Trial Outcomes & Findings for To Observe the Impacts of Anti-Tumor Necrosis Factor (TNF) Effectiveness on Improvement in Work Place and Household Productivity for Patients With Psoriatic Arthritis (PsA) (NCT NCT02028169)

NCT ID: NCT02028169

Last Updated: 2017-04-27

Results Overview

Absenteeism, presented as the mean percentage of work time missed due to PsA (as reported on the WPAI), and calculated as: 100\*number of hours of work missed due to PsA / (number of hours of work missed due to PsA + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

• Recruitment status: COMPLETED
• Target enrollment: 120 participants
• Primary outcome timeframe: Baseline, Month 3, Month 6, Month 9
• Results posted on: 2017-04-27

Participant Flow

Participant milestones

Measure	Participants Receiving Anti-TNF for PsA Participants who are actively working (full-time or part-time) with rheumatologist-confirmed psoriatic arthritis (PsA) for which the physician has initiated treatment with an anti-tumor necrosis factor (TNF).
Overall Study STARTED	120
Overall Study COMPLETED	92
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Measure	Participants Receiving Anti-TNF for PsA Participants who are actively working (full-time or part-time) with rheumatologist-confirmed psoriatic arthritis (PsA) for which the physician has initiated treatment with an anti-tumor necrosis factor (TNF).
Overall Study Lost to Follow-up	21
Overall Study Lack of Efficacy	2
Overall Study Withdrawal by Subject	2
Overall Study Adverse Event	1
Overall Study Cessation of Drug	1
Overall Study Concomitant Medication Usage	1

Baseline Characteristics

To Observe the Impacts of Anti-Tumor Necrosis Factor (TNF) Effectiveness on Improvement in Work Place and Household Productivity for Patients With Psoriatic Arthritis (PsA)

Baseline characteristics by cohort

Measure	Participants Receiving Anti-TNF for PsA n=120 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
Age, Continuous	41.65 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9

Population: Participants with an assessment at given time point.

Absenteeism, presented as the mean percentage of work time missed due to PsA (as reported on the WPAI), and calculated as: 100*number of hours of work missed due to PsA / (number of hours of work missed due to PsA + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=58 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Up to Month 9 Baseline	20.5 percentage of work time missed Standard Deviation 22.2
Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Up to Month 9 Month 3	10.0 percentage of work time missed Standard Deviation 20.0
Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Up to Month 9 Month 6	7.9 percentage of work time missed Standard Deviation 16.2
Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Up to Month 9 Month 9	4.9 percentage of work time missed Standard Deviation 10.5

PRIMARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9

Population: Participants with an assessment at given time point.

Presenteeism (the extent to which PsA decreased productivity) is presented as the mean percentage of impairment while working due to PsA, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=59 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
WPAI Questionnaire: Mean Percentage of Impairment While Working Due to PsA (Presenteeism) Up to Month 9 Baseline	53.7 percentage of impairment while working Standard Deviation 22.9
WPAI Questionnaire: Mean Percentage of Impairment While Working Due to PsA (Presenteeism) Up to Month 9 Month 3	26.5 percentage of impairment while working Standard Deviation 24.1
WPAI Questionnaire: Mean Percentage of Impairment While Working Due to PsA (Presenteeism) Up to Month 9 Month 6	27.1 percentage of impairment while working Standard Deviation 24.2
WPAI Questionnaire: Mean Percentage of Impairment While Working Due to PsA (Presenteeism) Up to Month 9 Month 9	19.5 percentage of impairment while working Standard Deviation 19.9

PRIMARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9

Population: Participants with an assessment at given time point.

The mean percentage of OWPI due to PsA (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) +[1- Absenteeism(%)*Presenteeism(%)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=58 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to PsA Up to Month 9 Baseline	42.8 percentage of OWPI Standard Deviation 21.4
WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to PsA Up to Month 9 Month 3	21.6 percentage of OWPI Standard Deviation 18.4
WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to PsA Up to Month 9 Month 6	21.0 percentage of OWPI Standard Deviation 17.2
WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to PsA Up to Month 9 Month 9	15.3 percentage of OWPI Standard Deviation 14.2

PRIMARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9

Population: Participants with an assessment at given time point.

Activity impairment due to PsA (the extent to which PsA affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=120 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
WPAI Questionnaire: Mean Percentage of Activity Impairment Due to PsA Up to Month 9 Baseline	60.2 percentage of activity impairment Standard Deviation 19.2
WPAI Questionnaire: Mean Percentage of Activity Impairment Due to PsA Up to Month 9 Month 3	35.3 percentage of activity impairment Standard Deviation 23.7
WPAI Questionnaire: Mean Percentage of Activity Impairment Due to PsA Up to Month 9 Month 6	28.7 percentage of activity impairment Standard Deviation 20.9
WPAI Questionnaire: Mean Percentage of Activity Impairment Due to PsA Up to Month 9 Month 9	23.0 percentage of activity impairment Standard Deviation 20.6

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9

Population: Participants with an assessment at given time point.

