A propensity score‐matched, real‐world comparison of ustekinumab vs vedolizumab as a second‐line treatment for Crohn’s disease. The Cross Pennine study II

Summary Background The optimal choice of biological agents after failure of anti‐tumour‐necrosis‐factor‐(TNF)α agent in Crohn’s disease (CD) is yet to be defined. Aims To assess the effectiveness and safety of ustekinumab compared to vedolizumab as second‐line treatment in CD patients who failed anti‐TNFα therapy. Methods Retrospective analysis of clinical response and remission at 14 and 52 weeks to ustekinumab by physician global assessment (PGA). A propensity score‐matched analysis with a cohort treated with vedolizumab was performed. Results Of 282 patients (mean age 40 ± 15, F:M ratio 1.7:1) treated with ustekinumab, clinical response or remission was reached by 200/282 patients (70.9%) at 14 weeks, and 162/259 patients (62.5%) at 52 weeks. Overall, 74 adverse events occurred, of which 26 were labelled as serious (8.3 per 100 person‐year). After exclusion of patients without prior anti‐TNFα exposure and patients previously exposed to vedolizumab or ustekinumab, we analysed 275/282 patients (97.5%) on ustekinumab and 118/135 patients (87.4%) on vedolizumab. Propensity score analysis revealed that at 14 weeks, patients treated with ustekinumab were 38% (95% CI 25%‐50%; P < 0.001) more likely to achieve clinical remission, while at 52 weeks, the difference of 9% (95% CI −15% to 33%; P = 0.462) was not significant. Conclusions Ustekinumab was effective and well tolerated in this real‐world cohort. While ustekinumab proved more effective at 14‐weeks, we found no statistically significant differences at 52 weeks compared to vedolizumab.