Lebwohl Mark G, Carvalho André, Asahina Akihiko, Zhang Jianzhong, Fazeli Mir Sohail, Kasireddy Ellen, Serafini Paul, Ferro Thomas, Gogineni Ranga, Thaçi Diamant
Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, New York, NY, 10029-5674, USA.
Hospital Moinhos de Vento, Porto Alegre, Brazil.
Dermatol Ther (Heidelb). 2025 May 6. doi: 10.1007/s13555-025-01423-0.
Moderate-to-severe plaque psoriasis is a chronic disease impacting quality of life (QoL). This network meta-analysis (NMA) compared efficacy and safety of all biologics approved for the treatment of moderate-to-severe plaque psoriasis to better inform providers on mid-term outcomes, with a focus on the interleukin-23 p19 inhibitor tildrakizumab.
MEDLINE®, Embase, and CENTRAL were searched for randomized clinical trials (RCT) from inception through January 2024. RCTs comparing biologics against placebo or each other reporting Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA) 0/1, or Dermatology Life Quality Index (DLQI) 0/1 responses and safety outcomes (adverse events [AEs] or serious AEs [SAEs]) were sought. Bayesian NMAs were performed at week 28 as the primary time point of interest. Analyses were also performed at weeks 12 and 16. Findings were expressed as risk ratios (RR; efficacy outcomes), risk differences (RD; safety outcomes), and numbers needed to treat (NNT) with 95% credible intervals.
Of 7418 publications screened, 187 describing 124 RCTs of 12 biologics were included in the systematic literature review, and 103 RCTs were included for NMA. All treatments demonstrated improved efficacy and QoL vs. placebo at week 28. Tildrakizumab efficacy at week 28 was comparable to risankizumab and guselkumab, respectively, for PASI 75 (RR 8.74 vs. 8.92 and 8.91), PASI 90 (RR 14.09 vs. 14.81 and 14.77), and PGA 0/1 (RR 9.34 vs. 10.29 and 10.23). No biologics exhibited an increased risk of SAEs vs. placebo; tildrakizumab exhibited no increased risk vs. placebo for AEs.
The investigated biologics demonstrated improved efficacy and QoL relative to placebo at week 28, with no increased risk of SAEs vs. placebo through week 16. At week 28, efficacy of tildrakizumab, risankizumab, and guselkumab was comparable. Limitations include lack of placebo comparators after week 12 or 16, which could affect results.
中重度斑块状银屑病是一种影响生活质量(QoL)的慢性疾病。这项网状荟萃分析(NMA)比较了所有获批用于治疗中重度斑块状银屑病的生物制剂的疗效和安全性,以便为医疗服务提供者提供更多关于中期疗效的信息,重点关注白细胞介素-23 p19抑制剂替拉珠单抗。
检索MEDLINE®、Embase和CENTRAL数据库,查找从建库至2024年1月的随机临床试验(RCT)。纳入比较生物制剂与安慰剂或生物制剂之间对比的RCT,这些试验报告了银屑病面积和严重程度指数(PASI)、医师整体评估(PGA)0/1或皮肤病生活质量指数(DLQI)0/1反应以及安全性结果(不良事件[AE]或严重不良事件[SAE])。以第28周作为主要关注时间点进行贝叶斯网状荟萃分析。在第12周和第16周也进行了分析。结果以风险比(RR;疗效结果)、风险差异(RD;安全性结果)和需治疗人数(NNT)表示,并给出95%可信区间。
在筛选的7418篇文献中,187篇描述了12种生物制剂的124项RCT被纳入系统文献综述,103项RCT被纳入网状荟萃分析。与安慰剂相比,所有治疗在第28周时均显示出疗效改善和生活质量提高。在第28周时,替拉珠单抗对于达到PASI 75(RR分别为8.74、8.92和8.91)、PASI 90(RR分别为14.09、14.81和14.77)以及PGA 0/1(RR分别为9.34、10.29和10.23)的疗效分别与司库奇尤单抗和古塞奇尤单抗相当。与安慰剂相比,没有生物制剂显示出严重不良事件风险增加;与安慰剂相比,替拉珠单抗的不良事件风险也未增加。
在第28周时,所研究的生物制剂相对于安慰剂显示出疗效改善和生活质量提高,至第16周时与安慰剂相比严重不良事件风险未增加。在第28周时,替拉珠单抗、司库奇尤单抗和古塞奇尤单抗的疗效相当。局限性包括在第12周或第16周之后缺乏安慰剂对照,这可能会影响结果。