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Published online before print August 16, 2006, doi:10.1212/01.wnl.0000237641.33768.8d)
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Received March 24, 2006
Accepted June 28, 2006

Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes

L. Kappos MD*, C. H. Polman MD, PhD, M. S. Freedman MD, G. Edan MD, H. P. Hartung MD, D. H. Miller MD, X. Montalban MD, F. Barkhof MD, PhD, L. Bauer MD, P. Jakobs DiplMath, C. Pohl MD, R. Sandbrink MD, PhD, for the BENEFIT Study Group

From University Hospital (L.K.), Basel, Switzerland; Vrije Universiteit Medical Centre (C.H.P., F.B.), Amsterdam, The Netherlands; The Ottawa Hospital (M.S.F.), Ottawa, Canada; Clinique Neurologique (G.E.), Rennes, France; Heinrich-Heine-Universität (H.P.H.), Düsseldorf, Germany; Institute of Neurology (D.H.M.), University College, London, UK; Hospitals Vall d’Hebron (X.M.), Barcelona, Spain; Schering AG (L.B., P.J., C.P., R.S.), Berlin, Germany; and University Hospital (Dr Pohl), Bonn, Germany.


* To whom correspondence should be addressed. E-mail: lkappos{at}uhbs.ch.

Abstract-- Objective: To assess efficacy, safety, and tolerability of every-other-day interferon beta-1b treatment in patients with a first clinical event suggestive of multiple sclerosis (MS) (clinically isolated syndrome). Methods: We conducted a multicenter, randomized, double-blind, placebo-controlled trial. Patients with a first clinical demyelinating event and at least two clinically silent brain MRI lesions were randomized to interferon beta-1b (IFNB-1b) 250 µg subcutaneously (SC) every other day (EOD) (n = 292) or placebo (n = 176), until clinically definite MS (CDMS) was diagnosed or they had been followed for 24 months. Results: After 2 years, 45% of placebo patients had converted to CDMS (Kaplan-Meier estimate; primary outcome measure) and 85% fulfilled the McDonald criteria (co-primary outcome measure). Overall interferon beta-1b delayed the time to diagnosis of CDMS (p < 0.0001) and McDonald MS (p < 0.00001). Hazard ratios (95% CI) were 0.50 (0.36 to 0.70) for CDMS and 0.54 (0.43 to 0.67) for McDonald MS favoring treatment with IFNB-1b. Treatment was well tolerated, as indicated by the low rate of patients dropping out of the study before CDMS was reached (6.6% overall, 7.2% in the IFNB-1b group). Conclusions: Interferon beta-1b 250 µg subcutaneously every other day delayed conversion to clinically definite multiple sclerosis, and should be considered as a therapeutic option in patients presenting with a first clinical event suggestive of multiple sclerosis.




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Correspondence:

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Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patien
Marcus W. Koch, et al.
Neurology Online, 31 Oct 2006 [Full text]
Reply from the Authors
Ludwig Kappos, et al.
Neurology Online, 31 Oct 2006 [Full text]

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