Trial Outcomes & Findings for Quality of Life and Psychosocial Factors Associated With Severe Psoriasis Following Treatment With Adalimumab (NCT NCT01328366)

NCT ID: NCT01328366

Last Updated: 2015-07-09

Results Overview

The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicating a greater impact on a participant's QOL. Data are reported as the mean DLQI score ± standard deviation.

• Recruitment status: COMPLETED
• Target enrollment: 153 participants
• Primary outcome timeframe: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
• Results posted on: 2015-07-09

Participant Flow

Participant milestones

Measure	Participants With Severe Psoriasis The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
Overall Study STARTED	153
Overall Study COMPLETED	143
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	Participants With Severe Psoriasis The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
Overall Study Death	1
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	7

Baseline Characteristics

Quality of Life and Psychosocial Factors Associated With Severe Psoriasis Following Treatment With Adalimumab

Baseline characteristics by cohort

Measure	Participants With Severe Psoriasis n=138 Participants The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
Age, Continuous	24.0 years STANDARD_DEVIATION 12.68 • n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation

Population: Participants who completed the DLQI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.

The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicating a greater impact on a participant's QOL. Data are reported as the mean DLQI score ± standard deviation.

Outcome measures

Measure	Participants With Severe Psoriasis n=134 Participants The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
Dermatology Life Quality Index (DLQI) Scores Baseline	17.25 units on a scale Standard Deviation 6.51
Dermatology Life Quality Index (DLQI) Scores 4 Weeks (n=43)	8.65 units on a scale Standard Deviation 6.51
Dermatology Life Quality Index (DLQI) Scores 16 Weeks (n=80)	4.51 units on a scale Standard Deviation 5.88
Dermatology Life Quality Index (DLQI) Scores 6 Months (n=100)	3.65 units on a scale Standard Deviation 6.41

PRIMARY outcome

Timeframe: 4 weeks, 16 weeks, and 6 months following adalimumab initiation

Population: Participants who completed the DLQI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.

The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicated a greater impact on a participant's QOL. "Responders" to adalimumab had a ≥5 point reduction in DLQI scores or DLQI score of 0. Data are reported as the mean DLQI score ± standard deviation.

Outcome measures

Measure	Participants With Severe Psoriasis n=134 Participants The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline 4 Weeks (n=38)	-9.95 units on a scale Interval -12.07 to -7.82
Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline 16 Weeks (n=76)	-13.03 units on a scale Interval -14.69 to -11.36
Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline 6 Months (n=94)	-13.63 units on a scale Interval -15.29 to -11.97

SECONDARY outcome

Timeframe: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation

Population: Participants who completed the SAPASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment.

The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean SAPASI score ± standard deviation.

Outcome measures

Measure	Participants With Severe Psoriasis n=128 Participants The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores 16 Weeks (n=78)	4.42 units on a scale Standard Deviation 6.54
Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores 6 Months (n=97)	4.41 units on a scale Standard Deviation 7.81
Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores Baseline (n=128)	21.02 units on a scale Standard Deviation 11.42
Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores 4 Weeks (n=43)	7.37 units on a scale Standard Deviation 7.13

SECONDARY outcome

Timeframe: 4 weeks, 16 weeks, and 6 months after adalimumab initiation

Population: Participants who completed the SAPASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.

The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean change in SAPASI score ± standard deviation.

Outcome measures

Measure	Participants With Severe Psoriasis n=128 Participants The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline 4 Weeks (n=35)	-16.41 units on a scale Interval -20.18 to -12.65
Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline 16 Weeks (n=72)	-18.79 units on a scale Interval -21.78 to -15.8
Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline 6 Months (n=87)	-17.34 units on a scale Interval -19.94 to -14.74

SECONDARY outcome

Timeframe: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation

Population: Participants who completed the PASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment.

The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean PASI score ± standard deviation.

