Vitamin D As Predictor Of Multiple Sclerosis Activity And Progression In Patients With CIS Treated Early With Interferon beta-1b (P5.016)

OBJECTIVE: To examine the predictive effects of 25(OH)D on disease activity and prognosis in patients starting IFNB-1b at the CIS and the effect of 25(OH)D on the occurrence of flu-like symptoms (FLS) during treatment. BACKGROUND: The BENEFIT study examined the effects of interferon beta-1b (IFNB-1b) in clinically isolated syndrome (CIS). In prior analyses 25-hydroxyvitamin D (25[OH]D) contributed to the prediction of rate of conversion to clinically definite multiple sclerosis (CDMS), MS activity, and rate of progression up to 5-years after CIS. DESIGN/METHODS: Patients with a first clinical demyelinating event and >=2 clinically silent brain MRI lesions randomized to early IFNB-1b treatment with serum 25(OH)D concentration measurements at baseline, 6, 12, and 24 months were included. Clinical and MRI follow-up lasted for 5 years. Cox proportional hazard models or generalized mixed effects models related season-adjusted 25(OH)D concentrations to outcomes. Occurrence of FLS was compared by Chi-Square. RESULTS: Patients were dichotomized into high (>=50 nmol/L) and low ( 0.28). CONCLUSIONS: Among patients who started IFNB-1b treatment right after CIS, low 25(OH)D levels were a strong risk factor for long-term MS activity and severity but not for the occurrence of FLS, suggesting a role of vitamin D supplementation as an add-on to IFNB-1b in early treatment of patients with MS. Study Supported by: Bayer HealthCare Pharmaceuticals Disclosure: Dr. Stolz has received personal compensation for activities with Precept Medical as an employee. Dr. Munger has nothing to disclose. Dr. White has received personal compensation for activities with Bayer Schering. Dr. Kochert has received personal compensation for activities with Bayer Pharmaceuticals Corp. as a consultant. Dr. Simon has nothing to disclose. Dr. Freedman has received personal compensation for activities with Actelion, Bayer, Biogen Idec, EMD Canada, Genzyme Corporation, Novartis, Opexa, Teva Neuroscience, and Sanofi-Aventis Pharmaceuticals, Inc. Dr. Freedman has received research support from Bayer and Genzyme. Dr. Hartung has received personal compensation for activities with Bayer Pharmaceuticals Corp., CSL Behring, Biogen Idec, Genzyme Corp., Grifols, Merck Serono, Novartis, Roche Diagnostics Corp., Teva Neuroscience, and Sanofi-Aventis Pharmaceuticals Inc. as a consultant and speaker. Dr. Miller has received personal compensation for activities with UCL Institute of Neurology, Biogen Idec, GlaxoSmithKline Inc., Novartis, Merck & Co. Inc., Chugai, and Mitsubishi Pharma. Dr. Miller has received personal compensation in an editorial capacity for the Journal of Neurology. Dr. Miller has received research support from Biogen Idec, Schering AG, Apitope, Richmond Pharma, GlaxoSmithKline Inc., and Novartis. Dr. Montalban has received personal compensation for activities with Bayer Pharmaceuticals Corp., BIogen Idec, EMD Serono, and Genente. Dr. Edan has received personal compensation for activities with Bayer Pharmaceuticals Corp., Biogen Idec, Teva Neuroscience, Novartis, and LFB. Dr. Barkhof has received personal compensation for activities with Sanofi-Aventis Pharmaceuticals Inc., Biogen Idec, Teva Neuroscience, Merck & Co. Inc., Novartis, Synthon BV, Janssen, Genzyme Inc., and Roche Diagnostics Corporation. Dr. Pleimes has received personal compensation for activities with Myelo Therapeutics GmbH as an employee, and with Bayer Pharmaceuticals Corp. as an employee and consultant. Dr. Sandbrink has received personal compensation for activities with Bayer Pharmaceuticals Inc. Dr. Kappos has received personal compensation for activities with the University Hospital Basel. Dr. Kappos has received research support from the Swiss MS Society, Swiss National Research Foundation, the European Union, Gianni Rubatto Foundation, Novartis, and Roche Diagnostics Corp. Dr. Pohl has received personal compensation for activities with Bayer Pharmaceuticals Corp.