Real-world Effectiveness of Ustekinumab Versus Anti-TNF or Vedolizumab in Ulcerative Colitis: Induction and 12-Month Maintenance Results from the Prospective, Observational RUN-UC Study.

Abstract

Background: Real-world evidence (RWE) studies of ustekinumab (UST) in ulcerative colitis (UC) are needed because randomized controlled trials do not represent unselected patient populations in everyday clinical practice. Patients with UC were recruited when starting biologic therapy for the first time or switching to a new biologic therapy. This study assessed the effectiveness of maintenance therapy with UST in comparison to anti-TNF or vedolizumab (VDZ) at 12 months.

Methods: Between 2020-2022, 507 UC patients starting biologic therapy for the first time or switching to a new biologic therapy were enrolled at 34 IBD-specialized centres in Germany. After excluding patients receiving other biologics or small molecules, as well as those with stomas or missing outcomes, the final sample consisted of 476 patients. The outcomes were clinical response, clinical remission (CR), and steroid-free remission. Propensity score (PS) adjustment with inverse probability of treatment weighting (IPTW) was used to reduce the effect of confounding due to physician selection of therapy.

Results: A total of 476 patients with UC were included in the analysis (UST: 147, anti-TNF: 168, VDZ: 161). Treatment persistence over 12 months differed significantly (p < 0.001) between UST (93.9%), VDZ (87.0%), and anti-TNF (75.0%). The PS-weighted effectiveness of UST in the mITT analysis at month 12 was not significantly different to anti-TNF or VDZ (CR: UST 26.9%, anti-TNF 34.7%, VDZ 40.9%; p=0.063).

Conclusion: In the prospective RUN-UC study with PS-weighted groups, UST showed higher treatment persistence but no significant difference in maintenance effectiveness compared to anti-TNF or VDZ in UC.