Author information 1Gastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Madrid, Spain mariachs2005@gmail.com javier.p.gisbert@gmail.com. 2Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain. 3Gastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Madrid, Spain. 4Gastroenterology Department, Hospital Universitario Central de Asturias, e Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain. 5Gastroenterology Department, Hospital General de Tomelloso, Instituto de Investigación Sanitaria de Castilla-La Mancha (IDISCAM), Tomelloso, Spain. 6Gastroenterology Department, Hospital Universitario Reina Sofía, IMIBIC, Cordoba, Spain. 7Gastroenterology Department, Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain. 8Gastroenterology Department, Hospital Universitario Río Hortega, Gerencia Regional de Salud de Castilla y León (SACYL), Valladolid, Spain. 9Gastroenterology Department, Hospital General de Granollers, Granollers, Spain. 10Gastroenterology Department, Hospital Universitario Marqués de Valdecilla e IDIVAL, Santander, Spain. 11Gastroenterology Department, Hospital Dr. Josep Trueta, IDIBGI, Girona, Spain. 12Gastroenterology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain. 13Gastroenterology Department, Hospital Universitario Cruces, Barakaldo, Spain. 14Gastroenterology Department, Hospital Universitario de Navarra, Pamplona, Spain. 15Gastroenterology Department, Hospital Clínico Universitario de Valencia, Valencia, Spain. 16Gastroenterology Department, Hospital Universitario de Torrejón, Universidad Francisco de Vitoria, Torrejón de Ardoz, Spain. 17Gastroenterology Department, Hospital General Universitario Dr Balmis de Alicante, ISABIAL, Alicante, Spain. 18Gastroenterology Department, Hospital Universitario de Canarias (H.U.C), Santa Cruz de Tenerife, Spain. 19Gastroenterology Department, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain. 20Gastroenterology Department, Hospital Clínico Universitario de Valladolid, Gerencia Regional de Salud de Castilla y León (SACYL). Universidad de Valladolid, Valladolid, Spain. 21Gastroenterology Department, Hospital Universitari i Politecnic La Fe, Valencia, Spain. 22Gastroenterology Department, Hospital Universitario La Paz, Facultad de Medicina, Universidad Autónoma de Madrid, Instituto de Investigación Hospital Universitario La Paz (IdiPAZ), Madrid, Spain. 23Gastroenterology Department, Xerencia Xestión Integrada de Vigo, SERGAS, Research Group In Digestive Diseases, Galicia Sur Health Research Institute, SERGAS-UVIGO, Vigo, Spain. 24Gastroenterology Department, Hospital de Mataró, Mataró, Spain. 25Gastroenterology Department, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain. 26Gastroenterology Department, Hospital Santa Bárbara, Puertollano, Spain. 27Gastroenterology Department, Hospital Universitari Mutua Terrassa, Terrassa, Spain. 28Gastroenterology Department, Hospital Universitario de Basurto, Bilbao, Spain. 29Gastroenterology Department, Hospital Universitario de Galdakao, Instituto de Investigación Sanitaria Biobizkaia, Galdakao, Spain. Abstract 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. Trial registration number: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-001410-10 https://clinicaltrials.gov/study/NCT02994836. |
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