Bokemeyer, B.(1,2,3)*;Plachta-Danielzek, S.(2);Howaldt, S.(4);Mohl, W.(5);Efken, P.(6);Ehehalt, R.(7);Kahl, M.(8);Krause, T.(9);Trentmann, L.(10);Lügering, A.(11);Schnoy, E.(12);Jochum, C.(13);Fajardo Salmon, S.(2);Hartmann, P.(6);Gilman, E.(2);Schreiber, S.(2,3);
(1)Prof. Dr. Bernd Bokemeyer, Interdisciplinary Crohn Colitis Centre Minden, Minden, Germany;(2)Competence Network IBD, Study Department, Kiel, Germany;(3)University Hospital Schleswig-Holstein Campus Kiel, Clinic of General Internal Medicine I, Kiel, Germany;(4)Research Institut for IBD-HaFCED Hamburg, Gastroenterology Practice, Hamburg, Germany;(5)Center for Gastroenterology Saar MVZ, Gastroenmterology, Saarbruecken, Germany;(6)Gastroenterology Practice Minden, Gastroenterology, Minden, Germany;(7)Gastroenterology Practice Heidelberg, Gastroenterology, Heidelberg, Germany;(8)Gastroenterology Practice Hamburg, Gastroenterology, Hamburg, Germany;(9)Gastroenterology Practice Kassel, Gastroenterology, Kassel, Germany;(10)Gastroenterology Practice Bremen, Gastroenterology, Bremen, Germany;(11)Center for Gastroenterology Portal 10 Münster MVZ, Gastroenterology, Münster, Germany;(12)University Hospital Augsburg, III. Medical Clinic - Gastroenterology, Augsburg, Germany;(13)University Hospital Charite Berlin- Campus Mitte, Department of Hepatology and Gastroenterology, Berlin, Germany;
Background
Observational real-world evidence (RWE) studies on the effectiveness and safety of ustekinumab (UST) in ulcerative colitis (UC) are required in addition to RCTs, which are usually confined to selected patients and thus may not represent distinct treatment patterns and everyday clinical practice. For this reason, the prospective, controlled, propensity score (PS)-adjusted RUN-UC study was conducted in UC patients starting a newly initiated biologics therapy with a follow-up period of 3 years. The aim of the present analysis was to investigate the induction phase effectiveness of UST vs anti-TNF vs vedolizumab (VEDO) in UC in terms of clinical and steroid-free remission.
Methods
Between 2020-2022, 507 UC patients starting a new therapy with UST or other biologics were enrolled in 34 IBD-experienced centres across Germany. After exclusion of small molecules and missing outcomes, the final sample consisted of 317 patients. Response modified (reduction of partial Mayo score (pMayo) by >3 points from baseline to week-16 and a reduction of at least 30% or reaching remission at week-16), clinical remission (pMayo ≤ 1 plus a bleeding subscore=0), and steroid-free remission (pMayo ≤ 1, bleeding subscore=0 and no systemic use of steroids or oral budesonide during the last 8 weeks) were considered as outcomes. To reduce the effect of confounders, PS adjustment with inverse probability of treatment weighting (IPTW) was implemented. A weighted logistic regression was used, and the results were reported as odds ratio (OR) and 95% confidence interval (CI). Health-related quality of life was assessed by using the self-reported visual analogue scale (EQ-VAS) of the EQ-5D. Changes in EQ-VAS from baseline to week-16 were assessed with a linear model.
Results
101 UST (bio-naïve: 6), 106 anti-TNF (ADA: 24.5%, IFX: 65.1%, GOL: 10.4%) (bio-naïve: 70) and 110 VEDO (bio-naïve: 73) UC-patients were included. PS adjustment removed systematic differences between the three groups (UST/anti-TNF/VEDO: 44.9/43.8/48.1% males, 6.7/9.9/5.5% smokers, 7.9/12.5/9.3% EIM). The effectiveness of UST in terms of response, clinical and steroid-free remission was comparable to that of anti-TNF and VEDO at week 16 (Tab. 1). We observed a significant increase in EQ-VAS within all three groups (Tab. 2). The increase in the UST group was significantly higher than in the VEDO group and numerically higher than in the anti-TNF group.
Conclusion
In this prospective RUN-UC study, with propensity score weighted groups, UST showed similar induction phase effectiveness in comparison with anti-TNF and VEDO. Quality of life was significantly improved in the UST group vs VEDO and was numerically higher than anti-TNF after the induction phase.
