Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission: study protocol of a prospective, multicentre, randomized clinical trial

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inflammatory bowel disease who achieve remission with anti-tumour necrosis factor (anti-TNF) drugs may have treatment withdrawn due to safety concerns and cost considerations, but there is a lack of prospective, controlled data investigating this strategy.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. Clinical trial reference number: EudraCT 2015-001410-1

Nutrición parenteral domiciliaria en paciente con enfermedad de Crohn: a propósito de un caso Home parenteral nutrition in Crohn's disease patient: a case report

Paciente diagnosticada de Enfermedad de Crohn con patrón inflamatorio que evoluciona a estenosante-perforante, provocando una perforación abdominal con peritonitis fecaloidea. Es sometida a tres intervenciones quirúrgicas, derivando en numerosas complicaciones y una evolución clínica tórpida. Dado el estado de desnutrición al ingreso se le prescribe Nutrición Parenteral Total (NPT), prolongándose la administración durante más de 10 meses. En este periodo se le suspende durante 5 días, pero la persistencia de una fístula enterocutánea provoca la restauración de la NPT. Tras su estabilización clínica, la paciente es dada de alta hasta recuperación de su estado nutricional necesario para realizar una cirugía de reconstrucción del intestino, continuando con NPT en su domicilio. Después de 7 meses y medio, la paciente con un estado nutricional óptimo, es sometida a la intervención quirúrgica, evolucionando favorablemente y suspendiendo la NPT a los 9 días.Patient diagnosed with Crohn's Disease with inflammatory pattern that evolves stenosing-piercing, causing abdominal perforation and fecal peritonitis. She was underwent to three surgeries, leading to numerous complications and a torpid clinical course. Given the state of malnutrition on admission it was prescribed Total Parenteral Nutrition (TPN), extending the administration for more than 10 months. In this period the TPN is suspended for 5 days, but the persistence of an enterocutaneous fistula causes the restoration of the TPN. After clinical stabilization, the patient is discharged to recover her nutritional status necessary to perform a bowel reconstruction surgery, continuing with TPN at home. After 7 and a half months, the patient with an optimal nutritional status, undergoes surgery, evolving favorably and suspending the TPN at 9 days