Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT)

• Published in: Annals of the rheumatic diseases Vol. 68; no. 5; p. 702
• Main Authors: Mease, P J, Ory, P, Sharp, J T, Ritchlin, C T, Van den Bosch, F, Wellborne, F, Birbara, C, Thomson, G T D, Perdok, R J, Medich, J, Wong, R L, Gladman, D D
• Format: Journal Article
• Language: English
• Published: England 01-05-2009
• Subjects: Adalimumab; Adult; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - therapeutic use; Antibodies, Monoclonal, Humanized; Antirheumatic Agents - adverse effects; Antirheumatic Agents - therapeutic use; Arthritis, Psoriatic - diagnostic imaging; Arthritis, Psoriatic - drug therapy; Arthritis, Psoriatic - pathology; Disease Progression; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Psoriasis - drug therapy; Psoriasis - pathology; Quality of Life; Radiography; Severity of Illness Index; Treatment Outcome; Tumor Necrosis Factor-alpha - antagonists & inhibitors
• ISSN: 1468-2060
• DOI: 10.1136/ard.2008.092767

To evaluate the long-term effectiveness and tolerability of adalimumab in the treatment of psoriatic arthritis (PsA).
Patients with PsA who completed a 24-week, double-blind study of adalimumab versus placebo were eligible to enroll in an open-label extension study and receive adalimumab 40 mg subcutaneously every other week for up to an additional 120 weeks. At the time of this analysis, available efficacy evaluations throughout 2 years of treatment (n = 245) included American College of Rheumatology (ACR) 20%, 50% and 70% improvement scores, measures of joint disease and skin disease, disability and quality of life; modified total Sharp scores (mTSS) were available for 2.75 years of treatment for patients who received adalimumab in the 24-week study.
After 24 weeks of double-blind treatment, the mean change in mTSS was -0.2 for the adalimumab group (N = 144) and 1.0 for the placebo group (N = 152; p<0.001), and outcomes for all individual ACR component variables were significantly improved in adalimumab compared with placebo-treated patients. Compared with 24-week responses, inhibition of radiographic progression and improvements in joint disease were maintained in most patients during long-term, open-label adalimumab treatment. Also, improvements in skin disease were maintained, with >20% of patients achieving the strict criterion of psoriasis area and severity index 100. The nature and frequency of adverse events during long-term adalimumab treatment were consistent with the safety profile during short-term treatment.
The clinical and radiographic efficacy of adalimumab demonstrated during short-term treatment was sustained during long-term treatment. Adalimumab has a favourable risk-benefit profile in patients with PsA.
NCT00195689.