科研之友
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摘要
Background Etanercept plus methotrexate combination therapy has not been adequately investigated in psoriasis. %26lt;br%26gt;Objectives To evaluate etanercept plus methotrexate vs. etanercept monotherapy in patients with moderate to severe plaque psoriasis who had not failed prior methotrexate or tumour necrosis factor-inhibitor therapy. %26lt;br%26gt;Methods Patients received etanercept 50 mg twice weekly for 12 weeks followed by 50 mg once weekly for 12 weeks and were randomized 1 : 1 to receive methotrexate (7.5-15 mg weekly) or placebo. The primary endpoint was the proportion of patients achieving %26gt;= 75% improvement in Psoriasis Area and Severity Index (PASI 75) at week 24. %26lt;br%26gt;Results In total, 239 patients were enrolled in each arm. PASI 75 was significantly higher at week 24 for the combination therapy group compared with the monotherapy group (77.3% vs. 60.3%; P %26lt; 0 0001). Other PASI improvement scores at week 12 [PASI 75, 70.2% vs. 54.3% (P = 0.01); PASI 50, 92.4% vs. 83.8% (P = 0.01); and PASI 90, 34.0% vs. 23.1% (P = 0.03)] showed similar results as did week 24 PASI 50 (91.6% vs. 84.6%; P = 0.01) and PASI 90 (53.8% vs. 34 2%; P = 0 01). Significantly more patients receiving combination therapy than monotherapy had static Physician%26apos;s Global Assessment of clear/almost clear at week 12 (65.5% vs. 47.0%; P = 0.01) and week 24 (71.8% vs. 54.3%; P = 0.01). Adverse events (AEs) were reported in 74.9% and 59.8% of combination therapy and monotherapy groups, respectively; three serious AEs were reported in each arm. %26lt;br%26gt;Conclusions Combination therapy with etanercept plus methotrexate had acceptable tolerability and increased efficacy compared with etanercept monotherapy in patients with moderate to severe psoriasis.
- 出版日期2012-9
