP Therapy None of the above	5 Participants n=5 Participants
Prior Infliximab Use Yes	3 Participants n=5 Participants
Prior Infliximab Use No	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 16

Population: Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment; non-responder imputation was used for participants with missing data

Clinical Response was defined as reduction of the Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) relative to baseline (Day 1), according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical Response was defined as the improvement (reduction) of total skin score of at least 1 point (if the participant's baseline total skin score was 3); improvement (reduction) at least 2 points (if the participant's baseline total skin score was 4-9); or remission if the total skin score was 0.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Proportion of Participants Achieving Clinical Response at Week 16	7 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52

Population: Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment; non-responder imputation was used for participants with missing data

Clinical Response was defined as reduction of the Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) relative to baseline (Day 1), according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical Response was defined as the improvement (reduction) of total skin score of at least 1 point (if the participant's baseline total skin score was 3); improvement (reduction) at least 2 points (if the participant's baseline total skin score was 4-9); or remission if the total skin score was 0.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Number of Participants Achieving Clinical Response Over Time Week 24	6 participants
Number of Participants Achieving Clinical Response Over Time Week 36	6 participants
Number of Participants Achieving Clinical Response Over Time Week 2	5 participants
Number of Participants Achieving Clinical Response Over Time Week 4	6 participants
Number of Participants Achieving Clinical Response Over Time Week 8	6 participants
Number of Participants Achieving Clinical Response Over Time Week 12	5 participants
Number of Participants Achieving Clinical Response Over Time Week 52	5 participants

SECONDARY outcome

Timeframe: Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment; non-responder imputation was used for participants with missing data

The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical remission was defined as a total skin score of 0.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Number of Participants Achieving Clinical Remission Over Time Week 2	0 participants
Number of Participants Achieving Clinical Remission Over Time Week 4	1 participants
Number of Participants Achieving Clinical Remission Over Time Week 8	0 participants
Number of Participants Achieving Clinical Remission Over Time Week 12	0 participants
Number of Participants Achieving Clinical Remission Over Time Week 16	0 participants
Number of Participants Achieving Clinical Remission Over Time Week 24	0 participants
Number of Participants Achieving Clinical Remission Over Time Week 36	0 participants
Number of Participants Achieving Clinical Remission Over Time Week 52	0 participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score ([range 0-8, with 8 representing severe disease] assesses body temperature, white blood cell [WBC] count, high-sensitivity C-reactive protein [hs-CRP], and serum albumin). Negative values indicate improvement from baseline.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Mean Change From Baseline in the Total GPP Score Over Time Week 2	-2.9 units on a scale Standard Deviation 2.08
Mean Change From Baseline in the Total GPP Score Over Time Week 4	-3.8 units on a scale Standard Deviation 2.15
Mean Change From Baseline in the Total GPP Score Over Time Week 8	-3.2 units on a scale Standard Deviation 2.57
Mean Change From Baseline in the Total GPP Score Over Time Week 12	-3.1 units on a scale Standard Deviation 2.85
Mean Change From Baseline in the Total GPP Score Over Time Week 16	-4.6 units on a scale Standard Deviation 1.85
Mean Change From Baseline in the Total GPP Score Over Time Week 24	-3.8 units on a scale Standard Deviation 3.15
Mean Change From Baseline in the Total GPP Score Over Time Week 36	-5.5 units on a scale Standard Deviation 2.07
Mean Change From Baseline in the Total GPP Score Over Time Week 52	-6.0 units on a scale Standard Deviation 2.55