The HAQ-DI is a participant-reported questionnaire. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide a total score ranging from 0 (no disability) to 3 (very severe, high-dependency disability).

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=120 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
Health Assessment Questionnaire Disability Index (HAQ-DI) Score Up to Month 9 Baseline	1.73 units on a scale Standard Deviation 0.50
Health Assessment Questionnaire Disability Index (HAQ-DI) Score Up to Month 9 Month 3	1.24 units on a scale Standard Deviation 0.65
Health Assessment Questionnaire Disability Index (HAQ-DI) Score Up to Month 9 Month 6	1.15 units on a scale Standard Deviation 0.63
Health Assessment Questionnaire Disability Index (HAQ-DI) Score Up to Month 9 Month 9	1.08 units on a scale Standard Deviation 0.59

SECONDARY outcome

Timeframe: Month 9

Population: Participants with an assessment.

A participant is an ACR20, ACR50, or ACR70 responder if the following 3 criteria for improvement from Baseline are met:

• ≥ 20%, ≥ 50%, or ≥ 70% improvement in tender joint count;
• ≥ 20%, ≥ 50%, or ≥ 70% improvement in swollen joint count; and
• ≥ 20%, ≥ 50%, or ≥ 70% improvement in at least 3 of the 5 following parameters:

• Physician's global assessment of disease activity
• Participant's global assessment of disease activity
• Participant's assessment of pain
• HAQ-DI
• Acute phase reactant (erythrocyte sedimentation rate/C-reactive protein).

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=91 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
Percentage of Participants With American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Month 9 ACR20 Responder = No	13.2 percentage of participants
Percentage of Participants With American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Month 9 ACR20 Responder = Yes	86.8 percentage of participants
Percentage of Participants With American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Month 9 ACR50 Responder = No	36.3 percentage of participants
Percentage of Participants With American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Month 9 ACR50 Responder = Yes	63.7 percentage of participants
Percentage of Participants With American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Month 9 ACR70 Responder = No	58.2 percentage of participants
Percentage of Participants With American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Month 9 ACR70 Responder = Yes	41.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9

Population: All participants

The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. Participants were classified according to their scores as below:

• DAS28 > 5.1 = High disease activity
• DAS28 < 3.2 = Low disease activity
• DAS28 < 2.6 = Remission

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=120 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
Disease Activity Score (DAS 28) Up to Month 9 Baseline · < 2.6	1 Participants
Disease Activity Score (DAS 28) Up to Month 9 Baseline · 2.6 to 3.2	6 Participants
Disease Activity Score (DAS 28) Up to Month 9 Baseline · 3.2 to 5.1	49 Participants
Disease Activity Score (DAS 28) Up to Month 9 Baseline · > 5.1	62 Participants
Disease Activity Score (DAS 28) Up to Month 9 Baseline · Missing	2 Participants
Disease Activity Score (DAS 28) Up to Month 9 Month 3 · < 2.6	32 Participants
Disease Activity Score (DAS 28) Up to Month 9 Month 3 · 2.6 to 3.2	19 Participants
Disease Activity Score (DAS 28) Up to Month 9 Month 3 · 3.2 to 5.1	34 Participants
Disease Activity Score (DAS 28) Up to Month 9 Month 3 · > 5.1	16 Participants
Disease Activity Score (DAS 28) Up to Month 9 Month 3 · Missing	19 Participants
Disease Activity Score (DAS 28) Up to Month 9 Month 6 · 2.6 to 3.2	29 Participants
Disease Activity Score (DAS 28) Up to Month 9 Month 6 · 3.2 to 5.1	20 Participants
Disease Activity Score (DAS 28) Up to Month 9 Month 6 · > 5.1	6 Participants
Disease Activity Score (DAS 28) Up to Month 9 Month 6 · Missing	27 Participants
Disease Activity Score (DAS 28) Up to Month 9 Month 9 · < 2.6	49 Participants
Disease Activity Score (DAS 28) Up to Month 9 Month 9 · 2.6 to 3.2	21 Participants
Disease Activity Score (DAS 28) Up to Month 9 Month 9 · 3.2 to 5.1	15 Participants
Disease Activity Score (DAS 28) Up to Month 9 Month 9 · > 5.1	4 Participants
Disease Activity Score (DAS 28) Up to Month 9 Month 9 · Missing	31 Participants
Disease Activity Score (DAS 28) Up to Month 9 Month 6 · < 2.6	38 Participants

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9

Population: Participants with an assessment at given time point.

