Randomized controlled trial of interferon- beta-1a in secondary progressive MS
- 12 June 2001
- journal article
- Published by Ovid Technologies (Wolters Kluwer Health) in Neurology
- Vol. 56 (11), 1496-1504
- https://doi.org/10.1212/wnl.56.11.1496
Abstract
Background: The beneficial effect of interferon beta on exacerbations in relapsing-remitting MS has been demonstrated repeatedly, but results concerning disability vary. Objective: This multicenter, randomized, parallel-group, placebo-controlled study tested two doses of interferon beta-1a in patients with secondary progressive MS, which may include relapses but is dominated by accumulating disability. Methods: A total of 618 patients received subcutaneous placebo or interferon beta-1a, 22 or 44 μg three times weekly for 3 years. Patients were assessed every 3 months. Results: The primary outcome, time to confirmed progression in disability, was not significantly affected by treatment (hazard ratio, 0.83; 95% CI, 0.65 to 1.07; p = 0.146 for 44 μg versus placebo). Relapse rate was reduced from 0.71 per year with placebo to 0.50 per year with treatment (p < 0.001 for both doses). Significant treatment effects were seen on other exacerbation-related outcomes and on a composite measure incorporating five separate clinical and MRI outcomes. The hazard ratio for time to progression for the combined interferon beta-1a groups compared with placebo was 0.74 among patients reporting relapses in the 2 years before study (p = 0.055), and 1.01 for those without prestudy relapses (p = 0.934). An unexpected treatment-by-sex interaction favored women. The drug was well tolerated. Conclusions: Treatment with interferon beta-1a did not significantly affect disability progression in this cohort, although significant treatment benefit was observed on exacerbation-related outcomes. Exploratory post hoc analyses suggested greater benefit in women and in patients who had reported at least one relapse in the 2 years before the study.Keywords
This publication has 17 references indexed in Scilit:
- Axonal Transection in the Lesions of Multiple SclerosisNew England Journal of Medicine, 1998
- Magnetic resonance studies of intramuscular interferon β–1a for relapsing multiple sclerosisAnnals of Neurology, 1998
- Defining the clinical course of multiple sclerosisNeurology, 1996
- Intramuscular interferon beta‐1a for disease progression in relapsing multiple sclerosisAnnals of Neurology, 1996
- Chemical pathology of acute demyelinating lesions and its correlation with disabilityAnnals of Neurology, 1995
- Interferon beta‐lb in the treatment of multiple sclerosisNeurology, 1995
- Proton magnetic resonance spectroscopy for metabolic characterization of plaques in multiple sclerosisNeurology, 1991
- A scaled version of the General Health QuestionnairePsychological Medicine, 1979
- The CES-D ScaleApplied Psychological Measurement, 1977
- PROBLEMS OF EXPERIMENTAL TRIALS OF THERAPY IN MULTIPLE SCLEROSIS: REPORT BY THE PANEL ON THE EVALUATION OF EXPERIMENTAL TRIALS OF THERAPY IN MULTIPLE SCLEROSISAnnals of the New York Academy of Sciences, 1965