D2 | Abstract 11

Annual NUTRIM Symposium 18 November 2020

APPLIED SCIENCE

Control Crohn Safe with episodic adalimumab monotherapy as first line treatment study (CoCroS): a study protocol

L.M. Janssen1,2, L. Brandts3, M.A. Joore3,4, A.A.M. Masclee1, D.M.A.E. Jonkers2, M.J. Pierik1

1 Maastricht University Medical Center+, Department of Gastroenterology and Hepatology, Maastricht, The Netherlands.
2 Maastricht University Medical Center+, NUTRIM - School for Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands.
3 Maastricht University Medical Center+, Clinical Epidemiology and Medical Technology Assessment (KEMTA), Maastricht, The Netherlands.
4 Maastricht University, CAPHRI – School for Care and Public Health Research Institute, Maastricht, The Netherlands.
Background:
Crohn’s disease (CD) is a chronic inflammatory bowel disease with a heterogeneous clinical presentation, relapse rate and treatment response. At present, no markers are available to adequately predict disease course at diagnosis. To prevent overtreatment of patients with a relative mild disease course, a step-up approach starting with corticosteroids is usually applied. Timely introduction of potentially disease modifying drugs and tight control of mucosal inflammation are crucial to prevent disease-related complications in patients with a complex disease course. We hypothesize that episodic treatment with adalimumab monotherapy in combination with close monitoring after drug discontinuation improves long-term outcome and reduces drug-related side effects, while preventing overtreatment.

Methods:
In this pragmatic multicenter randomized controlled trial, newly diagnosed CD patients or CD patients with a flare, naïve to thiopurines and biologicals, will be included and randomized 1:1 to open label episodic adalimumab monotherapy or step-up care starting with corticosteroids. The primary outcome is the number of yearly quarters of corticosteroid free clinical (MIAH score ≤3) and biochemical (C-reactive protein within normal range and fecal calprotectin ≤200 μ g/g) remission at week 96. Secondary outcomes are total health care costs, cumulative corticosteroid dose, proportion of patients with endoscopic remission at week 24, corticosteroid free clinical remission, time to remission and patient reported outcome measures on quality of life, (work)disability and treatment adherence. Safety outcomes are drug- and disease-related adverse events and disease progression on MRI-enterography at week 96.

Discussion:
The CoCroS study will provide evidence on efficacy, safety and costs of episodic adalimumab monotherapy compared to conventional step-up care in the treatment of Crohn’s disease.

NUTRIM | School of Nutrition and Translational Research in Metabolism
NUTRIM aims to contribute to health maintenance and personalised medicine by unraveling lifestyle and disease-induced derangements in metabolism and by developing targeted nutritional, exercise and drug interventions. This is facilitated by a state of the art research infrastructure and close interaction between scientists, clinicians, master and PhD students.
www.maastrichtuniversity.nl/nutrim