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

Kira Hongell; Daniela Piani Meier; Merja Soilu-Hänninen; Diego G. Silva; Shannon Ritter

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

Kira Hongell
Daniela Piani Meier
Merja Soilu-Hänninen
Diego G. Silva
Shannon Ritter
Katso/Avaa
Final draft (35.89Kb)
Lataukset: 

doi:10.1007/s00415-017-8697-3
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Julkaisun pysyvä osoite on:
https://urn.fi/URN:NBN:fi-fe2021042717846
Tiivistelmä

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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