Contributors: Gisbert JP, Donday MG Gastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS- Princesa), Universidad Autónoma de Madrid (UAM), Madrid, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain. Riestra S Gastroenterology Department, Hospital Universitario Central de Asturias, e Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain. Lucendo AJ Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain. Gastroenterology Department, Hospital General de Tomelloso, Instituto de Investigación Sanitaria de Castilla- La Mancha (IDISCAM), Tomelloso, Spain. Benítez JM Gastroenterology Department, Hospital Universitario Reina Sofía, IMIBIC, Cordoba, Spain. Navarro-Llavat M Servei de Digestologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain. Morales-Alvarado VJ Àrea d’aparell digestiu, Hospital General de Granollers, Granollers, Spain. Busquets D Servei de Digestiu, Hospital Dr. Josep Trueta, IDIBGI, Girona, Spain. Serra Nilsson Servei d'Aparell Digestiu, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain; Hospital General de Granollers
Abstract: Inflammatory bowel disease; Inflixmab; Ulcerative colitis ; Enfermedad inflamatoria intestinal; Inflixmab; Colitis ulcerosa ; Malaltia inflamatòria intestinal; Inflixmab; Colitis ulcerosa ; 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. 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. 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. 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). 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. ...
Processing Request
No Comments.