The effectiveness, safety, and healthcare resource utilization outcomes during the 36-month treatment period are similar across biologic-naïve patients with Crohn’s disease (CD), regardless of baseline disease location, according to a study.
Furthermore, “[t]he risk of CD-related surgeries was higher with vedolizumab than with ustekinumab in patients with ileal disease and similar between treatments in other disease locations,” the researchers said. “[H]owever, the number of patients requiring CD-related surgeries was low.”
In the multicentre, observational, retrospective EVOLVE Expansion study, the research team analysed the medical charts of biologic-naïve patients with CD aged ≥18 years who initiated vedolizumab or ustekinumab. They compared outcomes for vedolizumab vs ustekinumab in patients with baseline isolated ileal, ileocolonic, and isolated colonic CD over 36 months.
Of the participants, 293 had ileal (vedolizumab: n=158; ustekinumab: n=135), 185 had ileocolonic (vedolizumab: n=91; ustekinumab: n=94), and 121 had colonic CD (vedolizumab: n=84; ustekinumab: n=37). [J Clin Gastroenterol 2026;60:722-734]
The 36-month cumulative rates were comparable between vedolizumab and ustekinumab in all CD subgroups for clinical response, remission, mucosal healing, and treatment persistence. Likewise, no significant differences were observed in the risks of serious adverse events, serious infections, CD exacerbations, and CD-related hospitalizations between cohorts across disease locations.
Furthermore, CD-related surgery risk was similar in patients with ileocolonic and colonic CD, but higher with vedolizumab vs ustekinumab in patients with ileal CD. Specifically, CD-related surgeries were done in 12 of 158 (7.6 percent) vedolizumab-treated patients and in three of 135 (2.2 percent) ustekinumab-treated patients.
“Together, these results suggest that physicians can use both treatments as first-line biologics in patients with CD, regardless of the location of the disease,” the researchers said.
Previous studies
A pooled analysis of four earlier clinical trials using patient-level data from 299 patients with CD revealed no differences in endoscopic healing at 1 year between vedolizumab and ustekinumab. [Am J Gastroenterol 2022;117:1106-1117]
However, efficacy outcomes in these trials differed by disease location, with greater 1-year endoscopic healing seen with adalimumab and infliximab compared with ustekinumab in patients with colonic disease. No differences were noted between biologics in those with ileal disease (simple endoscopic score for CD ≥3). [Am J Gastroenterol 2022;117:1106-1117]
On the other hand, a large, retrospective, observational cohort study found no significant difference in disease remission between anti-TNF therapy (ie, infliximab, adalimumab, and certolizumab) and vedolizumab in CD. There was also no substantial difference in comparative effectiveness estimates between anti-TNF therapy and vedolizumab based on disease location. [Aliment Pharmacol Ther 2020;52:669-681]
“As data differ across studies, further research is required to determine the comparative real-world effectiveness and safety of these agents and to enable physicians to determine which agents are best suited for first-line biological treatment for individual patients,” the researchers said.
CD is a chronic relapsing, remitting inflammatory condition that affects the gastrointestinal tract and requires lifelong treatment. [Mayo Clin Proc 2017;92:1088-1103; Therap Adv Gastroenterol 2015;8:352-359]
Many biologic treatments have been approved for the treatment of moderately to severely active CD, including the gut-selective antilymphocyte trafficking α4β7-integrin inhibitor vedolizumab and the interleukin-12/23 p40 inhibitor ustekinumab.