Dan Turner © Dan Turner

Academia can generate high-quality paediatric data during off-label use of drugs: the example of the prospective multicentre VEDOKIDS study

Remarkably, of the numerous biologics approved in adults with IBD, only infliximab and adalimumab have been approved in children. The long delay between approval of new drugs in adults versus children leads to their extensive off-label use, in the absence of appropriate dosing and safety data. Prospective paediatric data regarding vedolizumab are limited to a small phase 2 study (n=88; HUBBLE trial) focusing on pharmacokinetics. A paediatric phase 3 trial is underway but its completion is long overdue, also since vedolizumab is easily accessible in most countries without the constraints of study protocols. With that challenge in mind, once vedolizumab received approval in adults we initiated a prospective cohort study to explore the effectiveness, dosing and safety of vedolizumab in children. The VEDOKIDS study was sponsored by ECCO, The Paediatric Porto group of ESPGHAN and Takeda. Explicit demographic, clinical and safety data were prospectively recorded, and serum was collected for drug levels and stool for faecal calprotectin.

Edouard Louis © Edouard Louis

The SPARE clinical trial

A treat-to-target strategy and tight disease control may improve outcome in Crohn’s Disease (CD). However, this approach may necessitate long-term use of biological agents and immunosuppression. Combination therapy with anti-TNF and antimetabolite agents is now well established in this context. These drugs may be associated with long-term risks and elevated costs. It is important to establish whether treatment de-escalation, once deep remission has been achieved, is feasible and whether this strategy may improve safety profile and costs without jeopardising disease control.

Laurent Beaugerie © ECCO

The efficacy profile of IBD drugs is rapidly characterised by pivotal randomised controlled trials, but the safety profile of both old and new IBD drugs can only be established after years or decades of post-approval use. This is particularly true for relatively rare events, such as immunosuppression-related cancers. Clinical trials, meta-analyses and safety-dedicated registries are in general underpowered to evaluate the impact of IBD therapies on the risk of development of particular cancers. Data on clinical activity and phenotype of IBD are missing from nationwide administrative health databases, making it impossible to distinguish between the respective effects of IBD drugs and IBD activity on the risk of outcomes of particular interest, such as lymphomas.

Shaji Sebastian  © ECCO

ClinCom Workshops are aimed at clinicians, surgeons and paediatricians and aim to provide an update on the latest clinical research trends in IBD. This year’s 8th ClinCom Workshop focused on two clinically relevant and practical topics.

Shaji Sebastian © ECCO

The ECCO Congress offers an ideal opportunity to learn, share and interact. This was also the main purpose of the 6th Basic ECCO: EduCational COurse for Industry, held on Wednesday, February 16, 2022. The course aimed to provide corporate and non-corporate members who have recently entered the field of IBD with an introduction to IBD, focussing on the clinical essentials and ‘need-to-knows’. Despite the obvious challenges relating to the format and the pandemic, 34 registrants attended the course.

Take your study to the next level with the IBD National Study Group Meeting at the ECCO Congress

Uri Kopylov  © ECCO

One of the missions of the Clinical Research Committee of ECCO (ClinCom) is to facilitate innovative clinical research in the area of Inflammatory Bowel Diseases (IBD).

To promote international scientific collaboration among researchers from different European countries, ClinCom established the IBD National Study Group Meeting, which takes place at the annual ECCO Congress. With this great platform, ClinCom enables investigators to have their studies challenged and promoted at the same time. Before the meeting, investigators are invited to provide a study synopsis for their project, including background, design, objectives, outcome parameters, major inclusion and exclusion criteria, statistics and co-variates. Submitted projects are then reviewed by ClinCom and, if found feasible, discussed during the IBD National Study Group Meeting at the ECCO Congress.

Nicolas Pierre © Nicolas Pierre

Blood proteins related to immunoregulation or cellular junctions reveal distinct biological profiles associated with the risk of short-term versus mid/long-term relapse in Crohn’s Disease patients stopping infliximab

In Crohn’s Disease (CD), anti-tumour necrosis factor α (TNFα) therapy can induce mucosal healing and stable remission. When this objective is achieved, treatment de-escalation may be considered for safety, economic and patient preference purposes. Indeed, chronic exposure to anti-TNFα has been linked to serious complications (e.g. lymphoma, infections, melanoma and non-melanoma skin cancers) [1–4], and this treatment is a burden for the healthcare system [5]. On the other hand, around 50% of CD patients relapse 1–2 years after stopping anti-TNFα [6]. Thus, this strategy cannot be proposed to every patient in remission; rather, decisions should be made on an individualised basis [6].

The 5^th Advanced ECCO: EduCational COurse for Industry, organised by the Clinical Research Committee of ECCO (ClinCom), was one of the highlights of the educational programme during the ECCO’21 Congress and was held virtually, with live presentations and discussions. The course was aimed at our industry partners and had the broad goal of discussing the areas of IBD research of key importance in the immediate future. 

Laurent Beaugerie © ECCO

This year’s 4^th School for Clinical Trialists, organised by the ECCO Clinical Research Committee (ClinCom), offered an excellent opportunity to review all the key points of the balance between expected efficacy and potential risks of IBD drugs, in the contexts of both clinical trials and routine care.

The call for research proposals returns with opportunities for Y-ECCO Members to propose and perform a brief, focused research project with ClinCom/Y-ECCO guidance and ECCO support.

Based on the successes of the surveys jointly conducted by the Young ECCO Committee (Y-ECCO) and the Clinical Research Committee of ECCO (ClinCom) at the ECCO Congresses in the past, we are asking Y-ECCO Members to propose a new survey study.