Article
Author: 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
