Effectiveness and safety of rectal tacrolimus in patients with ulcerative colitis. TACRO-TOPIC study of GETECCU.
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.
Fuentes-Valenzuela Esteban, Bastón-Rey Iria, García-Alonso Francisco Javier, Elosua Alfonso, Zabalza San Martín Lucía, Leo Carnerero Eduardo, Garcia de la Filia Irene, Pedraza Pérez Andoni, Sáiz Chumillas Rosa María, Pascual Oliver Andrea, Muñoz Villafranca Carmen, Moreno Violeta, Suárez Ferrer Cristina, Molina Gema, Ferreiro-Iglesias Rocío, Vega Villaamil Pablo, Gardeazábal Mateos Diego, Segarra-Ortega José Xavier, Garrido Marín Alejandro, Doallo Alberto I, Alonso-Galán Horacio, Brunet-Mas Eduard, Jimenez García Nuria, López Romero-Salazar Francisco, Velayos Benito, Carballo-Folgoso Lorena, Pérez Santamaría Cristina, Mata Román Laura, Núñez Ortiz Andrea, Barrio Jesús, Barreiro-de Acosta Manuel, Gutiérrez-Casbas Ana
Аннотация
METHODS: A multicenter retrospective study was conducted at 27 hospitals across Spain. Adult patients with UC who had received suppositories, enemas, or tacrolimus ointment due to persistent clinical or endoscopic activity despite topical mesalamine and/or steroids from January 2009 to January 2023 were included. The primary outcome was clinical response at week 8.
RESULTS: A total of 148 patients were included. Sixty-nine patients (46.6%) received suppositories, 78 (52.7%) received enemas, and one patient used an ointment (0.7%). Clinical remission was achieved in 43 (33.6%), and clinical response in 76 (59.4%) patients at week 4. The primary outcome was achieved in 87 (67.4%), and clinical remission was achieved in 61 patients (47.3%) at week 8. Median tacrolimus trough level was 3.4 ng/mL (IQR 1.5-6.7) at week 4 and 2.9 ng/mL (IQR 1.5-6) at week 8. After a median follow-up of 55.1 weeks (IQR 40.6-55.7) since starting TT, 63 (42.6%) patients needed treatment escalation other than tacrolimus during the follow-up period, with a 1-year risk of treatment escalation of 46.2% (95% CI 37.3-56.1%). Adverse events were detected in 21 patients (14.2%), with 12 graded as mild and 9 as moderate (42.6%).
CONCLUSIONS: Topical tacrolimus is an effective therapy and could be considered in distal UC patients before initiating other advanced therapies when endoscopic activity remains.