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Lookup NU author(s): Emeritus Professor David Bates
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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-la 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 mug 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 mug 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-la 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-la 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.
Author(s): Bates D; King J; McLeod J; Gonsette RE; Duquette P; Ebers G; Rice G; Francis G; Lapierre Y; Freedman MS; Oger J; Paty D; Sorensen PS; Pelletier J; Hommes OR; Jongen PJH; Sanders EACM; Andersen O; Wollheim-Sandberg M; Chofflon M; Barnes D; Blumhardt LD; Hawkins C; Hughes RAC; Palace J; Newsom-Davis JM; Young CA; Ammoury N; Bacchi M; Francis G; Galazka A; Hyde R; Shah S; SPECTRIMS Study Grp
Publication type: Article
Publication status: Published
Journal: Neurology
Year: 2001
Volume: 56
Issue: 11
Pages: 1505-1513
ISSN (print): 0028-3878
ISSN (electronic): 1526-632X
Publisher: Lippincott Williams & Wilkins
URL: http://www.neurology.org/content/56/11/1505
