What have the OPERA studies shown about the effectiveness of ocrelizumab (Ocrevus) in the treatment of relapsing multiple sclerosis (MS)?

Updated: Oct 08, 2019
  • Author: Christopher Luzzio, MD; Chief Editor: Jasvinder Chawla, MD, MBA  more...
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Answer

Ocrelizumab (Ocrevus) was approved in March 2017 for adults with relapsing or primary progressive forms of multiple sclerosis. Approval for RRMS was based on the OPERA 1 and 2 phase 3 trials that included about 800 patients with RMS who received intravenous ocrelizumab or subcutaneous interferon-beta1a. Results showed the annualized relapse rate was lower with ocrelizumab than with interferon beta-1a in trial 1 (0.16 vs. 0.29; 46% lower rate with ocrelizumab; P< 0.001) and in trial 2 (0.16 vs. 0.29; 47% lower rate; P< 0.001). The percentage of patients with disability progression confirmed at 12 weeks was significantly lower with ocrelizumab than with interferon beta-1a (9.1% vs. 13.6%; P< 0.001), as was the percentage of patients with disability progression confirmed at 24 weeks (6.9% vs. 10.5%; P=0.003). The mean number of gadolinium-enhancing lesions per T1-weighted MRI 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). [23]

Further analysis of participants from the OPERA studies in October 2017 showed that ocrelizumab may improve visual outcomes in adult patients with RMS. Patients who received the drug intravenously had significantly greater improvement on low-contrast letter acuity (LCLA) tests compared with those who received subcutaneous interferon β-1a. Within the visually impaired subgroup, significantly more patients receiving ocrelizumab showed at least a 7-letter improvement at 12 weeks compared to the interferon group. [108]


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