Center for Dermatology Research, Departments of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC 27157-1071, USA.
Am J Clin Dermatol. 2012 Dec 1;13(6):365-74. doi: 10.2165/11633110-000000000-00000.
Psoriasis is a chronic, immune-mediated skin disease that also has systemic manifestations. Safe and effective long-term treatments are needed. Biologic treatments that inhibit the immunopathogenesis of psoriasis have helped meet this need.
The purpose of this study was to compare the efficacy of biologic therapies used for psoriasis.
A literature search was performed using PubMed and the keywords '(PASI-75 OR efficacy) AND psoriasis AND (adalimumab OR alefacept OR etanercept OR infliximab OR ustekinumab).' Randomized, double-blind, and placebo-controlled studies on US FDA-approved biologics were selected. Studies assessing the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index (PASI-75) within a 12-week period were included. Studies on pediatric populations and psoriatic arthritis were excluded. The weighted average of PASI-75 for each reported regimen was calculated to determine the efficacy of biologic agents used for moderate-to-severe psoriasis. Tolerance and secondary efficacy measures were also examined for the selected studies.
FDA-approved regimens of adalimumab, infliximab, ustekinumab, and alefacept were effective in treating moderate-to-severe psoriasis. Weighted average PASI-75 scores for infliximab, ustekinumab, adalimumab, etanercept, and alefacept were 78.6%, 72.1%, 70.5%, 48.1%, and 21%, respectively.
The comparative efficacy of biologic agents data was limited to 12 weeks, thus generalizing the results to longer treatment periods may not be accurate.
Various biologic agents for psoriasis were effective at 12 weeks in placebo-controlled trials. Available data cannot fully account for situations in clinical practice, in which combination and longer duration of therapy may be required. When choosing the most effective or best agent, multiple factors should be considered including patient preference, cost, tolerance, adverse effects, dosing schedule, and mode of administration.
银屑病是一种慢性、免疫介导的皮肤疾病,也有全身表现。需要安全有效的长期治疗方法。抑制银屑病免疫发病机制的生物治疗已有助于满足这一需求。
本研究旨在比较用于银屑病的生物疗法的疗效。
使用 PubMed 进行文献检索,并使用关键词“(PASI-75 或疗效)和银屑病和(阿达木单抗或阿法赛普或依那西普或英夫利昔单抗或乌司奴单抗)”。选择了美国食品和药物管理局 (FDA) 批准的生物制剂的随机、双盲、安慰剂对照研究。纳入了在 12 周内评估受试者达到银屑病面积和严重程度指数(PASI-75)改善 75%比例的研究。排除了儿科人群和银屑病关节炎的研究。为了确定用于中重度银屑病的生物制剂的疗效,计算了每个报告方案的 PASI-75 的加权平均值。还检查了选定研究的耐受性和次要疗效指标。
阿达木单抗、英夫利昔单抗、乌司奴单抗和阿法赛普的 FDA 批准方案对治疗中重度银屑病有效。英夫利昔单抗、乌司奴单抗、阿达木单抗、依那西普和阿法赛普的加权平均 PASI-75 评分分别为 78.6%、72.1%、70.5%、48.1%和 21%。
生物制剂比较疗效数据仅限于 12 周,因此将结果推广到更长的治疗期可能不准确。
在安慰剂对照试验中,各种用于银屑病的生物制剂在 12 周时有效。现有数据不能充分说明临床实践中的情况,在临床实践中可能需要联合治疗和更长的治疗时间。在选择最有效或最佳的药物时,应考虑多个因素,包括患者的偏好、成本、耐受性、不良反应、剂量方案和给药方式。