Larger and longer studies of the safety of ocrelizumab are required. Neoplasms occurred in 0.5% of the patients treated with ocrelizumab and in 0.2% of those treated with interferon beta-1a.Īmong patients with relapsing multiple sclerosis, ocrelizumab was associated with lower rates of disease activity and progression than interferon beta-1a over a period of 96 weeks. Get the latest version of opera-beta for Linux - Fast and secure web browser. Serious infection occurred in 1.3% of the patients treated with ocrelizumab and in 2.9% of those treated with interferon beta-1a. Infusion-related reactions occurred in 34.3% of the patients treated with ocrelizumab.
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The change in the Multiple Sclerosis Functional Composite score (a composite measure of walking speed, upper-limb movements, and cognition for this z score, negative values indicate worsening and positive values indicate improvement) significantly favored ocrelizumab over interferon beta-1a in trial 2 (0.28 vs. The mean number of gadolinium-enhancing lesions per T 1-weighted magnetic resonance scan was 0.02 with ocrelizumab versus 0.29 with interferon beta-1a in trial 1 (94% lower number of lesions with ocrelizumab, P<0.001) and 0.02 versus 0.42 in trial 2 (95% lower number of lesions, P<0.001).
13.6% hazard ratio, 0.60 95% confidence interval, 0.45 to 0.81 P<0.001), as was the percentage of patients with disability progression confirmed at 24 weeks (6.9% vs. In prespecified pooled analyses, the percentage of patients with disability progression confirmed at 12 weeks was significantly lower with ocrelizumab than with interferon beta-1a (9.1% vs. 0.29 46% lower rate with ocrelizumab P<0.001) and in trial 2 (0.16 vs. The annualized relapse rate was lower with ocrelizumab than with interferon beta-1a in trial 1 (0.16 vs. The primary end point was the annualized relapse rate.
In two identical phase 3 trials, we randomly assigned 821 and 835 patients with relapsing multiple sclerosis to receive intravenous ocrelizumab at a dose of 600 mg every 24 weeks or subcutaneous interferon beta-1a at a dose of 44 μg three times weekly for 96 weeks. Ocrelizumab is a humanized monoclonal antibody that selectively depletes CD20+ B cells. B cells influence the pathogenesis of multiple sclerosis.
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