Effectiveness and safety of azathioprine for inflammatory pouch disorders: results from the RESERVO study of GETECCU.
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Mesonero Francisco, Zabana Yamile, Fernández-Clotet Agnès, Leo-Carnerero Eduardo, Caballol Berta, Núñez-Ortiz Andrea, García María José, Bertoletti Federico, Mínguez Alejandro, Suris Gerard, Casis Begoña, Ferreiro-Iglesias Rocío, Calafat Margalida, Jiménez Itxaso, Miranda-Bautista José, Lamuela Luis Javier, Fajardo Ingrid, Torrealba Leyanira, Nájera Rodrigo, Sáiz-Chumillas Rosa María, González Irene, Vicuña Miren, García-Morales Natalia, Gutiérrez Ana, López-García Alicia, Benítez José Manuel, Rubín de Célix Cristina, Tejido Coral, Brunet Eduard, Hernández-Camba Alejandro, Suárez Cristina, Rodríguez-Lago Iago, Piqueras Marta, Castaño Andrés, Ramos Laura, Sobrino Ana, Rodríguez-Grau María Carmen, Elosua Alfonso, Montoro Miguel, Baltar Ruth, Huguet José María, Hermida Benito, Caballero-Mateos Antonio, Sánchez-Guillén Luis, Bouhmidi Abdel, Pajares Ramón, Baston-Rey Iria, López-Sanromán Antonio, Albillos Agustin, Barreiro-de Acosta Manuel
Аннотация
OBJECTIVE: To evaluate the effectiveness and safety of azathioprine as maintenance therapy in inflammatory pouch disorders.
DESIGN: This was a retrospective and multicentre study.
METHODS: We included patients diagnosed with inflammatory pouch disorders treated with azathioprine in monotherapy. Effectiveness was evaluated at 1 year and in the long term based on normalization of stool frequency, absence of pain, faecal urgency or fistula discharge (clinical remission), or any improvement in these symptoms (clinical response). Endoscopic response was evaluated using the Pouchitis Disease Activity Index (PDAI).
RESULTS: In all, 63 patients were included [54% males; median age, 49 (28-77) years]. The therapy was used to treat pouchitis (n = 37) or Crohn's disease of the pouch (n = 26). The rate of clinical response, remission and non-response at 12 months were 52%, 30% and 18%, respectively. After a median follow-up of 23 months (interquartile range 11-55), 19 patients (30%) were in clinical remission, and 45 (66%) stopped therapy. Endoscopic changes were evaluated in 19 cases. PDAI score decreased from 3 (range 2-4) to 1 (range 0-3). In all, 21 patients (33%) presented adverse events and 16 (25%) needed to stop therapy.
CONCLUSION: Azathioprine may be effective in the long term for the treatment of inflammatory pouch disorders and could be included as a therapeutic option.