Project details


Anti-TNF de-escalation in Inflammatory Bowel Disease

ulcerative colitis Inflammatory bowel disease Crohn's disease

Dr. P.F. van Rheenen
drs. M. Bouhuys

Nature of the research:
On-going partially randomised patient preference trial

Fields of study:
pediatrics gastroenterology Patient Related Research

Background / introduction
Treatment outcomes of patients with inflammatory bowel disease (IBD) have improved enormously during the past decade due to the use of anti-tumour necrosis factor (anti-TNF). However, prolonged use of anti-TNFs comes with disadvantages such as dose dependent susceptibility to infections, dermatological adverse effects and frequent injections and/or hospital visits. Preliminary, mostly uncontrolled studies suggest that dose reduction by interval lengthening in patients with sustained remission is safe to cut down these adverse effects, provided that intensive disease monitoring is applied. We aim to compare the effectiveness of interval lengthening with standard dosing in patients with IBD in sustained remission, during one year of follow-up.
Research question / problem definition
What is the effectiveness of anti-TNF dosing interval lengthening in maintaining remission in patients with IBD, compared with standard dosing?
The student will be involved in an on-going partially randomised patient preference trial. In a partially randomised patient preference trial patients are offered randomisation, but those with strong preferences can choose a strategy instead, and are followed-up identically.
The student can choose or formulate his/her own sub-question within the overall research question. Possible sub-questions are: (1) What are the attitudes of patients (and parents, if appropriate) towards anti-TNF de-escalation?, (2) What is the prevalence of skin manifestations in patients treated with anti-TNF therapy? (3) What is the effect of anti-TNF dosing interval lengthening on anti-TNF trough levels? (4)
The student will analyse data from patients that have already been enrolled in the study and will recruit and include new patients.
- van Rheenen H, van Rheenen PF. Long-Term Efficacy of Anti-Tumor Necrosis Factor Agents in Pediatric Luminal Crohn's Disease: A Systematic Review of Real-World Evidence Studies. Pediatric Gastroenterology, Hepatology & Nutrition. 2020;23(2).
- Bressler B, Mantzaris G, Silverberg M, Zezos P, Stein D, Colby C, et al. Real-world effectiveness and safety of vedolizumab and anti-TNF in biologic-naïve Crohn’s disease patients: results from the EVOLVE study [ECCO abstract P621]. J Crohns Colitis. 2019;13(suppl 1).
- Papamichael K, Karatzas P, Mantzaris GJ. De-escalation of Infliximab Maintenance Therapy from 8- to 10-week Dosing Interval Based on Faecal Calprotectin in Patients with Crohn's Disease. J Crohns Colitis. 2016;10(3):371-2.
- Van Steenbergen S, Bian S, Vermeire S, Van Assche G, Gils A, Ferrante M. Dose de-escalation to adalimumab 40 mg every 3 weeks in patients with Crohn's disease - a nested case-control study. Aliment Pharmacol Ther. 2017;45(7):923-32.
- Pouillon L, Lamoureux A, Pineton de Chambrun G, Vuitton L, Pariente B, Zallot C, et al. Dose de-escalation to adalimumab 40mg every three weeks in patients with inflammatory bowel disease-A multicenter, retrospective, observational study. Dig Liver Dis. 2019;51(2):236-41.
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