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31 monoclonal antibodies to watch for in 2018
Source:药事纵横 | Author:pro954f45 | Published time: 2018-01-14 | 2980 Views | Share:

       Ocrelizumab
       Ocrelizumab (Ocrevus) is a humanized IgG1 monoclonal antibody that targets Cd-20-positive B cells. These B cells play a role in myelin damage and multiple sclerosis by producing pro-inflammatory cytokines, secreting autoantibodies, and activating pro-inflammatory T cells. Ocrevus destroys CD20 positive B cells in three main ways: complement dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity, and by binding to CD20 on target cells to apoptosis. This monoclonal antibody has been studied in both internal rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE), but the expected results are not satisfactory. Ocrevus received FDA approval on March 29 for relapsing and relapsing multiple sclerosis as well as primary progressive multiple sclerosis, following the indication's FDA breakthrough therapy designation, fast-track and priority review. Two trials, OPERAI (NCT01247324) and OPERAII (NCT01412333), respectively, assessed the safety and efficacy of Ocrevus in the treatment of multiple sclerosis with remission, and showed significantly lower recurrence rates in the Ocrevus group than in the beta interferon group, with OPERAI 46% lower and OPERAII 57% lower. In primary progressive multiple sclerosis, results from the ORATORIO trial showed that Ocrevus significantly reduced clinical disability progression at 12 weeks (primary endpoint) compared with placebo (32.9% vs 39.3%). In addition, MRI showed a 3.4 percent decrease in the overall volume of encephalopathy in patients treated with Ocrevus, compared with a 7.4 percent increase in placebo.