靶向药物治疗俄罗斯联邦成人中重度斑块型银屑病的疗效:系统文献综述更新

V. Sokolova, N. Sableva, V. Mladov, D. Tolkacheva
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引用次数: 1

摘要

背景。系统的文献综述有助于确定主要的治疗方案,证据综合通过比较不同治疗的临床疗效来支持决策。如今,新药和临床试验层出不穷,因此以前的网络荟萃分析可能需要更新。目的:通过增加在俄罗斯注册的一种新的白细胞介素(IL) 23抑制剂risankizumab的随机临床试验(rct)和2019年以后发表的其他rct,更新现有的比较靶向药物治疗成人中重度斑块性银屑病疗效的系统评价和网络荟萃分析;重新评估银屑病面积和严重程度指数(PASI) 75/90患者需要治疗达到临床治疗反应的数量和每个应答者在12-16周和1年治疗中的成本。材料和方法。我们更新了PubMed/MEDLINE和Embase数据库中的系统文献检索。证据合成包括评价阿达木单抗(ADA)、英夫利昔单抗(INF)、依他那西普(ETN)、certolizumab pegol (CZP)、ixekizumab (ixxe)、netakimab (NTK)、secukinumab (SEC)、risankizumab (RIS)、guselkumab (GUS)、ustekinumab (UST)、tofacitinib (TOFA)和apremilast (APR)治疗12周后疗效的随机对照试验。为了解释患者特征的高度异质性和安慰剂反应率的显着差异,使用元回归模型进行了贝叶斯元分析。根据累积排序曲线(SUCRA)下的曲面值对考虑的药物进行排序。此外,还进行了药物分类分析。23个新的随机对照试验被添加到网络中。IL-23抑制剂RIS最近在俄罗斯联邦获得批准,加入了IL-17抑制剂NTK和IXE以及IL-23抑制剂GUS等最有效药物的行列。在PASI 75方面,RIS和IXE优于所有肿瘤坏死因子α (TNFα)抑制剂(INF、ADA、ETN)、小分子抑制剂(TOFA和APR)和IL-12/23抑制剂UST,而NTK和GUS的疗效与INF相当,优于其他药物。所有TNFα抑制剂的疗效差异无统计学意义。GUS、IXE、INF、NTK、RIS和SEC表明,达到一个PASI 75缓解需要治疗的患者不超过2例,达到一个PASI 90缓解需要治疗的患者不超过3例(根据95%可信区间上限)。与先前发表的研究相同,NTK显示,在12周和1年期间,每位应答者的成本最低。增加的头对头试验和增加的网络统计能力揭示了中度至重度斑块性银屑病治疗方案之间先前未确定的显着差异。
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Efficacy of targeted drugs for the treatment of adults with moderate-to-severe plaque psoriasis in the Russian Federation: a systematic literature review update
Background. A systematic literature review helps to identify the main treatment options, and evidence synthesis supports decision-making by comparing clinical efficacy of different treatments. Nowadays new drugs and clinical trials emerge rapidly, so previous network meta-analyses might need to be updated.Objective: to update the existing systematic review and network meta-analysis comparing efficacy of targeted drugs in adult patients with moderate-to-severe plaque psoriasis by adding randomized clinical trials (RCTs) on a new interleukin (IL) 23 inhibitor registered in the Russian Federation – risankizumab, and other RCTs published after 2019; to reassess the Psoriasis Area and Severity Index (PASI) 75/90 numbers of patients needed to treat to achieve clinical response to therapy and the costs per responder for 12–16 weeks and 1 year of therapy.Material and methods. We updated our systematic literature search in the PubMed/MEDLINE and Embase databases. Evidence synthesis included RCTs evaluating the efficacy of adalimumab (ADA), infliximab (INF), etanercept (ETN), certolizumab pegol (CZP), ixekizumab (IXE), netakimab (NTK), secukinumab (SEC), risankizumab (RIS), guselkumab (GUS), ustekinumab (UST), tofacitinib (TOFA), and apremilast (APR) after 12 weeks of therapy. The Bayesian meta-analyses with meta-regression models were performed in order to account for high heterogeneity in patient characteristics and significant differences in the placebo response rates. The considered drugs were ranked based on values of surface under the cumulative ranking curve (SUCRA). Additionally, drug class analyses were carried out.Results. Twenty three new RCTs were added to the network. IL-23 inhibitor RIS, recently approved in the Russian Federation, has joined the group of the most efficacious drugs, such as IL-17 inhibitors NTK and IXE, as well as IL-23 inhibitor GUS. In terms of PASI 75, RIS and IXE showed superiority compared to all tumor necrosis factor alpha (TNFα) inhibitors (INF, ADA, ETN), small molecules (TOFA and APR), and IL-12/23 inhibitor UST, while NTK and GUS were characterized by comparable efficacy with INF and outperformed the remaining drugs. There were no statistically significant differences in efficacy between all the TNFα inhibitors. GUS, IXE, INF, NTK, RIS and SEC demonstrated that no more than 2 patients need to be treated to achieve one PASI 75 response, and no more than 3 need to be treated for one PASI 90 response (according to the upper limit of 95% credible interval). Same as in the previously published study, NTK showed the lowest costs per responder for both 12-week and 1-year periods.Conclusion. The addition of head-to-head trials and increased statistical power of the network revealed previously unidentified significant differences between treatment options for moderate-to-severe plaque psoriasis.
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来源期刊
Farmakoekonomika
Farmakoekonomika Medicine-Health Policy
CiteScore
1.70
自引率
0.00%
发文量
43
审稿时长
8 weeks
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