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From the Danish Multiple Sclerosis Registry (N.K.-H.), Rigshospitalet, Copenhagen, Department of Neurology (N.K.-H.), Aarhus University Hospital in Aalborg, Danish Multiple Sclerosis Research Centre (P.S.S., M.R.), Rigshospitalet, University of Copenhagen, MR Centre (T.C.), Department of Radiology, Skejby Hospital, University of Aarhus, Department of Neurology (J.F.), Glostrup Hospital, University of Copenhagen, Department of Neurology (K.J.), Hillerød Hospital, Department of Neurology (A.H.), Roskilde Hospital, Roskilde, Department of Neurology (O.K.), Odense University Hospital, MS Clinics (E.S.), Sønderborg, Vejle, and Esbjerg Hospitals, Department of Neurology (T.P.), Aarhus University Hospital, and National Institute for Public Health (T.H.), Copenhagen, Denmark.
Address correspondence and reprint requests to Dr. N. Koch-Henriksen, Department of Neurology, Aalborg Hospital North, DK 9000 Aalborg, Denmark; e-mail: koch-henriksen{at}stofanet.dk
Objective: To investigate whether the efficacy of interferon-beta (IFNß) treatment of relapsingremitting MS (RR-MS) was influenced by type, dose, and frequency of administration.
Methods: From June 1996 through October 1997, the authors offered participation to all Danish RR-MS patients who met the following criteria: definite MS, at least two relapses within 2 years, age 18 to 55, and an Expanded Disability Status Scale (EDSS) score of
5.5. The study was multicenter, controlled, open-label, randomized, head-to-head comparing IFNß-1a 22 µg once a week (n = 143) with IFNß-1b 250 µg every other day (n = 158), both subcutaneously, for 24 months. Patients who declined randomization were offered treatment with IFNß-1b 250 µg every other day (n = 120). The primary end-points were the annualized relapse rate, the time to first relapse, and neutralizing antibody formation. The secondary endpoint was time to sustained progression
Results: The annual relapse rates were virtually equal in the two arms of the randomized study (IFNß-1a: 0.70; IFNß-1b: 0.71); so were the time to first relapse and the time to sustained progression. In the nonrandomized patients (IFNß-1b), the annual relapse rate was not significantly different, but the time to progression was shorter.
Conclusion: In this study, 250 µg interferon-beta-1b administered every other day did not prove clinically superior to once-a-week administration of 22 µg interferon-beta-1a.
Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the April 11 issue to find the title link for this article.
This article was previously published in electronic format as an Expedited E-Pub on March 1, 2006, at www.neurology.org.
*See the Appendix for a complete list of Group members.
Dr. Koch-Henriksen has received honoraria for lecturing and advisory councils and travel expenses for attending meetings from Schering and Serono. Prof. Soelberg Sørensen has received honoraria for lecturing and advisory councils, travel expenses for attending meetings, and/or financial support for his department from Schering and Serono. Dr. Kristensen has received grants from Schering and Serono. Drs. Christensen, Frederiksen, Ravnborg, Jensen, Heltberg, Stenager, Petersen, and Hansen have nothing to disclose.
Disclosure: The authors report no conflicts of interest.
Received February 10, 2005. Accepted in final form December 5, 2005.
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