The trial enrolled 385 biologic-naive patients aged 18 years or older with moderately to severely active Crohn's disease and a Crohn's Disease Activity Index (CDAI) score of 220 to 450, who had failed to respond to or couldn't tolerate conventional therapy and had at least one ulcer at baseline endoscopic evaluation.
Roughly half were randomly allocated to monotherapy with either subcutaneous adalimumab (160 mg at baseline, 70 mg at week 2, then 40 mg every two weeks) or ustekinumab (given intravenously on day zero at a dose of 6 mg/kg, then subcutaneously at 90 mg every eight weeks).
There was no significant difference in the primary endpoint of clinical remission (CDAI score < 150) at one year, which occurred in 65% of patients receiving ustekinumab and 61% receiving adalimumab (P=0.42), researchers report in The Lancet.
Both treatment groups showed "robust and similar" endoscopic response (42% of patients in the ustekinumab group vs. 37% in the adalimumab group), the authors note. They say that, to their knowledge, these are the first endoscopic data in Crohn's disease from a trial with treat-through design, "which is reflective of real-world use."
Safety for both agents was consistent with prior reports. Serious infections were noted in four (2%) patients in the ustekinumab group and five (3%) in the adalimumab group, with no deaths on study.
"As the number of therapeutic options for Crohn's disease grows, rigorous evidence from direct comparisons in blinded, randomized controlled trials such as SEAVUE are becoming increasingly important in selecting the right treatments for our patients," corresponding author Dr. Bruce E. Sands, chief of the Division of Gastroenterology for the Mount Sinai Health System in New York City, said in a statement emailed to Reuters Health.
"While SEAVUE failed to show superior efficacy of ustekinumab in biologic-naïve patients with Crohn's disease, the study provides important benchmarks of efficacy in this patient population, and will help patients and providers choose the drug that best meets the patient's values in balancing efficacy, safety and convenience," Dr. Sands added.
Funding for the study was provided by Janssen Scientific Affairs. Several authors have disclosed relationships with the company.
SOURCE: https://bit.ly/3aXXeJW The Lancet, online June 11, 2022.
By Reuters Staff
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