RT Journal Article
T1 Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission: study protocol of a prospective, multicentre, randomized clinical trial
A1 Chaparro, Maria
A1 Donday, Maria G.
A1 Barreiro-de Acosta, Manuel
A1 Domenech, Eugeni
A1 Esteve, Maria
A1 Garcia-Sanchez, Valle
A1 Nos, Pilar
A1 Panes, Julian
A1 Martinez, Concepcion
A1 Gisbert, Javier P.
A1 EXIT Study Grp GETECCU, 
K1 anti-tumour necrosis factor
K1 inflammatory bowel disease
K1 withdrawal
K1 Spanish work productivity
K1 Anti-tnf discontinuation
K1 Evidence-based consensus
K1 Crohns-disease
K1 Ulcerative-colitis
K1 Relapse
K1 Questionnaire
K1 Validation
K1 Therapy
K1 Management
AB Background: Patients with inflammatory bowel disease who achieve remission with anti-tumour necrosis factor (anti-TNF) drugs may have treatment withdrawn due to safety concerns and cost considerations, but there is a lack of prospective, controlled data investigating this strategy. The primary study aim is to compare the rates of clinical remission at 1 year in patients who discontinue anti-TNF treatment versus those who continue treatment. Methods: This is an ongoing, prospective, double-blind, multicentre, randomized, placebo-controlled study in patients with Crohn's disease or ulcerative colitis who have achieved clinical remission for > 6 months with an anti-TNF treatment and an immunosuppressant. Patients are being randomized 1:1 to discontinue anti-TNF therapy or continue therapy. Randomization stratifies patients by the type of inflammatory bowel disease and drug (infliximab versus adalimumab) at study inclusion. The primary endpoint of the study is sustained clinical remission at 1 year. Other endpoints include endoscopic and radiological activity, patient-reported outcomes (quality of life, work productivity), safety and predictive factors for relapse. The required sample size is 194 patients. In addition to the main analysis (discontinuation versus continuation), subanalyses will include stratification by type of inflammatory bowel disease, phenotype and previous treatment. Biological samples will be obtained to identify factors predictive of relapse after treatment withdrawal. Results: Enrolment began in 2016, and the study is expected to end in 2020. Conclusions: This study will contribute prospective, controlled data on outcomes and predictors of relapse in patients with inflammatory bowel disease after withdrawal of anti-TNF agents following achievement of clinical remission.
PB Sage publications ltd
SN 1756-283X
YR 2019
FD 2019-09-01
LK http://hdl.handle.net/10668/19102
UL http://hdl.handle.net/10668/19102
LA en
DS RISalud
RD Apr 9, 2025