Real-World Effectiveness and Safety of Vedolizumab and Ustekinumab in Biologic-Naive Patients With Crohn's Disease: Results From the EVOLVE Expansion Chart Review Study

Marc Ferrante; Britt Christensen; Brian Bressler; Neil R Brett; Marielle Bassel; Pravin Kamble; Shashi Adsul; Lauren Gianchetti; Michael Scharl

doi:10.1097/MCG.0000000000002350

Real-World Effectiveness and Safety of Vedolizumab and Ustekinumab in Biologic-Naive Patients With Crohn's Disease: Results From the EVOLVE Expansion Chart Review Study

J Clin Gastroenterol. 2026 Feb 24. doi: 10.1097/MCG.0000000000002350. Online ahead of print.

Authors

Marc Ferrante^{1

2}, Britt Christensen^{3

4}, Brian Bressler⁵, Neil R Brett⁶, Marielle Bassel⁶, Pravin Kamble⁷, Shashi Adsul⁷, Lauren Gianchetti⁸, Michael Scharl⁹

Affiliations

¹ Department of Gastroenterology and Hepatology, University Hospitals Leuven.
² Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.
³ Department of Gastroenterology, The Royal Melbourne Hospital.
⁴ Department of Medicine, The University of Melbourne, Melbourne, Australia.
⁵ St Paul's Hospital, University of British Columbia, Vancouver, BC.
⁶ PPD, part of Thermo Fisher Scientific, Montreal, Quebec, Canada.
⁷ Takeda Pharmaceuticals, Cambridge, MA.
⁸ PPD, part of Thermo Fisher Scientific, Philadelphia, PA.
⁹ Department of Gastroenterology and Hepatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.

PMID: 41729856
DOI: 10.1097/MCG.0000000000002350

Abstract

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).

Keywords: Crohn’s disease; biologics (IBD); inflammatory bowel disease; outcomes research.

Associated data

ClinicalTrials.gov/NCT05056441