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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Veröffentlicht in:	Journal of neurology Jg. 265; H. 2; S. 348 - 355
Hauptverfasser:	Hongell, Kira, Silva, Diego G., Ritter, Shannon, Meier, Daniela Piani, Soilu-Hänninen, Merja
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	Berlin/Heidelberg Springer Berlin Heidelberg 01.02.2018 Springer Nature B.V
Schlagworte:	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
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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.
AbstractList	BackgroundLow 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.ObjectiveWhether patients in the phase 3 fingolimod trials using vitamin D supplements have better clinical, MRI and safety outcomes than non-users.Materials and methodsPooled 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).ResultsExpanded 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).ConclusionsWe 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. 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. Whether patients in the phase 3 fingolimod trials using vitamin D supplements have better clinical, MRI and safety outcomes than non-users. 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). 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). 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. 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.BACKGROUNDLow 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.Whether patients in the phase 3 fingolimod trials using vitamin D supplements have better clinical, MRI and safety outcomes than non-users.OBJECTIVEWhether patients in the phase 3 fingolimod trials using vitamin D supplements have better clinical, MRI and safety outcomes than non-users.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).MATERIALS AND METHODSPooled 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).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).RESULTSExpanded 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).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.CONCLUSIONSWe 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.
Author	Soilu-Hänninen, Merja Hongell, Kira Silva, Diego G. Meier, Daniela Piani Ritter, Shannon
Author_xml	– sequence: 1 givenname: Kira orcidid: 0000-0002-6371-2107 surname: Hongell fullname: Hongell, Kira email: kira.hongell@utu.fi organization: Division of Clinical Neurosciences, Turku University Hospital and University of Turku – sequence: 2 givenname: Diego G. surname: Silva fullname: Silva, Diego G. organization: Novartis Pharma AG – sequence: 3 givenname: Shannon surname: Ritter fullname: Ritter, Shannon organization: Novartis Pharmaceuticals Corporation – sequence: 4 givenname: Daniela Piani surname: Meier fullname: Meier, Daniela Piani organization: Novartis Pharma AG – sequence: 5 givenname: Merja surname: Soilu-Hänninen fullname: Soilu-Hänninen, Merja organization: Division of Clinical Neurosciences, Turku University Hospital and University of Turku
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/29243005$$D View this record in MEDLINE/PubMed
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Cites_doi	10.1136/bmj.327.7410.316 10.1136/jnnp-2011-301876 10.1001/jamaneurol.2015.4800 10.1016/S1474-4422(08)70042-5 10.1212/WNL.0b013e31825fdec7 10.1002/acn3.91 10.1016/S1474-4422(10)70086-7 10.1002/ana.23591 10.1001/jamaneurol.2015.2742 10.1001/jamaneurol.2013.5993 10.1016/S1474-4422(14)70049-3 10.1212/01.WNL.0000101723.79681.38 10.1177/1352458513489756 10.1038/nrneurol.2010.76 10.1056/NEJMoa0909494 10.1212/WNL.0b013e31825fded9 10.1080/09638280500191753 10.1007/s00415-006-0395-5 10.1212/WNL.0b013e31825fdf01 10.1007/s12603-012-0418-0 10.1212/NXI.0000000000000167 10.1001/jama.296.23.2832 10.1016/j.cct.2014.10.004 10.1186/s12888-014-0327-3 10.1002/ana.22043 10.1212/01.wnl.0000413180.13413.ce
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Snippet	Background Low serum levels of 25-hydroxyvitamin D have been associated with worse outcomes in multiple sclerosis (MS) patients treated with interferon-beta.... Low serum levels of 25-hydroxyvitamin D have been associated with worse outcomes in multiple sclerosis (MS) patients treated with interferon-beta. Association... BackgroundLow serum levels of 25-hydroxyvitamin D have been associated with worse outcomes in multiple sclerosis (MS) patients treated with interferon-beta....
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SubjectTerms	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
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Title	Efficacy and safety outcomes in vitamin D supplement users in the fingolimod phase 3 trials
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