Bram Verstockt © ECCO |
The introduction of new non-anti-TNF agents such as the anti-adhesion and anti-IL-12/IL-23 molecules will increase the therapeutic armamentarium for patients with IBD. It is nevertheless anticipated that clinical response and adverse events will vary significantly between individuals. Therefore, we need predictors of efficacy and safety so that we can select the right drug at the right time for the right patient. Targeted strategies in patients with poor prognostic factors and head-to-head trials are currently lacking.
The specific aims of this project are (a) to define predictors of primary (non-) response to the different therapeutic classes for patients with IBD and (b) to develop a comprehensive algorithm to direct personalised medicine in patients with IBD. For these purposes, we will explore which clinical, endoscopic, genetic, transcriptomic and microbial factors influence the response to and the safety of existing and novel therapeutic modalities.
This prospective, observational study will include patients with IBD, both CD and UC, who are naive for a specific drug of interest (anti-TNF agents, vedolizumab or ustekinumab). Patients will be recruited at the tertiary referral IBD unit of the University Hospitals Leuven. Samples (blood, faeces, intestinal biopsies) and clinical data will be collected at inclusion and at fixed time points during study follow-up to integrate clinical, endoscopic, genetic, transcriptomic and microbial data to design a predictive biomarker.
During the first year and a half, patients will be recruited and samples will be collected at our tertiary referral clinic. Afterwards, samples will be processed for DNA, RNA and microbial sequencing. Similarly, proteomic analyses will be performed. During the final year of this project, data integration and extensive bio-informatics will be performed as the basis for proposition of a comprehensive algorithm to direct personalised medicine in patients with IBD.