The first head-to-head trial of biologic therapies for Crohn disease found no statistically significant differences in the primary endpoint of clinical remission at week 52—defined as a Crohn Disease Activity Index (CDAI) of less than 150, or the major secondary endpoints of steroid-free remission and clinical response at week 52, Bruce E. Sands, MD, reported at Digestive Disease Week on May 23.

Dr Sands is the Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine in New York City.

The SEAVUE trial sought to compare the safety and efficacy of adalimumab and ustekinumab among biologic-naïve patients with moderate to severe Crohn disease who had failed previous treatments and had at least one ulceration. Almost half of patients in each randomized group were male, white, and aged approximately 30 years.

In the multicenter, blinded, active controlled study, 195 patients were randomized to the adalimumab arm, with 191 patients randomized to the ustekinumab cohort. Both groups received monotherapy with on-label dosing.

Almost 65% of patients treated with ustekinumab and 61% of patients treated with adalimumab achieved the primary endpoint at week 52, Dr Sands reported. Similarly there was no statistically significant difference between the groups in regard to major secondary endpoints, including clinical response (a decrease of 100 or more points from baseline; 66.2% for adalimumab and 60.7 for ustekinumab); patient-reported outcomes of remission, including abdominal pain (66.2% adalimumab, 72.3% ustekinumab); and endoscopic response (37% adalimumab vs 41% ustekinumab).

“At no time point was the difference in clinical remission statistically significant,” Dr Sands stated.

Both therapies also proved safe, he said, with infections more frequent with adalimumab but serious infections occurring at a similar rate. There were no deaths in either group. The most common serious adverse event was Crohn’s disease, which occurred at 7.2% in the adalimumab group and 2.5% among the ustekinumab group. There was one case of basal cell carcinoma recorded.

“In this first head-to-head study of biologics in Crohn’s disease, we found that both were highly effective, with no statistical difference in clinical remission rates,” Dr Sands stated. “The maintenance of clinical response was 78% in the adalimumab group and 88% in the ustekinumab group, illustrating that both these agents evidenced robust endoscopic results and clinical remission rates.”

--Rebecca Mashaw

Sands, BE. Ustekinumab versus adalimumab for induction and maintenance therapy in moderate-to-severe crohn’s disease: The SEAVUE study. Presented at Digestive Disease Week, May 23, 2021; Virtual