Efficacy and safety outcomes in vitamin D supplement users in the fingolimod phase 3 trials

Background Low serum levels of 25-hydroxyvitamin D have been associated with worse outcomes in multiple sclerosis (MS) patients treated with interferon-beta. Association of vitamin D nutrition on the outcomes of other MS therapies has been studied less. Objective Whether patients in the phase 3 fing...

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Published in:Journal of neurology Vol. 265; no. 2; pp. 348 - 355
Main Authors: Hongell, Kira, Silva, Diego G., Ritter, Shannon, Meier, Daniela Piani, Soilu-Hänninen, Merja
Format: Journal Article
Language:English
Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.02.2018
Springer Nature B.V
Subjects:
25-Hydroxyvitamin D
Clinical trials
Dietary supplements
Gadolinium
Lesions
Magnetic resonance imaging
Medicine & Public Health
Multiple sclerosis
Neurology
Neuroradiology
Neurosciences
Original Communication
Patients
Serum levels
Vitamin D
β-Interferon
Vitamin D
Fingolimod
MRI
MS
EDSS
ISSN:0340-5354, 1432-1459, 1432-1459
Online Access:Get full text
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Summary:Background Low serum levels of 25-hydroxyvitamin D have been associated with worse outcomes in multiple sclerosis (MS) patients treated with interferon-beta. Association of vitamin D nutrition on the outcomes of other MS therapies has been studied less. Objective Whether patients in the phase 3 fingolimod trials using vitamin D supplements have better clinical, MRI and safety outcomes than non-users. Materials and methods Pooled data from phase 3 FREEDOMS trials was analyzed post hoc. Vitamin D use was defined as ‘non-users’ ( n  = 562), ‘casual users’ ( n  = 157) and ‘daily users’ (usage 100% time in the study, n  = 110). Results Expanded Disability Status Scale change from baseline to month 24, and annual relapse rate and proportion of patients with relapses were similar across the vitamin D user groups. Proportion of patients free of new/enlarging T2 lesions significantly favored vitamin D ‘daily users’ versus ‘non-users’. Mean number of lesions were lower and proportion of patients free of gadolinium-enhanced T1-lesions were higher in the ‘daily users’. At month 12, percent brain volume change was significantly lower in the ‘daily users’ versus ‘non-users’ and remained low at month 24 (non-significant). Incidence of depression was lower for vitamin D ‘daily users’ (non-significant). Conclusions We observed improved MRI outcomes on percent brain volume change and proportion of patients free of new/enlarging T2 lesions, and a trend of less depression in the ‘daily users’ of vitamin D supplement in patients in the FREEDOMS trials.
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ISSN:0340-5354
1432-1459
1432-1459
DOI:10.1007/s00415-017-8697-3