United European Gastroenterol J. 2024 May 11. doi: 10.1002/ueg2.12572. Online ahead of print.

Ferdinando D'Amico ^1 2, Fernando Gomollón ³, Giorgos Bamias ⁴, Fernando Magro ⁵, Laura Targownik ⁶, Claudia Leitner ⁷, Tobias Heatta-Speicher ⁷, Naiara Michelena ⁷, Stefanie Kolterer ⁷, Jennifer Lapthorn ⁸, Laura Kauffman ⁸, Axel Dignass ⁹; IBD PODCAST investigators

Author information

¹Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University, Milan, Italy.

²Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.

³Facultad de Medicina, IIS Aragón, Hospital Clínico Universitario "Lozano Blesa", CIBEREHD, Zaragoza, Spain.

⁴GI-Unit, 3rd Academic Department of Internal Medicine, Sotiria Hospital, National & Kapodistrian University of Athens, Athens, Greece.

⁵CINTESIS@RISE Departament, Faculdade de Medicina da Universidade do Porto, Porto, Portugal.

⁶Division of Gastroenterology and Hepatology, Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.

⁷AbbVie Inc., North Chicago, Illinois, USA.

⁸Market Access and HEOR Services, Fortrea, Burlington, North Carolina, USA.

⁹Department of Medicine I, Agaplesion Markus Hospital, Goethe University, Frankfurt am Main, Germany.

Abstract

Background: Crohn's disease and ulcerative colitis (UC) are inflammatory bowel diseases (IBD) characterized by a progressive nature of the disease resulting in subsequent intestinal damage, limited efficacy of current treatments and suboptimal disease management and a significant burden for patients.

Objectives: The IBD-PODCAST study aims to estimate the proportion of Crohn's disease and UC patients with suboptimal disease control (SDC) in a real-world setting.

Methods: A non-interventional and cross-sectional study was conducted across 103 sites in 10 countries (Austria, Belgium, Canada, Germany, Greece, Italy, Portugal, Spain, Turkey, and UK). Criteria for SDC were based on STRIDE-II criteria and adapted by an expert panel.

Results: 2185 patients (Crohn's disease: n = 1,108, UC: n = 1077) with a mean (SD) age of 44.0 (14.8) years and mean (SD) disease duration of 12.4 (9.2) years were included (52.2% male). Ileal involvement was present in 39.1% of Crohn's disease patients, 35.3% of UC patients had extensive colitis. 77.3% of Crohn's disease and 65.3% of UC patients were on targeted immunomodulators and, according to STRIDE-II-based treatment phases, 85.6% of Crohn's disease and 85.4% of UC patients were assigned to the long-term treatment phase. SDC was detected in 52.2% of Crohn's disease and 44.3% of UC patients predominantly due to impaired quality of life (QoL), clinically significant extraintestinal manifestations, steroid overuse, signs of active inflammation in UC and Crohn's disease, and active fistulas in Crohn's disease. More than one criterion was seen in 37% of patients with SDC. Opportunities for on-label treatment optimization were observed in 49% of Crohn's disease and 61% of UC patients on advanced therapy.

Conclusion: The high percentage of SDC in this global, real-world cohort suggests a large disease burden and high unmet medical need in IBD patients. Future analysis should focus on monitoring and responding to SDC in this cohort and on patients' QoL.