Real-World Effectiveness of Golimumab in Ulcerative Colitis: A Pooled Analysis from the Prospective UMBRELLA-IBD Registry in Germany.

Background: The efficacy and safety of the anti-TNF inhibitor golimumab in ulcerative colitis (UC) have been demonstrated in pivotal randomized controlled trials (RCTs). However, real-world data are needed to assess its effectiveness and safety in routine clinical practice, where patient populations and treatment settings are more heterogeneous. Methods: This pooled, retrospective-prospective cohort analysis draws on primary data from four IBD registries that contribute UC data to the UMBRELLA-IBD data warehouse: BioColitis, RUN-UC, TARGET-IBD, and VEDO-IBD. Data for each registry were collected across multiple centers under routine clinical care conditions in Germany. Eligible patients had a confirmed diagnosis of UC according to DGVS/ECCO criteria, were ≥18 years of age, and had newly initiated treatment with golimumab between 2017 and 2023. In total, 222 patients met these criteria and were included in the analysis. Statistical analyses included descriptive summaries, group comparisons, and Kaplan-Meier analysis of treatment persistence. Adverse events (AEs) and serious adverse events (SAEs) were also assessed and compared to other anti-TNF therapies from UMBRELLA-IBD. Results: Of the 222 patients who newly initiated golimumab, 134 had a documented month 12 visit with a documented pMayo score and were included in the modified intention-to-treat (mITT) analysis. A high proportion of the patients in the study had previously received treatment with at least two biologics (81%). In this mITT population, clinical remission was achieved in 38.1% and steroid-free clinical remission (SFCR) in 36.6% at 12 months. In the full cohort, treatment persistence at 12 months was 67.2%. Safety data on adverse events (AEs) and serious adverse events (SAEs) were reported in 14.8% and 5.8% of cases, respectively, with no significant differences compared with other anti-TNF therapies. Conclusions: In addition to the positive findings from the pivotal RCTs, these real-world data further support the clinical effectiveness and safety of golimumab in routine care for UC.