000			02999nam a2200337 4500
001			ESSALUD
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040			_aBMG
041			_aeng
100			_aVleugels, Ruth Ann _954448
245			_aA phase 3 trial of brepocitinib in dermatomyositis
300			_apáginas: 1883-1893
520			_aBackground: Brepocitinib is a first-in-class, oral, selective TYK2–JAK1 inhibitor that blocks cytokine signaling, which has been implicated in dermatomyositis. Methods: In this phase 3, double-blind, randomized, placebo-controlled trial, adults with dermatomyositis were assigned in a 1:1:1 ratio to receive once-daily oral brepocitinib at a dose of 30 mg, brepocitinib at a dose of 15 mg, or placebo for 52 weeks. Standard therapies were continued, and glucocorticoids were tapered. The primary end point was the Total Improvement Score, a validated composite myositis index (with scores ranging from 0 to 100 and higher scores indicating greater improvement) at week 52. Key secondary end points, including skin disease activity, glucocorticoid tapering, and physical function, were tested in a multiplicity-controlled sequence. Results: A total of 241 patients underwent randomization: 81 to receive brepocitinib 30 mg, 81 to receive brepocitinib 15 mg, and 79 to receive placebo. At week 52, the mean Total Improvement Score was 46.5, 37.5, and 31.2, respectively (difference with brepocitinib 30 mg vs. placebo, 15.3; 95% confidence interval [CI], 6.7 to 24.0; P<0.001; difference with brepocitinib 15 mg vs. placebo, 6.3; 95% CI, −2.4 to 14.9). Brepocitinib 30 mg was superior to placebo across all nine key secondary end points, including skin disease activity, systemic glucocorticoid tapering, and functional disability, with improvements observed as early as week 4. Serious infections were more frequent in the brepocitinib 30-mg group than in the placebo group (10% vs. 1%). No deaths occurred during the trial. Conclusions: In adults with dermatomyositis that was resistant to previous therapy, the use of brepocitinib at a dose of 30 mg (but not at a dose of 15 mg) resulted in significant benefits with respect to a composite myositis index, skin disease severity, glucocorticoid tapering, and functional disability
650			_aENFERMEDAD AUTOINMUNE _953665
650			_aALERGIA _97055
650			_aNEUROLOGÍA
650			_aDERMATOLOGÍA GENERAL _954449
650			_aENFERMEDAD INFLAMATORIA _953667
650			_aREUMATOLOGÍA GENERAL _954450
650			_aCÉLULAS T _954097
700			_aPaik, Julie J. _954451
700			_aVentura, Iazsmin Bauer _954452
700			_aMangold, Aaron R. _954453
700			_aGandiga, Prateek C. _954454
700			_aHaemel, Anna _954455
700			_aChinoy, Héctor _954456
773	0		_022717 _922669 _dMassachusetts NEJM Group _oNEJM014 _tThe New England Journal of Medicine _wESSALUD _x0028-4793
942			_cARTICULOS _e2026-08-31 _zsqb
999			_c22899 _d22899