Efficacy, safety, and quality-of-life of treatments for acute relapses of multiple sclerosis: results from a literature review of randomized controlled trials

Abstract

Background

Intravenous methylprednisolone (IVMP), repository corticotropin injection (RCI), plasmapheresis (PMP), and intravenous immunoglobulin (IVIG) are used in the treatment of acute multiple sclerosis (MS) relapse. A systematic literature review (SLR) of randomized controlled trials (RCTs) was conducted to examine the highest quality evidence available for these therapies.

Methods

English-language articles were searched in MEDLINE, Embase, and Cochrane Library through May 2016 per Preferred Reporting Items for Systematic Reviews and Meta-Analyses standards. MS conferences, SLRs, and bibliographies of included studies were also searched. Eligible studies included adults treated with ≥1 aforementioned therapy.

Results

Twenty-three RCTs were identified: 22 on efficacy, 11 on safety, and 3 on QOL (ie 18 IVMP, 2 RCI, 2 PMP, and 2 IVIG). IVMP and RCI improved relapse-related disability; however, IVIG and PMP showed inconsistent efficacy. QOL data were only ascertained for IVMP.

Conclusions

RCTs indicate IVMP and RCI are efficacious and well tolerated treatments for MS relapse. Overall, many RCTs were dated, with sample sizes of fewer than 30 patients and no definitions for relapse nor clinically significant change. Contemporary evidence generation for all relapse treatments of interest, across efficacy, safety, and QOL outcomes, is still needed.

Keywords:

• multiple sclerosis relapse
• efficacy
• safety
• systematic literature review

Acknowledgments

This work was supported by fund from Mallinckrodt Pharmaceuticals.

Article highlights

• RCTs confirm IVMP and RCI are efficacious for the treatment of acute MS relapse

• RCI is a well-documented and supported treatment relative to IVIG and PMP

• The benefit of IVIG and PMP in treating acute relapses in MS is unclear

• IVMP, RCI and IVIG are well tolerated; no safety data for PMP are available

• QOL data are only available for IVMP, and show improvement

Supplementary material

MEDLINE search strategy

Table S1 MEDLINE literature search strategy, limited to english language

Disclosure

Jessica Costello, Annete Njue, Matthew Lyall, and Anne Heyes were employees of RTI Health Solutions at the time this SLR was developed and provided consulting services to Mallinckrodt Pharmaceuticals. Nancy Mahler is an employee of Mallinckrodt Pharmaceuticals. Tara Nazareth and Michael Philbin were employees of Mallinckrodt Pharmaceuticals at the time this work was done. The authors report no other conflicts of interest in this work.