Kira Hongell1, Diego G Silva2, Shannon Ritter3, Daniela Piani Meier2, Merja Soilu-Hänninen4. 1. Division of Clinical Neurosciences, Turku University Hospital and University of Turku, PB 52, 20521, Turku, Finland. kira.hongell@utu.fi. 2. Novartis Pharma AG, Fabrikstrasse 12, 4056, Basel, Switzerland. 3. Novartis Pharmaceuticals Corporation, One Health Plaza, Bldg. 200, Office 238, East Hanover, NJ, 07936-1080, USA. 4. Division of Clinical Neurosciences, Turku University Hospital and University of Turku, PB 52, 20521, Turku, Finland.
Abstract
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.
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.
Authors: L Grimaldi; F Barkhof; M Beelke; J Burton; T Holmoy; R Hupperts; J Killestein; P Rieckmann; M Schluep; J Smolders Journal: Neurology Date: 2012-03-13 Impact factor: 9.910
Authors: Ludwig Kappos; Ernst-Wilhelm Radue; Paul O'Connor; Chris Polman; Reinhard Hohlfeld; Peter Calabresi; Krzysztof Selmaj; Catherine Agoropoulou; Malgorzata Leyk; Lixin Zhang-Auberson; Pascale Burtin Journal: N Engl J Med Date: 2010-01-20 Impact factor: 91.245
Authors: Kathryn C Fitzgerald; Kassandra L Munger; Karl Köchert; Barry G W Arnason; Giancarlo Comi; Stuart Cook; Douglas S Goodin; Massimo Filippi; Hans-Peter Hartung; Douglas R Jeffery; Paul O'Connor; Gustavo Suarez; Rupert Sandbrink; Ludwig Kappos; Christoph Pohl; Alberto Ascherio Journal: JAMA Neurol Date: 2015-12 Impact factor: 18.302
Authors: Keryn L Taylor; Emily J Hadgkiss; George A Jelinek; Tracey J Weiland; Naresh G Pereira; Claudia H Marck; Dania M van der Meer Journal: BMC Psychiatry Date: 2014-12-03 Impact factor: 3.630