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

Mean Tender Joint Count (TJC) Over Time

时间窗: Baseline, and Months 3, 6, 9, 12, 18, and 24

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.

Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time

时间窗: Baseline, and Months 3, 6, 9, 12, 18, and 24

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.

Number of Participants With Adverse Events (AEs)

时间窗: Baseline up to 24 months

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.

Mean Change From Baseline in Disease Activity Score (DAS)28

时间窗: Baseline and Months 3, 6, 9, 12, 18, and 24

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.

Mean Target Lesion Score (TLS) Over Time

时间窗: Baseline, and Months 3, 6, 9, 12, 18, and 24

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).

Mean Swollen Joint Count (SJC) Over Time

时间窗: Baseline, and Months 3, 6, 9, 12, 18, and 24

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.