Trial Outcomes & Findings for Special Investigation in Patients With Psoriatic Arthritis (PsA) (Working Productivity and Activity Impairment [WPAI]) (NCT NCT02414633)

NCT ID: NCT02414633

Last Updated: 2018-10-16

Results Overview

WPAI:PsA is a questionnaire used to evaluate lost productivity due to PsA; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Percentage of overall work impairment due to PsA (OWI) is calculated as: Absenteeism + (1 - Absenteeism) \* Presenteeism. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.

• Recruitment status: COMPLETED
• Target enrollment: 148 participants
• Primary outcome timeframe: Baseline (Week 0), Week 24
• Results posted on: 2018-10-16

Participant Flow

Participant milestones

Measure	Humira Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
Overall Study STARTED	148
Overall Study COMPLETED	148
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Humira n=148 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
Age, Continuous	49.1 years STANDARD_DEVIATION 11.3 • n=148 Participants
Sex: Female, Male Female	41 Participants n=148 Participants
Sex: Female, Male Male	107 Participants n=148 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 24

Population: Efficacy analysis population: All enrolled participants with available OWI scores.

WPAI:PsA is a questionnaire used to evaluate lost productivity due to PsA; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Percentage of overall work impairment due to PsA (OWI) is calculated as: Absenteeism + (1 - Absenteeism) * Presenteeism. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.

Outcome measures

Measure	Humira n=106 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
Work Productivity and Activity Impairment Psoriatic Arthritis Questionnaire (WPAI:PsA) Percentage of Overall Work Impairment (OWI): Change From Baseline to Week 24 Baseline	40.22 percentage of OWI Standard Deviation 32.84
Work Productivity and Activity Impairment Psoriatic Arthritis Questionnaire (WPAI:PsA) Percentage of Overall Work Impairment (OWI): Change From Baseline to Week 24 Change from Baseline to Week 24	-25.24 percentage of OWI Standard Deviation 35.27

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 4, Week 12, and Week 16

Population: Efficacy analysis population: All enrolled participants with available OWI scores.

WPAI:PsA is a questionnaire used to evaluate lost productivity due to PsA; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Percentage of overall work impairment due to PsA (OWI) is calculated as: Absenteeism + (1 - Absenteeism) * Presenteeism. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.

Outcome measures

Measure	Humira n=106 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
WPAI:PsA Percentage of OWI: Change From Baseline to Weeks 4, 12, and 16 Baseline	40.22 percentage of OWI Standard Deviation 32.84
WPAI:PsA Percentage of OWI: Change From Baseline to Weeks 4, 12, and 16 Change from Baseline to Week 4	-16.35 percentage of OWI Standard Deviation 24.35
WPAI:PsA Percentage of OWI: Change From Baseline to Weeks 4, 12, and 16 Change from Baseline to Week 12	-18.83 percentage of OWI Standard Deviation 32.64
WPAI:PsA Percentage of OWI: Change From Baseline to Weeks 4, 12, and 16 Change from Baseline to Week 16	-25.91 percentage of OWI Standard Deviation 32.26

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 4, Week 12, Week 16, and 24

Population: Efficacy analysis population

WPAI:PsA is a questionnaire used to evaluate lost productivity due to PsA; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Absenteeism (percentage of work time missed due to PsA) is calculated as the number of hours of work missed due to PsA / (number of hours of work missed due to PsA + number of hours worked) * 100. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.

Outcome measures

Measure	Humira n=106 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
WPAI:PsA Absenteeism: Change From Baseline to Weeks 4, 12, 16 and 24 Baseline	8.41 percentage of work time missed Standard Deviation 22.97
WPAI:PsA Absenteeism: Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 4	-5.13 percentage of work time missed Standard Deviation 16.96
WPAI:PsA Absenteeism: Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 12	-4.96 percentage of work time missed Standard Deviation 16.73
WPAI:PsA Absenteeism: Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 16	-5.37 percentage of work time missed Standard Deviation 17.54
WPAI:PsA Absenteeism: Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 24	-4.90 percentage of work time missed Standard Deviation 20.13

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 4, Week 12, Week 16, and 24

Population: Efficacy analysis population

WPAI:PsA is a questionnaire used to evaluate lost productivity due to PsA; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Presenteeism (percentage of impairment while working due to PsA) is calculated as the patient's rating of how much PsA affected productivity while working (0 = no effect; 10 = completely prevented from working) / 10 * 100. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.

