Article
作者: Ceballos, Daniel  ; Torrealba, Leyanira  ; Rivero, Montserrat  ; Riestra, Sabino  ; Navarro-Llavat, Mercè  ; Barreiro-de Acosta, Manuel  ; Garre, Ana  ; Rodríguez-Lago, Iago  ; Iborra, Marisa  ; Delgado-Guillena, Pedro  ; Torrella, Emilio  ; Mejuto, Rafael  ; Sampedro, Manuela Josefa  ; Donday, María G  ; Gutiérrez, Ana  ; García, María José  ; Acosta, Diana  ; Esteve, Maria  ; Guerra, Iván  ; Mañosa, Miriam  ; Bosca-Watts, Marta Maia  ; García-Alonso, Francisco Javier  ; Morales-Alvarado, Víctor J  ; García-Sánchez, Valle  ; Chaparro, María  ; Fernández-Salazar, Luis  ; Benítez, José-Manuel  ; Busquets, David  ; Alonso-Abreu, Inmaculada  ; Van Domselaar, Manuel  ; Casanova, María José  ; Serra Nilsson, Katja  ; Navarro, Pablo  ; Blázquez, Isabel  ; Martín-Arranz, María Dolores  ; Merino, Olga  ; Nantes Castillejo, Óscar  ; Marín Jiménez, Ignacio  ; Nos, Pilar  ; Muñoz Villafranca, Carmen  ; García-Bosch, Orlando  ; Baldán, Montse  ; Marín Pedrosa, Sandra  ; Gisbert, Javier P  ; Vicuña Arregui, Miren  ; Barrio, Jesús  ; Domènech, Eugeni  ; Pineda, Juan Ramón  ; Batista, Lissette  ; de Francisco, Ruth  ; Vera Mendoza, Maribel  ; Martínez, Concepción  ; Bouhmidi, Abdel  ; Arias-González, Laura  ; Lucendo, Alfredo J  ; Núñez-Ortiz, Andrea  ; Panés, Julián  ; Leo Carnerero, Eduardo 
Background and objectivesPrimary 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.DesignProspective, 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.ResultsOne-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).ConclusionAnti-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.Trial registration numberhttps://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-001410-10https://clinicaltrials.gov/study/NCT02994836