Fingolimod versus interferon beta 1-a: Benefit–harm assessment approach based on TRANSFORMS individual patient data

Author:

Spanu Alessandra1ORCID,Aschmann Hélène E12ORCID,Kesselring Jürg3,Puhan Milo A1

Affiliation:

1. Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland

2. Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA

3. RehaKliniken Valens, Valens, Switzerland

Abstract

Background Fingolimod is a disease-modifying drug approved for multiple sclerosis but its benefit–harm balance has never been assessed compared to other active treatments. Objectives Our aim was to compare the benefits and harms of fingolimod with interferon beta-1a using individual patient data from TRial Assessing injectable interferon versus FTY720 Oral in RRMS trial. Methods We modelled the health status of patients over time including Expanded Disability Status Scale measurements, relapses and any adverse events. We assessed the mean health status between arms and the proportion of patients whose health deteriorated or improved relatively to baseline, using a prespecified minimal important difference of 4.6. We performed sensitivity analyses to test our assumptions. Results Main and sensitivity analyses favoured fingolimod 0.5 mg over interferon beta-1a. The average health status difference was 1.01 (95% CI 0.93–1.08). Patients on fingolimod 0.5 mg were 0.47 (95% CI: 0.35–0.63, p < 0.001) times less likely to experience a relevant decline in health status compared to interferon beta-1a patients, with a number needed to treat of 7.10 [5.18, 11.23]. Conclusions Fingolimod's net benefit over interferon beta-1a did not reach the clinical relevance over 1 year, but the decreased risk for health status deterioration may be more pronounced more long term and patients may prefer less treatment burden associated with fingolimod. [Formula: see text]

Funder

Universität Zürich

Beatrice Ederer-Weber foundation

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung

Publisher

SAGE Publications

Subject

Cellular and Molecular Neuroscience,Neurology (clinical)

Reference34 articles.

1. FDA See FDA Adverse Event Reporting System (FAERS) Public Dashboard 2022 (search for fingolimod). Available at: https://fis.fda.gov/sense/app/95239e26-e0be-42d9-a960-9a5f7f1c25ee/overview

2. NICE. Fingolimod for the treatment of highly active relapsing–remitting multiple sclerosis. 2012. Available from: https://www.nice.org.uk/guidance/ta254/chapter/4-Consideration-of-the-evidence.

3. FDA. MEDICATION GUIDE GILENYA®. 2019. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s029s030lbl.pdf#page=26.

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