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Efficacy and Safety of Tacrolimus in Myasthenia Gravis: A Systematic Review and Meta-analysis.

ABSTRACT: Aims:This study was designed to determine whether treatments with tacrolimus would provide benefit for patients with myasthenia gravis (MG). Materials and Methods:The databases of Medline, EMBASE, the Cochrane Library, and four Chinese databases were searched for eligible studies. Weighted mean differences and standardized mean differences (SMD) with corresponding 95% confidence intervals (CIs) were used to summarize the primary outcome, namely, steroid-sparing effect of tacrolimus in maintaining minimal manifestations, and the secondary outcome, namely, the effect of tacrolimus in reducing the severity of MG, respectively. Results:After systematic retrieval, 13 researches with two randomized controlled trials (RCTs) and 11 prospective open-label single-arm clinical trials were included in the study. For the primary outcome of two RCTs, one RCT which was followed up for 1 year showed a positive effect and the other RCT which was associated with treatment duration of 28 weeks showed a negative result. For the secondary outcome, meta-analyses of other 11 trials showed a benefit effect, overall. For the quantitative MG (QMG) score, there were significant differences with high heterogeneity (SMD: 2.93; 95% CI: 1.14-4.73; I2 = 86%). In contrast, for MG activities of daily living (MGADL) score, it was reduced by tacrolimus with significant SMD and less heterogeneity (SMD: 0.59; 95% CI: 0.33-0.85; I2 = 7%). Adverse effects were mentioned as mild. Discussion:The opposite results of two RCTs showed that tacrolimus with enough treatment duration might have positive steroid-sparing effect. The most possible cause of heterogeneity in the outcome of QMG score between trials was the baseline severity of MG. Conclusion:The above finding suggests that there might be a potential beneficial role with no serious side effects of tacrolimus, and additional better RCTs including larger sample sizes and long-term study are needed to confirm or refute the results.

SUBMITTER: Zhang Z

PROVIDER: S-EPMC5682735 | biostudies-literature | 2017 Oct-Dec

REPOSITORIES: biostudies-literature

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Efficacy and Safety of Tacrolimus in Myasthenia Gravis: A Systematic Review and Meta-analysis.

Zhang Zuojie Z Yang Chunsong C Zhang Lingli L Yi Qiusha Q Hao Zilong Z

Annals of Indian Academy of Neurology 20171001 4

<h4>Aims</h4>This study was designed to determine whether treatments with tacrolimus would provide benefit for patients with myasthenia gravis (MG).<h4>Materials and methods</h4>The databases of Medline, EMBASE, the Cochrane Library, and four Chinese databases were searched for eligible studies. Weighted mean differences and standardized mean differences (SMD) with corresponding 95% confidence intervals (CIs) were used to summarize the primary outcome, namely, steroid-sparing effect of tacrolimu ...[more]

PMID: 29184334

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Project description:Background and Objective: Myasthenia gravis (MG) is an autoimmune neuromuscular disease. Nearly 10-30% of patients with MG are refractory to conventional therapy. Rituximab (RTX), a monoclonal antibody targeting CD20, is increasingly used in autoimmune disorders. We performed a systematic review and meta-analysis to evaluate the effectiveness and safety of RTX for refractory MG. Methods: Studies published between January 1, 2000 and January 17, 2021 were searched in PubMed, EMBASE, Cochrane Library, and ClincalTrails.gov. Primary outcomes included proportion of patients achieving minimal manifestation status (MMS) or better and quantitative MG (QMG) score change from baseline. Secondary outcomes were glucocorticoids (GC) doses change from baseline and proportion of patients discontinuing oral immunosuppressants. Results: A total of 24 studies involving 417 patients were included in the meta-analysis. An overall 64% (95% confidence interval, 49-77%) of patients achieved MMS or better. The estimated reduction of QMG score was 1.55 (95% confidence interval, 0.88-2.22). The mean reduction of GC doses was 1.46 (95% confidence interval, 1.10-1.82). The proportion of patients discontinuing oral immunosuppressants was 81% (95% confidence interval, 66-93%). Subgroup analyses showed that the proportion of patients achieving MMS or better and discontinuing oral immunosuppressants was higher in MuSK-MG group than those in AChR-MG group. Improvement was more pronounced in patients with mild to moderate MG compared to those with severe MG. Moreover, the efficacy appeared to be independent of the dose of RTX. 19.6% of patients experienced adverse events, most of which were mild to moderate. Only one patient developed progressive multifocal leukoencephalopathy. Conclusions: RTX can alleviate the symptom of weakness, decrease QMG score and reduce the doses of steroids and non-steroid immunosuppressive agents in refractory MG. It is well-tolerated with few severe adverse events. Randomized controlled trials are urgently needed to study the efficacy of RTX in treating refractory MG and to identify the characteristics of patients who might respond well to RTX.

Dataset Information

Efficacy and Safety of Tacrolimus in Myasthenia Gravis: A Systematic Review and Meta-analysis.

Publications

Efficacy and Safety of Tacrolimus in Myasthenia Gravis: A Systematic Review and Meta-analysis.

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