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生物制剂联合甲氨蝶呤治疗银屑病和银屑病关节炎优于生物制剂单药治疗:一项随机对照试验的荟萃分析。

Are biologics combined with methotrexate better than biologics monotherapy in psoriasis and psoriatic arthritis: A meta-analysis of randomized controlled trials.

机构信息

Department of Rheumatology and Immunology, West China Hospital, Sichuan University, Chengdu, China.

Tsinghua Clinical Research Institute (TCRI), School of Medicine, Tsinghua University, Beijing, China.

出版信息

Dermatol Ther. 2021 May;34(3):e14926. doi: 10.1111/dth.14926. Epub 2021 Mar 16.

DOI:10.1111/dth.14926
PMID:33655646
Abstract

To investigate if the combination of biologics with methotrexate (MTX) would have better performance than biological monotherapy in clinical efficiency and safety for the treatment of psoriasis and psoriatic arthritis (PsA), a systematic review of randomized controlled trials (RCTs) searched from the Pubmed, Cochrane Library, and Embase was conducted. Psoriasis Area and Severity Index (PASI) responses (including PASI 50, 75, and 90), and proportion of patients with Physician's Global Assessment Scale (sPGA) scored 0 or 1, were used for psoriasis assessment. The American College of Rheumatology (ACR)20/50/70 responder indices were used to assess the efficiency for treating PsA. The incidences of adverse events and antidrug antibodies' development were also recorded. A total of 15 studies with 4221 patients were included in this study. Three of the 15 RCTs were categorized as low risk of bias, nine studies as unclear, and three as high. Significant greater improvement in the combination group than monotherapy group for psoriasis was observed at week 12, week 24, and week 48, with no increased risk of severe adverse events and drug withdrawals due to adverse events. There was no significant difference in the comparison of clinical efficiency for the treatment of PsA at week 24. In conclusion, biologics plus MTX made better performance on improving the clinical efficiency for the treatment of psoriasis when compared with biologic monotherapy, without a difference in tolerability. However, this combination cannot improve the clinical efficiency of PsA treatment and more studies are warranted to elucidate relevant problems.

摘要

为了探究生物制剂联合甲氨蝶呤(MTX)治疗银屑病和银屑病关节炎(PsA)的临床疗效和安全性是否优于生物制剂单药治疗,我们对 Pubmed、Cochrane Library 和 Embase 进行了系统评价,纳入了随机对照试验(RCT)。采用银屑病面积和严重程度指数(PASI)应答(包括 PASI50、75 和 90)和医生整体评估量表(sPGA)评分 0 或 1 的患者比例来评估银屑病。采用美国风湿病学会(ACR)20/50/70 应答指数评估治疗 PsA 的疗效。还记录了不良反应的发生率和抗药物抗体的产生。这项研究共纳入了 15 项研究,共 4221 例患者。其中 3 项 RCT 被归类为低偏倚风险,9 项研究为不确定,3 项为高偏倚风险。在第 12、24 和 48 周,联合组的银屑病改善情况明显优于单药组,且严重不良事件和因不良事件停药的风险没有增加。在第 24 周治疗 PsA 的临床疗效比较中,两组之间没有显著差异。总之,与生物制剂单药治疗相比,生物制剂联合 MTX 在改善银屑病的临床疗效方面表现更好,且耐受性无差异。然而,这种联合治疗并不能改善 PsA 的临床疗效,需要更多的研究来阐明相关问题。

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