METHODS: We will conduct a systematic review of the literature for RCTs and observational studies that used upadacitinib, ritlecitinib, brepocitinib, ifidancitinib, cerdulatinib, deglocitinib, baricitinib, tofacitinib, and ruxolitinib JAK inhibitors as treatments for vitiligo compared to placebo, no treatment, or combination therapies. We will systematically search from inception in Epistemonikos, MEDLINE, Scopus, Cochrane Central Register of Controlled Trials, EMBASE, ClinicalTrials.gov, PsycINFO, Allied and Complementary Medicine Database, Latin American and Caribbean Health Sciences Literature, Web of Science Core Collection, relevant preprint servers, and the gray literature. Ethics approval was not sought as the protocol and systematic review will not involve human participants, but rather summarized and anonymous data from studies. Primary outcomes include quality of life, percentage repigmentation, decreased vitiligo within 1 year or more, lasting repigmentation after a 2-year follow-up, cosmetic acceptability of repigmentation and tolerability or burden of treatment, and adverse events. Secondary outcomes are patient and study characteristics. We will include full-text articles, preprints, and clinical trial data in any language and all geographic regions. For data sources unavailable in English, we will obtain translations from global collaborators via the Cochrane Engage network. We will exclude articles for which sufficient information cannot be obtained from the authors of articles and systematic reviews. At least two investigators will independently assess articles for inclusion and extract data; reliability will be assessed before subsequent selection and data extraction of remaining studies. The risk of bias and certainty of evidence with Grading of Recommendations Assessment, Development, and Evaluation guidelines will be assessed independently by at least two investigators. We will estimate treatment effects by random-effects meta-analyses and assess heterogeneity using I2. Data that cannot be included in the meta-analysis will be reported narratively using themes.
CONCLUSIONS: The proposed systematic review and meta-analysis describe the methods for summarizing and synthesizing the evidence on the effectiveness and patient-centered outcomes concerning the treatment of vitiligo with JAK inhibitors that were recently approved for this indication. To disseminate further the results of our systematic review, we plan to present them at international conferences and meetings. Our findings will provide robust evidence to facilitate decision-making at the policy or practitioner level.
BACKGROUND: PROSPERO CRD42023383920.
方法:我们将对使用upadacitinib的随机对照试验和观察性研究的文献进行系统回顾,利替尼,布雷帕替尼,伊菲坦替尼,赛度替尼,地洛替尼,baricitinib,托法替尼,与安慰剂相比,鲁索替尼JAK抑制剂作为白癜风的治疗方法,没有治疗,或组合疗法。我们将从《开幕词》开始系统地搜索,MEDLINE,Scopus,Cochrane中央控制试验登记册,EMBASE,ClinicalTrials.gov,PsycINFO,联合和补充医学数据库,拉丁美洲和加勒比健康科学文献,WebofScience核心合集,相关的预打印服务器,和灰色文学。没有寻求伦理批准,因为方案和系统审查将不涉及人类参与者,而是总结和匿名的研究数据。主要结果包括生活质量,色素沉着百分比,白癜风在1年或更长时间内减少,2年随访后持续的色素沉着,色素沉着的美容可接受性和耐受性或治疗负担,和不良事件。次要结果是患者和研究特征。我们将包括全文文章,预印本,以及任何语言和所有地理区域的临床试验数据。对于英语不可用的数据源,我们将通过CochraneEngage网络从全球合作者那里获得翻译。我们将排除无法从文章和系统评论的作者那里获得足够信息的文章。至少两名研究人员将独立评估文章的纳入和提取数据;可靠性将在后续选择和剩余研究的数据提取之前进行评估。建议评估分级的偏见和证据确定性的风险,发展,和评估指南将由至少两名研究者独立评估。我们将通过随机效应荟萃分析评估治疗效果,并使用I2评估异质性。无法包含在荟萃分析中的数据将使用主题进行叙述报告。
结论:拟议的系统评价和荟萃分析描述了总结和综合最近批准的JAK抑制剂治疗白癜风的有效性和以患者为中心的结果的证据的方法。为了进一步传播我们系统审查的结果,我们计划在国际会议上介绍它们。我们的发现将提供有力的证据,以促进政策或从业者层面的决策。
背景:PROSPEROCRD42023383920.