ABSTRACT

Objectives

To synthetize the available evidence concerning efficacy and safety of imatinib mesylate, a tyrosine kinase inhibitor, in systemic sclerosis (SSc).

Methods

A systematic search following the PRISMA-statement in PubMed/MEDLINE, Cochrane CENTRAL, and Web of Science databases up to 7 February 2020 was conducted. Considering the substantial heterogeneity expected, a random-effects model to pool data from selected studies was adopted.

Results

After a treatment period ranging from 6 to 12 months, the pooled analysis revealed that imatinib mesylate significantly improved modified Rodnan skin score (mRSS) (mean difference [MD] = −3.091, 95%CI −6.081 to −0.102, p = 0.043), whereas health-related assessment questionnaire (HAQ) remains unchanged (−0.096; 95 CI −0.197 to −0.006). Data regarding change in pulmonary function tests were insufficiently consistent to be considered eligible for meta-analysis. Finally, regarding safety, the authors found a pooled dropout rate due to all adverse events of 22% and a rate of serious adverse events of 17%.

Conclusion

The significant change within the range of clinical relevance of mRSS suggests the possible use of imatinib mesylate in SSc, whereas it is still not possible to draw firm conclusions regarding the efficacy of the drug on lung involvement. Specifically designed and powered studies are needed to investigate imatinib mesylate therapy in SSc.

中文翻译：

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甲磺酸伊马替尼治疗系统性硬化症的疗效和安全性。系统评价和荟萃分析。

摘要

目标

综合有关甲磺酸伊马替尼（一种酪氨酸激酶抑制剂）在系统性硬化症 (SSc) 中的有效性和安全性的现有证据。

方法

根据 PRISMA 声明在 PubMed/MEDLINE、Cochrane CENTRAL 和 Web of Science 数据库中进行了系统搜索，直至 2020 年 2 月 7 日。考虑到预期的大量异质性，采用了随机效应模型来汇集选定研究的数据。

结果

在 6 至 12 个月的治疗期后，汇总分析显示甲磺酸伊马替尼显着改善改良 Rodnan 皮肤评分 (mRSS)（平均差异 [MD] = -3.091，95%CI -6.081 至 -0.102，p = 0.043） ，而健康相关评估问卷 (HAQ) 保持不变（-0.096；95 CI -0.197 至 -0.006）。有关肺功能测试变化的数据不够一致，无法被视为符合荟萃分析的条件。最后，关于安全性，作者发现所有不良事件导致的汇总退出率为 22%，严重不良事件率为 17%。

结论

mRSS 临床相关性范围内的显着变化表明甲磺酸伊马替尼可能用于 SSc，但仍无法得出关于该药物对肺部受累疗效的确切结论。需要专门设计和有效的研究来调查 SSc 中的甲磺酸伊马替尼治疗。