Multicenter Spanish study on vedolizumab intravenous to subcutaneous switch in patients with inflammatory bowel disease in clinical remission.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Gros Beatriz, Manceñido Noemí, Benítez José Manuel, Guardiola Jordi, Alonso Abreu Inmaculada, Rodríguez-Lago Iago, Alvarado Rubén, Ponferrada Díaz Ángel, Argüelles-Arias Federico, Rodríguez G Esther, Mesonero Gismero Francisco, Guerra Iván, Iborra Marisa, Borrás Pere, Cañete Fiorella, Madero Velázquez Lucía, Castro Poceiro Jesús, Caballero-Mateos Antonio M, Barreiro de Acosta Manuel, Huguet José María, Castro Senosain Beatriz, Brunet Eduard, López Romero-Salazar Francisco, Caballol Berta, Suria Carles, Alfambra Erika, García García Laura, Orobitg Judit, Marín Pedrosa Sandra, Soto Escribano Pilar, Zabana Yamile, Gutiérrez Ana, Iglesias Flores Eva
Аннотация
METHODS: inflammatory bowel diseases (IBD) patients on IV vedolizumab treatment in clinical remission from 24 Spanish hospitals were given the option to transition to SC injections (where this formulation was available) or to remain on IV, whereas patients from centers without access to SC vedolizumab remained on IV therapy. Data encompassing clinical disease activity, biochemical markers, adverse events, treatment persistence, and disease-related outcomes were retrospectively gathered from prospectively maintained clinical records at baseline, and at weeks 12, 24, and 48.
RESULTS: a total of 207 patients were identified and 23 were excluded as they were not in clinical remission, resulting in a final total of 184 patients included in the study. Of these, 53 (28.8 %) remained on IV vedolizumab, while 131 (71.2 %) transitioned to SC. There were 108 (58.7 %) patients with ulcerative colitis and 76 (41.3 %) with Crohn's disease. Both groups had comparable demographic characteristics, except for Crohn's disease behavior, with non-inflammatory non-stricturing pattern (B1 Montreal classification) being predominant among patients who transitioned to SC (p = 0.023). No differences were observed in drug persistence (log rank test p = 0.82). Clinical, biochemical and fecal calprotectin remission at the different time-points were comparable at each time point with the exception of clinical remission at week 12, favoring SC over IV. Drug intensification occurred in 24.5 % of patients on IV versus none on SC, p < 0.0001. Safety was consistent with that previously reported, and there were no differences between the groups (13 [8 %] SC vs 1 [2.1 %] IV, p = 0.059), most being mild in nature.
CONCLUSIONS: transitioning from IV to SC vedolizumab in patients with IBD in remission showed a comparable effectiveness to maintain disease remission and persistence. Patients on IV are more likely to require drug intensification during follow-up.