Yiu Zenas Z N, Exton Lesley S, Jabbar-Lopez Zarif, Mohd Mustapa M Firouz, Samarasekera Eleanor J, Burden A David, Murphy Ruth, Owen Caroline M, Parslew Richard, Venning Vanessa, Ashcroft Darren M, Griffiths Christopher E M, Smith Catherine H, Warren Richard B
Dermatology Centre, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK; Centre for Pharmacoepidemiology and Drug Safety, Manchester Pharmacy School, The University of Manchester, Manchester, UK.
British Association of Dermatologists, London, UK.
J Invest Dermatol. 2016 Aug;136(8):1584-1591. doi: 10.1016/j.jid.2016.03.035. Epub 2016 Apr 13.
A comprehensive evaluation of the risk of serious infections in biologic therapies for psoriasis is lacking. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) and prospective cohort studies reporting serious infections in people taking any licensed biologic therapy for psoriasis compared with those taking placebo, nonbiologic therapy, or other biologic therapies. The quality of the studies was assessed using Grading of Recommendations Assessment, Development and Evaluation criteria. No significant heterogeneity was detected in data from 32 RCTs (n = 13,359 participants) and one cohort study (n = 4,993 participants). In adults, low- to very-low-quality RCT data showed no significant difference between any biologic therapy and placebo at weeks 12-16 (overall pooled Peto odds ratio = 0.71, 95% confidence interval = 0.36-1.41) and weeks 20-30 (odds ratio = 2.27, 95% confidence interval = 0.45-11.49). No significant differences were found in any of the other comparisons in underpowered RCT data. Prospective cohort study data of low quality suggests that only adalimumab (adjusted hazard ratio [adjHR] = 2.52, 95% confidence interval = 1.47-4.32) was associated with a significantly higher risk of serious infection compared with retinoid and/or phototherapy in adults. No association between biologic therapies and serious infections in patients with psoriasis who were eligible for RCTs was detected. Further observational studies are needed to inform the uncertainty around this risk in the real world.
目前缺乏对银屑病生物疗法中严重感染风险的全面评估。我们对随机对照试验（RCT）和前瞻性队列研究进行了系统评价和荟萃分析，这些研究报告了接受任何已获许可的银屑病生物疗法的患者与接受安慰剂、非生物疗法或其他生物疗法的患者相比发生严重感染的情况。使用推荐分级评估、制定和评价标准对研究质量进行评估。在32项RCT（n = 13359名参与者）和1项队列研究（n = 4993名参与者）的数据中未检测到显著异质性。在成人中，低质量至极低质量的RCT数据显示，在第12 - 16周（总体合并Peto比值比 = 0.71，95%置信区间 = 0.36 - 1.41）和第20 - 30周（比值比 = 2.27，95%置信区间 = 0.45 - 11.49）时，任何生物疗法与安慰剂之间均无显著差异。在效能不足的RCT数据的任何其他比较中均未发现显著差异。低质量的前瞻性队列研究数据表明，与类维生素A和/或光疗相比，仅阿达木单抗（校正风险比[adjHR] = 2.52，95%置信区间 = 1.47 - 4.32）在成人中与严重感染风险显著升高相关。在符合RCT条件的银屑病患者中，未检测到生物疗法与严重感染之间的关联。需要进一步的观察性研究来明确现实世界中围绕这一风险的不确定性。
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