03109nam a2200361   4500001000800000005001700008007000300025008004100028040000800069041000800077100003900085245008100124300002100205520190300226650001802129650003302147650003302180650003602213650003502249650003102284650001702315650003402332650002602366700003702392700003702429700003802466700002302504700003202527700003002559773011002589942003102699999001702730ESSALUD20260804123817.0ta      t        pe ||||| |||| 00| 0 spa d  aBMG  aeng  aTorkildsen, Øivind eAutor953663  aRituximab versus ocrelizumab in newly diagnosed relapsing multiple sclerosis  apáginas: 32-43  aBackground: Anti-CD20 monoclonal antibodies are effective for relapsing multiple sclerosis. However, data from head-to-head trials are lacking.
Methods: In this phase 3, multicenter, double-blind, noninferiority trial, we randomly assigned adults with newly diagnosed relapsing multiple sclerosis and recent disease activity in a 3:2 ratio to receive rituximab or ocrelizumab every 6 months for 24 months. The primary end point was the absence of new or enlarging lesions on T2-weighted magnetic resonance imaging (MRI) from month 6 to month 24. Noninferiority was defined as a lower limit of the 95% confidence interval for the risk difference (rituximab minus ocrelizumab) of greater than or equal to −10 percentage points. Secondary end points included efficacy and safety.
Results: A total of 218 participants underwent randomization; 216 received treatment (132 assigned to the rituximab group and 84 assigned to the ocrelizumab group). Between months 6 and 24, the estimated probability of having no new or enlarging lesions detected on T2-weighted MRI was 92.2% with rituximab and 94.8% with ocrelizumab, corresponding to a risk difference of –2.6 percentage points (95% confidence interval, –9.4 to 4.3), which met the prespecified noninferiority criterion. Relapse rates, disability outcomes, and cognitive-performance profiles appeared to be similar in the two groups. Infections were more common in the rituximab group than in the ocrelizumab group (in 82% vs. 69% of participants), although the percentage of participants with serious adverse events was similar in the two groups (8% and 7%, respectively).
Conclusions: In participants with newly diagnosed relapsing multiple sclerosis and recent disease activity, rituximab was noninferior to ocrelizumab in suppressing disease activity as detected by MRI from 6 to 24 months, with a similar incidence of serious adverse events.   aALERGIA97055  aINMUNOLOGÍA GENERAL953664  aENFERMEDAD AUTOINMUNE953665  aMEDICINA CLINICA GENERAL953666  aENFERMEDAD INFLAMATORIA953667  aESCLEROSIS MULTIPLE914091  aNEUROLOGÍA  aNEUROCIRUGÍA GENERAL953668  aOFTALMOLOGÍA932364  aKjelgaard Brustad, Hilde 953669  aHøgestøl, Einar August 953670  aAlstadhaug, Karl Bjørnar 953671  aBhan, Alok 953672  aFlemmen, Heidi Øyen953673  aHabbestad, Andrea 9536740 022717922634dMassachusetts NEJM GroupoNEJM001tThe New England Journal of Medicine wESSALUDx0028-4793  cARTICULOSe2026-07-31zsqb  c22724d22724