Esophagus to Small Intestine
J Crohns Colitis. 2025;19(4):jjaf051
Comparative real-world effectiveness of ustekinumab versus anti-TNF in Crohn’s disease: 12-month maintenance phase results from the prospective, observational RUN-CD study using propensity score adjustment
Background: The prospective RUN-CD registry investigates the effectiveness of ustekinumab (UST) and other biologics in Crohn’s disease (CD) across Germany. Based on data from the registry, this study presents the maintenance phase results of a 12-month real-world-evidence (RWE) comparison of CD patients initiating new biologic therapies with UST or anti-TNF.
Methods: After excluding patients using biologics other than UST and anti-TNF and those with missing outcomes, the final sample consisted of 618 CD patients. Clinical remission (CR), defined as a Harvey-Bradshaw Index (HBI) ≤ 4, was the prespecified endpoint at 12 months. Switching to another biologic therapy was considered an outcome failure. Propensity score adjustment was used to reduce the effect of confounders.
Results: The study included 343 CD patients treated with UST and 264 treated with anti-TNF. Over 12 months, the frequency of therapy switches was significantly higher for infliximab (28%) compared with UST (17%) and adalimumab (17%) (p = 0.045). There was no significant difference in CR rates at 12 months between the UST and anti-TNF groups (65.8% vs. 60.0%, p = 0.262). However, in week-16 responders, CR rates at 12 months were significantly higher with UST (77.6%) versus anti-TNF (65.4%) (p = 0.041). The change in EQ-VAS (QoL) scores between UST and anti-TNF showed a 5.1-point difference favoring UST (p = 0.002).
Conclusions: In this 12-month real-world-evidence comparison, overall clinical remission (CR) rates were similar between ustekinumab (UST) and anti-TNF. However, among week-16 responders, CR rates were significantly higher with UST. Additionally, UST was associated with a significantly greater improvement in quality of life compared with anti-TNF.