Esophagus to Small Intestine
Inflamm Bowel Dis. 2023;29(11):1741–50
Real-world comparative effectiveness of ustekinumab vs. anti-TNF in Crohn’s disease with propensity score adjustment: Induction phase results from the prospective, observational RUN-CD study
Background: In addition to randomized controlled trials (RCTs), real-world studies on the effectiveness of ustekinumab (UST) in Crohn’s disease (CD) are required inasmuch as RCTs are usually confined to selected patients, which may not represent everyday clinical practice. Within the framework of the prospective real-world RUN-CD registry, a total of approximately 900 CD patients from 44 inflammatory bowel disease centers from all over Germany starting a new therapy with UST or other biologics were screened for a real-world evidence (RWE) comparison of CD patients with UST versus anti-tumor necrosis factor (TNF).
Methods: A total of 618 CD patients with a non-randomized biological therapy were qualified for this induction phase effectiveness RUN-CD study of UST versus anti-TNF. To reduce selection bias in estimations of treatment effects, the propensity score with inverse probability of treatment weighting was implemented. The results were reported as odds ratio (OR) and 95% confidence interval (CI).
Results: A total of 339 UST and 279 anti-TNF patients were analyzed. The effectiveness of UST versus anti-TNF, in terms of clinical remission (UST, 65.4% vs. anti-TNF, 63.0%; OR = 1.11; 95% CI: 0.71–1.74) and steroid-free remission (UST, 51.0% vs. anti-TNF, 53.8%; OR = 0.94; 95% CI: 0.60–1.47) was comparable at the end of induction therapy. Similar results were observed in the bio-naive and bio-experienced UST versus anti-TNF groups. For both, the remission rates were higher in the bio-naive than in the bio-experienced groups (p < 0.05).
Conclusions: In this prospective, observational RUN-CD study, the real-world evidence head-to-head comparison of ustekinumab versus anti-tumor necrosis factor showed similar induction effectiveness in both groups, remarkably higher than those found in prior randomized controlled trials.
DOI: 10.1093/ibd/izac271