000 03107nam a2200361 4500
001 ESSALUD
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040 _aBMG
041 _aeng
100 _aTorkildsen, Øivind
_eAutor
_953663
245 _aRituximab versus ocrelizumab in newly diagnosed relapsing multiple sclerosis
300 _apáginas: 32-43
520 _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.
650 _aALERGIA
_97055
650 _aINMUNOLOGÍA GENERAL
_953664
650 _aENFERMEDAD AUTOINMUNE
_953665
650 _aMEDICINA CLINICA GENERAL
_953666
650 _aENFERMEDAD INFLAMATORIA
_953667
650 _aESCLEROSIS MULTIPLE
_914091
650 _aNEUROLOGÍA
650 _aNEUROCIRUGÍA GENERAL
_953668
650 _aOFTALMOLOGÍA
_932364
700 _aKjelgaard Brustad, Hilde
_953669
700 _aHøgestøl, Einar August
_953670
700 _aAlstadhaug, Karl Bjørnar
_953671
700 _aBhan, Alok
_953672
700 _aFlemmen, Heidi Øyen
_953673
700 _aHabbestad, Andrea
_953674
773 0 _022717
_922634
_dMassachusetts NEJM Group
_oNEJM001
_tThe New England Journal of Medicine
_wESSALUD
_x0028-4793
942 _cARTICULOS
_e2026-07-31
_zsqb
999 _c22724
_d22724