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This phase 3 noninferiority trial compared rituximab with ocrelizumab in adults with newly diagnosed relapsing multiple sclerosis and recent disease activity. Participants were randomized in a 3:2 ratio to receive rituximab or ocrelizumab every six months for 24 months. Of 218 randomized participants, 216 received treatment: 132 received rituximab and 84 received ocrelizumab. The primary outcome was the absence of new or enlarging T2-weighted MRI lesions between months 6 and 24. The estimated probability of remaining free of new or enlarging lesions was 92.2% with rituximab and 94.8% with ocrelizumab, a risk difference of −2.6 percentage points (95% CI, −9.4 to 4.3), meeting the prespecified noninferiority criterion. Relapse rates, disability outcomes, and cognitive performance appeared similar between groups. Infections were reported in 82% of participants receiving rituximab and 69% receiving ocrelizumab; serious adverse events occurred in 8% and 7%, respectively. Conclusion: Rituximab was noninferior to ocrelizumab for suppressing MRI-detected disease activity over the specified period, with broadly similar serious adverse-event rates. These findings may inform treatment selection, although infection risk, cost, local availability, and longer-term outcomes remain important considerations
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This phase 3 noninferiority trial compared rituximab with ocrelizumab in adults with newly diagnosed relapsing multiple sclerosis and recent disease activity. Participants were randomized in a 3:2 ratio to receive rituximab or ocrelizumab every six months for 24 months. Of 218 randomized participants, 216 received treatment: 132 received rituximab and 84 received ocrelizumab. The primary outcome was the absence of new or enlarging T2-weighted MRI lesions between months 6 and 24. The estimated probability of remaining free of new or enlarging lesions was 92.2% with rituximab and 94.8% with ocrelizumab, a risk difference of −2.6 percentage points (95% CI, −9.4 to 4.3), meeting the prespecified noninferiority criterion. Relapse rates, disability outcomes, and cognitive performance appeared similar between groups. Infections were reported in 82% of participants receiving rituximab and 69% receiving ocrelizumab; serious adverse events occurred in 8% and 7%, respectively. Conclusion: Rituximab was noninferior to ocrelizumab for suppressing MRI-detected disease activity over the specified period, with broadly similar serious adverse-event rates. These findings may inform treatment selection, although infection risk, cost, local availability, and longer-term outcomes remain important considerations
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