David Drobne © ECCO

Julien Kirchgesner © ECCO

IBD manifests with numerous faces. It became clear some time ago that only by joining forces across multiple countries would we perhaps be able to identify and study rare manifestations of IBD and its complications. This was the reason why the CONFER taskforce (COllaborative Network For Exceptionally Rare case reports) was initiated under the auspices of the ClinCom committee.

María Chaparro © ECCO

Murat Toruner © ECCO

Julien Kirchgesner © ECCO

During the last ECCO’24 Congress in Stockholm, the ECCO Governing Board announced the new strategy REACH. The REACH strategy is the acronym of five clear goals to shape the current and future ECCO activities for the next years, better defining and expanding ECCO global mission to improve the care for all IBD patients.

Murat Toruner © ECCO

Dear IBD Friends and Colleagues, 

ClinCom organised two courses at the recent 19^th Congress of ECCO in Stockholm. The first course was the 9^th ClinCom Workshop, which comprised two sessions and attracted 39 participants.

Shaji Sebastian  © ECCO

Murat Toruner © ECCO

In the past, IBD was believed to be predominantly a disease of the Western world. However, recent studies have shown a rapidly increasing incidence of IBD in newly developing areas such as the Middle East, South America and Asia. By the middle of this century, the prevalence of IBD in low and lower-middle income countries (LLMICs) and newly industrialised nations may surpass that in the West. At the same time, the compound prevalence in the Western world and increasing health care costs will add to the challenges in IBD care. As a result of these epidemiological trends, IBD is projected to be an increasing global health burden.

Tanja Kuehbacher © ECCO

In the fast-paced world of medical research and drug development, efficient data management and transparent communication are critical factors for success. To address these challenges, the European Medicines Agency (EMA) has launched a new Clinical Trials Information System (CTIS) that went live on January 31, 2022 [1, 2]. The CTIS is the backbone of the Clinical Trials Regulation, which will harmonise the assessment and supervision of clinical trials in the European Union. There is a transition period until January 31, 2025. Any ongoing trial that has been approved under the Clinical Trial Directive will then fall under the Clinical Trials Regulation [1–3].

Maria Chaparro © ECCO

The study entitled "Withdrawal of anti-tumour necrosis factor in Inflammatory Bowel Disease patients in remission: a randomised placebo-controlled clinical trial" received one of the two Best Investigator-Initiated Study Award at ECCO’23.

Biologic anti-TNF drugs have been a game changer for patients with Inflammatory Bowel Disease. However, long-term maintenance of these drugs may be associated with potential adverse events and high costs. Therefore, patients and physicians are wondering whether it is possible to discontinue these drugs without significantly increasing the risk of recurrence.

Peter Bossuyt © ECCO

Designing, organising and performing clinical trials in IBD is a challenge. Drug development trials often follow the well-known pathways, with established endpoints and a more or less standardised study design. Things become more complicated when the clinical researcher departs from these trusted routes.  In this context, ClinCom (the Clinical Research Committee of ECCO) organised two courses during the last ECCO Congress in Copenhagen.

Shaji Sebastian © ECCO

Antonino Spinelli © ECCO

It is well known that the outcomes of surgery, and especially of IBD surgery, are not merely dependent on the operative procedure but are influenced by a number of factors before, during and after surgery. The multidisciplinary team involved in the care of IBD patients has the opportunity to optimise patient care and status prior to surgery to ensure optimal outcomes and reduce the risk of complications.

Peter Bossuyt © ECCO

Multiple collaborations exist between ECCO Members in the collection of clinical data in a real-world setting. These observational data are an elegant addition to data from randomised controlled trials, as they reflect the efficacy and safety of clinical interventions in a more heterogeneous population who may not be included in randomised controlled trails and take into account the specific hurdles and challenges of everyday care for patients with IBD. The utility of real-world data, however, is dependent on the quality and homogeneity of the reported data. Data collection standardisation may enhance the quality of real-world evidence.

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.