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

@article{citeulike:3245074, abstract = {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. 10.1191/1352458503ms923oa}, author = {Polman, C. and Barkhof, F. and Kappos, L. and Pozzilli, C. and Sandbrink, R. and Dahlke, F. and Jakobs, P. and Lorenz, A. and European}, citeulike-article-id = {3245074}, citeulike-linkout-0 = {http://dx.doi.org/10.1191/1352458503ms923oa}, citeulike-linkout-1 = {http://msj.sagepub.com/cgi/content/abstract/9/4/342}, citeulike-linkout-2 = {http://view.ncbi.nlm.nih.gov/pubmed/12926838}, citeulike-linkout-3 = {http://www.hubmed.org/display.cgi?uids=12926838}, day = {1}, doi = {10.1191/1352458503ms923oa}, journal = {Mult Scler}, keywords = {abstract, interferon, multiple\_sclerosis}, month = {August}, number = {4}, pages = {342--348}, posted-at = {2008-09-12 11:46:37}, priority = {2}, title = {Oral interferon beta-1a in relapsing-remitting multiple sclerosis: a double-blind randomized study}, url = {http://dx.doi.org/10.1191/1352458503ms923oa}, volume = {9}, year = {2003} }

TY - JOUR ID - citeulike:3245074 L3 - citeulike-article-id:3245074 N2 - 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. 10.1191/1352458503ms923oa IS - 4 JF - Mult Scler EP - 348 TI - Oral interferon beta-1a in relapsing-remitting multiple sclerosis: a double-blind randomized study VL - 9 SP - 342 KW - abstract KW - interferon KW - multiple_sclerosis AU - Polman, C AU - Barkhof, F AU - Kappos, L AU - Pozzilli, C AU - Sandbrink, R AU - Dahlke, F AU - Jakobs, P AU - Lorenz, A AU - European PY - 2003/08/01/ UR - http://dx.doi.org/10.1191/1352458503ms923oa ER -