Outcome measures

Measure	Participants With Severe Psoriasis n=124 Participants The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
Psoriasis Area and Severity Index (PASI) Scores Baseline	16.98 units on a scale Standard Deviation 8.47
Psoriasis Area and Severity Index (PASI) Scores 4 Weeks (n=24)	5.52 units on a scale Standard Deviation 4.48
Psoriasis Area and Severity Index (PASI) Scores 16 Weeks (n=81)	3.42 units on a scale Standard Deviation 5.31
Psoriasis Area and Severity Index (PASI) Scores 6 Months (n=91)	2.38 units on a scale Standard Deviation 3.98

SECONDARY outcome

Timeframe: 4 weeks, 16 weeks, and 6 months following adalimumab initiation

Population: Participants who completed the PASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.

The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores range from 0-72, a higher score indicating more severe psoriasis. Data are reported as the mean change in PASI score ± standard deviation.

Outcome measures

Measure	Participants With Severe Psoriasis n=124 Participants The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline 4 Weeks (n=24)	-10.90 units on a scale Interval -14.05 to -7.75
Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline 16 Weeks (n=80)	-13.93 units on a scale Interval -15.9 to -11.96
Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline 6 Months (n=89)	-13.99 units on a scale Interval -15.75 to -12.22

SECONDARY outcome

Timeframe: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation

Population: Participants who completed the HADS questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment. HADS-A refers to the anxiety, while HADS-D refers to the depression portion of the survey.

The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. Data are reported as the mean anxiety or depression score ± standard deviation.

Outcome measures

Measure	Participants With Severe Psoriasis n=132 Participants The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
Hospital Anxiety and Depression Scale (HADS) Scores HADS-A 6 Months (n=100)	6.00 units on a scale Standard Deviation 4.29
Hospital Anxiety and Depression Scale (HADS) Scores HADS-D Baseline	7.08 units on a scale Standard Deviation 4.46
Hospital Anxiety and Depression Scale (HADS) Scores HADS-D 4 Weeks (n=43)	6.19 units on a scale Standard Deviation 4.68
Hospital Anxiety and Depression Scale (HADS) Scores HADS-D 16 Weeks (n=80)	4.18 units on a scale Standard Deviation 3.67
Hospital Anxiety and Depression Scale (HADS) Scores HADS-D 6 Months (n=100)	3.43 units on a scale Standard Deviation 3.63
Hospital Anxiety and Depression Scale (HADS) Scores HADS-A Baseline	9.63 units on a scale Standard Deviation 4.70
Hospital Anxiety and Depression Scale (HADS) Scores HADS-A 4 Weeks (n=43)	8.21 units on a scale Standard Deviation 4.95
Hospital Anxiety and Depression Scale (HADS) Scores HADS-A 16 Weeks (n=80)	6.65 units on a scale Standard Deviation 4.22

SECONDARY outcome

Timeframe: 4 weeks, 16 weeks, and 6 months following adalimumab initiation

Population: Participants who completed the HADS questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis. HADS-A refers to the anxiety, while HADS-D refers to the depression portion of the survey.

The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. Data are reported as the mean change in anxiety or depression score ± standard deviation.

Outcome measures

Measure	Participants With Severe Psoriasis n=132 Participants The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline HADS-A 4 Weeks (n=36)	-1.56 units on a scale Interval -2.87 to -0.24
Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline HADS-A 16 Weeks (n=74)	-2.81 units on a scale Interval -3.7 to -1.92
Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline HADS-A 6 Months (n=93)	-3.32 units on a scale Interval -4.17 to -2.48
Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline HADS-D 4 Weeks (n=36)	-1.58 units on a scale Interval -2.83 to -0.34
Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline HADS-D 16 Weeks (n=74)	-2.68 units on a scale Interval -3.56 to -1.79
Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline HADS-D 6 Months (n=93)	-3.14 units on a scale Interval -3.97 to -2.31

SECONDARY outcome

Timeframe: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation

Population: Participants who completed the CBI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.

