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- Title
Disability improvement as a clinically relevant outcome in clinical trials of relapsing forms of multiple sclerosis.
- Authors
Cree, Bruce AC; Cohen, Jeffrey A; Reder, Anthony T; Tomic, Davorka; Silva, Diego; Piani Meier, Daniela; Laflamme, Annik K; Ritter, Shannon; Leppert, David; Kappos, Ludwig
- Abstract
Background: Disease-modifying therapies (DMTs) can reduce the risk of disability worsening in patients with relapsing forms of multiple sclerosis (RMS). High-efficacy DMTs can lead to confirmed or sustained disability improvement (CDI and SDI). Objective and Methods: Post hoc analyses of data from the TRANSFORMS, FREEDOMS, and FREEDOMS II trials and their extensions assessed the effects of fingolimod (0.5–1.25 mg/day) on stabilizing or improving disability over ⩽8 years in participants with RMS. CDI and SDI rates were compared between participants initially randomized to fingolimod, interferon (IFNβ-1a), or placebo. Results: At 8 years' follow-up in TRANSFORMS, 35.1% (95% confidence interval [CI], 28.2%–43.1%) of assessed participants in the IFNβ-1a–fingolimod switch group and 41.9% (36.6%–47.6%) on continuous fingolimod experienced CDI; disability did not worsen in approximately 70%. Similar results were seen in the combined FREEDOMS population. Proportionally fewer TRANSFORMS participants achieved SDI in the IFNβ-1a–fingolimod switch group than on continuous fingolimod (5.4% [3.0%–9.5%] vs 14.2% [10.8%–18.4%], p = 0.01). Conclusion: CDI and SDI are outcomes of interest for clinical trials and for long-term follow-up of participants with RMS. Monitoring CDI and SDI in addition to disability worsening may facilitate understanding of the therapeutic benefit of RMS treatments.
- Subjects
TREATMENT effectiveness; MULTIPLE sclerosis; DISEASE relapse; CLINICAL trials; CONTINUOUS groups; PEOPLE with disabilities; CHILDREN with disabilities
- Publication
Multiple Sclerosis Journal, 2021, Vol 27, Issue 14, p2219
- ISSN
1352-4585
- Publication type
Article
- DOI
10.1177/13524585211000280