Efficacy, safety, and quality-of-life of treatments for acute relapses of multiple sclerosis: results from a literature review of randomized controlled trials
Authors Costello J, Njue A, Lyall M, Heyes A, Mahler N, Philbin M, Nazareth T
Received 15 March 2019
Accepted for publication 6 June 2019
Published 1 July 2019 Volume 2019:9 Pages 55—78
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Editor who approved publication: Prof. Dr. Thomas Müller
Jessica Costello,1 Annete Njue,1 Matthew Lyall,1 Anne Heyes,1 Nancy Mahler,2 Michael Philbin,2 Tara Nazareth3
1Health Economics and Outcome Research/ Health Technology Assessment Services, RTI Health Solutions, Manchester, M20 2LS, UK; 2Health Economics and Outcome Research-Medical Science Liaison, Mallinckrodt Pharmaceuticals, Bedminister, NJ 07921, USA; 3Health Economics and Outcome Research, Mallinckrodt Pharmaceuticals, Bedminister, NJ 07921, USA
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
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