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

Zuojie Zhang; Chunsong Yang; Lingli Zhang; Qiusha Yi; Zilong Hao

doi:10.4103/aian.AIAN_97_17

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

Ann Indian Acad Neurol. 2017 Oct-Dec;20(4):341-347. doi: 10.4103/aian.AIAN_97_17.

Authors

Zuojie Zhang^{1

2

3}, Chunsong Yang^{1

2}, Lingli Zhang^{1

2}, Qiusha Yi³, Zilong Hao⁴

Affiliations

¹ Department of Pharmacy, Evidence-based Pharmacy Center, West China Second Hospital, Sichuan University, Sichuan, P.R China.
² Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Sichuan University, Sichuan, P.R China.
³ West China School of Pharmacy, Sichuan University, Sichuan, P.R China.
⁴ Department of Neurology, West China Hospital, Sichuan University, Sichuan, P.R China.

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.

Keywords: Efficacy; meta-analysis; myasthenia gravis; safety; tacrolimus.

Publication types

Review