Outcome measures

Measure	Humira n=106 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
WPAI:PsA Presenteeism: Change From Baseline to Weeks 4, 12, 16 and 24 Baseline	37.5 percentage of impairment while working Standard Deviation 32.0
WPAI:PsA Presenteeism: Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 4	-15.1 percentage of impairment while working Standard Deviation 24.3
WPAI:PsA Presenteeism: Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 12	-16.2 percentage of impairment while working Standard Deviation 31.1
WPAI:PsA Presenteeism: Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 16	-24.9 percentage of impairment while working Standard Deviation 31.5
WPAI:PsA Presenteeism: Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 24	-24.3 percentage of impairment while working Standard Deviation 33.4

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 4, Week 12, Week 16, and 24

Population: Efficacy analysis population with evaluable data

WPAI:PsA is a questionnaire used to evaluate lost productivity due to PsA; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Activity impairment (percentage of activity impairment due to PsA) is calculated as the patient's rating of how much PsA affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely prevented from working) / 10 * 100. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.

Outcome measures

Measure	Humira n=104 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
WPAI:PsA Activity Impairment: Change From Baseline to Weeks 4, 12, 16 and 24 Baseline	41.7 percentage of impairment Standard Deviation 30.1
WPAI:PsA Activity Impairment: Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 4	-17.4 percentage of impairment Standard Deviation 23.0
WPAI:PsA Activity Impairment: Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 12	-20.1 percentage of impairment Standard Deviation 28.5
WPAI:PsA Activity Impairment: Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 16	-25.0 percentage of impairment Standard Deviation 32.0
WPAI:PsA Activity Impairment: Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 24	-27.1 percentage of impairment Standard Deviation 32.7

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 4, Week 12, Week 16, and 24

Population: Efficacy analysis population

The PASE is a patient-administered questionnaire used to screen patients with psoriasis for evidence of psoriatic arthritis. The PASE consists of 15 questions divided into 2 subscales (system sub-scale and function sub-scale); 7 questions assess symptoms and 8 questions assess function. Questions are scored on a numeric scale ranging from 1 (strongly disagree) to 5 (strongly agree), with a total possible PASE score of 15 to 75. Individuals who are more likely to have PsA will score higher than individuals without PsA. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.

Outcome measures

Measure	Humira n=106 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
Psoriatic Arthritis Screening and Evaluation Questionnaire (PASE): Change From Baseline to Weeks 4, 12, 16 and 24 Baseline	47.4 units on a scale Standard Deviation 11.7
Psoriatic Arthritis Screening and Evaluation Questionnaire (PASE): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 4	-11.8 units on a scale Standard Deviation 11.0
Psoriatic Arthritis Screening and Evaluation Questionnaire (PASE): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 12	-14.5 units on a scale Standard Deviation 13.8
Psoriatic Arthritis Screening and Evaluation Questionnaire (PASE): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 16	-16.6 units on a scale Standard Deviation 13.6
Psoriatic Arthritis Screening and Evaluation Questionnaire (PASE): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 24	-18.1 units on a scale Standard Deviation 14.0

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 4, Week 12, Week 16, and 24

Population: Efficacy analysis population with evaluable data

PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on of the lesions rated on a a scale from 0 (no symptoms) to 4 (very marked), together with the percentage of the area affected, rated on a scale from 0 (0%) to 6 (100%). 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. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.

Outcome measures

Measure	Humira n=98 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
Psoriasis Area and Severity Index (PASI) Score: Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 24	-6.63 units on a scale Standard Deviation 6.72
Psoriasis Area and Severity Index (PASI) Score: Change From Baseline to Weeks 4, 12, 16 and 24 Baseline	8.97 units on a scale Standard Deviation 8.55
Psoriasis Area and Severity Index (PASI) Score: Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 4	-4.06 units on a scale Standard Deviation 5.46
Psoriasis Area and Severity Index (PASI) Score: Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 12	-5.14 units on a scale Standard Deviation 6.49
Psoriasis Area and Severity Index (PASI) Score: Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 16	-7.35 units on a scale Standard Deviation 7.92

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 4, Week 12, Week 16, and 24

Population: Efficacy analysis population with evaluable data

DAS28 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.

