Efficacy and safety of imatinib mesylate in systemic sclerosis. A systematic review and meta-analysis

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.

KEYWORDS:

• Imatinib mesylate
• meta-analysis
• systematic review
• systemic sclerosis

Article highlights

•Imatinib mesylate, an antifibrotic drug was used to treat SSc, a rare and clinically heterogeneous disease with high unmet therapeutic needs.

•This meta-analysis suggests that imatinib mesylate may lead to a significant change within the range of clinical relevance of mRSS. Although not significant, a trend showing an improvement of quality of life of these patients may be observed in our analysis.

•It is still not possible to draw firm conclusions regarding the efficacy of imatinib mesylate in SSc lung involvement.

•Specifically designed and powered studies are needed to fully investigate the role of imatinib mesylate in SSc.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author’s contributions

V Liakouli, J Ciaffi, F Ursini, P Ruscitti, R Meliconi, F Ciccia, P Cipriani, R Giacomelli: Conception/design of the work, revision of the literature, acquisition, analysis and interpretation of data, drafting of the manuscript, revision of data and revision of the manuscript. All authors read and approved the final manuscript. V Liakouli and J Ciaffi contributed equally to this work. P Cipriani and R Giacomelli contributed equally to this work.

Ethical approval

All data for this study were obtained from existing publications and ethical approval was not required for this research.

Supplementary material

Supplemental data for this article can be accessed here.