A phase 3 trial of brepocitinib in dermatomyositis (Registro nro. 22899)

000 -Cabecera
Campo de control interno 02999nam a2200337 4500
001 - Número de control
control field ESSALUD
005 - Fecha y hora de la última transacción
Campo de control 20260902155020.0
007 - Tipo material - Descripcion fisica - info general
Tipo material - Descripcion fisica - info general ta
008 - Elementos de Longitud Fija - Información General
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040 ## - Origen de la Catalogación
Origen de la Catalogación BMG
041 ## - Idioma
Idioma eng
100 ## - Autor
Autor Vleugels, Ruth Ann
9 (RLIN) 54448
245 ## - Titulo
Titulo A phase 3 trial of brepocitinib in dermatomyositis
300 ## - Páginas
Paginación páginas: 1883-1893
520 ## - Resumen
Resumen Background: 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 ## - Temas - Descriptores
Temas - Descriptores ENFERMEDAD AUTOINMUNE
9 (RLIN) 53665
650 ## - Temas - Descriptores
Temas - Descriptores ALERGIA
9 (RLIN) 7055
650 ## - Temas - Descriptores
Temas - Descriptores NEUROLOGÍA
650 ## - Temas - Descriptores
Temas - Descriptores DERMATOLOGÍA GENERAL
9 (RLIN) 54449
650 ## - Temas - Descriptores
Temas - Descriptores ENFERMEDAD INFLAMATORIA
9 (RLIN) 53667
650 ## - Temas - Descriptores
Temas - Descriptores REUMATOLOGÍA GENERAL
9 (RLIN) 54450
650 ## - Temas - Descriptores
Temas - Descriptores CÉLULAS T
9 (RLIN) 54097
700 ## - Autor Personal
Autor Personal Paik, Julie J.
9 (RLIN) 54451
700 ## - Autor Personal
Autor Personal Ventura, Iazsmin Bauer
9 (RLIN) 54452
700 ## - Autor Personal
Autor Personal Mangold, Aaron R.
9 (RLIN) 54453
700 ## - Autor Personal
Autor Personal Gandiga, Prateek C.
9 (RLIN) 54454
700 ## - Autor Personal
Autor Personal Haemel, Anna
9 (RLIN) 54455
700 ## - Autor Personal
Autor Personal Chinoy, Héctor
9 (RLIN) 54456
773 0# - Revista (Relacion con el numero)
Host Biblionumber 22717
Host Itemnumber 22669
Ciudad, Editorial Massachusetts NEJM Group
Codigo barras item/ejemplar NEJM014
Titulo de la Revista The New England Journal of Medicine
Número de control de registro ESSALUD
ISSN 0028-4793
942 ## - Elementos de Koha
Tipo de Documento Artículos
Fecha procesamiento 2026-08-31
Catalogador sqb

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