ABSTRACT
OBJECTIVE: To evaluate the long-term effectiveness and tolerability of adalimumab in the treatment of psoriatic arthritis (PsA). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION NUMBER: NCT00195689.
Subject(s)
Antibodies, Monoclonal/therapeutic use , Antirheumatic Agents/therapeutic use , Arthritis, Psoriatic/drug therapy , Adalimumab , Adult , Antibodies, Monoclonal/adverse effects , Antibodies, Monoclonal, Humanized , Antirheumatic Agents/adverse effects , Arthritis, Psoriatic/diagnostic imaging , 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 & inhibitorsABSTRACT
False-positive proteinuria by acid precipitation testing in tolmetin-treated patients has been noted on routine urinalysis screening. However, the magnitude of such false positivity has not been previously reported. We present a patient with systemic lupus erythematosus who presented with nephrotic range pseudoproteinuria using an acid precipitation method of testing. This misleading laboratory result and alternative methods of testing for proteinuria in tolmetin-treated patients are discussed.