Efficacy and Safety of Humira® in Patients With Psoriatic Arthritis in Normal Medical Practice

Study Overview
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Brief Summary
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This study is a documentation of effectiveness and safety of Humira in patients with psoriatic arthritis.

Detailed Description
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Psoriatic Arthritis participants receiving adalimumab are evaluated in a prospective, non-interventional study (NIS) for 2 years. Patients receive adalimumab 40 mg every other week (eow), per its label. Efficacy and safety parameters are measured routinely at baseline and after 3, 6, 9, 12, 18 and 24 months.

Official Title
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A Long Term Documentation to Demonstrate Long Term Efficacy and Safety of Humira® in Patients With Psoriatic Arthritis Under Conditions of Daily Practice

Conditions
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Psoriatic Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion: 18 years of age or older (younger patients may be enrolled at the discretion of physician) Diagnosis of Psoriatic Arthritis (or any indication at the discretion of physician) and initiating adalimumab therapy Signed/dated Informed Consent Exclusion: -None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Psoriatic Arthritis<br>Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Disease Activity Score (DAS)28 | The DAS28 is a validated index of rheumatoid 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. A DAS28 score greater than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. | Baseline and Months 3, 6, 9, 12, 18, and 24 | 
| Mean Tender Joint Count (TJC) Over Time | Tender joint count represents the number of joints displaying tenderness. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not. | Baseline, and Months 3, 6, 9, 12, 18, and 24 | 
| Mean Swollen Joint Count (SJC) Over Time | Swollen joint count represents the number of joints displaying swelling. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not. | Baseline, and Months 3, 6, 9, 12, 18, and 24 | 
| Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time | Body surface area was used to evaluate the extent of psoriatic skin involvement. At baseline, investigators classified participants as having BSA less than 3%, 3 to 10%, 11 to 20%, or greater than 20%. At all post-baseline time points, clinicians were asked to estimate BSA on a scale of 0% to 100% rather than as categories. BSA was visually determined by the investigator using the 'rule of nines' and estimating that the palm of the patient's hand was equal to 1% BSA. | Baseline, and Months 3, 6, 9, 12, 18, and 24 | 
| Mean Target Lesion Score (TLS) Over Time | The Target Lesion Score (TLS) was based on the severity of erythema, scaling, and infiltration of a prospectively-defined psoriasis target lesion of at least 2 cm in width that was considered to be representative of all other affected areas. Each of the three characteristics was evaluated by the clinician on a scale of 0 (absent) to 5 (maximal expression), and these scores were totaled to provide a TLS ranging from 0 (lowest severity) to 15 (highest severity). | Baseline, and Months 3, 6, 9, 12, 18, and 24 | 
| Number of Participants With Adverse Events (AEs) | Adverse Events (AEs) were reported that clinicians considered to be related to the study drug. An AE was considered to be a serious adverse event (SAE) if any of the following criteria were met: Death of participant, life-threatening event, hospitalization, prolongation of hospitalization, congenital anomaly, persistent or significant disability or incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, or spontaneous or elective abortion. | Baseline up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants by Severity of Enthesitis Over Time | Enthesitis is a distinguishing characteristic of PsA. Enthesitis involves inflammation at the site where tendons and other connective tissues enter the bone. Investigators reported the presence or absence of enthesitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression. | Baseline, and Months 3, 6, 9, 12, 18, and 24 | 
| Number of Participants by Severity of Dactylitis Over Time | Dactylitis is a distinguishing characteristic of PsA. Dactylitis, sometimes referred to sausage digit, involves swelling of the entire finger. Investigators reported the presence or absence of dactylitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression. | Baseline, and Months 3, 6, 9, 12, 18, and 24 | 
| Number of Participants by Severity of Nail Psoriasis Levels Over Time | Nail psoriasis is a distinguishing characteristic of PsA. Nail psoriasis is characterized by changes in the nail and nail matrix, including pitting, onycholysis (painless separation of the nail from the nail bed), and reddish spots. Investigators reported the presence or absence of nail psoriasis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of this condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression. | Baseline, and Months 3, 6, 9, 12, 18, and 24 | 
| Mean Erythrocyte Sedimentation Rate (ESR) Over Time | The Erythrocyte Sedimentation Rate (ESR) is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity. | Baseline, and Months 3, 6, 9, 12, 18, and 24 | 
| Mean C-Reactive Protein (CRP) Levels Over Time | The C-Reactive Protein (CRP) is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL. | Baseline, and Months 3, 6, 9, 12, 18, and 24 | 
| Patients Global Assessment of Disease Activity Over Time | Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status. | Baseline, and Months 3, 6, 9, 12, 18, and 24 | 
| Participants Assessment of Fatigue Over Time | Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status. | Baseline, and Months 3, 6, 9, 12, 18, and 24 | 
| Participants Assessment of Pain Over Time | Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status. | Baseline, and Months 3, 6, 9, 12, 18, and 24 | 
| Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time | A self-administered participant questionnaire used to assess patient function on a scale of 0 (total loss of functional capacity) to 100 (maximal functional capacity) units; the FFbH score indicates the remaining percentage of participant function. | Baseline, and Months 3, 6, 9, 12, 18, and 24 | 
| Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit |  | Baseline, and Months 3, 6, 9, 12, 18, and 24 | 
| Mean Number of Days Missed From Work Due to Psoriatic Arthritis | Mean number of days missed from work were derived from patient recall of events in the preceding 12 months (at baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24). | Baseline, and Months 3, 6, 9, 12, 18, and 24 | 
| Percentage of Participants With In-Patient Hospitalization | Percentage of participants with in-patient hospitalization were derived from patient recall of events in the preceding 12 months (at Baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24). | Baseline, and Months 3, 6, 9, 12, 18, and 24 | 
| Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication | Prior and concomitant non-biologic disease-modifying antirheumatic drugs (DMARDs): methotrexate (MTX) and other DMARDs | Baseline, and Months 6 and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Humira, Long-term safety and effectiveness, Psoriatic Arthritis