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment

The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score ([range 0-8, with 8 representing severe disease] assesses body temperature, white blood cell [WBC] count, high-sensitivity C-reactive protein [hs-CRP], and serum albumin). A total score on the JDA severity index of 0-6 is categorized as "Mild", "Moderate" is 7-10, and "Severe" is 11-17.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Mean Change From Baseline in JDA Severity Index of GPP Over Time Baseline · Mild	3 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Baseline · Moderate	6 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Baseline · Severe	1 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Baseline · Missing	0 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 2 · Mild	7 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 2 · Moderate	3 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 2 · Severe	0 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 2 · Missing	0 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 4 · Mild	9 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 4 · Moderate	1 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 4 · Severe	0 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 4 · Missing	0 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 8 · Mild	8 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 8 · Moderate	1 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 8 · Severe	1 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 8 · Missing	0 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 12 · Mild	7 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 12 · Moderate	0 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 12 · Severe	1 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 12 · Missing	2 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 16 · Mild	7 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 16 · Moderate	1 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 16 · Severe	0 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 16 · Missing	2 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 24 · Mild	7 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 24 · Moderate	0 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 24 · Severe	1 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 24 · Missing	2 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 36 · Mild	6 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 36 · Moderate	0 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 36 · Severe	0 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 36 · Missing	4 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 52 · Mild	5 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 52 · Moderate	0 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 52 · Severe	0 Participants
Mean Change From Baseline in JDA Severity Index of GPP Over Time Week 52 · Missing	5 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Negative values indicate improvement from baseline.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Mean Change From Baseline in Total Skin Score Over Time Week 2	-1.9 units on a scale Standard Deviation 1.66
Mean Change From Baseline in Total Skin Score Over Time Week 4	-2.4 units on a scale Standard Deviation 1.65
Mean Change From Baseline in Total Skin Score Over Time Week 8	-2.3 units on a scale Standard Deviation 1.49
Mean Change From Baseline in Total Skin Score Over Time Week 12	-2.3 units on a scale Standard Deviation 1.98
Mean Change From Baseline in Total Skin Score Over Time Week 16	-3.1 units on a scale Standard Deviation 1.36
Mean Change From Baseline in Total Skin Score Over Time Week 24	-2.6 units on a scale Standard Deviation 1.92
Mean Change From Baseline in Total Skin Score Over Time Week 36	-3.8 units on a scale Standard Deviation 1.47
Mean Change From Baseline in Total Skin Score Over Time Week 52	-4.2 units on a scale Standard Deviation 1.79

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Negative values indicate improvement from baseline.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Mean Percent Change From Baseline in Total Skin Score Over Time Week 2	-33.8 percentage change from baseline Standard Deviation 27.71
Mean Percent Change From Baseline in Total Skin Score Over Time Week 4	-43.4 percentage change from baseline Standard Deviation 27.28
Mean Percent Change From Baseline in Total Skin Score Over Time Week 8	-42.9 percentage change from baseline Standard Deviation 27.12
Mean Percent Change From Baseline in Total Skin Score Over Time Week 12	-39.9 percentage change from baseline Standard Deviation 30.36
Mean Percent Change From Baseline in Total Skin Score Over Time Week 16	-54.6 percentage change from baseline Standard Deviation 20.77
Mean Percent Change From Baseline in Total Skin Score Over Time Week 24	-46.6 percentage change from baseline Standard Deviation 33.15
Mean Percent Change From Baseline in Total Skin Score Over Time Week 36	-67.9 percentage change from baseline Standard Deviation 13.58
Mean Percent Change From Baseline in Total Skin Score Over Time Week 52	-72.3 percentage change from baseline Standard Deviation 16.34

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The Generalized Pustular Psoriasis (GPP) total systemic/laboratory test score ([range 0-8, with 8 representing severe disease] assesses body temperature, white blood cell [WBC] count, high-sensitivity C-reactive protein [hs-CRP], and serum albumin). Negative values indicate improvement from baseline.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time Week 2	-1.0 units on a scale Standard Deviation 1.05
Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time Week 4	-1.4 units on a scale Standard Deviation 0.97
Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time Week 8	-0.9 units on a scale Standard Deviation 1.45
Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time Week 12	-0.9 units on a scale Standard Deviation 1.25
Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time Week 16	-1.5 units on a scale Standard Deviation 1.20
Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time Week 24	-1.1 units on a scale Standard Deviation 1.64
Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time Week 36	-1.7 units on a scale Standard Deviation 1.21
Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time Week 52	-1.8 units on a scale Standard Deviation 1.30

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of erythema (redness) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total erythema area is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 75%; moderate, ≥ 25% and < 75%; mild, < 25%); and none (0%). Negative values indicate improvement from baseline.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Mean Change From Baseline in Total Erythema Area Over Time Week 2	-17.0 units on a scale Standard Deviation 20.08
Mean Change From Baseline in Total Erythema Area Over Time Week 4	-21.6 units on a scale Standard Deviation 22.81
Mean Change From Baseline in Total Erythema Area Over Time Week 8	-19.7 units on a scale Standard Deviation 26.62
Mean Change From Baseline in Total Erythema Area Over Time Week 12	-23.0 units on a scale Standard Deviation 26.28
Mean Change From Baseline in Total Erythema Area Over Time Week 16	-34.6 units on a scale Standard Deviation 27.30
Mean Change From Baseline in Total Erythema Area Over Time Week 24	-27.6 units on a scale Standard Deviation 29.48
Mean Change From Baseline in Total Erythema Area Over Time Week 36	-48.3 units on a scale Standard Deviation 27.72
Mean Change From Baseline in Total Erythema Area Over Time Week 52	-44.6 units on a scale Standard Deviation 37.50

