TUESDAY, Nov. 1 (HealthDay News) -- Ocrelizumab administered in doses of 600 and 2,000 mg in patients with relapsing-remitting multiple sclerosis (MS) is safe, and reduces the total number of gadolinium-enhancing lesions (GEL) on T1-weighted magnetic resonance imaging (MRI), according to a study published online Nov. 1 in The Lancet.
Ludwig Kappos, M.D., from the University Hospital in Basel, Switzerland, and colleagues evaluated the safety and efficacy of two dose regimens of ocrelizumab in 218 patients (aged 18 to 55 years) with relapsing-remitting MS. Participants were randomized to receive either placebo, low-dose (600 mg) or high-dose (2,000 mg) ocrelizumab, or 30 µg of intramuscular interferon beta-1. At week 24, 600 mg ocrelizumab was administered to the patients in the initial placebo, 600 mg ocrelizumab, and interferon beta-1a groups, and 1,000 mg ocrelizumab was administered to the 2,000 mg group. The total number of GEL on T1-weighted MRI at weeks 12, 16, 20, and 24 was the primary end point.
The investigators found that, compared to the placebo group, the number of GEL was 89 and 96 percent lower in the 600 and 2,000 mg ocrelizumab groups, respectively. Exploratory analyses revealed that GEL reduction was better in both the 600 and 2,000 mg ocrelizumab groups than in the interferon beta-1a group. Serious adverse events were found in 4, 2, 5, and 4 percent of the patients in the placebo, 600 mg, 2,000 mg ocrelizumab, and interferon beta-1a groups, respectively.
"Our findings show that ocrelizumab rapidly suppresses inflammatory activity as depicted by contrast enhancing lesions in frequent MRIs, and by clinical relapses," the authors write.
All study authors disclosed financial relationships with pharmaceutical companies, including F. Hoffmann-La Roche and Biogen Idec, which funded the study and developed ocrelizumab.
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