Impact of advanced therapies for inflammatory bowel disease on disease activity, health-related quality of life, fatigue and psychological symptoms – real-world evidence from a prospective cohort study at a tertiary care center

Introduction and objectives: To date, predictive biomarkers of therapeutic response in IBD are still lacking. The CLINNOVA-IBD study aims to identify such markers by integrative analysis of clinical, laboratory and multi-omics data in IBD patients undergoing treatment changes. In preparation for this trial, we performed a pilot study to assess clinical response and other patient-reported outcomes (PROs) and to explore potential influencing and predictive factors in an IBD outpatient cohort.

Methods: Patients were enrolled at the time of a substantial treatment change and followed up for up to one year (scheduled visits after 3, 6 and 12 months), including regular assessments of clinical outcomes, PROs (quality of life [QoL], fatigue, anxiety and depression) and laboratory parameters. Patients were asked to provide blood samples for biobanking.

Results: Between June 2020 and October 2022, 118 patients (51 with Ulcerative Colitis, 67 with Crohn’s disease) were enrolled, the majority of whom had received advanced therapies before. High rates of clinical response were observed by the first follow-up visit already (UC: 69%, CD: 55%). Clinical remission was achieved in 61 and 73% by the end of the follow-up period. Approximately half of patients suffered from anxiety, depression or fatigue and this percentage markedly decreased following treatment initiation (48 vs. 23,9% after 3 months, p=0,02). Fatigue was significantly more prevalent in clinically active disease (33,8 vs. 3,8%, p=0,003) and responders showed numerically higher rates of fatigue improvement (70% vs. 40%, p=0,329). Anemia was associated with higher fatigue levels even after correction for disease activity, while there was no evidence for an association between fatigue and iron status, vitamin D or zinc levels resp. Fatigue was correlated with coexisting anxiety and depression and inversely correlated with QoL.

Conclusions: Our data demonstrate high rates of clinical response following the initiation of advanced IBD therapies, even in an extensively pretreated population with a long disease history. Fatigue and psychological comorbidities were highly prevalent, especially during active disease, and partially reversible following treatment initiation. QoL was markedly impaired during active disease and in fatigued patients. The pathogenetic links between disease activity and fatigue in IBD remain to be elucidated and biobanking studies such as CLINNOVA-IBD will play a pivotal role in this field.

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Artikel online veröffentlicht:
04. September 2025