TY - JOUR
T1 - Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission :
T2 - a randomised placebo-controlled clinical trial of GETECCU
AU - P. Gisbert, Javier
AU - Donday, María G.
AU - Riestra, Sabino
AU - Lucendo, Alfredo J.
AU - Benítez, José Manuel
AU - Navarro-Llavat, Mercè
AU - Barrio, Jesús
AU - Morales-Alvarado, Víctor J.
AU - Rivero, Montserrat
AU - Busquets, David
AU - Leo Carnerero, Eduardo
AU - Merino, Olga
AU - Nantes Castillejo, Óscar
AU - Navarro, Pablo
AU - Van Domselaar, Manuel
AU - Gutiérrez, Ana
AU - Alonso-Abreu, Inmaculada
AU - Mejuto, Rafael
AU - Fernández-Salazar, Luis
AU - Iborra, Marisa
AU - Martín-Arranz, María Dolores
AU - Pineda, Juan Ramón
AU - Sampedro, Manuela Josefa
AU - Serra Nilsson, Katja
AU - Bouhmidi, Abdel
AU - Batista, Lissette
AU - Muñoz Villafranca, Carmen
AU - Rodríguez-Lago, Iago
AU - Ceballos, Daniel
AU - Guerra, Iván
AU - Marín-Jiménez, Ignacio
AU - Torrella, Emilio
AU - Vera Mendoza, Maribel
AU - Casanova, María José
AU - de Francisco, Ruth
AU - Arias-González, Laura
AU - Marín Pedrosa, Sandra
AU - García-Bosch, Orlando
AU - García-Alonso, Francisco Javier
AU - Delgado-Guillena, Pedro
AU - García García, María José
AU - Torrealba, Leyanira
AU - Núñez-Ortiz, Andrea
AU - Vicuña Arregui, Miren
AU - Bosca-Watts, Marta Maia
AU - Blázquez, Isabel
AU - Acosta, Diana
AU - Garre, Ana
AU - Baldán, Montse
AU - Martínez, Concepción
AU - Barreiro de-Acosta, Manuel
AU - Domènech, Eugeni
AU - Esteve, Maria
AU - García-Sánchez, Valle
AU - Nos, Pilar
AU - Panés, Julián
AU - Chaparro, María
AU - Ramírez, Esther
AU - Alvarez-Manceñido, Felipe
AU - Sánchez-Casanueva, Tomás
AU - Cárdenas Aranzana, Manuel J.
AU - Gracia García, Berta
AU - Caro-Patón, Tomás
AU - Seguí Solanes, Carlos
AU - Giménez Poderós, Teresa
AU - Castelló Nòria, Àngela
AU - Villalba Moreno, Angela
AU - Bustinza Txertudi, Alazne
AU - Aranda Alcántara, María
AU - Guillot Yacyszyn, Verónica
AU - Morales Martínez, Lorena
AU - Gracia, Ángel
AU - Virgós Aller, Tirso
AU - Espino Paisán, Esther
AU - Hernando Verdugo, Mercedes
AU - Tordera, María
AU - Cárdenas, Cristina
AU - Sánchez Ulayar, Azhara
AU - Ferrer-Artola, Anna
AU - Ventura López, Purificación
AU - Loizaga Diaz, Irunne
AU - Santos, Amaya
AU - Amat López, Mireya
AU - Hernández Musiesa, Belén
AU - Quiñones, Carles
AU - Mur Mur, Ana
AU - García Motos, Consuelo
AU - Sánchez Guerrero, Amelia
PY - 2024
Y1 - 2024
N2 - Background and objectives: Primary objectives: to compare the rates of sustained clinical remission at 12 months in patients treated with antitumour necrosis factor (anti-TNF) and immunomodulators who withdraw anti-TNF treatment versus those who maintain it. Secondary objectives: to evaluate the effect of anti-TNF withdrawal on relapse-free time, endoscopic and radiological activity, safety, quality of life and work productivity; and to identify predictive factors for relapse. Design: Prospective, quadruple-blind, multicentre, randomised, controlled trial. Patients with ulcerative colitis or Crohn's disease in clinical remission for >6 months and absence of severe endoscopic (and radiological in Crohn's disease) lesions were randomised to maintain anti-TNF treatment (maintenance arm (MA)) or to withdraw it (withdrawal arm (WA)). All patients maintained immunomodulators. Patients were followed-up until month 12 or up to clinical relapse. Results: One-hundred forty patients were randomised: 70 were allocated to the MA and 70 to the WA. The proportion of patients with sustained clinical remission at 12 months was similar in the MA and WA: 59/70 (84%), 95% CI=74% to 92% versus 53/70 (76%), 95% CI=64% to 85%. The proportion of patients with significant endoscopic lesions at the end of follow-up was 8.5% in the MA and 19% in the WA (p=0.1); a higher proportion of patients had faecal calprotectin >250 μg/g at the end of follow-up in the WA (p=0.01). The same percentage of patients in both groups had at least one adverse event (69%). The proportion of patients with serious adverse events was also similar in both groups (4% in MA vs 7% in WA). Conclusion: Anti-TNF withdrawal in selected patients with IBD in clinical, endoscopic and radiological remission has no impact on sustained clinical remission at 1 year although objective markers of activity were higher in patients who withdrew treatment.
AB - Background and objectives: Primary objectives: to compare the rates of sustained clinical remission at 12 months in patients treated with antitumour necrosis factor (anti-TNF) and immunomodulators who withdraw anti-TNF treatment versus those who maintain it. Secondary objectives: to evaluate the effect of anti-TNF withdrawal on relapse-free time, endoscopic and radiological activity, safety, quality of life and work productivity; and to identify predictive factors for relapse. Design: Prospective, quadruple-blind, multicentre, randomised, controlled trial. Patients with ulcerative colitis or Crohn's disease in clinical remission for >6 months and absence of severe endoscopic (and radiological in Crohn's disease) lesions were randomised to maintain anti-TNF treatment (maintenance arm (MA)) or to withdraw it (withdrawal arm (WA)). All patients maintained immunomodulators. Patients were followed-up until month 12 or up to clinical relapse. Results: One-hundred forty patients were randomised: 70 were allocated to the MA and 70 to the WA. The proportion of patients with sustained clinical remission at 12 months was similar in the MA and WA: 59/70 (84%), 95% CI=74% to 92% versus 53/70 (76%), 95% CI=64% to 85%. The proportion of patients with significant endoscopic lesions at the end of follow-up was 8.5% in the MA and 19% in the WA (p=0.1); a higher proportion of patients had faecal calprotectin >250 μg/g at the end of follow-up in the WA (p=0.01). The same percentage of patients in both groups had at least one adverse event (69%). The proportion of patients with serious adverse events was also similar in both groups (4% in MA vs 7% in WA). Conclusion: Anti-TNF withdrawal in selected patients with IBD in clinical, endoscopic and radiological remission has no impact on sustained clinical remission at 1 year although objective markers of activity were higher in patients who withdrew treatment.
UR - https://www.scopus.com/pages/publications/85214805526
U2 - 10.1136/gutjnl-2024-333385
DO - 10.1136/gutjnl-2024-333385
M3 - Article
C2 - 39794921
SN - 0017-5749
VL - 74
SP - 387
EP - 396
JO - Gut
JF - Gut
IS - 3
ER -