The BIOCYCLE project has now been ongoing for almost 3,5 years. This project, funded by the European commission under the Horizon 2020 program, aims at exploring different aspects of the question of treatment de-escalation in moderate-severe Crohn’s disease, first requiring a combination therapy with anti-TNF and antimetabolites to control the disease. Once the disease has been stabilized, an unsolved question is to whether it is possible to de-escalate therapy. This question is important for several reasons including safety, tolerance, quality of life or costs to name the most prominent. Biocycle includes a randomized three arms, controlled clinical trial on 300 patients in 5 European countries, several patients and health care providers’ surveys in Europe and the USA, a biomarker research program and pharmaco-economic analysis. ECCO is mainly involved in the monitoring of the project (through the Sci Com and the Clin Com) and is the work package leader for dissemination of the results. Biocycle is a 6 years-long project and has been launched in April 2015.
The global aim of Biocycle is to try and bring an integrated multidimensional and tailored response to this difficult question of treatment de-escalation in Crohn’s disease, also taking into account patients’ preferences and perspectives.
What has been achieved so far?
All work packages have now started and made progress.
The clinical trial is progressing well with close to 230 patients screened in France, Belgium, United Kingdom, Germany, Sweden, Australia and most recently The Netherland. The AMC Amsterdam team has joined the project in the summer 2018. The recruitment is planned to end in December 2018. According to current recruitment rate, we should be able to reach the appropriate number of patients to have a robust analysis of our co-primary end-points (relapse rate over two years and time spent in remission over two year). Last patient in the trial will then be December 2020, and first results expected in the spring 2021.
The health care providers’ and patients’ surveys, coordinated by the CCFA in the USA and by the patients’ association AFA in France, with the help of ECCO, and in which participated more than 400 patients and close to 300 doctors, are finished and results have been presented at ECCO congress 2017 and 2018. The results are currently prepared for final publication which will be submitted in the coming weeks.
As we are approaching completeness of recruitment in the clinical trial, the biological samples collected at baseline and regularly transferred to the central biobank in Liège are currently being prepared for a first set of biomarker research in Oxford (DNA methylation, miRNA, glycomics…), in Liège (proteomics, central CRP and fecal calprotectin) and Tel Aviv (pharmacokinetic).
The pharmaco-economic work package led by Gothenburg University has started and a theoretical pharmaco-economic model for the cycling of Immunomodulators or biologics has been generated based on a Markov-type decision tree model. The results of this model will be presented at the ECCO 2019 congress.
The final global aim of Biocycle is to generate a multidimensional integrated tool to help making decision as far as treatment withdrawal and cycles in Crohn’s disease and more broadly in IMIDs. To this end, the consortium is working on a clinical decision support system. A publication on this concept has recently been accepted for publication in the Journal of Crohn and Colitis and the consortium is currently working on a theoretical model. This theoretical model will then be fed by the results of the SPARE clinical trial and the other BIOCYCLE work packages.
The second administrative and scientific report has been approved by the European commission in the Spring 2018 and the next is due in October 2019. We have no passed half of the project.
[EU reference: grant agreement No 633168 – BIOCYCLE (PHC-13-2014)]