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. 2022 Sep 7;8(3):20552173221117784.
doi: 10.1177/20552173221117784. eCollection 2022 Jul-Sep.

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

Alessandra Spanu  1 , Hélène E Aschmann  1   2 , Jürg Kesselring  3 , Milo A Puhan  1
Affiliations

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

Alessandra Spanu et al. Mult Scler J Exp Transl Clin. .

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.

Keywords: Benefit–harm assessment; adverse events; fingolimod; health status; interferon beta-1a; multiple sclerosis.

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Conflict of interest statement

Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Jürg Kesselring was a member of the Data Safety Monitoring Board of Fingolimod studies from 2005 to 2017.

Figures

Figure 1.
Figure 1.
Mean health status of patients with fingolimod 0.5 mg, fingolimod 1.25mg and interferon beta-1a over 1 year.
Figure 2.
Figure 2.
Difference in mean health status between patients with fingolimod 0.5 mg and interferon beta-1a in the TRANSFORMS trial. If the difference is positive, patients on fingolimod 0.5 mg had a better health status on average than those on interferon beta-1a ± 4.6.
Figure 3.
Figure 3.
Sensitivity analyses. Figure 3 shows all sensitivity analyses compared with the main analysis mean difference.
See this image and copyright information in PMC

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