The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant's satisfaction with their hair, nails, and skin. Scores range from 0-9, higher scores indicated a higher level of satisfaction. Data are reported as the mean CBI score ± standard deviation.

Outcome measures

Measure	Participants With Severe Psoriasis n=134 Participants The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
Cutaneous Body Image Scale (CBI) Scores Baseline	2.73 units on a scale Standard Deviation 1.83
Cutaneous Body Image Scale (CBI) Scores 4 Weeks (n=42)	4.38 units on a scale Standard Deviation 1.92
Cutaneous Body Image Scale (CBI) Scores 16 Weeks (n=80)	5.58 units on a scale Standard Deviation 1.85
Cutaneous Body Image Scale (CBI) Scores 6 Months (n=100)	6.16 units on a scale Standard Deviation 1.98

SECONDARY outcome

Timeframe: 4 weeks, 16 weeks, and 6 months following adalimumab initiation

Population: Participants who completed the CBI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.

The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant's satisfaction with their hair, nails, and skin. Scores range from 0-9, higher scores indicated a higher level of satisfaction. Data are reported as the mean change in CBI score ± standard deviation.

Outcome measures

Measure	Participants With Severe Psoriasis n=134 Participants The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline 4 Weeks (n=37)	2.05 units on a scale Interval 1.28 to 2.82
Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline 16 Weeks (n=76)	2.83 units on a scale Interval 2.29 to 3.38
Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline 6 Months (n=95)	3.45 units on a scale Interval 2.92 to 3.97

SECONDARY outcome

Timeframe: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation

Population: Participants who completed the SF-12 questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.

The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains. Scores range from 0-100 for each domain, higher scores indicated better physical or mental health. Data are reported as the mean SF-12 score physical or mental ± standard deviation.

Outcome measures

Measure	Participants With Severe Psoriasis n=127 Participants The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
12-item Short Form Survey (SF-12) Score SF-12 Physical 4 Weeks (n=42)	46.38 units on a scale Standard Deviation 11.35
12-item Short Form Survey (SF-12) Score SF-12 Physical 16 Weeks (n=74)	50.53 units on a scale Standard Deviation 8.50
12-item Short Form Survey (SF-12) Score SF-12 Physical 6 Months (n=97)	49.53 units on a scale Standard Deviation 10.05
12-item Short Form Survey (SF-12) Score SF-12 Physical Baseline	43.08 units on a scale Standard Deviation 11.61
12-item Short Form Survey (SF-12) Score SF-12 Mental Baseline	41.23 units on a scale Standard Deviation 11.25
12-item Short Form Survey (SF-12) Score SF-12 Mental 4 Weeks (n=42)	45.50 units on a scale Standard Deviation 10.53
12-item Short Form Survey (SF-12) Score SF-12 Mental 16 Weeks (n=74)	46.84 units on a scale Standard Deviation 11.12
12-item Short Form Survey (SF-12) Score SF-12 6 Months (n=97)	49.22 units on a scale Standard Deviation 10.15

SECONDARY outcome

Timeframe: 4 weeks, 16 weeks, and 6 months following adalimumab initiation

Population: Participants who completed the SF-12 questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.

The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains. Scores range from 0-100 for each domain, higher scores indicated better physical or mental health. Data are reported as the mean change SF-12 score physical or mental ± standard deviation.

Outcome measures

Measure	Participants With Severe Psoriasis n=127 Participants The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
Change in 12-item Short Form Survey (SF-12) Score From Baseline SF-12 Physical 6 Months (n=89)	6.46 units on a scale Interval 4.39 to 8.54
Change in 12-item Short Form Survey (SF-12) Score From Baseline SF-12 Mental 4 Weeks (n=36)	4.96 units on a scale Interval 1.21 to 8.71
Change in 12-item Short Form Survey (SF-12) Score From Baseline SF-12 Mental 16 Weeks (n=69)	6.10 units on a scale Interval 3.32 to 8.88
Change in 12-item Short Form Survey (SF-12) Score From Baseline SF-12 Mental 6 Months (n=89)	6.47 units on a scale Interval 4.11 to 8.84
Change in 12-item Short Form Survey (SF-12) Score From Baseline SF-12 Physical 4 Weeks (n=36)	4.60 units on a scale Interval 1.77 to 7.44
Change in 12-item Short Form Survey (SF-12) Score From Baseline SF-12 Physical 16 Weeks (n=69)	6.84 units on a scale Interval 4.6 to 9.08