For calculation of the enthesitis (tenderness) score, MASES was used in practice by the physicians. This scale takes into account the sites (first costochondral joint, seventh costochondral joint, posterior superior iliac spine, anterior superior iliac spine, iliac crest, fifth lumbar spinous process and proximal insertion of the Achilles tendon) and they scored from 0 to 13. Minimum tenderness score was 0; maximum tenderness score was 13.

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=119 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
Maastricht Ankylosing Spondylitis Enthesitis Scale (MASES) Up to Month 9 Baseline	1.75 units on a scale Standard Deviation 2.37
Maastricht Ankylosing Spondylitis Enthesitis Scale (MASES) Up to Month 9 Month 3	0.60 units on a scale Standard Deviation 1.50
Maastricht Ankylosing Spondylitis Enthesitis Scale (MASES) Up to Month 9 Month 6	0.19 units on a scale Standard Deviation 0.76
Maastricht Ankylosing Spondylitis Enthesitis Scale (MASES) Up to Month 9 Month 9	0.45 units on a scale Standard Deviation 1.50

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9

Population: Participants with an assessment at given time point.

A total of 20 digits were assessed as entire digits, looking for signs of tender dactylitis. Dactylitis is defined as a uniform swelling of the digits where the joints cannot be defined. Investigators entered scores between 0 (no swelling or pain) and 6 (most severe swelling and pain).

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=118 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
Dactylitis Score Up to Month 9 Baseline	0.47 units on a scale Standard Deviation 1.01
Dactylitis Score Up to Month 9 Month 3	0.15 units on a scale Standard Deviation 0.60
Dactylitis Score Up to Month 9 Month 6	0.06 units on a scale Standard Deviation 0.43
Dactylitis Score Up to Month 9 Month 9	0.03 units on a scale Standard Deviation 0.24

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9

Population: Participants with an assessment at given time point.

Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The presence of swelling is scored 1 and no swelling is 0; range of score is 0-28, with higher scores indicating more swollen joints.

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=120 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
Number of Swollen Joints Up to Month 9 Baseline	4.91 swollen joints Standard Deviation 4.88
Number of Swollen Joints Up to Month 9 Month 3	1.99 swollen joints Standard Deviation 3.78
Number of Swollen Joints Up to Month 9 Month 6	0.39 swollen joints Standard Deviation 0.87
Number of Swollen Joints Up to Month 9 Month 9	0.54 swollen joints Standard Deviation 1.38

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9

Population: Participants with an assessment at given time point.

Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The presence of tenderness is scored 1 and no tenderness is 0; range of score is 0-28, with higher scores indicating more tender joints.

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=120 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
Number of Tender Joints Up to Month 9 Month 9	1.92 tender joints Standard Deviation 4.14
Number of Tender Joints Up to Month 9 Baseline	8.24 tender joints Standard Deviation 8.22
Number of Tender Joints Up to Month 9 Month 3	3.91 tender joints Standard Deviation 6.98
Number of Tender Joints Up to Month 9 Month 6	1.38 tender joints Standard Deviation 2.41

SECONDARY outcome

Timeframe: Up to Month 9

Population: Since sufficient data could not be collected, this analysis was not performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Month 9

Population: Participants with an assessment at given time point.

ESR values were measured as an inflammatory parameter. Low ESR values mean less inflammation.

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=96 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
Erythrocyte Sedimentation Rate (ESR) Up to Month 9 Baseline	6.46 mm/h Standard Deviation 11.99
Erythrocyte Sedimentation Rate (ESR) Up to Month 9 Month 3	14.71 mm/h Standard Deviation 12.23
Erythrocyte Sedimentation Rate (ESR) Up to Month 9 Month 6	14.28 mm/h Standard Deviation 12.32
Erythrocyte Sedimentation Rate (ESR) Up to Month 9 Month 9	15.65 mm/h Standard Deviation 12.94

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9

Population: Participants with an assessment at given time point.

CRP values were measured as an inflammatory parameter. Low CRP values mean less inflammation.

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=118 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
C-reactive Protein (CRP) Up to Month 9 Baseline	19.73 mg/dL Standard Deviation 48.06
C-reactive Protein (CRP) Up to Month 9 Month 3	26.64 mg/dL Standard Deviation 18.63
C-reactive Protein (CRP) Up to Month 9 Month 6	5.89 mg/dL Standard Deviation 10.20
C-reactive Protein (CRP) Up to Month 9 Month 9	4.95 mg/dL Standard Deviation 7.85

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9

Population: Participants with an assessment at given time point.

A VAS was used to measure the participant's assessment of disease activity. For this assessment a 10-point scale was used (0: very well; 10: very poor).