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of erythema with pustules (small pockets of pus) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total erythema area with pustules is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 50%; moderate, ≥ 10% and < 50%; mild, < 10%); and none (0%). Negative values indicate improvement from baseline.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Mean Change From Baseline in Total Erythema Area With Pustules Over Time Week 2	-9.3 units on a scale Standard Deviation 8.96
Mean Change From Baseline in Total Erythema Area With Pustules Over Time Week 4	-11.7 units on a scale Standard Deviation 9.01
Mean Change From Baseline in Total Erythema Area With Pustules Over Time Week 8	-8.3 units on a scale Standard Deviation 11.42
Mean Change From Baseline in Total Erythema Area With Pustules Over Time Week 12	-8.3 units on a scale Standard Deviation 14.63
Mean Change From Baseline in Total Erythema Area With Pustules Over Time Week 16	-11.8 units on a scale Standard Deviation 10.65
Mean Change From Baseline in Total Erythema Area With Pustules Over Time Week 24	-7.1 units on a scale Standard Deviation 16.75
Mean Change From Baseline in Total Erythema Area With Pustules Over Time Week 36	-13.3 units on a scale Standard Deviation 12.44
Mean Change From Baseline in Total Erythema Area With Pustules Over Time Week 52	-14.8 units on a scale Standard Deviation 13.31

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of edema (swelling) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total area of edema is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 50%; moderate, ≥ 10% and < 50%; mild, < 10%); and none (0%). Negative values indicate improvement from baseline.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Mean Change From Baseline in Total Edema Area Over Time Week 2	-9.1 units on a scale Standard Deviation 9.45
Mean Change From Baseline in Total Edema Area Over Time Week 4	-12.8 units on a scale Standard Deviation 11.29
Mean Change From Baseline in Total Edema Area Over Time Week 8	-12.4 units on a scale Standard Deviation 17.30
Mean Change From Baseline in Total Edema Area Over Time Week 12	-6.3 units on a scale Standard Deviation 31.96
Mean Change From Baseline in Total Edema Area Over Time Week 16	-15.4 units on a scale Standard Deviation 17.30
Mean Change From Baseline in Total Edema Area Over Time Week 24	-14.0 units on a scale Standard Deviation 17.72
Mean Change From Baseline in Total Edema Area Over Time Week 36	-21.2 units on a scale Standard Deviation 14.68
Mean Change From Baseline in Total Edema Area Over Time Week 52	-18.6 units on a scale Standard Deviation 14.31

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

Body temperature (oral) was obtained at each visit prior to blood sampling.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Mean Change From Baseline in Body Temperature Over Time Week 2	-0.3 degrees Celsius Standard Deviation 0.68
Mean Change From Baseline in Body Temperature Over Time Week 4	-0.5 degrees Celsius Standard Deviation 0.52
Mean Change From Baseline in Body Temperature Over Time Week 8	-0.3 degrees Celsius Standard Deviation 0.50
Mean Change From Baseline in Body Temperature Over Time Week 12	-0.1 degrees Celsius Standard Deviation 0.64
Mean Change From Baseline in Body Temperature Over Time Week 16	-0.3 degrees Celsius Standard Deviation 0.50
Mean Change From Baseline in Body Temperature Over Time Week 24	-0.5 degrees Celsius Standard Deviation 1.04
Mean Change From Baseline in Body Temperature Over Time Week 36	-0.3 degrees Celsius Standard Deviation 0.86
Mean Change From Baseline in Body Temperature Over Time Week 52	-0.1 degrees Celsius Standard Deviation 0.64

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

Blood was drawn at each study visit, and white blood cell concentration was determined.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time Week 2	-1220.0 cells/µL Standard Deviation 1970.22
Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time Week 4	-1770.0 cells/µL Standard Deviation 2572.96
Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time Week 8	-810.0 cells/µL Standard Deviation 3104.28
Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time Week 12	-1650.0 cells/µL Standard Deviation 2857.57
Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time Week 16	-2562.5 cells/µL Standard Deviation 2960.18
Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time Week 24	-1162.5 cells/µL Standard Deviation 4444.88
Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time Week 36	-2550.0 cells/µL Standard Deviation 3229.09
Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time Week 52	-2760.0 cells/µL Standard Deviation 2966.99