SECONDARY outcome

Timeframe: Baseline; 16 weeks, and 6 months following adalimumab initiation

Population: Female participants who completed the FSFI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.

The Female Sexual Function Index (FSFI) was a participant-reported questionnaire used to measure a female's sexual function. Scores range from 2-36, higher scores indicated better sexual function. Data are reported as the mean FSFI score ± standard deviation.

Outcome measures

Measure	Participants With Severe Psoriasis n=36 Participants The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
Female Sexual Function Index (FSFI) Score Baseline	15.77 units on a scale Standard Deviation 10.50
Female Sexual Function Index (FSFI) Score 16 Weeks (n=18)	18.65 units on a scale Standard Deviation 12.70
Female Sexual Function Index (FSFI) Score 6 Months (n=26)	20.73 units on a scale Standard Deviation 11.70

SECONDARY outcome

Timeframe: 4 week, 16 weeks, and 6 months following adalimumab initiation

Population: Female participants who completed the FSFI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.

The Female Sexual Function Index was a participant-reported questionnaire used to measure a female's sexual function. Scores range from 2-36, higher scores indicated better sexual function. Data are reported as the mean change in FSFI score ± standard deviation.

Outcome measures

Measure	Participants With Severe Psoriasis n=36 Participants The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
Mean Change in Female Sexual Function Index (FSFI) Score From Baseline 4 Weeks (n=4)	3.78 units on a scale Interval -8.76 to 16.31
Mean Change in Female Sexual Function Index (FSFI) Score From Baseline 16 Weeks (n=15)	0.53 units on a scale Interval -5.73 to 6.8
Mean Change in Female Sexual Function Index (FSFI) Score From Baseline 6 Months (n=21)	4.72 units on a scale Interval 1.33 to 8.11

SECONDARY outcome

Timeframe: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation

Population: Male participants who completed the IIEF questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.

The International Index of Erectile Function (IIEF) was a participant-reported questionnaire used to measure a male's erection function. Scores range from 5-75, higher scores indicated better erection quality. Data are reported as the mean IIEF score ± standard deviation.

Outcome measures

Measure	Participants With Severe Psoriasis n=64 Participants The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
International Index of Erectile Function Score Baseline	56.05 units on a scale Standard Deviation 19.20
International Index of Erectile Function Score 4 Weeks (n=24)	58.33 units on a scale Standard Deviation 13.80
International Index of Erectile Function Score 16 Weeks (n=36)	60.61 units on a scale Standard Deviation 17.50
International Index of Erectile Function Score 6 Months (n=47)	54.43 units on a scale Standard Deviation 22.90

Adverse Events

Participants With Severe Psoriasis

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Participants With Severe Psoriasis n=143 participants at risk The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.4% 2/143 • From informed consent to completion of final study questionnaire
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.4% 2/143 • From informed consent to completion of final study questionnaire
Nervous system disorders Headache	0.70% 1/143 • From informed consent to completion of final study questionnaire
Skin and subcutaneous tissue disorders Rash pustular	0.70% 1/143 • From informed consent to completion of final study questionnaire
General disorders Fatigue	0.70% 1/143 • From informed consent to completion of final study questionnaire
Gastrointestinal disorders Dry mouth	0.70% 1/143 • From informed consent to completion of final study questionnaire

Additional Information

Global Medical Information

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

• 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.
• Publication restrictions are in place

Restriction type: OTHER