News
2 mars 2023
Distinct biological profiles associated with the risk of short-term relapse and mid/long-term relapse in Crohn’s disease patients stopping infliximab.
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Biological therapy cycles
Towards tailored, needs-driven, safer and cost-effective management of Crohn’s disease.'
This project receives funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 633168 – BIOCYCLE (PHC-13-2014).
Objective
The objective of the BIOCYCLE project is to assess long-term treatment strategies in Crohn’s disease that will improve both safety and related 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 current 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 may lead to cost and safety issues. The BIOCYCLE action will assess the efficacy, safety, effectiveness and feasibility of either anti-TNFα or immunosuppressant withdrawal in those patients.
Project overview
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Objective 1
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: first arm where both infliximab and anti-metabolites are continued, second arm where infliximab is stopped and third arm where anti-metabolites are stopped. The enrolment of 200-220 patients is planned in France, UK, Sweden, Germany, Belgium, the Netherlands and Australia. 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 in their ability to correctly predict the risk of relapse and the disease progression.
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Objective 2
Health economics impact of treatment cycles will be evaluated with comparative cost-of-illness and cost-effectiveness calculations between the three arms of the SPARE clinical study. Main factors that drive the direct healthcare costs burden will be identified. Finally, cost models for completing specific recommendations according to patients’ characteristics and risks profiles will be created.
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Objective 3
The “acceptance vs. reluctance” will be assessed through surveys carried out among patients, caregivers and healthcare systems. This set of surveys will provide profiles of patients and healthcare providers in terms of their readiness to use treatment cycles during remission, list of main hurdles that may delay the implementation of a new regimen and consolidated networks with stakeholders.
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Objective 4
All BIOCYCLE data (effectiveness, clinical benefits, costs and real world data) will be synthesized, analyzed and assessed to measure the relevance and the degree of readiness of the treatment cycle concept to be transferred to the healthcare decision makers prior to its dissemination.
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Objective 5
The most appropriate dissemination actions and communication channels to implement the new treatment strategy will be identified. The central part will be the preparation of an innovative decision-making tool and corresponding guidelines including all the considerations to elect the best treatment option based on specific needs.
Crohn's disease
Description of the disease
Crohn’s disease (CD) is a chronic inflammatory bowel disease (IBD) affecting the gastro-intestinal tract. CD often begins at young age and lasts the whole life. The prevalence is 20-30% higher for women than for men. CD is characterized by a sequence of active disease episodes (flare-ups) and remissions of variable duration. The chronicity of CD has a significant impact on patients’ quality of life (QoL).
Treatment
Curative therapies do not yet exist and the current best treatments are symptoms relieving therapies. The drug of choice and treatment strategies depend on the clinical characteristics and severity of the disease.
Treatment
Crohn’s disease (CD) is a chronic inflammatory bowel disease (IBD) affecting the gastro-intestinal tract. CD often begins at young age and lasts the whole life. The prevalence is 20-30% higher for women than for men.
CD is characterized by a sequence of active disease episodes (flare-ups) and remissions of variable duration. The chronicity of CD has a significant impact on patients’ quality of life (QoL).
Genetic susceptibility, modified composition of the gut microbiota and impaired function of the mucosal immune system are the main known contributors to the etiology of CD. However, the primary cause remains unknown.
Description of the disease
Curative therapies do not yet exist and the current best treatments are symptoms relieving therapies. The drug of choice and treatment strategies depend on the clinical characteristics and severity of the disease.
Mild disease may be treated by mesalazine or no treatment with limited number of courses of topical steroids.
The gold standard of care for moderate to severe Crohn’s disease is the Combo therapy, the uninterrupted combination of anti-TNFα monoclonal antibodies and immunosuppressant. However, this kind of treatment raises safety and costs issues.
Indeed, anti-TNFα is the most expensive medication and potential adverse effects are associated with the Combo therapy, namely cancers and possible increase of severe infections. In addition, patients are exposed to class-specific drug complications.
Partners
The BIOCYCLE project involves a consortium between 13 partners.
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Coordinateur - CHU
Centre Hospitalier Universitaire de Liège [BE]
CHU is the coordinator of the BIOCYCLE project. CHU has contributed to the design of the SPARE study protocol and is involved in the SPARE clinical trial with Belgian centres. CHU leads the proteomics exploratory research on new biomarkers associated with disease relapse, disease progression and mucosal healing, with the help of GIGA (ULg), as third party. CHU is also responsible for the coordination of the SPARE biobanking.
The participating members are E. LOUIS, MA. MEUWIS and M. CHAVEZ.
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GETAID
Groupe d'Étude Thérapeutique des Affections Inflammatoires du Tube Digestif [FR]
GETAID is the main promoter of the SPARE clinical trial and is involved with French centres. GETAID is responsible for the global clinical study coordination.
The participating members are MJ. BERTIN, G. BRILLAULT and M. MANDRET.
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UEDIN
University of Edinburgh [UK]
UEDIN is the leader of the work on biomarkers and is involved in the SPARE clinical trial with UK centres.
The participating members are J. SATSANGI and H. ENNIS
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RS-SUH
Region Skane - Skane University Hospital Lund [SW]
RS-SUH has contributed to the design of the SPARE study protocol and is involved in the SPARE clinical trial with Swedish centres.
The participating members are E. HERTERVIG and S. ALMER.
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CHARITÉ
Universitätsmedizin Berlin [GE]
The CHARITE is involved in the SPARE clinical trial with German centres.
The participating members are B. SIEGMUND and J. PREISS.
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SRF
Sheba Research Fund [IL]
SRF is responsible for the pharmacokinetic and immunogenicity tests. SRF will participate in the interpretation of drug/anti-drug antibodies results for the outcome prediction.
The participating members are S. BEN-HORIN and O. PICARD.
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IBDIM
IBD in Motion GmbH [AT]
IBDIM, the research organization affiliated to ECCO (European Crohn’s and colitis organization), is the continuous head of the dissemination process. IBDIM is responsible for managing the knowledge platform, the critical appraisal of the concept and organizing guidelines writing.
The participating members are J. GABRIEL, M. FERRANTE and C. LEES.
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AFA
Association François Aupetit [FR]
AFA is responsible for the patients’ perception survey.
The participating members are A. BUISSON and A. OLYMPIE.
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UGOT
Göteborgs Universitet [SW]
UGOT is the leader of the work on health economics.
The participating member is K. BOLIN.
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INSERM, Paris 7 University
ECSTRA Team, UMR 1153 [FR]
INSERM is in charge of the integration of both clinical and non-clinical data generated during the project in a comprehensive database. INSERM is also responsible for doing global analyses.
The participating members are S. CHEVRET, M. RESCHE-RIGON and J. LAMBERT.
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UCL
Université Catholique de Louvain [BE]
UCL is involved in the healthcare authorities survey and in the global appraisal of the strategy.
The participating members are J. MACQ, O. SCHMITZ and T. VAN DURME.
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BRIDGE2HEALTH
BRIDGE2HEALTH
Bridge2Health is responsible for the project management and for providing a daily assistance to the coordinator.
The participating member is J. DIEUPART.
Find here all the documents and tools related to this project.