Outcome measures

Measure	Humira n=61 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
Disease Activity Score 28, C-reactive Protein (DAS28 [CRP]): Change From Baseline to Weeks 4, 12, 16 and 24 Baseline	3.77 units on a scale Standard Deviation 1.33
Disease Activity Score 28, C-reactive Protein (DAS28 [CRP]): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 4	-1.48 units on a scale Standard Deviation 0.86
Disease Activity Score 28, C-reactive Protein (DAS28 [CRP]): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 12	-1.83 units on a scale Standard Deviation 0.92
Disease Activity Score 28, C-reactive Protein (DAS28 [CRP]): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 16	-1.84 units on a scale Standard Deviation 1.07
Disease Activity Score 28, C-reactive Protein (DAS28 [CRP]): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 24	-2.13 units on a scale Standard Deviation 1.20

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 4, Week 12, Week 16, and 24

Population: Efficacy analysis population with evaluable data

DAS28 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.

Outcome measures

Measure	Humira n=48 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
Disease Activity Score 28, Erythrocyte Sedimentation Rate (DAS28 [ESR]): Change From Baseline to Weeks 4, 12, 16 and 24 Baseline	4.25 units on a scale Standard Deviation 1.40
Disease Activity Score 28, Erythrocyte Sedimentation Rate (DAS28 [ESR]): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 4	-1.60 units on a scale Standard Deviation 0.65
Disease Activity Score 28, Erythrocyte Sedimentation Rate (DAS28 [ESR]): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 12	-1.99 units on a scale Standard Deviation 0.92
Disease Activity Score 28, Erythrocyte Sedimentation Rate (DAS28 [ESR]): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 16	-2.13 units on a scale Standard Deviation 0.94
Disease Activity Score 28, Erythrocyte Sedimentation Rate (DAS28 [ESR]): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 24	-2.57 units on a scale Standard Deviation 1.20

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 4, Week 12, Week 16, and 24

Population: Efficacy analysis population with evaluable data

At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.

Outcome measures

Measure	Humira n=99 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
Tender Joint Count (TJC68): Change From Baseline to Weeks 4, 12, 16 and 24 Baseline	7.2 tender joints Standard Deviation 8.7
Tender Joint Count (TJC68): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 4	-3.8 tender joints Standard Deviation 7.2
Tender Joint Count (TJC68): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 12	-4.8 tender joints Standard Deviation 9.7
Tender Joint Count (TJC68): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 16	-4.5 tender joints Standard Deviation 7.3
Tender Joint Count (TJC68): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 24	-6.2 tender joints Standard Deviation 9.4

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 4, Week 12, Week 16, and 24

Population: Efficacy analysis population with evaluable data

At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.

Outcome measures

Measure	Humira n=99 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
Swollen Joint Count (SJC66): Change From Baseline to Weeks 4, 12, 16 and 24 Baseline	5.3 swollen joints Standard Deviation 7.0
Swollen Joint Count (SJC66): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 4	-2.7 swollen joints Standard Deviation 5.0
Swollen Joint Count (SJC66): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 12	-3.9 swollen joints Standard Deviation 6.6
Swollen Joint Count (SJC66): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 16	-3.9 swollen joints Standard Deviation 5.4
Swollen Joint Count (SJC66): Change From Baseline to Weeks 4, 12, 16 and 24 Change from Baseline to Week 24	-4.9 swollen joints Standard Deviation 7.2

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 12, and Week 24

Population: Efficacy analysis population with evaluable data

The BASDAI uses a scale from 1 (no problem) to 10 (worst problem) to answer 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (also called enthesitis, or inflammation of tendons and ligaments), morning stiffness duration, and morning stiffness severity. To give each symptom equal weighting, the mean (average) of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final BASDAI score ranging from 0-10. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.

Outcome measures

Measure	Humira n=99 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Change From Baseline to Weeks 12 and 24 Baseline	4.203 units on a scale Standard Deviation 2.334
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Change From Baseline to Weeks 12 and 24 Change from Baseline to Week 12	-2.058 units on a scale Standard Deviation 2.212
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Change From Baseline to Weeks 12 and 24 Change from Baseline to Week 24	-2.745 units on a scale Standard Deviation 2.573

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 12, and Week 24

Population: Efficacy analysis population with evaluable data

The HAQ-DI is a patient-reported outcome which is usually self-administered by the patient. The HAQ-DI assesses the categories of dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. The patients report the amount of difficulty they have in performing these activities using a scale ranging from 0 (can be performed without any difficulty) to 3 (cannot be done at all). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.

