A randomized, open-label trial of continuous versus interrupted etanercept therapy in the treatment of psoriasis.
BACKGROUND: Although etanercept is used as a continuous therapy for moderate to severe plaque psoriasis, intermittent use may be necessary in some instances. OBJECTIVE: In this randomized, open-label study, we evaluated the effectiveness and safety of continuous versus interrupted etanercept therapy. METHODS: All patients received uninterrupted etanercept 50 mg twice weekly during the first 12 weeks, followed by either continuous (n = 1272) or interrupted (n = 1274) etanercept 50 mg once weekly in the next 12 weeks. The primary effectiveness end point was the proportion of responders (those who achieved a Physician's Global Assessment [PGA] score <or=2 and improvement from baseline) at week 24. Secondary end points included the PGA "clear/almost clear" status, the PGA Scalp Psoriasis score, and the Dermatology Life Quality Index. A modified intent-to-treat analysis was performed. RESULTS: At week 12, comparable high proportions of responders were reported in the continuous (71.3%) and interrupted (72.0%) arms. However, the proportion of responders at week 24 was greater in the continuous group than in the interrupted group (71.0% vs 59.5%; P < .0001). Similar results were observed in secondary end points. The mean number of etanercept doses (1 dose = 50 mg) received by patients in the continuous group was 33.4, compared with 28.0 in the interrupted group. Etanercept was well tolerated in both treatment arms. LIMITATIONS: We examined one round of discontinuation and re-treatment; interrupted therapy provided less total medication to responding patients. CONCLUSIONS: Continuous and interrupted etanercept therapy was effective and generally well tolerated in patients with psoriasis, with greater improvements observed in the continuous arm at week 24. Most patients regained their response after reinitiation of etanercept.