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

). The purpo se o f this study was to evaluate safety, to lerability and effects on MRI lesions o f three different do ses o f oral IFNB-1a co mpared with placebo o ver six mo nths in relapsing ¡/remitting (RR) MS patients. Methods: In this multicenter, do uble-blind randomized trial, RR ¡/MS patients received 0.06, 0.6 or 6 million inter natio nal units (MIU) IFNB-1a o r placebo every o ther day for up to six mo nths. G adolinium DTPAenhanced brain MRI scans were per formed at screening and mo nthly during treatment. The primar y variable was the cumulative number o f new ly active lesions. Seco ndary variables included volume o f enhancing lesions o n T1-weighted images each month and lesion volume o n T2-weighted images at months three and six. Safety measures included adverse events, laborator y variables, vital signs, EC G , physical examinatio n, EDSS and number of relapses. Neo pterin was measured in 21 patients and neutr alizing antibo dies in 24 patients. Results: O f 194 screened patients, 173 were rando mized (42¡/44 patients per gro up) in 15 center s. Median cumulative number s o f new ly active lesions o ver six mo nths were 4.0 in the placebo and 0.6 MIU gro ups, co mpared with 7.5 and 9.0 in the 0.06 and 6 MIU groups (no significant differences). Seco ndary efficacy endpo ints showed small and inconsistent differences between groups. A dverse events showed no no table group differences. A ppro ximately two -thir ds o f patients in each group remained relapse free. N o patients showed neutr alizing antibo dies. N eo pter in levels were co mparable betw een gro ups. Conclusion: O ral IFNB-1a showed neither beneficial effects in RRMS no r any systemic bio lo gical effects. Treatment was safe and well to lerated. Multiple Sclerosis (2003) 9, 342¡/348

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