Outcome measures

Measure	Humira n=105 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
Health Assessment Questionnaire Disability Index (HAQ-DI): Change From Baseline to Weeks 12 and 24 Baseline	0.5429 units on a scale Standard Deviation 0.5017
Health Assessment Questionnaire Disability Index (HAQ-DI): Change From Baseline to Weeks 12 and 24 Change from Baseline to Week 12	-0.2522 units on a scale Standard Deviation 0.4255
Health Assessment Questionnaire Disability Index (HAQ-DI): Change From Baseline to Weeks 12 and 24 Change from Baseline to Week 24	-0.3996 units on a scale Standard Deviation 0.4719

SECONDARY outcome

Timeframe: Baseline (Week 0) and final visit (up to 24 weeks)

Population: Efficacy analysis population

The percentage of participants with enthesitis.

Outcome measures

Measure	Humira n=106 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
Enthesitis: Change From Baseline to Final Visit Baseline	36.8 percentage of participants
Enthesitis: Change From Baseline to Final Visit Final Visit	12.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0) and final visit (up to 24 weeks)

Population: Efficacy analysis population

The percentage of participants with dactylitis.

Outcome measures

Measure	Humira n=106 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
Dactylitis: Change From Baseline to Final Visit Baseline	55.7 percentage of participants
Dactylitis: Change From Baseline to Final Visit Final Visit	7.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0) and final visit (up to 24 weeks)

Population: Efficacy analysis population

The percentage of participants with spondylitis.

Outcome measures

Measure	Humira n=106 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
Spondylitis: Change From Baseline to Final Visit Baseline	29.2 percentage of participants
Spondylitis: Change From Baseline to Final Visit Final Visit	4.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0) and final visit (up to 24 weeks)

Population: Efficacy analysis population

The percentage of participants with nail psoriasis .

Outcome measures

Measure	Humira n=106 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
Nail Psoriasis: Change From Baseline to Final Visit Baseline	50.9 percentage of participants
Nail Psoriasis: Change From Baseline to Final Visit Final Visit	29.2 percentage of participants

SECONDARY outcome

Timeframe: From the first dose of study drug until the end of the study (up to 24 weeks)

Population: Safety analysis population: All participants enrolled in the study.

An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probable, possible, not related, or impossible to judge. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the physician obtained the patient's authorization or informed consent until the end of the study (week 28 or discontinuation).

Outcome measures

Measure	Humira n=148 Participants Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
Number of Participants With Adverse Events (AEs) Any TEAE	28 participants
Number of Participants With Adverse Events (AEs) Any TESAE	4 participants

Adverse Events

Humira

Serious events: 4 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Measure	Humira n=148 participants at risk Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
Infections and infestations Cellulitis staphylococcal	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Renal and urinary disorders Lupus nephritis	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
General disorders Paradoxical drug reaction	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]

Other adverse events

Measure	Humira n=148 participants at risk Subjects with Psoriatic Arthritis taking adalimumab under conditions of daily clinical practice.
Infections and infestations Bronchiolitis	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Infections and infestations Bronchitis	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Infections and infestations Cellulitis	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Infections and infestations Paronychia	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Infections and infestations Pharyngitis	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Infections and infestations Sinusitis	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Infections and infestations Viral infection	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Infections and infestations Viral upper respiratory tract infection	2.0% 3/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Infections and infestations Herpes zoster infection neurological	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Nervous system disorders Hypoaesthesia	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Respiratory, thoracic and mediastinal disorders Asthma	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Respiratory, thoracic and mediastinal disorders Cough	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Gastrointestinal disorders Oral disorder	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Hepatobiliary disorders Hepatic function abnormal	1.4% 2/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Hepatobiliary disorders Liver disorder	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Skin and subcutaneous tissue disorders Eczema	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Skin and subcutaneous tissue disorders Rash	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Skin and subcutaneous tissue disorders Cutaneous symptom	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Musculoskeletal and connective tissue disorders Arthralgia	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
General disorders Injection site erythema	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
General disorders Injection site pruritus	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
General disorders Oedema	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
General disorders Paradoxical drug reaction	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Investigations Alanine aminotransferase increased	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Investigations Aspartate aminotransferase increased	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Investigations Transaminases increased	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Investigations Antinuclear antibody positive	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Investigations Hepatic enzyme increased	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]
Investigations Cell marker increased	0.68% 1/148 • Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until the end of the study (up to 24 weeks)]

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: abbvieclinicaltrials@abbvie.com

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