Relapse Rate and MRI Activity in Young Adult Patients With Multiple Sclerosis: A Post Hoc Analysis of Phase 3 Fingolimod Trials.

Mult Scler J Exp Transl Clin 2018 Apr-Jun;4(2):2055217318778610. Epub 2018 May 25.

Novartis Pharma AG, Switzerland.

Background: Disease activity differs in young patients with multiple sclerosis (MS) compared with the overall adult MS population.

Objective: The objective of this paper is to evaluate the effect of fingolimod 0.5 mg on disease activity in young adults with MS from three randomized, double-blind Phase 3 trials.

Methods: Annualized relapse rate (ARR), number of new/newly enlarging T2 lesions (neT2), and no evidence of disease activity (NEDA-3) were estimated in the intent-to-treat population at age 20 (youngest) and 30 (young) and compared to the overall population. Models used included a negative binomial regression (ARR/neT2) and a logistic regression (NEDA), with age at baseline as a continuous covariate.

Results: ARRs were higher in younger patients (all  < 0.05), and significantly reduced with fingolimod versus placebo or interferon beta-1a (IFN β-1a), with the percentage reduction inversely proportional to age. Fingolimod was significantly associated with a lower number of neT2 lesions versus placebo/IFN in all age groups except versus IFN in the youngest patients. Regardless of age, fingolimod-treated patients were more likely to achieve NEDA-3 versus placebo/IFN β-1a, with strongest benefits in the youngest patients (all  < 0.05).

Conclusions: Young adults show higher levels of MS disease activity, and may particularly benefit from fingolimod treatment compared with the overall study population.

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Source
http://dx.doi.org/10.1177/2055217318778610DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5971396PMC
May 2018
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References

(Supplied by CrossRef)

Hunter SF. et al.
Am J Manag Care 2016

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