Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University, Milan, Italy.
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
United European Gastroenterol J. 2024 Jul;12(6):705-716. doi: 10.1002/ueg2.12572. Epub 2024 May 11.
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.
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.
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.
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.
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.
克罗恩病和溃疡性结肠炎（UC）是炎症性肠病（IBD），其疾病具有进展性，导致随后的肠道损伤，目前治疗的疗效有限，疾病管理不佳，患者负担沉重。
IBD-PODCAST 研究旨在评估真实环境中患有治疗不达标（SDC）的克罗恩病和 UC 患者的比例。
在 10 个国家/地区的 103 个地点进行了一项非干预性、横断面研究（奥地利、比利时、加拿大、德国、希腊、意大利、葡萄牙、西班牙、土耳其和英国）。SDC 的标准基于 STRIDE-II 标准，并由专家小组进行了调整。
共纳入 2185 例患者（克罗恩病：n=1108，UC：n=1077），平均（SD）年龄为 44.0（14.8）岁，平均（SD）疾病病程为 12.4（9.2）年（52.2%为男性）。39.1%的克罗恩病患者存在回肠受累，35.3%的 UC 患者为广泛性结肠炎。77.3%的克罗恩病患者和 65.3%的 UC 患者接受靶向免疫调节剂治疗，根据基于 STRIDE-II 的治疗阶段，85.6%的克罗恩病患者和 85.4%的 UC 患者被分配到长期治疗阶段。52.2%的克罗恩病和 44.3%的 UC 患者存在 SDC，主要原因是生活质量（QoL）受损、有临床意义的肠外表现、皮质类固醇滥用、UC 和克罗恩病的活动性炎症迹象以及克罗恩病的活动性瘘管。37%的 SDC 患者存在不止一个标准。在接受高级治疗的克罗恩病患者中，有 49%和 UC 患者中有 61%有机会进行标签内治疗优化。
在这个全球真实世界队列中，SDC 的高比例表明 IBD 患者的疾病负担很大，且医疗需求未得到满足。未来的分析应侧重于监测和应对该队列中患者的 SDC 以及患者的 QoL。