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=120 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Up to Month 9 Baseline	6.73 units on a scale Standard Deviation 1.63
Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Up to Month 9 Month 9	2.89 units on a scale Standard Deviation 2.15
Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Up to Month 9 Month 3	3.93 units on a scale Standard Deviation 2.76
Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Up to Month 9 Month 6	3.04 units on a scale Standard Deviation 1.82

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9

Population: Participants with an assessment at given time point.

A VAS was used to measure the physician's assessment of disease activity. For this assessment a 10-point scale was used (0: very well; 10: very poor).

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=120 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
Physician's Global Assessment of Disease Activity VAS Up to Month 9 Baseline	6.45 units on a scale Standard Deviation 1.35
Physician's Global Assessment of Disease Activity VAS Up to Month 9 Month 3	3.49 units on a scale Standard Deviation 2.16
Physician's Global Assessment of Disease Activity VAS Up to Month 9 Month 6	2.62 units on a scale Standard Deviation 1.54
Physician's Global Assessment of Disease Activity VAS Up to Month 9 Month 9	2.26 units on a scale Standard Deviation 1.74

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9

Population: Participants with an assessment at given time point.

A VAS was used to measure the participant's assessment of nocturnal back pain and fatigue. For this assessment a 10-point scale was used (0: very well; 10: very poor).

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=120 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
Participant's Assessment of Nocturnal Back Pain and Fatigue VAS Up to Month 9 Baseline	5.57 units on a scale Standard Deviation 2.50
Participant's Assessment of Nocturnal Back Pain and Fatigue VAS Up to Month 9 Month 3	3.06 units on a scale Standard Deviation 2.84
Participant's Assessment of Nocturnal Back Pain and Fatigue VAS Up to Month 9 Month 6	2.58 units on a scale Standard Deviation 2.24
Participant's Assessment of Nocturnal Back Pain and Fatigue VAS Up to Month 9 Month 9	2.08 units on a scale Standard Deviation 2.08

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9

Population: Participants with an assessment at given time point.

A VAS was used to measure the participant's assessment of back pain. For this assessment a 10-point scale was used (0: very well; 10: very poor).

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=120 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
Participant's Assessment of Total Back Pain VAS Up to Month 9 Baseline	5.25 units on a scale Standard Deviation 2.64
Participant's Assessment of Total Back Pain VAS Up to Month 9 Month 3	3.28 units on a scale Standard Deviation 2.46
Participant's Assessment of Total Back Pain VAS Up to Month 9 Month 6	2.47 units on a scale Standard Deviation 2.22
Participant's Assessment of Total Back Pain VAS Up to Month 9 Month 9	2.22 units on a scale Standard Deviation 2.16

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 9

Population: Participants with an assessment at given time point.

A VAS was used to measure the participant's assessment of pain and fatigue. For this assessment a 10-point scale was used (0: very well; 10: very poor).

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=120 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
Participant's Assessment of Pain and Fatigue VAS Up to Month 9 Baseline	6.37 units on a scale Standard Deviation 1.75
Participant's Assessment of Pain and Fatigue VAS Up to Month 9 Month 3	4.31 units on a scale Standard Deviation 6.93
Participant's Assessment of Pain and Fatigue VAS Up to Month 9 Month 6	2.91 units on a scale Standard Deviation 2.17
Participant's Assessment of Pain and Fatigue VAS Up to Month 9 Month 9	2.67 units on a scale Standard Deviation 2.45

SECONDARY outcome

Timeframe: Up to Month 9

Population: All participants

Number of participants with any serious adverse event (SAE) occurring during treatment with anti-TNF agents and/or participants who discontinued treatment due to SAEs or AEs which were caused by the treatment with anti-TNF agents during the course of treatment. An SAE is defined as an event that: results in the death; is life-threatening; results in an admission to the hospital or prolongation of hospitalization; is a congenital anomaly; results in a condition that substantially interferes with the activities of daily living of a study subject; is an important medical event according to the Investigator.

Outcome measures

Measure	Participants Receiving Anti-TNF for PsA n=120 Participants Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Treatment-Related Adverse Events (AEs) Up to Month 9 Any SAE	1 Participants
Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Treatment-Related Adverse Events (AEs) Up to Month 9 Discontinuations	0 Participants

Adverse Events

Participants Receiving Anti-TNF for PsA

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Participants Receiving Anti-TNF for PsA n=120 participants at risk Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
Infections and infestations Tuberculosis of genitourinary system	0.83% 1/120 • Up to Month 9 SAEs were collected and reported; per protocol, non-serious AE data was not collected for this observational study.

Other adverse events

Adverse event data not reported

Additional Information

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AbbVie

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