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Background  Topical corticosteroids are used with systemic therapies for treatment of plaque psoriasis, but data from randomized clinical trials to document efficacy of combination therapy are lacking.    Objective  To evaluate efficacy and safety of adding topical corticosteroid therapy from the time that etanercept dosage is reduced from initial label dose [50 mg twice weekly ( BIW )] to maintenance dose [50 mg once weekly ( QW )].    Methods  In this phase 3b, multicentre, randomized, open‐label study, patients with moderate‐to‐severe plaque psoriasis received etanercept 50 mg BIW for 12 weeks, and then were randomized to etanercept 50 mg BIW or 50 mg QW plus topical agent as needed to achieve static physician global assessment ( sPGA ) status of clear for 12 weeks. Endpoints included percentage change in Psoriasis Area and Severity Index (PASI) score from week 12 to week 24 (primary endpoint); proportion of patients achieving 50% improvement in (PASI 50), PASI 75 and PASI 90; patients achieving  sPGA  of clear/almost clear; and change in affected body surface area (BSA).    Results  Mean difference [95% confidence interval (CI)] between etanercept arm ( n  = 140) and etanercept plus topical arm ( n  = 142) in change in PASI score from week 12 to week 24 was 16.2% (−3.5%, 35.8%). PASI response rates were similar between groups. Percentage (95% CI) of patients achieving  sPGA  status of clear/almost clear was 40.6% (32.5%, 48.6%) and 45.8% (37.6%, 54.0%) at week 12 for patients in etanercept and etanercept plus topical arms, respectively, and 53.5% (45.3%, 61.7%) and 45.4% (37.2%, 53.6%) at week 24. Difference (95% CI) between groups in change in affected BSA from week 12 to week 24 was 4.9% (−23.4%, 33.2%).    Conclusion  Patients who received etanercept 50 mg  QW  at week 12 plus as‐needed topical therapy and those who stayed on etanercept 50 mg  BIW  maintained clinical response through week 24 with no notable differences in  PASI  responses.

journal of the european academy of dermatology and venereology

A  R andomized, blinded assessor study to  E valuate the ef FI cacy and safety of etanercept 50 mg once weekly plus as  N eeded topical agent vs.  E tanercept 50 mg twice weekly in patients with moderate to severe plaque psoriasis ( REFINE )