de Carvalho André Vicente Esteves, Duquia Rodrigo Pereira, Horta Bernardo Lessa, Bonamigo Renan Rangel
Irmandade Santa Casa de Misericórdia de Porto Alegre, Ramiro Barcelos 1176/702, Porto Alegre, RS, 90035-002, Brazil.
Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brazil.
Drugs R D. 2017 Mar;17(1):29-51. doi: 10.1007/s40268-016-0152-x.
Psoriasis is an immune-mediated inflammatory disease for which treatment has evolved over the past few years due to the introduction of immunobiologic and small molecule inhibitor medications. A better understanding of the comparative efficacies of drugs may help doctors to choose the most appropriate treatment for patients.
The aim of this study was to conduct a systematic review and meta-analysis to assess the efficacy of immunobiologic and small molecule inhibitor drugs for patients with moderate to severe psoriasis.
The EMBASE, PUBMED, LILACS, Web of Science and ClinicalTrials.org databases were searched for trials published to 21 July 2016.
Only randomized, double-blind, placebo-controlled clinical trials that evaluated the efficacy of immunobiologics or small molecule inhibitors for moderate to severe plaque-type psoriasis were selected by two independent authors. No restrictions were used.
Two authors independently extracted the data and a random-effects model meta-analysis was performed.
The Psoriasis Area and Severity Index (PASI) 75 was considered the primary outcome, measured at the primary endpoint of each study.
Thirty-eight studies were included in our analysis. The overall pooled effect favored biologics and small molecule inhibitors over placebo (risk difference [RD] 0.59, 95% confidence interval [CI] 0.58-0.60). Ixekizumab at a dose of 160 mg on week 0 and then every 2 weeks (RD 0.84, 95% CI 0.81-0.88), brodalumab 210 mg (RD 0.79, 95% CI 0.76-0.82), infliximab 5 mg/kg (RD 0.76, 95% CI 0.73-0.79), and secukinumab 300 mg (RD 0.76, 95% CI 0.71-0.81) showed a greater chance of response (PASI 75) when compared with placebo.
The methodology of a traditional meta-analysis does not allow for drugs to be ranked. Included studies used short-term endpoints (10-16 weeks) to evaluate the primary outcome, therefore long-term efficacy could not be determined.
The anti-IL-17 drugs brodalumab, ixekizumab and secukinumab showed an equal or greater chance of helping patients achieve a 75% improvement on PASI compared with other reviewed drugs.
银屑病是一种免疫介导的炎症性疾病,在过去几年中,由于免疫生物制剂和小分子抑制剂药物的引入,其治疗方法不断发展。更好地了解药物的相对疗效可能有助于医生为患者选择最合适的治疗方法。
本研究的目的是进行系统评价和荟萃分析,以评估免疫生物制剂和小分子抑制剂药物治疗中度至重度银屑病患者的疗效。
检索了EMBASE、PUBMED、LILACS、Web of Science和ClinicalTrials.org数据库中截至2016年7月21日发表的试验。
两名独立作者仅选择评估免疫生物制剂或小分子抑制剂治疗中度至重度斑块型银屑病疗效的随机、双盲、安慰剂对照临床试验。没有设置限制条件。
两名作者独立提取数据,并进行随机效应模型荟萃分析。
银屑病面积和严重程度指数(PASI)改善75%被视为主要结局,在每项研究的主要终点进行测量。
我们的分析纳入了38项研究。总体汇总效应显示,生物制剂和小分子抑制剂优于安慰剂(风险差[RD]0.59,95%置信区间[CI]0.58 - 0.60)。与安慰剂相比,第0周剂量为160mg、之后每2周一次的司库奇尤单抗(RD 0.84,95%CI 0.81 - 0.88)、210mg的布罗达单抗(RD 0.79,95%CI 0.76 - 0.82)、5mg/kg的英夫利昔单抗(RD 0.76,95%CI 0.73 - 0.79)和300mg的苏金单抗(RD 0.76,95%CI 0.71 - 0.81)显示出更高的达到缓解(PASI 75)的可能性。
传统荟萃分析的方法不允许对药物进行排名比较。纳入研究使用短期终点(10 - 16周)来评估主要结局,因此无法确定长期疗效。
与其他纳入评价的药物相比,抗IL - 17药物布罗达单抗、司库奇尤单抗和苏金单抗在帮助患者实现PASI改善75%方面显示出相同或更高的可能性。