High dose cholecalciferol (vitamin D3) oil as add-on therapy in subjects with relapsing-remitting multiple sclerosis receiving subcutaneous interferon ?-1a
Author(s): ,
J Smolders
Department of Neurology, Orbis, Zuyderland Medical Centre Sittard, Maastricht University Medical Centre, Maastricht;Department of Neurology, Canisius Wilhelmina Ziekenhuis, Nijmegen, The Netherlands
R Hupperts
Department of Neurology, Orbis, Zuyderland Medical Centre Sittard, Maastricht University Medical Centre, Maastricht
R Vieth
Department of Nutritional Sciences, University of Toronto, Toronto, ON, Canada
T Holmøy
Akershus University Hospital and University of Oslo, Oslo, Norway
K Marhardt
Merck GmbH, Vienna, Austria
M Schluep
Service de Neurologie, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
J Killestein
Radiology and Image Analysis Centre & Nuclear Medicine, VU University Medical Centre, Amsterdam, The Netherlands
F Barkhof
Radiology and Image Analysis Centre & Nuclear Medicine, VU University Medical Centre, Amsterdam, The Netherlands
L.M.E Grimaldi
Fondazione Istituto San Raffaele G. Giglio di Cefalù, Cefalù, Italy
M Beelke
Worldwide Clinical Trials GmbH, Germering, Germany
ECTRIMS Online Library. Hu M. Sep 16, 2016; 147013; 166
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Abstract: 166

Type: Oral

Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression

Background: The SOLAR study (NCT01285401) is the largest randomised double-blind placebo‑controlled study of vitamin D3 as add-on therapy in MS. This study aimed to investigate effects of cholecalciferol as add-on therapy to subcutaneous interferon (scIFN) β‑1a.

Methods: This was a prospective, randomised, double-blind, multicentre, 48-week study to evaluate the efficacy of daily oral cholecalciferol (14,000 IU [350 µg] vitamin D3) vs placebo as add-on therapy to 44 µg scIFN β‑1a tiw in patients with relapsing-remitting MS and a 25-hydroxyvitamin D serum concentration of ≤150 nmol/L. The primary endpoint was % of subjects disease-activity-free (DAF) at Week 48. DAF was the absence of relapses, Expanded Disability Status Scale (EDSS) progression or new combined unique active (CUA) lesions. Due to difficulties in patient recruitment, the primary endpoint, that initially included clinical variables at Week 96, was changed during the study to enable the study duration and sample size to be reduced. Secondary endpoints at Week 48 included mean annualised relapse rate (ARR), % subjects free from any EDSS progression and mean number of new CUA lesions per subject.

Results: 229 patients were randomised to the cholecalciferol or placebo groups. The ITT population (81.2%) had a follow-up of 48 weeks. Demographics and disease activities at baseline between groups were similar. At Week 48 there were no statistically significant differences in DAF between the cholecalciferol group and placebo group (37.2% vs 35.3%; p=0.912). No differences between groups were observed for mean ARR (0.28 vs 0.41; p=0.165) or % of subjects free from any EDSS progression (71.7% vs 75.0%; p=0.566). At Week 48, cholecalciferol was associated with a 32% reduction in the number of new CUA lesions compared with placebo (p=0.005). The % of subjects free from new T1 hypo-intense lesions was significantly higher with cholecalciferol compared with placebo in patients 18-30 years of age (85.7% vs 46.8%; p=0.006), though not in the overall cohort.

Conclusions: Compared with placebo, cholecalciferol as add-on therapy to scIFN β-1a was not associated with an increased % of subjects DAF at Week 48, although it reduced the number of new CUA lesions in the overall population and increased % of subjects free from new T1 hypo‑intense lesions in patients 18-30 years of age. Cholecalciferol supplementation might be more effective in early stages of disease when intense inflammatory activity is likely.

Disclosure: Study supported by Merck KGaA, Darmstadt, Germany.

F Barkhof is director of the IAC, contracted by Merck to perform the blinded MRI analysis.

M Beelke is a former Merck employee.

LME Grimaldi serves on a scientific advisory board for Merck; has received funding for travel or speaker honoraria from Merck, Biogen Idec, Sanofi-Aventis, Teva Pharmaceutical Industries Ltd. and Bayer Schering Pharma; and receives institutional research support from Biogen Idec and Merck.

T Holmøy has received institutional research funding from The Research Council of Norway and from The Norwegian South-Eastern Health Authorities, and has received speakers honoraria from Merck, Biogen Idec, Sanofi and Novartis.

J. Killestein has accepted speaker and consulting fees from Merck, Biogen, Teva, Genzyme and Novartis; VU University Medical Center has received financial support for research activities from Bayer Schering Pharma, Biogen-Idec, GlaxoSmithKline, Merck, Novartis, Genzyme and Teva.

J Smolders has no conflicts of interest.

K Marhardt is an employee of Merck KGaA.

R Hupperts is the initiator and PI of this trial.

R Vieth has received patent royalties for an infant vitamin D supplement.

M. Schluep served on the scientific advisory board for and received travel funding and/or speaker honoraria from Biogen, Genzyme, Merck, Novartis, and Sanofi-Aventis, consulted for Biogen, Merck, Novartis, Genzyme, Roche, and Sanofi-Aventis, and received research support from Merck, Novartis, and Biogen.

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