Objective: To assess the efficacy and tolerability of etanercept to treat psoriatic arthritis.
Materials and methods: A total of 1,122 patients who had active psoriatic arthritis were enrolled in a Phase 4, non-randomized, open-label, single-arm, 24-week study. These patients had clinically stable, plaque psoriasis involving >or=10% body surface area and joint disease (either >or=two swollen and >or=two tender/painful joints for >or=3 months, or >or=one joint with sacroiliitis or spondylitis). They received etanercept therapy 50 mg subcutaneously once weekly for 24 weeks.
Results: After 24 weeks of treatment, 865 patients (77.1%; 95% CI: 74.64-79.55%) achieved a 'mild or better' score on the physician global assessment of psoriasis and were improved from baseline. Mean improvement in body surface area involvement was 16.9 percentage points (15.89-17.91). Patient global assessment of psoriasis, joint pain, and joint disease scores were improved by means of 2.2 (2.15-2.34), 2.7 (2.53-2.84), and 1.5 (1.39-1.55), respectively. Thirty-five patients (3.1%) experienced at least one serious adverse event. No patient died during the study.
Conclusions: These results support the effectiveness and tolerability of etanercept treatment in patients with psoriatic arthritis being treated at dermatology clinics.