Literature review and meta-analysis of natalizumab therapy for the treatment of highly active relapsing remitting multiple sclerosis in the 'suboptimal therapy' patient population.

Autor: Chappell M; York Health Economics Consortium, University of York, York, United Kingdom., Sanderson A; York Health Economics Consortium, University of York, York, United Kingdom., Arun T; University Hospitals of Coventry and Warwickshire, Department of Neurosciences, University of Warwick, Coventry, United Kingdom., Green C; Biogen Idec Ltd, B5 Foundation Park, Roxborough Way, Maidenhead, United Kingdom. Electronic address: colin.green@biogen.com., Davies H; Biogen Idec Ltd, B5 Foundation Park, Roxborough Way, Maidenhead, United Kingdom., Tempest M; Biogen Idec Ltd, B5 Foundation Park, Roxborough Way, Maidenhead, United Kingdom., Watkins D; York Health Economics Consortium, University of York, York, United Kingdom., Arber M; York Health Economics Consortium, University of York, York, United Kingdom., McCool R; York Health Economics Consortium, University of York, York, United Kingdom.
Jazyk: angličtina
Zdroj: Journal of the neurological sciences [J Neurol Sci] 2024 Sep 15; Vol. 464, pp. 123172. Date of Electronic Publication: 2024 Aug 06.
DOI: 10.1016/j.jns.2024.123172
Abstrakt: Background: Highly active (HA) relapsing remitting multiple sclerosis (RRMS) is associated with frequent relapses and high burden of disease/disability. Natalizumab is licensed for HA RRMS, including rapidly evolving severe (RES) (≥2 relapses in previous year) and sub-optimally treated (SOT) (≥1 relapse in previous year despite treatment) populations. However, there is limited RCT evidence in the SOT subpopulation.
Objective: To review the non-RCT evidence for natalizumab in SOT HA RRMS.
Methods: Databases were searched to January 2023 for non-randomised studies of natalizumab in HA RRMS. Studies in patients with ≥1 relapse during previous treatment were eligible for inclusion. Meta-analyses were conducted to compare natalizumab with platform and higher efficacy disease-modifying therapies, with sensitivity analysis restricted to studies of low risk of bias.
Results: Included comparative studies (n = 16) showed natalizumab had lower relapse rates, disease activity and MRI (radiological) outcomes compared with platform and higher efficacy therapy. Case series (n = 11) showed natalizumab was associated with high rates of freedom from relapse and clinical/radiological disease activity and reductions in annualised relapse rate and disability progression.
Conclusions: Literature reviewed indicates that natalizumab is more effective than other included treatments for SOT patients. Findings were consistent with studies in the broad HA RRMS population, suggesting that natalizumab may have similar efficacy for SOT and RES HA RRMS.
Competing Interests: Declaration of competing interest MC, AS, TA, DW, MA and RM have no conflicts of interests. CG, HD, MT are Biogen Employees and stockholders.
(Copyright © 2024. Published by Elsevier B.V.)
Databáze: MEDLINE
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