Infliximab and Ustekinumab Both Effective for Crohn’s Disease

Neeraj Narula, MD

Two widely used treatments for Crohn’s disease yield similar results in biologic-naïve patients.

A team, led by Neeraj Narula, McMaster University Medical Centre, compared the efficacy and rapidity of onset of action of infliximab and ustekinumab induction therapy for moderate to severe biologic-naïve Crohn’s disease.

The Study

In the post-hoc analysis of 2 large Crohn’s disease clinical trial programs, the researchers used patient-level data to identify 420 biologic-naïve Crohn’s disease patients.

The investigators compared differences in proportions of patients achieving week 6 clinical remission, clinical response, and normalization of calprotectin.

They also used multivariate logistic regression to adjust for confounders and sensitivity analysis using propensity scores to create a cohort of matched participants with similar distribution of baseline co-variates.

Results After 6 Weeks

At week 6, the researchers identified a comparable number of patients achieved clinical remission with infliximab as compared to patients treated with ustekinumab (44.9% vs. 37.9%; aOR, 1.22; 95% CI, 0.79-1.89). However, at week 6 clinical response rates were not significantly different (58.4% infliximab vs. 54.9% ustekinumab; aOR, 1.25; 95% CI, 0.82-1.90).

The researchers also did not identify significant differences between treatment groups for achieving week 6 fecal calprotectin <250 mcg/L in those with elevated values at baseline (42.3% infliximab vs. 34.7% ustekinumab; aOR. 1.34; 95% CI, 0.79-2.28).

There were similar results identified for all analyses done within the propensity matched cohort.

“Based on this post-hoc analysis, infliximab and ustekinumab appear to have similar efficacy and speed of onset in patients with Crohn’s disease who are biologic-naïve,” the authors wrote.

Ustekinumab

Last year, researchers conducted a study showing ustekinumab could be suitable as a treat-to-target therapy for Crohn’s disease patients.

During the 5th Congress of the European Crohn's & Colitis Organization (ECCO) in Vienna, Austria, investigators from Italy presented interim data comparing a treat-to-target maintenance treatment strategy against standard of care from the phase 3B STARDUST open label study.

After 16 weeks, 79% of patients with moderately to severely active Crohn’s disease achieved a clinical response and 67% were in clinic remission after treatment with ustekinumab.

In the study, patients received a ~6 mg/kg intravenous dose, followed by a single 90 mg subcutaneous dose of ustekinumab.

Intestinal ultrasound is often used to evaluate transmural disease activity in Crohn’s disease patients. STARDUST represents the first ever study of a treat-to-target strategy in Crohn’s disease patients using endoscopic response to guide treatment.

“Crohn's disease patients may respond to treatment while continuing to experience internal inflammation that can cause irreversible damage,” Silvio Danese, MD, PhD, Head of the Inflammatory Bowel Diseases Center at Humanities Research Hospital and principal investigator, said in a statement. “These patients may benefit from a more proactive, robust treatment approach and less invasive monitoring methods.”

The study, “Comparative Efficacy and Rapidity of Action for Infliximab vs. Ustekinumab in Biologic Naive Crohn’s Disease,” was published online in Clinical Gastroenterology and Hepatology.