The two abstracts awarded the Best Investigator-Initiated Study Awards at ECCO’26 reflect a move toward implementing precision medicine in routine care, using biomarker-based strategies to stratify patient risk and guide treatment in IBD.
The first study, entitled “Biomarker-informed therapy guidance improved clinical outcomes of anti-tumour necrosis factor treatment in patients with inflammatory bowel disease in a multi-centre, randomized, controlled, open-label, prospective clinical trial (GUIDE-IBD)”, was presented by F. Tran from the University Hospital Schleswig-Holstein, Campus Kiel, and was conducted across three German university hospitals. Adults with Crohn’s Disease (CD) or Ulcerative Colitis (UC) requiring first-time infliximab therapy were randomised to either “molecular medicine care” (MMC) or “best care” (BC), stratified by diagnosis, centre and baseline corticosteroid use. Molecular assessments were performed at baseline and at weeks 2, 6, 14 and 26, including mRNA-based biomarkers from blood and biopsy samples.
At week 52, Comprehensive Disease Control—defined as the combination of clinical remission, endoscopic remission and biochemical normalisation—was achieved more frequently in the MMC group (22/48 patients; adjusted proportion 43%) than in the BC group (14/55 patients; adjusted proportion 23%), with more than a twofold higher likelihood of achieving this outcome (OR 2.53; 95% CI 1.09–5.86; p=0.031). All secondary outcomes, including steroid-free remission, clinical remission and endoscopic remission, also favoured the MMC arm. Notably, the MMC approach was associated with more frequent therapy adjustments and a higher rate of treatment switching. These findings show that biomarker-informed treatment guidance can significantly improve therapeutic outcomes, supporting the integration of molecular medicine approaches into clinical decision-making.
The second abstract, entitled “NORDTREAT: a randomised, multicentre, biomarker-strategy design, open-label, controlled trial of top-down versus clinical management in newly diagnosed IBD”, was led by J. Halfvarson from the Faculty of Medicine and Health, Örebro University. In this multicentre, randomised trial conducted across 15 Nordic centres, adults with newly diagnosed IBD were assigned to either access or no access to a prognostic protein signature. In the access arm, patients identified as high-risk received early “top-down” therapy with anti-TNF agents with or without immunomodulators, while those in the non-access arm were managed according to standard step-up clinical practice at the investigator’s discretion.
A total of 313 patients with IBD (CD, n=133; UC/IBD-unclassified, n=180) were randomised. Among patients in the access arm (n=157), 24 (15%) were classified as high-risk. In the non-access arm, 29/156 patients (19%) were retrospectively identified as high-risk at baseline; of these, 16 (55%) received advanced therapy after a median delay of 15 days. The primary endpoint—corticosteroid-free clinical and endoscopic remission at week 52—was achieved in 10/24 (42%) patients in the “top-down” group and 8/29 (27%) in the “clinical management” group, with no statistically significant difference (absolute difference 15%; 95% CI −11 to 41; p=0.26). Endoscopic remission rates at week 52 did not differ between the groups (53% vs 53%; p=0.99). Overall, a biomarker-guided “top-down” approach did not significantly increase corticosteroid-free clinical and endoscopic remission compared with standard care. However, a potential benefit was observed in patients with CD, suggesting that early “top-down” therapy may improve outcomes in this subgroup.
Taken together, these studies highlight the growing commitment of the scientific community to advancing personalised care in IBD in clinical practice.
