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Oral interferon beta-1a in relapsing-remitting multiple sclerosis: a double-blind randomized study

Department of Neurology, Free University Medical Center, de Boelelaan 1117, NL-1007 MB Amsterdam, the Netherlands, ch.polman{at}vumc.nl

F Barkhof

Department of Radiology, Free University Medical Center, de Boelelaan 1117, NL-1007 MB Amsterdam, the Netherlands

L Kappos

Department of Neurology, University Hospitals Basel, Petersgraben 4, CH-4031 Basel, Switzerland

C Pozzilli

Department of Neurology, University of Rome ‘La Sapienza’, Viale Università 30, I-00185 Roma, Italy;

R Sandbrink

Schering AG, Sellerstr. 31, D-13342 Berlin, Germany

F Dahlke

Schering AG, Sellerstr. 31, D-13342 Berlin, Germany

P Jakobs

Schering AG, Sellerstr. 31, D-13342 Berlin, Germany

A Lorenz

Rentschler Biotechnologie GmbH & Co. KG, Erwin-Rentschler-Str. 21, D-88471 Laupheim, Germany

European Oral Interferon Beta-1a in Relapsing-Remitting MS Study Group

Background: Interferon beta (IFNB) is available in parenter al formulations for treatment of multiple sclerosis (MS). The purpo se of this study was to evaluate safety, tolerability and effects on MRI lesions of three different doses of oral IFNB-1a compared with placebo over six months in relapsing-remitting (RR) MS patients. Methods: In this multicenter, double-blind randomized trial, RR -MS patients received 0.06, 0.6 or 6 million international units (MIU) IFNB-1a or placebo every other day for up to six months. G adolinium DTPA enhanced brain MRI scans were performed at screening and monthly during treatment. The primary variable was the cumulative number of newly active lesions. Secondary variables included volume of enhancing lesions on T1-weighted images each month and lesion volume on T2-weighted images at months three and six. Safety measures included adverse events, laboratory variables, vital signs, ECG, physical examination, EDSS and number of relapses. Neopterin was measured in 21 patients and neutralizing antibodies in 24 patients. Results: O f 194 screened patients, 173 were randomized (42-44 patients per group) in 15 centers. Median cumulative numbers of newly active lesions over six months were 4.0 in the placebo and 0.6 MIU groups, compared with 7.5 and 9.0 in the 0.06 and 6 MIU groups (no significant differences). Secondary efficacy endpoints showed small and inconsistent differences between groups. A dverse events showed no notable group differences. A pproximately two-thirds of patients in each group remained relapse free. No patients showed neutralizing antibodies. Neopterin levels were comparable between groups. Conclusion: O ral IFNB-1a showed neither beneficial effects in RRMS nor any systemic biological effects. Treatment was safe and well tolerated.

Key Words: multiple sclerosis • oral interferon beta-1a • relapsing-remitting

Multiple Sclerosis, Vol. 9, No. 4, 342-348 (2003)
DOI: 10.1191/1352458503ms923oa


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