Edouard LOUIS has received funding of the European Commission for his project «BIOlogical therapy CYCLEs towards tailored, needs-driven, safer and cost-effective management of Crohn’s disease –
The objective of the BIOCYCLE project is to assess long-term treatment strategies in Crohn’s disease that will improve safety and control associated costs while ensuring a constant level of efficacy
during maintenance therapy.
Crohn’s disease is a chronic longstanding disease that can’t be cured with currently available treatments. The aim of long-term treatment is to fully control the symptoms and avoid the progression of
intestinal damage. Currently, the preferred strategy for moderate-severe disease is a combination therapy with anti-TNFα and anti-metabolites (immunosuppressant). This long-term treatment adversely
affect cost and safety. The BIOCYCLE action will assess the efficacy, safety, effectiveness and feasibility of either anti-TNFα or immunosuppressant withdrawal in those patients.
The core of the project is a randomized controlled trial: SPARE clinical trial. Crohn’s disease patients with sustained remission without steroids for at least 6 months and treated with a combination therapy
(infliximab and anti-metabolites) will be randomized into three arms: a first arm where both infliximab and anti-metabolites are continued, a second arm where infliximab is stopped and a third arm where
anti-metabolites are stopped. The enrollment of 300 patients is planned in France, UK, Sweden, Germany and Belgium. The primary objective of the trial is to assess the relapse rate and the time spent in
remission in the three arms. Classical biomarkers (CRP, calprotectin) and new ones will also be assessed for their ability to correctly predict the risk of relapse and disease progression.
The impact on health economics of treatment cycles will be compared using comparative cost-of-illness and cost-effectiveness calculations between the three arms of the SPARE clinical study. The
main factors that drive the burden on direct healthcare costs will be identified. Finally, we will generate cost models for completing specific recommendations according to the patients’ characteristics
and risks profiles.