Phase 3 trial of secukinumab in polymyalgia rheumatica (Registro nro. 22824)

000 -Cabecera
Campo de control interno 03417nam a2200361 4500
001 - Número de control
control field ESSALUD
005 - Fecha y hora de la última transacción
Campo de control 20260817155615.0
007 - Tipo material - Descripcion fisica - info general
Tipo material - Descripcion fisica - info general ta
008 - Elementos de Longitud Fija - Información General
Elementos de Longitud Fija - Información t pe ||||| |||| 00| 0 spa d
040 ## - Origen de la Catalogación
Origen de la Catalogación BMG
041 ## - Idioma
Idioma spa
100 ## - Autor
Autor Stone, John H.
Rol del Autor Autor
9 (RLIN) 54096
245 ## - Titulo
Titulo Phase 3 trial of secukinumab in polymyalgia rheumatica
300 ## - Páginas
Paginación páginas: 637-647
520 ## - Resumen
Resumen Background: Polymyalgia rheumatica is a common inflammatory disease characterized by pain and stiffness in the shoulders and hips. Glucocorticoids are the first-line treatment, but relapses and glucocorticoid-related toxic effects are common, which underscores the need for effective alternatives. Secukinumab is a fully human monoclonal antibody that selectively inhibits interleukin-17A. Methods: We enrolled patients with recently relapsed polymyalgia rheumatica and randomly assigned them, in a 1:1:1 ratio, to receive secukinumab at a dose of 300 mg (SEC-300 group), secukinumab at a dose of 150 mg (SEC-150 group), or placebo for 52 weeks. Patients in all the groups also received prednisone on a tapering schedule for 24 weeks. The primary outcome was sustained remission at week 52, defined as remission (the absence of signs or symptoms attributable to polymyalgia rheumatica and no new diagnosis of giant-cell arteritis that warranted escape or rescue treatment) that was sustained from week 12 until week 52. The annual cumulative glucocorticoid dose was a secondary outcome. Safety was also assessed. Results: A total of 381 patients underwent randomization, and 127 were assigned to each group. At 52 weeks, sustained remission was observed in 41.2% (95% confidence interval [CI], 32.8 to 49.7) of the patients in the SEC-300 group, in 40.6% (95% CI, 32.2 to 49.0) of those in the SEC-150 group, and in 20.4% (95% CI, 13.6 to 27.2) of those in the placebo group (P<0.001 for the comparison of each secukinumab dose with placebo). The mean adjusted annual cumulative glucocorticoid dose was 1603.7 mg in the SEC-300 group, 1683.2 mg in the SEC-150 group, and 2093.0 mg in the placebo group. Serious adverse events occurred in 13.5% of the patients in the SEC-300 group, in 15.9% in the SEC-150 group, and in 14.2% in the placebo group. Nasopharyngitis, hypersensitivity reactions, urinary tract infections, fungal infections, and back pain were more common in the secukinumab groups than in the placebo group. Conclusions: Among patients with relapsed polymyalgia rheumatica, treatment with secukinumab plus a 24-week glucocorticoid taper resulted in a higher percentage of patients with remission and in lower cumulative glucocorticoid doses than a glucocorticoid taper alone.
650 ## - Temas - Descriptores
Temas - Descriptores ALERGIA
9 (RLIN) 7055
650 ## - Temas - Descriptores
Temas - Descriptores INMUNOLOGÍA
9 (RLIN) 34121
650 ## - Temas - Descriptores
Temas - Descriptores ENFERMEDAD AUTOINMUNE
9 (RLIN) 53665
650 ## - Temas - Descriptores
Temas - Descriptores MEDICINA CLÍNICA
9 (RLIN) 33681
650 ## - Temas - Descriptores
Temas - Descriptores GERIATRÍA
9 (RLIN) 1852
650 ## - Temas - Descriptores
Temas - Descriptores REUMATOLOGÍA
9 (RLIN) 7490
650 ## - Temas - Descriptores
Temas - Descriptores CÉLULAS T
9 (RLIN) 54097
650 ## - Temas - Descriptores
Temas - Descriptores VASCULITIS
9 (RLIN) 32232
700 ## - Autor Personal
Autor Personal Buttgereit, Frank
9 (RLIN) 54098
700 ## - Autor Personal
Autor Personal Saraux, Alain
9 (RLIN) 54099
700 ## - Autor Personal
Autor Personal Schmidt, Wolfgang A.
9 (RLIN) 54100
700 ## - Autor Personal
Autor Personal Dejaco, Christian
9 (RLIN) 54101
700 ## - Autor Personal
Autor Personal Spiera, Robert
9 (RLIN) 54102
700 ## - Autor Personal
Autor Personal Dasgupta, Bhaskar
9 (RLIN) 54103
700 ## - Autor Personal
Autor Personal Drescher, Edit
9 (RLIN) 54104
773 0# - Revista (Relacion con el numero)
Host Biblionumber 22717
Host Itemnumber 22647
Ciudad, Editorial Massachusetts NEJM Group
Codigo barras item/ejemplar NEJM010
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 2026-08-17
Catalogador SQB

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