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

Blood was drawn at each study visit, and high-sensitivity C-reactive protein (hs-CRP) concentration was determined.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time Week 2	-1.5 mg/dL Standard Deviation 4.12
Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time Week 4	-1.6 mg/dL Standard Deviation 4.05
Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time Week 8	-0.3 mg/dL Standard Deviation 5.97
Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time Week 12	-1.7 mg/dL Standard Deviation 4.76
Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time Week 16	-2.5 mg/dL Standard Deviation 4.06
Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time Week 24	-1.5 mg/dL Standard Deviation 5.63
Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time Week 36	-2.7 mg/dL Standard Deviation 5.02
Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time Week 52	-3.8 mg/dL Standard Deviation 4.73

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

Blood was drawn at each study visit, and serum albumin concentration was determined.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Mean Change From Baseline in Serum Albumin Over Time Week 2	0.0 g/dL Standard Deviation 0.33
Mean Change From Baseline in Serum Albumin Over Time Week 4	0.1 g/dL Standard Deviation 0.44
Mean Change From Baseline in Serum Albumin Over Time Week 8	0.1 g/dL Standard Deviation 0.38
Mean Change From Baseline in Serum Albumin Over Time Week 12	-0.2 g/dL Standard Deviation 0.59
Mean Change From Baseline in Serum Albumin Over Time Week 16	-0.0 g/dL Standard Deviation 0.39
Mean Change From Baseline in Serum Albumin Over Time Week 24	-0.0 g/dL Standard Deviation 0.26
Mean Change From Baseline in Serum Albumin Over Time Week 36	-0.1 g/dL Standard Deviation 0.54
Mean Change From Baseline in Serum Albumin Over Time Week 52	-0.0 g/dL Standard Deviation 0.43

