Randomized study of interferon beta-1a, low-dose azathioprine, and low-dose corticosteroids in multiple sclerosis
Language English Country England, Great Britain Media print-electronic
Document type Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
19465443
DOI
10.1177/1352458509105229
PII: 1352458509105229
Knihovny.cz E-resources
- MeSH
- Administration, Oral MeSH
- Atrophy MeSH
- Azathioprine administration & dosage adverse effects MeSH
- Time Factors MeSH
- Double-Blind Method MeSH
- Adrenal Cortex Hormones administration & dosage adverse effects MeSH
- Immunologic Factors administration & dosage adverse effects MeSH
- Immunosuppressive Agents administration & dosage adverse effects MeSH
- Injections, Intramuscular MeSH
- Interferon beta-1a MeSH
- Interferon-beta administration & dosage adverse effects MeSH
- Drug Therapy, Combination MeSH
- Humans MeSH
- Magnetic Resonance Imaging MeSH
- Brain pathology MeSH
- Disability Evaluation MeSH
- Prednisone administration & dosage adverse effects MeSH
- Disease Progression MeSH
- Prospective Studies MeSH
- Recurrence MeSH
- Multiple Sclerosis, Relapsing-Remitting diagnosis drug therapy MeSH
- Drug Administration Schedule MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Azathioprine MeSH
- Adrenal Cortex Hormones MeSH
- Immunologic Factors MeSH
- Immunosuppressive Agents MeSH
- Interferon beta-1a MeSH
- Interferon-beta MeSH
- Prednisone MeSH
BACKGROUND: Studies evaluating interferon beta (IFNbeta) for multiple sclerosis (MS) showed only partial efficacy. In many patients, IFNbeta does not halt relapses or disability progression. One strategy to potentially enhance efficacy is to combine IFNbeta with classical immunosuppressive agents, such as azathioprine (AZA) or corticosteroids, commonly used for other autoimmune disorders. OBJECTIVE: The Avonex-Steroids-Azathioprine study was placebo-controlled trial and evaluated efficacy of IFNbeta-1a alone and combined with low-dose AZA alone or low-dose AZA and low-dose corticosteroids as initial therapy. METHODS: A total of 181 patients with relapsing-remitting MS (RRMS) were randomized to receive IFNbeta-1a 30 microg intramuscularly (IM) once weekly, IFNbeta-1a 30 microg IM once weekly plus AZA 50 mg orally once daily, or IFNbeta-1a 30 microg IM once weekly plus AZA 50 mg orally once daily plus prednisone 10 mg orally every other day. The primary end point was annualized relapse rate (ARR) at 2 years. Patients were eligible for enrollment in a 3-year extension. RESULTS: At 2 years, adjusted ARR was 1.05 for IFNbeta-1a, 0.91 for IFNbeta-1a plus AZA, and 0.73 for combination. The cumulative probability of sustained disability progression was 16.8% for IFNbeta-1a, 20.7% for IFNbeta-1a plus AZA, and 17.5% for combination. There were no statistically significant differences among groups for either measure at 2 and 5 years. Percent T2 lesion volume change at 2 years was significantly lower for combination (+14.5%) versus IFNbeta-1a alone (+30.3%, P < 0.05). Groups had similar safety profiles. CONCLUSION: In IFNbeta-naïve patients with early active RRMS, combination treatment did not show superiority over IFNbeta-1a monotherapy.
References provided by Crossref.org
Time course of lesion-induced atrophy in multiple sclerosis
Evolution of Brain Volume Loss Rates in Early Stages of Multiple Sclerosis
Gray matter atrophy patterns in multiple sclerosis: A 10-year source-based morphometry study
Establishing pathological cut-offs for lateral ventricular volume expansion rates
