Background Results have been previously presented from a 12-week, double-blind placebo-controlled study of 60 patients with psoriatic arthritis (PsA) and psoriasis.1 ENBREL was well tolerated and provided clinically significant benefit to patients with PsA and psoriasis. All patients could receive open-label ENBREL in a 24-week extension study.
Objectives Observe the safety and clinical benefit of ENBREL in a longer-term open-label study.
Methods In the extension study, as in the blinded study, we evaluated improvements in patients with PsA according to PsA response criteria (PsARC) and ACR criteria. Patients with psoriasis were evaluated using the Psoriasis Area and Severity Index (PASI).
Results Fifty-eight patients from the 12-week study received open-label ENBREL in the 24-week extension study and were evaluated according to PsARC and ACR criteria. Thirty-seven patients with psoriasis were evaluated using the PASI. The original ENBREL patients sustained their improvement in both PsA and psoriasis in the extension study. The original placebo patients demonstrated similar improvements once they began receiving ENBREL. At 36 weeks of therapy, 81% of all patients achieved the PsARC, 74% achieved the ACR 20, and 55% achieved the ACR 50. The patients with psoriasis (n = 37) achieved median improvements of 62% in the PASI and 50% in the target lesion response. Of the 28 patients who were taking concomitant methotrexate (MTX) at baseline, 43% (12/28) have decreased their MTX dose and 25% (7/28) patients have discontinued MTX. Similarly, of 18 patients on corticosteroids at baseline, 67% (12/18) have decreased their steroid dose and 44% (8/18) have discontinued steroids. At 36 weeks, 28% of patients had zero tender joints, 41% had zero swollen joints, and 40% had a disability score of zero. ENBREL continued to be well tolerated, with no serious adverse events or infections and no increases in adverse events with extended exposure.
Conclusion ENBREL continues to be safe and effective in reducing the clinical signs and symptoms of PsA and psoriasis for up to 36 weeks.
Mease PJ, Goffe BS, Metz J, et al. Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomized trial. Lancet 2000;356:385–90
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