Gelfand Joel M, Wan Joy, Callis Duffin Kristina, Krueger Gerald G, Kalb Robert E, Weisman Jamie D, Sperber Brian R, Stierstorfer Michael B, Brod Bruce A, Schleicher Stephen M, Bebo Bruce F, Troxel Andrea B, Shin Daniel B, Steinemann Jane M, Goldfarb Jennifer, Yeung Howa, Van Voorhees Abby S
Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104, USA.
Arch Dermatol. 2012 Apr;148(4):487-94. doi: 10.1001/archdermatol.2012.370.
To compare the effectiveness of biologic systemic therapy, nonbiologic systemic therapy, and phototherapy for treatment of psoriasis.
A cross-sectional design was used.
Ten outpatient dermatology sites across the United States participating in the Dermatology Clinical Effectiveness Research Network contributed to the study.
A total of 713 patients with plaque psoriasis receiving systemic monotherapy (ie, methotrexate sodium, adalimumab, etanercept, or ustekinumab) or narrowband UV-B phototherapy.
The primary outcome of the study was clear or almost clear skin on the Physician Global Assessment scale. Secondary outcomes were score on the Psoriasis Area and Severity Index, affected body surface area, and score on the Dermatology Life Quality Index.
The proportion of patients with clear or almost clear ratings on the Physician Global Assessment scale differed among treatments: methotrexate (23.8%), adalimumab (47.7%), etanercept (34.2%), ustekinumab (36.1%), and narrowband UV-B (27.6%) (P < .001). In adjusted analyses, patients receiving adalimumab (relative response rate, 2.15; 95% CI, 1.60-2.90), etanercept (1.45; 1.06-1.97), and ustekinumab (1.57; 1.06-2.32) were more likely to have clear or almost clear skin vs patients receiving methotrexate. Patients receiving phototherapy showed no significant difference (1.35; 95% CI, 0.93-1.96) compared with those receiving methotrexate. No response difference was observed with respect to quality of life. Treatment doses were double the recommended doses in 36.1% of patients taking etanercept and 11.8% of those taking adalimumab;10.6% of patients undergoing phototherapy received the recommended treatment frequency.
The effectiveness of psoriasis therapies in clinical practice may be lower than that reported in previous trials. Although relative differences in objective response rates among therapies may exist, absolute differences are small and may not be clinically significant. Dosing of common therapies varied from trial recommendations. These results provide novel benchmarks emphasizing the critical importance of studying effectiveness in real-world practice.
比较生物系统性疗法、非生物系统性疗法和光疗治疗银屑病的有效性。
采用横断面设计。
美国十个门诊皮肤科站点参与了皮肤病临床疗效研究网络,为该研究做出了贡献。
共有713例斑块状银屑病患者接受系统性单一疗法(即甲氨蝶呤钠、阿达木单抗、依那西普或乌司奴单抗)或窄谱UV - B光疗。
研究的主要结局是医师整体评估量表上皮肤清除或几乎清除。次要结局包括银屑病面积和严重程度指数评分、受累体表面积以及皮肤病生活质量指数评分。
不同治疗方法在医师整体评估量表上皮肤清除或几乎清除的患者比例存在差异:甲氨蝶呤(23.8%)、阿达木单抗(47.7%)、依那西普(34.2%)、乌司奴单抗(36.1%)和窄谱UV - B(27.6%)(P <.001)。在调整分析中,与接受甲氨蝶呤治疗的患者相比,接受阿达木单抗(相对反应率,2.15;95%置信区间,1.60 - 2.90)、依那西普(1.45;1.06 - 1.97)和乌司奴单抗(1.57;1.06 - 2.32)治疗的患者更有可能皮肤清除或几乎清除。与接受甲氨蝶呤治疗的患者相比,接受光疗的患者无显著差异(1.35;95%置信区间,0.93 - 1.96)。在生活质量方面未观察到反应差异。在接受依那西普治疗的患者中,36.1%的患者治疗剂量是推荐剂量的两倍,接受阿达木单抗治疗的患者中11.8%是两倍;接受光疗的患者中有10.6%接受了推荐的治疗频率。
银屑病治疗在临床实践中的有效性可能低于先前试验报告的有效性。尽管不同疗法之间客观反应率可能存在相对差异,但绝对差异较小,可能无临床意义。常用疗法的给药剂量与试验推荐不同。这些结果提供了新的基准,强调了在实际临床实践中研究有效性的至关重要性。