Efficacy and safety of obinutuzumab in active systemic lupus erythematosus (Registro nro. 22738)
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| 000 -Cabecera | |
|---|---|
| Campo de control interno | 03452nam a2200289 4500 |
| 001 - Número de control | |
| control field | ESSALUD |
| 005 - Fecha y hora de la última transacción | |
| Campo de control | 20260804160119.0 |
| 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 | eng |
| 100 ## - Autor | |
| Autor | Furie, Richard A. |
| Rol del Autor | Autor |
| 9 (RLIN) | 53746 |
| 245 ## - Titulo | |
| Titulo | Efficacy and safety of obinutuzumab in active systemic lupus erythematosus |
| 300 ## - Páginas | |
| Paginación | páginas: 243-254 |
| 520 ## - Resumen | |
| Resumen | Background: Obinutuzumab, a glycoengineered type II anti-CD20 monoclonal antibody, induces potent B-cell depletion and is approved for the treatment of active lupus nephritis. Its efficacy and safety in patients with active systemic lupus erythematosus (SLE) are yet to be determined. Methods: We conducted a phase 3, multicenter, double-blind, placebo-controlled trial involving adults with active SLE but without proliferative or membranous lupus nephritis who were receiving standard therapy. Patients were randomly assigned in a 1:1 ratio to receive obinutuzumab (1000 mg) or placebo on day 1 and weeks 2, 24, and 26. In the prespecified analysis, the primary end point at week 52 was a response on the SLE Responder Index 4 (SRI-4), defined by a reduction from baseline of at least 4 points in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score, no worsening of disease as assessed by the British Isles Lupus Assessment Group (BILAG) 2004 index and Physician’s Global Assessment, and no intercurrent events (i.e., major concomitant-therapy violation, receipt of rescue medication, or early discontinuation of trial participation due to death, lack of efficacy, or adverse events). Results: Of 303 patients who underwent randomization, 151 were assigned to receive obinutuzumab and 152 to receive placebo. At week 52, an SRI-4 response was observed in 76.7% of the patients in the obinutuzumab group and in 53.5% of those in the placebo group (adjusted difference, 23.1 percentage points; 95% confidence interval [CI], 12.5 to 33.6; P<0.001). In an additional analysis whereby nonfatal intercurrent events did not affect response status, the respective percentages were 85.4% and 68.5% (adjusted difference, 16.8 percentage points; 95% CI, 7.1 to 26.4). Obinutuzumab was superior to placebo with respect to all key secondary end points: BILAG-based Composite Lupus Assessment response, sustained reduction in glucocorticoid dose, sustained SRI-4 response, SRI-6 response, and time to first BILAG-defined flare. Adverse events were reported in 88.7% of the patients in the obinutuzumab group and in 81.5% of those in the placebo group, and serious adverse events in 15.9% and 11.9%, respectively. One patient in the obinutuzumab group and 3 in the placebo group died during the double-blind period. Conclusions: Among adults with active SLE, treatment with obinutuzumab was superior to placebo with respect to the primary and all key secondary end points. |
| 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 | REUMATOLOGÍA |
| 9 (RLIN) | 7490 |
| 700 ## - Autor Personal | |
| Autor Personal | Dall’Era, Maria |
| 9 (RLIN) | 53747 |
| 700 ## - Autor Personal | |
| Autor Personal | Vital, Edward M. |
| 9 (RLIN) | 53748 |
| 700 ## - Autor Personal | |
| Autor Personal | Garg, Jay P. |
| 9 (RLIN) | 53749 |
| 700 ## - Autor Personal | |
| Autor Personal | Irazoque Palazuelos, Fedra |
| 9 (RLIN) | 53750 |
| 700 ## - Autor Personal | |
| Autor Personal | Zuta Santillán, Adolfina E. |
| 9 (RLIN) | 53751 |
| 700 ## - Autor Personal | |
| Autor Personal | Ravelo-Hernández, Jorge |
| 9 (RLIN) | 53752 |
| 773 0# - Revista (Relacion con el numero) | |
| Host Biblionumber | 22717 |
| Host Itemnumber | 22636 |
| Ciudad, Editorial | Massachusetts NEJM Group |
| Codigo barras item/ejemplar | NEJM003 |
| 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 | 2026-07-31 |
| Catalogador | SQB |
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