IIS Registry Grant Risk of relapse and retreatment success after vedolizumab discontinuation in IBD patients in long-standing remission

Abstract

Abstract Background and Aims Treatment withdrawal and “cycling” of anti-TNFs has been extensively investigated in the recent years. To date, none or scarce data are available for biological agents other than anti-TNFs, such as vedolizumab (VDZ), which is the first non-anti-TNF agent approved for the treatment of inflammatory bowel disease (IBD). Our aim will be to investigate the risk of relapse and retreatment success in IBD patients that discontinue vedolizumab due to sustained steroid-free remission. Methods This will be a prospective observational study in which two groups of patients in sustained remission will be formed, i.e., patients stopping vedolizumab and patients continuing the treatment. Differences regarding rates of disease flares, IBD-related hospitalisations and surgeries will be analysed. The rate of retreatment success in patients presenting a flare after discontinuation will also be recorded. In addition, potential predictive factors of disease relapse will be investigated to provide future guidance on the patient profile that might benefit the most from intermittent VDZ treatment. The study will last 3 years in total, with the first year dedicated to patient inclusions. Anticipated Impact Only few data are currently available regarding intermittent treatment with vedolizumab. Therefore, this study may provide insights on when to interrupt this biologic with high probability of maintaining remission, while also showing high-risk features that would suggest against stopping the treatment. The use of treatment cycles may represent an impactful cost reduction for our healthcare systems as well as a decrease of potential side effects that are an inevitable consequence of years of immunosuppression.