Real-World Effectiveness and Safety of Vedolizumab and Ustekinumab in Biologic-Naive Patients With Crohn’s Disease

BACKGROUND: Comparative data on vedolizumab versus ustekinumab in biologic-naive patients with moderate-to-severe Crohn's disease (CD) are lacking. AIMS: To compare the effectiveness and safety of vedolizumab versus ustekinumab as first-line biologic treatments in patients with CD. METHODS: EVOLVE expansion (ClinicalTrials.gov, NCT05056441) was a 36-month retrospective medical chart review study in biologic-naive patients who initiated vedolizumab or ustekinumab treatment in Australia, Belgium, and Switzerland. Outcomes included clinical remission, clinical response, mucosal healing, treatment persistence, serious adverse events (SAEs), serious infections (SIs), and health care resource utilization (HCRU). Inverse probability of treatment weighting was used to account for differences in baseline characteristics between treatment groups. RESULTS: The study included 623 patients (vedolizumab, 347; ustekinumab, 276). During 36 treatment months, cumulative rates of clinical remission (vedolizumab, 89.8%; ustekinumab, 89.1%; P=0.829) and clinical response (vedolizumab, 82.6%; ustekinumab, 83.8%; P=0.909) were similar between groups; mucosal healing was significantly higher with vedolizumab (vedolizumab, 91.1%; ustekinumab, 88.5%; P=0.036); treatment persistence was significantly higher with ustekinumab (vedolizumab, 69.9%; ustekinumab, 80.2%; P=0.035). SIs were higher in the vedolizumab group (vedolizumab, 14 events in 9 patients, 2.8/100 patient-years; ustekinumab, 6 events in 2 patients, 0.8/100 patient-years; P=0.026). No significant differences in SAEs, CD exacerbations, CD-related surgeries, or CD-related hospitalizations were observed. CONCLUSIONS: In a real-world setting, clinical response, clinical remission, SAEs, and HCRU were similar in patients treated with vedolizumab and ustekinumab during 36 treatment months. Treatment persistence was higher with ustekinumab. Mucosal healing was higher with vedolizumab (see Supplemental Digital Content 1 for visual summary, http://links.lww.com/JCG/B336).