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score ([range 0-8, with 8 representing severe disease] assesses body temperature, white blood cell [WBC] count, high-sensitivity C-reactive protein [hs-CRP], and serum albumin). A total score on the JDA severity index of 0-6 is categorized as "Mild", "Moderate" is 7-10, and "Severe" is 11-17.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Number of Participants Achieving "Mild" in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With "Moderate" or "Severe" at Baseline Over Time Week 2	4 Participants
Number of Participants Achieving "Mild" in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With "Moderate" or "Severe" at Baseline Over Time Week 4	6 Participants
Number of Participants Achieving "Mild" in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With "Moderate" or "Severe" at Baseline Over Time Week 8	5 Participants
Number of Participants Achieving "Mild" in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With "Moderate" or "Severe" at Baseline Over Time Week 12	5 Participants
Number of Participants Achieving "Mild" in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With "Moderate" or "Severe" at Baseline Over Time Week 16	5 Participants
Number of Participants Achieving "Mild" in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With "Moderate" or "Severe" at Baseline Over Time Week 24	5 Participants
Number of Participants Achieving "Mild" in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With "Moderate" or "Severe" at Baseline Over Time Week 36	5 Participants
Number of Participants Achieving "Mild" in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With "Moderate" or "Severe" at Baseline Over Time Week 52	4 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall severity was evaluated using the following categories: erythema, pustulation, and edema, and graded as follows. Grade 0 = cleared, except for residual discoloration; Grade 1 = minimal; Grade 2 = mild; Grade 3 = moderate; Grade 4 = severe; and Grade 5 = very severe. The score is an arithmetic average of the grades for erythema, pustulation, and edema, rounded to the nearest whole number. Treatment Success was defined by at least a 2 grade improvement relative to baseline.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time Week 2	3 Participants
Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time Week 4	5 Participants
Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time Week 8	4 Participants
Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time Week 12	3 Participants
Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time Week 16	5 Participants
Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time Week 24	4 Participants
Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time Week 36	5 Participants
Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time Week 52	3 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall severity was evaluated using the following categories: erythema, pustulation, and edema, and graded as follows. Grade 0 = cleared, except for residual discoloration; Grade 1 = minimal; Grade 2 = mild; Grade 3 = moderate; Grade 4 = severe; and Grade 5 = very severe. The score is an arithmetic average of the grades for erythema, pustulation, and edema, rounded to the nearest whole number.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 8 · PGA Grade 4	1 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 8 · PGA Grade 5	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 12 · PGA Grade 0	1 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 12 · PGA Grade 1	4 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 12 · PGA Grade 2	2 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 12 · PGA Grade 3	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 12 · PGA Grade 4	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 12 · PGA Grade 5	1 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 16 · PGA Grade 0	2 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 16 · PGA Grade 1	5 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 16 · PGA Grade 2	1 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 16 · PGA Grade 3	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 16 · PGA Grade 4	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 16 · PGA Grade 5	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 24 · PGA Grade 0	1 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 24 · PGA Grade 1	5 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 24 · PGA Grade 2	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 24 · PGA Grade 3	2 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 24 · PGA Grade 4	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 24 · PGA Grade 5	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 36 · PGA Grade 0	2 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 36 · PGA Grade 1	4 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 36 · PGA Grade 2	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 36 · PGA Grade 3	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 36 · PGA Grade 4	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 36 · PGA Grade 5	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 52 · PGA Grade 0	3 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 52 · PGA Grade 1	2 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 52 · PGA Grade 2	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 52 · PGA Grade 3	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 52 · PGA Grade 4	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 52 · PGA Grade 5	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Baseline · PGA Grade 0	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Baseline · PGA Grade 1	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Baseline · PGA Grade 2	4 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Baseline · PGA Grade 3	3 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Baseline · PGA Grade 4	3 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Baseline · PGA Grade 5	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 2 · PGA Grade 0	1 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 2 · PGA Grade 1	3 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 2 · PGA Grade 2	5 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 2 · PGA Grade 3	1 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 2 · PGA Grade 4	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 2 · PGA Grade 5	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 4 · PGA Grade 0	1 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 4 · PGA Grade 1	7 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 4 · PGA Grade 2	1 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 4 · PGA Grade 3	1 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 4 · PGA Grade 4	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 4 · PGA Grade 5	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 8 · PGA Grade 0	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 8 · PGA Grade 1	8 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 8 · PGA Grade 2	0 Participants
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time Week 8 · PGA Grade 3	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall severity was evaluated using the following categories: erythema, pustulation, and edema, and graded as follows. Grade 0 = cleared, except for residual discoloration; Grade 1 = minimal; Grade 2 = mild; Grade 3 = moderate; Grade 4 = severe; and Grade 5 = very severe. The score is an arithmetic average of the grades for erythema, pustulation, and edema, rounded to the nearest whole number.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time Week 2	4 Participants
Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time Week 4	8 Participants
Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time Week 8	8 Participants
Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time Week 12	5 Participants
Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time Week 16	7 Participants
Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time Week 24	6 Participants
Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time Week 36	6 Participants
Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time Week 52	5 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The proportion of participants with a ≥ 90% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time Week 2	1 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time Week 4	2 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time Week 8	1 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time Week 12	1 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time Week 16	0 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time Week 24	1 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time Week 36	3 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time Week 52	3 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The proportion of participants with a ≥ 75% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time Week 2	2 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time Week 4	2 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time Week 8	2 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time Week 12	2 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time Week 16	4 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time Week 24	4 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time Week 36	5 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time Week 52	3 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The proportion of participants with a ≥ 50% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time Week 2	4 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time Week 4	6 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time Week 8	6 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time Week 12	5 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time Week 16	5 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time Week 24	4 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time Week 36	5 Participants
Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time Week 52	4 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The mean change in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Negative values indicate improvement from baseline.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time Week 2	-12.9 units on a scale Standard Deviation 12.83
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time Week 4	-17.4 units on a scale Standard Deviation 14.66
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time Week 8	-14.9 units on a scale Standard Deviation 17.55
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time Week 12	-14.3 units on a scale Standard Deviation 20.03
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time Week 16	-19.1 units on a scale Standard Deviation 17.27
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time Week 24	-16.8 units on a scale Standard Deviation 19.61
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time Week 36	-28.1 units on a scale Standard Deviation 17.67
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time Week 52	-26.7 units on a scale Standard Deviation 22.24

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The percent change in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Negative values indicate improvement from baseline.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time Week 2	-44.2 percentage change from baseline Standard Deviation 27.47
Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time Week 4	-59.7 percentage change from baseline Standard Deviation 24.65
Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time Week 8	-43.9 percentage change from baseline Standard Deviation 45.01
Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time Week 12	-45.0 percentage change from baseline Standard Deviation 39.20
Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time Week 16	-55.5 percentage change from baseline Standard Deviation 31.89
Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time Week 24	-43.6 percentage change from baseline Standard Deviation 46.26
Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time Week 36	-79.0 percentage change from baseline Standard Deviation 24.13
Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time Week 52	-33.7 percentage change from baseline Standard Deviation 117.4

