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Objective: To assess the efficacy of interferon beta-1b (IFNβ-1b) in Japane se patients with relapsing-remitting multiple sclerosis (RRMS). Background: The effects of IFNβin RRMS have been assessed in study populations comprised predo minantly of white patients. MS in Japanese patients is different from that in wh ite patients in that there are two different presentations classic MS (C-MS) an d optic-spinal MS (OS-MS)and chronic progressive forms are infrequent. Methods : A total of 205 Japanese patients with RRMS were randomized to receive 50 μg o r 250 μg (1.6 or 8.0 MIU) IFNβ-1b administered SC every other day for up to 2 years. The primary endpoint was annual relapse rate. Secondary endpoints includ ed further relapse-related and MRI outcome measures, as well as changes in Expa nded Disability Status Scale and Neurologic Rating Scale.Efficacy was assessed i n 188 patients, and safety was assessed in 192 patients. Supplemental ad hoc sub group analyses were also performed for patients with OS-MS and those with C-MS .Results: Annual relapse rates were 0.763 in the 250 μg group and 1.069 in the 50 μg group, a relative reduction of 28.6%(p = 0.047). Results for all seconda ry endpoints favored 250μg IFNβ-1b. Subgroup analyses suggested that the magn itude and direction of treatment effect in patients with OS-MS and C-MS was si milar, albeit not significant due to small sample size. Conclusions: Interferon beta-1b (IFNβ-1b) 250 μg significantly reduced relapse rates and change in M RI lesion area in Japanese patients with relapsing-remitting multiple sclerosis ,and seemed to be comparably effective in optic-spinal multiple sclerosis (MS) and classic MS. The response to treatment with IFNβ1b in Japanese patients with MS suggests that a common pathogenesis and underlying genetic characteristics a re shared with white patients.
Objective: To assess the efficacy of interferon beta-1b (IFNβ-1b) in Japane se patients with relapsing-remitting multiple sclerosis (RRMS). Background: The effects of IFNβin RRMS have been assessed in study groups testimonial pre-minantly of white patients. MS in Japanese patients is different from that in wh ite patients in that there are two different presentations classic MS (C-MS) an d optic-spinal MS (OS-MS) and chronic progressive forms are infrequent. Methods: A total of 205 Japanese patients with RRMS were randomized to receive 50 μg or 250 μg (1.6 or 8.0 MIU) of IFNβ-1b administered SC every other day for up to 2 years. The primary endpoint was annual relapse rate. Secondary endpoints includ ed further relapse-related and MRI outcome measures, as well as changes in Expa nded Disability Status Scale and Neurologic Rating Scale. Compliance was assessed in 188 patients, and safety was assessed in 192 patients. Supplemental ad hoc sub group analyzes were also performed for p atients with OS-MS and those with C-MS. Results: Annual relapse rates were 0.763 in the 250 μg group and 1.069 in the 50 μg group, a relative reduction of 28.6% (p = 0.047). Results for all seconda ry endpoints favored 250 μg IFNβ-1b. Subgroup analyzes that that magnify it and direction of treatment effect in patients with OS-MS and C-MS was si milar, albeit not significant due to small sample size. Conclusions: Interferon beta-1b 1b) 250 μg significantly reduced relapse rates and change in M RI lesion area in Japanese patients with relapsing-remitting multiple sclerosis, and seemed to be comparably effective in optic-spinal multiple sclerosis (MS) and classic MS. The response to treatment with IFNβ1b in Japanese patients with MS suggests that a common pathogenesis and underlying genetic characteristics a re shared with white patients.