| 000 | 03107nam a2200361 4500 | ||
|---|---|---|---|
| 001 | ESSALUD | ||
| 005 | 20260804123817.0 | ||
| 007 | ta | ||
| 008 | t pe ||||| |||| 00| 0 spa d | ||
| 040 | _aBMG | ||
| 041 | _aeng | ||
| 100 |
_aTorkildsen, Øivind _eAutor _953663 |
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| 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 |
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| 650 |
_aINMUNOLOGÍA GENERAL _953664 |
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| 650 |
_aENFERMEDAD AUTOINMUNE _953665 |
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| 650 |
_aMEDICINA CLINICA GENERAL _953666 |
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| 650 |
_aENFERMEDAD INFLAMATORIA _953667 |
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| 650 |
_aESCLEROSIS MULTIPLE _914091 |
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| 650 | _aNEUROLOGÍA | ||
| 650 |
_aNEUROCIRUGÍA GENERAL _953668 |
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| 650 |
_aOFTALMOLOGÍA _932364 |
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| 700 |
_aKjelgaard Brustad, Hilde _953669 |
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| 700 |
_aHøgestøl, Einar August _953670 |
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| 700 |
_aAlstadhaug, Karl Bjørnar _953671 |
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| 700 |
_aBhan, Alok _953672 |
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| 700 |
_aFlemmen, Heidi Øyen _953673 |
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| 700 |
_aHabbestad, Andrea _953674 |
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| 773 | 0 |
_022717 _922634 _dMassachusetts NEJM Group _oNEJM001 _tThe New England Journal of Medicine _wESSALUD _x0028-4793 |
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| 942 |
_cARTICULOS _e2026-07-31 _zsqb |
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| 999 |
_c22724 _d22724 |
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