Real-world long-term effectiveness of ustekinumab in Crohn's disease: results from the ENEIDA registry.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
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Iborra Marisa, Beltrán Belén, Fernández-Clotet Agnes, Iglesias-Flores Eva, Navarro Pablo, Rivero Montserrat, Gutiérrez Ana, Sierra-Ausin Mónica, Mesonero Francisco, Ferreiro-Iglesias Rocío, Hinojosa Joaquín, Calvet Xavier, Sicilia Beatriz, González-Muñoza Carlos, Antolín Beatriz, González-Vivo María, Carbajo Ana Y, García-López Santiago, Martín-Cardona Albert, Surís Gerard, Martin-Arranz María Dolores, de Francisco Ruth, Cañete Fiorella, Domènech Eugeni, Nos Pilar, GETECCU group (Grupo Español de trabajo de Enfermedades de Crohn y Colitis Ulcerosa)
Аннотация
AIM: To assess the real-world, long-term effectiveness of ustekinumab in refractory Crohn's disease (CD).
METHODS: Multi-centre study of CD patients starting ustekinumab at the recommended dose, followed for 1 year. Values for the Harvey-Bradshaw Index (HBI), endoscopic activity, C-reactive protein (CRP), and faecal calprotectin (FC) were recorded at baseline and at weeks 26 and 52. Demographic and clinical data, previous treatments, adverse events (AEs) and hospitalisations were documented. Potential predictors of remission were examined.
RESULTS: A total of 407 patients were analysed. The initial maintenance dose of 90 mg SC was administered every 12, 8 and 4 weeks in 56 (14%), 347 (85%) and 4 (1%) patients, respectively. After 52 weeks, treatment was discontinued in 112 patients (27.5%). At baseline, 295 (72%) had an HBI >4 points. Of these, 169 (57%) and 190 (64%) achieved clinical remission at weeks 26 and 52, respectively. FC levels returned to normal in 44% and 54% of patients at weeks 26 and 52, and CRP returned to normal in 36% and 37% of patients at weeks 26 and 52, respectively. AEs were recorded in 60 patients. The use of fewer previous anti-TNFα agents and ileal localisation were associated with clinical remission, and endoscopic severity was associated with poor response. No factors correlated with endoscopic remission.
CONCLUSION: After 52 weeks, ustekinumab demonstrated effectiveness in inducing clinical and endoscopic remission in patients with refractory CD.