This study is a documentation of effectiveness and safety of Humira in patients with psoriatic arthritis.
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.
Study Type
OBSERVATIONAL
Enrollment
4,635
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Site Reference ID/Investigator# 35035
Aachen, Germany
Site Reference ID/Investigator# 64288
Aachen, Germany
Site Reference ID/Investigator# 35509
Ahlen, Germany
Site Reference ID/Investigator# 53118
Ahrensburg, Germany
Site Reference ID/Investigator# 35042
Altenburg, Germany
Site Reference ID/Investigator# 35045
Altenholz, Germany
Site Reference ID/Investigator# 35048
Amberg, Germany
Site Reference ID/Investigator# 96243
Annaberg-Buchholz, Germany
Site Reference ID/Investigator# 53205
Arnstadt, Germany
Site Reference ID/Investigator# 53091
Artern, Germany
...and 499 more locations
Time frame: 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).
Time frame: 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.
Time frame: Baseline up to 24 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: Baseline, and Months 6 and 24