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time Week 8	1 Participants
Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time Week 16	0 Participants
Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time Week 24	1 Participants
Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time Week 36	0 Participants
Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time Week 52	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Negative values indicate improvement from baseline.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time Week 8	-4.2 units on a scale Standard Deviation 6.55
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time Week 16	-6.6 units on a scale Standard Deviation 5.34
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time Week 24	-4.8 units on a scale Standard Deviation 7.59
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time Week 36	-6.5 units on a scale Standard Deviation 5.65
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time Week 52	-8.0 units on a scale Standard Deviation 7.18

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 24, Week 36, Week 52

Population: Participants with available data

The Short Form-36 Health Status Survey Version 2 (SF-36 V2) is a 36-item generic health-related quality of life questionnaire to assess the participant's view of their health consisting of 2 components: physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time Mental Component Summary- Week 16	0.9 units on a scale Standard Deviation 8.03
Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time Physical Component Summary- Week 8	4.7 units on a scale Standard Deviation 19.05
Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time Physical Component Summary- Week 16	9.2 units on a scale Standard Deviation 17.48
Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time Physical Component Summary- Week 24	8.2 units on a scale Standard Deviation 15.94
Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time Physical Component Summary- Week 36	4.9 units on a scale Standard Deviation 23.39
Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time Physical Component Summary- Week 52	12.0 units on a scale Standard Deviation 21.42
Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time Mental Component Summary- Week 8	0.6 units on a scale Standard Deviation 8.71
Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time Mental Component Summary- Week 24	2.0 units on a scale Standard Deviation 8.32
Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time Mental Component Summary- Week 36	1.6 units on a scale Standard Deviation 18.26
Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time Mental Component Summary- Week 52	6.4 units on a scale Standard Deviation 7.79

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52

Population: Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment

GPP-specific co-medications were documented at each scheduled study visit.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Proportion of Participants Taking Systemic Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study Etretinate	3 Participants
Proportion of Participants Taking Systemic Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study Methotrexate	2 Participants
Proportion of Participants Taking Systemic Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study Oral steroids	1 Participants
Proportion of Participants Taking Systemic Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study Cyclosporine	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52

Population: Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment

Participants using topical co-medications for GPP were documented at each scheduled study visit.

Outcome measures

Measure	Participants Receiving Adalimumab n=10 Participants 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Proportion of Participants Taking Topical Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study Corticosteroid	7 Participants
Proportion of Participants Taking Topical Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study Vitamin D3	0 Participants
Proportion of Participants Taking Topical Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study Tacrolimus	0 Participants

Adverse Events

Participants Receiving Adalimumab

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Participants Receiving Adalimumab n=10 participants at risk 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Cardiac disorders Cardiac failure	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Chronic sinusitis	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Enterocolitis bacterial	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Metabolism and nutrition disorders Dehydration	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Renal and urinary disorders Renal failure	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders Pustular psoriasis	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.

Other adverse events

Measure	Participants Receiving Adalimumab n=10 participants at risk 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Skin and subcutaneous tissue disorders Psoriasis	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders Pustular psoriasis	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Blood and lymphatic system disorders Eosinophilia	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Cardiac disorders Cardiac failure	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Endocrine disorders Autoimmune Thyroiditis	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Eye disorders Dry eye	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Eye disorders Episcleritis	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Eye disorders Glaucoma	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders Abdominal pain	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
General disorders Oedema	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
General disorders Oedema peripheral	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
General disorders Pyrexia	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Hepatobiliary disorders Hepatic Function Abnormal	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Hepatobiliary disorders Hepatic Steatosis	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Hepatobiliary disorders Liver disorder	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Bacterial infection	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Body tinea	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Cellulitis	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Chronic sinusitis	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Enterocolitis bacterial	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Enterocolitis infectious	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Folliculitis	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Herpes zoster	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Infection	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Nasopharyngitis	30.0% 3/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Urinary tract infection	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications Contusion	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications Eye contusion	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications Patella fracture	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications Tooth fracture	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Metabolism and nutrition disorders Dehydration	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Metabolism and nutrition disorders Hyperlipidaemia	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Metabolism and nutrition disorders Hypoalbuminaemia	20.0% 2/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Metabolism and nutrition disorders Hypoglycaemia	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Metabolism and nutrition disorders Hypokalaemia	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Metabolism and nutrition disorders Malnutrition	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders Periarthritis	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders Spondylolisthesis	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Psychiatric disorders Insomnia	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Renal and urinary disorders Renal failure	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 1/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders Pruritus	30.0% 3/10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks). TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.

Additional Information

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• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
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