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This Article Figures Only Full Text Full Text (PDF) CME: Take the course for this article: Volume 59, Number 10, November 26, 2002 Correspondence: Submit a response Alert me when this article is cited Alert me when Correspondence are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Clanet, M. Articles by Sandrock, A.W. Search for Related Content PubMed PubMed Citation Articles by Clanet, M. Articles by Sandrock, A.W. Related Collections All Clinical trials Clinical trials Randomized controlled (CONSORT agreement) Multiple sclerosis

A randomized, double-blind, dose-comparison study of weekly interferon ß-1a in relapsing MS

From the Service de Neurologie (Dr. Clanet), CHU Toulouse Purpan, Toulouse, France; University Hospitals (Drs. Radue and Kappos), Departments of Neurology and Neuroradiology, Basel, Switzerland; Department of Neurology (Dr. Hartung), Heinrich-Heine-Universität, Düsseldorf, Germany; Neurology Clinic (Dr. Hohlfeld), Munich, Germany; Department of Neurology (Dr. Sandberg-Wollheim), University Hospital, Lund, Sweden; and Biogen, Inc. (Drs. Kooijmans-Coutinho, Tsao, and Sandrock), Cambridge, MA.

Address correspondence and reprint requests to Dr. Ludwig Kappos, Department of Neurology, University Hospitals, Petersgraben 4, Basel, CH-4031, Switzerland; e-mail: lkappos{at}uhbs.ch

Background: Interferon ß-1a (IFNß-1a; Avonex) is effective for the treatment of relapsing MS; however, the optimal dose of IFNß-1a is not known.

Objective: To determine whether IFNß-1a 60 µg IM once weekly is more effective than IFNß-1a 30 µg IM once weekly in reducing disability progression in relapsing MS.

Methods: In a double-blind, parallel-group, dose-comparison study, 802 patients with relapsing MS from 38 centers in Europe were randomized to IFNß-1a 30 µg (n = 402) or 60 µg (n = 400) IM once weekly for 36 months. The primary endpoint was disability progression, defined as time to a sustained increase of 1.0 point on the Expanded Disability Status Scale (EDSS) persisting for 6 months. Additional endpoints included relapses, MRI, safety, immunogenicity, and subgroup analyses of disability progression.

Results: Both groups showed equal rates of disability progression (hazard ratio, 0.96; 95% CI, 0.77 to 1.20; p = 0.73). In both groups the proportion of subjects with progression of disability by 36 months estimated from Kaplan–Meier curves was 37%. No dose effects were observed on any of the secondary clinical endpoints. Only one MRI measure at one time point, number of new or enlarging T2 lesions at month 36 compared with month 24, showed a difference favoring the 60-µg dose. Both doses were well tolerated; however, slightly higher incidences of flulike symptoms and muscle weakness were observed in the 60-µg group. The incidences of neutralizing antibodies (titers 20) were 2.3% in the 30-µg group and 5.8% in the 60-µg group.

Conclusion: There was no difference between IFNß-1a 30 µg and 60 µg IM in clinical or MRI measures.