Association of Vitamin D Levels With Multiple Sclerosis Activity and Progression in Patients Receiving Interferon Beta-1b
Fitzgerald KC, Munger KL, Köchert K, Arnason BG, Comi G, Cook S, Goodin DS, Filippi M, Hartung HP, Jeffery DR, O'Connor P, Suarez G, Sandbrink R, Kappos L, Pohl C, Ascherio A
JAMA neurology · 122 citas
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2015-10-13 · JAMA Neurol · vol. 72 · número 12 · pág. 1458
- Editorial
- American Medical Association
- Citado
- 161 citas · más que el 99% de estudios similares · 12.2× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 30 trabajos
- Acceso
- De pago
- Áreas de investigación
- Multiple Sclerosis Research Studies · Vitamin D Research Studies · Psoriasis: Treatment and Pathogenesis
- Palabras clave
- vitamin D, 25-hydroxyvitamin D, multiple sclerosis, relapsing-remitting multiple sclerosis, interferon beta-1b, disease activity, disease progression, brain atrophy, relapse rate, disability progression, vitamin D supplementation, MRI lesion burden, Expanded Disability Status Scale, serum vitamin D levels, disease-modifying therapy
- MeSH
- humans, multiple sclerosis, disease progression, vitamin d, vitamin d-binding protein, adjuvants, immunologic, disability evaluation, retrospective studies, longitudinal studies, double-blind method, age factors, dose-response relationship, drug, genotype, time factors, adult, middle aged, female, male, hla-drb1 chains, interferon beta-1b
16 autores
- Kathryn C. Fitzgerald🇺🇸 · autor de correspondenciaHarvard University
- Kassandra L. Munger🇺🇸Harvard University
- Karl Köchert
- Barry G.W. Arnason🇺🇸University of Chicago
- Gıancarlo Comı🇮🇹IRCCS Ospedale San Raffaele
- Stuart D. Cook🇺🇸Rutgers New Jersey Medical School
- Douglas S. Goodin🇺🇸University of California, San Francisco
- Massimo Filippi🇮🇹Vita-Salute San Raffaele University
- Hans-Peter Hartung🇩🇪Heinrich Heine University Düsseldorf
- Douglas Jeffery🇺🇸Piedmont HealthCare
- Paul W O'Connor🇨🇦St. Michael's Hospital
- Gustavo Suarez🇺🇸Bayer (United States)
- Rupert Sandbrink🇩🇪Bayer (Germany)
- Ludwig Kappos🇨🇭University Hospital of Basel
- Christoph Pohl🇩🇪University Hospital Bonn
- Alberto Ascherio🇺🇸Harvard University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
Low serum 25-hydroxyvitamin D (25[OH]D) levels are associated with an increased risk of multiple sclerosis (MS) as well as with increased disease activity and rate of progression in clinically isolated syndromes and early MS.
Objective
To assess the association between 25(OH)D and disease course and prognosis in patients with relapsing-remitting MS treated with interferon beta-1b.
Design, setting, and participants
We conducted a prospective cohort study assessing 25(OH)D levels and subsequent MS disease course and progression characterized by magnetic resonance imaging (MRI) and clinical end points. The study took place between November 2003 and June 2005; data analysis was performed between June 2013 and December 2014. The study was conducted among participants in the Betaferon Efficacy Yielding Outcomes of a New Dose (BEYOND) study, a large, phase 3, prospective, multicenter, blinded, randomized clinical trial. Patients were monitored for at least 2 years. Clinic visits were scheduled every 3 months, and MRI was performed at baseline and annually thereafter. Eligible patients included 1482 participants randomized to receive 250 μg or 500 μg of interferon-1b with at least 2 measurements of 25(OH)D obtained 6 months apart.
Exposures
Serum 25(OH)D measurements were performed at baseline, 6 months, and 12 months.
Main outcomes and measures
Main outcomes included cumulative number of new active lesions (T2 lesions and gadolinium acetate-enhancing lesions), change in normalized brain volume, relapse rate, and progression determined by the Expanded Disability Status Scale (EDSS). Statistical analyses were adjusted for age, sex, randomized treatment, region, disease duration, and baseline EDSS score.
Results
Overall, average 25(OH)D levels in 1482 patients were significantly inversely correlated with the cumulative number of new active lesions between baseline and the last MRI, with a 50.0-nmol/L increase in serum 25(OH)D levels associated with a 31% lower rate of new lesions (relative rate [RR], 0.69; 95% CI, 0.55-0.86; P = .001). The lowest rate of new lesions was observed among patients with 25(OH)D levels greater than 100.0 nmol/L (RR, 0.53; 95% CI, 0.37-0.78; P = .002). No significant associations were found between 25(OH)D levels and change in brain volume, relapse rates, or EDSS scores. Results were consistent following adjustment for HLA-DRB1*15 or vitamin D-binding protein status.
Conclusions and relevance
Among patients with MS treated with interferon beta-1b, higher 25(OH)D levels were associated with lower rates of MS activity observed on MRI. Results for brain atrophy and clinical progression were more equivocal.
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