Vedolizumab, ustekinumab induce similar rates of clinical response, remission in Crohn’s
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CHICAGO — Biologic-naive patients treated with vedolizumab and ustekinumab for Crohn’s disease had similar rates of clinical response and remission, although mucosal healing and biologic treatment persistence differed at 36 months.
“Crohn’s disease is characterized by chronic gastrointestinal inflammation that often requires lifelong treatment,” Marc Ferrante, MD, PhD, an associate professor in the department of gastroenterology and hepatology at University Hospitals Leuven, said at Digestive Disease Week. “Both vedolizumab and ustekinumab are biological treatment options that we may deliver as first-line treatment in patients with moderate to severe Crohn’s disease.”
He added, “Currently, however, it is not clear where we have to position both biologics in the treatment algorithm.”
Ferrante and colleagues conducted the multicenter, retrospective cohort EVOLVE expansion study from 2016 to 2021 to compare the clinical effectiveness and safety of vedolizumab and ustekinumab in 623 biologic-naive adults with CD, of whom 347 started 300 mg vedolizumab and 276 started 90 mg ustekinumab every 8 weeks.
Evaluated outcomes included cumulative rates of clinical response, remission, mucosal healing and treatment persistence over 12, 24 and 36 months, as well as serious adverse events, serious infections, CD exacerbations and CD-related surgeries.
Over 36 months, researchers reported similar cumulative rates of clinical response in patients treated with vedolizumab and ustekinumab (82% vs. 84.1%), as well as similar rates in clinical remission (88.3% vs. 88.5%). However, higher rates of mucosal healing were reported in the vedolizumab arm (91.3% vs. 87.4%), while the ustekinumab arm had higher rates of treatment persistence (70.6% vs. 80.3%).
In the vedolizumab group, 54 serious adverse events and 12 serious infections occurred in 10.1% and 2.6% of patients, respectively, while in the ustekinumab group, 53 serious adverse events and five serious infections were reported in 9.8% and 0.7% of patients.
According to Ferrante, serious infections were predominantly in the GI and lower respiratory tracts and included abscesses.
Researchers noted no significant differences in the risk for CD exacerbations (HR = 1.01; 95% CI, 0.68-1.49), CD-related surgeries (HR = 1.8; 95% CI, 0.69-4.73) and CD-related hospitalizations (HR = 0.98; 95% CI, 0.61-1.57) between groups.
“In this real-world setting, clinical response and clinical remission were similar between bio-naive patients that started treatment with vedolizumab and ustekinumab,” Ferrante concluded. “Over the 3-year period, mucosal healing was higher in patients treated with vedolizumab compared to patients treated with ustekinumab.”
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Ferrante M, et al. Abstract 16: Real-world clinical effectiveness and safety of vedolizumab and ustekinumab in biologic-naïve patients with Crohn’s disease: Results from the EVOLVE expansion study. Presented at: Digestive Disease Week; May 5-9, 2023; Chicago, (hybrid).
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