ECCO, a partner of the BIOCYCLE project, has dedicated pages 16 to 17 of its ECCO News Volume 12, Issue 2, 2017 to the BIOCYCLE project, providing information on BIOCYCLE progresses (ECCO News).
The BIOCYCLE project has now been ongoing for almost 2 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 to severe Crohn’s Disease, the control of which first requires a combination therapy with anti-TNF and antimetabolites. An unsolved question is whether, once the disease has been stabilized, it is possible to de-escalate therapy. This question is important for several reasons, including safety, tolerance, quality of life and costs, to name the most prominent. BIOCYCLE includes a randomised three-arm, controlled clinical trial on 300 patients in five European countries, several patient and health care provider surveys in Europe and the United States, a biomarker research program and pharmaco-economic analysis. BIOCYCLE is a 6-year-long project that was launched in April 2015.
The global aim of BIOCYCLE is to try to deliver 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?
In accordance with the Grant Agreement, two work packages have mainly progressed over the first 2 years of the project: the SPARE clinical trial and the patient and health care provider surveys.
The clinical trial, with GETAID as the main promoter, was officially launched in September 2015 and a first patient was included in Belgium in October 2015 (local promoter: CHU Liège). First patients were included in France (local and general promoter: GETAID) in November 2015, in Sweden (local promoter: Skane University Hospital) and Germany (local promoter: Charité Berlin) in early 2016 and then in the United Kingdom (local promoter: Edinburgh University) later in 2016. Close to 110 patients have now been screened across the five participating countries and about 100 patients have been randomized into one of the three arms of the trial: continuing the combination therapy, withdrawing infliximab or withdrawing the antimetabolite. The recruitment was planned to end after 2 years but, as in all clinical trials, there has been some delay and we now plan to complete the recruitment of the 300 patients after 3 years. It is also planned that the trial will be extended to Australia, where a group of investigators coordinated by The St Vincent Center in Melbourne is almost ready to start recruitment.
The health care provider and patient surveys are being coordinated by the CCFA in the United States and by the patients’ association AFA in France, with the help of ECCO for the recruitment of doctors in Europe. The health care provider survey has been completed and results were recently presented at ECCO 2017 and DDW 2017. This survey has delivered important and original data on physicians’ perceptions of long-term therapy in moderate to severe Crohn’s Disease patients. It highlights physicians’ preferences, priorities and fears about these long-term therapies. It also emphasises some relevant differences between American and European doctors, the latter being more prone to de-escalate therapies, including withdrawal of biologics. The patient survey was launched in France and the United States in February 2017. It has recently closed in France, where over 300 patients have responded, and will soon close in the United States. The results should be available for the next ECCO Congress in 2018. It will be most interesting to compare patients’ and physicians’ perspectives.
The next steps include the start of the pharmaco-economic work package led by Gothenburg University in late 2017, while the biomarker work package looking for new biomarkers of disease relapse or progression after treatment de-escalation will start when all patients have been recruited in the SPARE trial, most probably in the second half of 2018.
For more information: BIOCYCLE website: biocycle-project.eu EU reference: grant agreement No 633168 – BIOCYCLE (PHC-13-2014)