Infliximab and Ustekinumab Show Comparable Effectiveness in Biologic-Naïve Crohn’s Disease
A prospective real-world cohort study found no meaningful differences between infliximab and ustekinumab in achieving clinical, endoscopic, or transmural remission among biologic-naïve patients with Crohn’s disease (CD), providing important comparative data to inform first-line biologic selection.
The study included 429 biologic-naïve patients with CD who initiated infliximab (n=283) or ustekinumab (n=146). Outcomes were assessed at weeks 14 to 26 and 44 to 56, with analyses adjusted for confounding using multivariable regression and propensity score matching. Endpoints included endoscopic remission and response, transmural remission and response, clinical remission, and C-reactive protein (CRP) normalization.
Across both time points, rates of endoscopic remission were similar between infliximab and ustekinumab. At weeks 14 to 26, endoscopic remission occurred in 37.5% of infliximab-treated patients and 30.8% of ustekinumab-treated patients, with no statistically significant difference. Comparable findings were observed at weeks 44 to 56. Endoscopic response rates followed a similar pattern, as did transmural remission and transmural response, with no significant differences between treatment groups at either assessment window.
Clinical remission rates were numerically higher with infliximab early but did not differ significantly after adjustment. By weeks 44 to 56, clinical remission was achieved in 73.5% of infliximab-treated patients and 71.2% of those receiving ustekinumab. Treatment durability was also comparable, with similar discontinuation rates by week 56 (24.4% vs 20.5%).
One distinction emerged early in biomarker response. The infliximab group demonstrated higher CRP remission at weeks 14 to 26, though this difference was no longer present by weeks 44 to 56.
The authors concluded that “infliximab and ustekinumab demonstrated similar effectiveness in achieving clinical, endoscopic, and transmural remission in biologic-naïve patients with CD.” They noted that these findings were consistent in propensity-matched analyses.
For gastroenterologists, the key takeaway is that both infliximab and ustekinumab are reasonable first-line biologic options for biologic-naïve Crohn’s disease. In the absence of clear efficacy differences across objective outcomes, treatment selection can be guided by patient preference, safety considerations, comorbidities, route of administration, and access factors rather than expectations of superior disease control.
Reference
Huang Z, Diao N, Guo Q, et al. Comparative effectiveness of infliximab vs ustekinumab for endoscopic and transmural remission in biologic naïve Crohn's disease. Clin Gastroenterol Hepatol. 2026;24(1):172-180. doi:10.1016/j.cgh.2024.12.040
