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Multicenter Study
. 2024 Jul;12(6):705-716.
doi: 10.1002/ueg2.12572. Epub 2024 May 11.

Proportion of inflammatory bowel diseases patients with suboptimal disease control in daily clinical practice-Real-world evidence from the inflammatory bowel diseases-podcast study

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
Affiliations
Multicenter Study

Proportion of inflammatory bowel diseases patients with suboptimal disease control in daily clinical practice-Real-world evidence from the inflammatory bowel diseases-podcast study

Ferdinando D'Amico et al. United European Gastroenterol J. 2024 Jul.

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.

Keywords: Crohn's disease; STRIDE II recommendations; extraintestinal manifestations; fistula; inflammatory bowel diseases; quality of life; steroid; treat to target strategy; ulcerative colitis.

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Conflict of interest statement

Ferdinando D’Amico served as a speaker for Sandoz, Jannsen, Omega Pharma, and Galapagos and served as an advisory board member for AbbVie, Ferring, Galapagos, and Nestlè. Fernando Gomollón has received honoraria as a speaker from Janssen, AbbVie, Takeda and MSD and has participated in advisory panels for Faes‐Farma and AbbVie. Giorgos Bamias has received honoraria as an Advisor/Lecturer and/or research grants and/or clinical trial participants from Janssen, Pfizer, Takeda, AbbVie, MSD, Mylan, Genesis Pharma, Adacyte Therapeutics, Amgen, Ferring, Cooper, and Aenorasis. Laura Targownik has received consultancy and/or speaking honoraria fees as an Advisor/Lecturer and/or research grants, and for review activities, such as data monitoring boards from AbbVie, Janssen, Pfizer, Takeda, Amgen, Viatris, Fresenius Kabi, Bristol Myers Squibb, Sanofi, Lilly, and GoodCap Pharmaceuticals. Fernando Magro has received fees from AbbVie, Arena, Biogen, Bristol‐Myers Squibb, Falk, Ferring, Hospira, Janssen, Laboratórios Vitoria, Pfizer, Lilly, Merck Sharp and Dohme, Sandoz, Takeda, UCB, and Vifor. Tobias Heatta‐Speicher, Claudia Leitner, Stefanie Kolterer and Naiara Michelena are employees of AbbVie and may own stock options. Jennifer Lapthorn and Laura Kauffman have received consulting fees as employees of Fortrea, which was under contract to conduct the study, analyze the data, and interpret the results. Axel Dignass reports fees for participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees from Abivax, AbbVie, Arena Pharmaceuticals, Bristol Myers Squibb/Celgene, Dr Falk Foundation, Galapagos, Gilead, Janssen, and Pfizer; consultancy fees from AbbVie, Amgen, Arena Pharmaceuticals, Biogen, Boehringer Ingelheim, Bristol Myers Squibb/Celgene, Celltrion, Dr Falk Foundation, Ferring Pharmaceuticals, Fresenius Kabi, Galapagos, Janssen, Lilly, MSD, Pfizer, Pharmacosmos, Roche/Genentech, Sandoz/Hexal, Takeda, Tillotts, and Vifor Pharma; payment from lectures including service on speakers bureaus from AbbVie, Biogen, CED Service GmbH, Celltrion, Falk Foundation, Ferring, Galapagos, Gilead, High5MD, Janssen, Materia Prima, MedToday, MSD, Pfizer, Streamed‐Up, Takeda, Tillotts, and Vifor Pharma; payment for manuscript preparation from Falk Foundation, Takeda, Thieme, and UniMed Verlag.

Figures

FIGURE 1
FIGURE 1
Enrollment information and Study Design for IBD‐PODCAST. CD, Crohn's disease; FACIT‐F, functional assessment of chronic illness therapy‐fatigue; HCRU, health care resource utilization; pSCCAI, Patient simple clinical colitis activity index (Questions three to five to assess stool urgency); SDC, suboptimal disease control, SIBDQ, short inflammatory bowel disease questionnaire; STRIDE, selecting therapeutic targets in inflammatory bowel disease; TIM, targeted immunomodulator (biologics and small molecules); UC, ulcerative colitis; WPAI, work productivity activity index.
FIGURE 2
FIGURE 2
Patients with suboptimal disease control at indexa—overall and by treatment phase. aDescribed as patients with the presence of red flag(s). DC, disease control; n, number of patients. Analysis for UC and CD were conducted separately. If there were no red flags indicating a patient had suboptimal disease control by default, the patient was considered to have optimal disease control.
FIGURE 3
FIGURE 3
Proportion of LT Patients by number and type of red flag. EIM, extraintestinal manifestation; SIBDQ, short inflammatory bowel disease questionnaire.
See this image and copyright information in PMC

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