Myrthe Jongsma © Myrthe Jongsma

Top-down infliximab is superior to step-up in children with moderate-to-severe Crohn’s Disease

In newly diagnosed paediatric patients with Crohn’s Disease (CD), rapid disease control is desirable, but this outcome is not always achieved with current treatment strategies [1]. Infliximab has been proven to be highly effective in paediatric CD patients [2], but its primary use is reserved for patients with perianal disease or a predicted severe disease course [3]. We investigated whether starting top-down infliximab immediately after diagnosis is more effective than conventional step-up treatment in achieving and sustaining remission in children with moderate to severe CD.

Toer Stevens © Toer Stevens

Reduced need for surgery and medical therapy after early ileocaecal resection for Crohn’s Disease:  Long-term follow-up of the LIR!C trial

The LIR!C trial was a randomised controlled trial conducted between 2008 and 2015. It included 143 patients with non-stricturing ileocaecal Crohn’s Disease (<40 cm) who failed conventional treatment.

Shaji Sebastian © ECCO

The mission of ClinCom is to promote investigator-initiated studies among ECCO Members. The Committee welcomes submissions from investigators and national study groups and evaluates and critically appraises the quality, feasibility and practicality of each study proposal. The 5^th IBD National Study Group Meeting, held on February 12 during the ECCO 2020 Congress, featured presentations from five investigators on proposals for high-quality collaborative studies which will be suitable for running across national study groups.

Uri Kopylov  © ECCO

This year’s 7^th ClinCom Workshop focussed on two main topics. The first session was devoted to sequencing and combination of different IBD treatments for IBD. The speakers addressed the possible biological implications of drug sequencing and the mechanistic changes in the inflammatory pathways.

Krisztina Gecse © ECCO

Peter Bossuyt © ECCO

The ECCO Congress offers an ideal opportunity to learn, share and interact. This was also the main purpose of the 5^th Basic ECCO: EduCational COurse for Industry, held on Wednesday, February 12, 2020.  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’. 104 participants from 23 countries attended the course.

ClinCom Activities in Vienna 2020

Peter Bossuyt © ECCO

The mission of the Clinical Research Committee of ECCO (ClinCom) is to improve the quality of IBD clinical studies in Europe through education. With this purpose in mind, ClinCom is organising several sessions during the upcoming ECCO Congress 2020 in Vienna, targeting clinicians, nurses and industry.

On the Wednesday of the Congress, we are organising the 5th Basic ECCO: EduCational COurse for Industry. The aim of this course is to provide a state of the art introduction to IBD for both corporate and non-corporate members. In the first session we will highlight the impact of IBD for the patient and the physician. Subsequently, the natural history and overall management of IBD will be discussed, covering the causes of IBD, diagnostic and monitoring procedures, extra-intestinal manifestations and risk assessment.

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

Uri Kopylov © ECCO

The Clinical Research Committee of ECCO (ClinCom) was established with the mission of facilitating innovative clinical research in the area of Inflammatory Bowel Diseases (IBD). It acts as an organ for the delivery of advice on investigator-initiated proposals: Throughout the year, investigators who are also ECCO Members are invited to submit their protocols for an objective and in-depth review process by the Committee. 

In order to promote international scientific collaboration through cooperation of researchers from different European countries even further, ClinCom has established the IBD National Study Group Meeting, which will take place at the annual ECCO Congress. At the last ECCO Congress in Copenhagen, representatives of IBD National Study Groups gathered for the 4^th edition of the meeting. With this great platform, ClinCom enables investigators to have their studies challenged and promoted at the same time.

Erwin Dreesen © ECCO

Targeting endoscopic outcomes through combined pharmacokinetic and pharmacodynamic monitoring of infliximab therapy in patients with Crohn’s Disease

In the multicentre, randomised, controlled TAILORIX trial, it was not possible to show a benefit of infliximab dose escalation based on a combination of pharmacokinetic monitoring (i.e. serum concentrations of infliximab) and pharmacodynamic monitoring (i.e. symptoms and biomarker) as compared to dose escalation based on symptoms alone [1]. However, infliximab dose escalations only commenced after the induction regimen. In the current post hoc pharmacokinetic–pharmacodynamic analysis of TAILORIX, we examined the roles of pharmacokinetic and pharmacodynamic monitoring during infliximab induction and maintenance therapy for targeting endoscopic outcomes [2].

Proactive adalimumab trough measurement is associated with improved treatment outcomes in children with Crohn’s Disease: The PAILOT randomised controlled trial

Amit Assa © ECCO

Loss of response (LOR) during anti-TNF treatment for Crohn's Disease (CD) is commonly approached through the measurement of trough concentration (TC) and anti-drug antibodies, with subsequent modification of treatment (reactive therapeutic drug measurement, TDM). It is appealing to speculate that tailored treatment based on routine TC and antibody measurements (proactive TDM) may assist in sustaining adequate drug levels and thus in improving efficacy and preventing the evolution of anti-drug antibodies. Nevertheless, two randomised controlled trials, the TAXIT [1] and the TAILORIX [2], have failed to demonstrate superiority of level-based over clinically based adjustment of infliximab treatment. To date, there are no prospective studies comparing proactive vs reactive TDM in paediatric CD nor are there any studies evaluating the proactive approach among adults or children treated with adalimumab. Hence, we aimed to investigate the effect of proactive drug monitoring-based treatment, in comparison with clinical and biologic-based monitoring of disease activity in children with CD treated with adalimumab.

John Mansfield © ECCO

The ECCO Clinical Research Committee (ClinCom) organises The School for Clinical Trialists as a half-day workshop at the ECCO Congress. This year the topics covered were: The Evolution of Trial Design and How to Optimise Recruitment to Clinical Trials.