CHARLOTTE, N.C.—Patients with Crohn’s disease who progress from anti–tumor necrosis factor agents to one of two relatively new biologics tend to fair equally well in terms of persistence, regardless of whether they are treated with ustekinumab or vedolizumab, according to a new study.
“As we’ve heard a lot over the last decade, anti–[tumor necrosis factor (TNF)] medications are really good medications for patients with Crohn’s disease, often as a first-line medical therapy. But for a number of patients, anti-TNFs either don’t work or they lose response over time. Fortunately, we have a growing number of tools in our toolbox,” said Michael D. Kappelman, MD, MPH, a professor of pediatrics and an adjunct professor of epidemiology at the University of North Carolina at Chapel Hill, who presented the study at the 2022 annual meeting of the American College of Gastroenterology (abstract D0342).
Because few real-world comparative effectiveness studies have evaluated the various therapies available or yielded mixed results, Dr. Kappelman and his co-investigators conducted a retrospective cohort study evaluating patients newly treated with ustekinumab (Stelara, Janssen) and vedolizumab (Entyvio, Takeda) after anti-TNF therapy. They used longitudinal healthcare claims data from Anthem representing a geographically diverse population.
The primary outcome was treatment persistence at 52 weeks (i.e., patients were still on the same drug a year after starting it). Secondary outcomes were all-cause hospitalization, Crohn’s disease–related hospitalization with or without surgery, and hospitalization for other infection-related causes.
They identified 885 new users of ustekinumab and 490 new users of vedolizumab who were balanced on all measured baseline characteristics.
They found that treatment persistence was 45.7% with ustekinumab and 42.3% with vedolizumab. “We found no difference in the primary outcome. Patients starting their journey with vedolizumab or ustekinumab were equally likely to stay on that agent for a minimum of 12 months,” Dr. Kappelman told Gastroenterology & Endoscopy News.
With respect to secondary outcomes, patients started on ustekinumab were less likely to undergo all-cause, Crohn’s disease–related or other infection-related hospitalization than patients on vedolizumab. “All of those other outcomes seem to slightly favor ustekinumab over vedolizumab,” Dr. Kappelman said.
“In sum, we are lucky to have new tools in the toolbox and an increasingly promising pipeline, and it’s great that the patients have a choice,” he added. The researchers advocated for the consideration of patient preference, past anti-TNF experience and factors such as cost and route of administration to guide individualized decision making for treatment in this refractory patient population.
Ellen J. Scherl, MD, the founding director of the Jill Roberts Center for Inflammatory Bowel Disease at Weill Cornell Medicine/NewYork-Presbyterian Hospital, in New York, said such comparative data on IBD therapeutics is valuable to clinicians. Specifically, she said it “would be interesting to do the comparative study evaluating ustekinumab versus vedolizumab as first-line therapies in bio-naive patients with no anti-TNF exposure.”
—Monica J. Smith
Dr. Kappelman reported financial relationships with Janssen, J&J and Takeda. Dr. Scherl reported financial relationships with companies including Janssen and Takeda. Dr. Scherl is on the Gastroenterology & Endoscopy News editorial board.
This article is from the December 2022 print issue.