CHICAGO—In biologic-experienced patients with ulcerative colitis, tofacitinib and ustekinumab achieve about the same rate of corticosteroid-free remission by 16 weeks, according to research presented at Digestive Disease Week 2023.

However, despite similar rates of corticosteroid-free remission (CFR), primary failure to a biologic and treatment with three or more biologics were associated with a significantly higher rate of poor response to ustekinumab (Stelara, Janssen) but not to tofacitinib (Xeljanz, Pfizer), reported Anthony Buisson, MD, PhD, from the Department of Hepatogastroenterology at the University of Clermont-Ferrand, in France, at the meeting.

To compare the drugs, Dr. Buisson and his co-investigators retrospectively evaluated 289 UC patients who were previously exposed to at least one tumor necrosis factor inhibitor (TNFi) (abstract 14). The patients, drawn from 10 participating institutions, had been treated between January 2019 and June 2022. For inclusion, patients had to have a partial Mayo score (pMs) of at least 2.

When calculated with a propensity score, 37.8% of the 124 patients in the tofacitinib group and 35.6% of the 165 patients in the ustekinumab group met the primary CFR end point at 16 weeks, a result that was not significantly different (P=0.75).

When compared by prior biologic experience, CFR rates were numerically but non-significantly lower with tofacitinib than with ustekinumab after failure of a single TNFi (43.3% vs. 57.1%; P=0.48) or after failure of two prior TNFis (20.7% vs. 37.9%; P=0.16). For those with failure of three or more TFNis, CFR rates at 16 weeks were higher with tofacitinib than with ustekinumab (46.7% vs 23.2%, respectively; P=0.047). Disease severity was not a meaningful variable.

“In cases of more severe UC, such as pMs at least 6, the primary end point was reached in about the same proportion of patients treated with tofacitinib or ustekinumab [40.6% vs. 41.5%],” Dr. Buisson reported.

Propensity scoring was applied to account for most of these differences, but Dr. Buisson acknowledged the limitations of this approach to generating comparative data. “We performed propensity matching for major characteristics known to affect response, but we could not control for all variables,” said Dr. Buisson, who noted that in addition to prior exposure to TNFi, which was a study entry criterion, approximately 75% of patients in both groups had previously been treated with vedolizumab (Entyvio, Takeda).

Stephen B. Hanauer, MD, a professor of gastroenterology and hepatology at Northwestern University Feinberg School of Medicine, in Chicago, agreed that a retrospective study with propensity matching “provides evidence but not high-level evidence.” He called this study in particular “more hypothesis-generating” than a reliable test of the relative clinical efficacy of tofacitinib and ustekinumab in UC patients with prior biologic failure.

—Ted Bosworth

Dr. Buisson reported financial relationships with AbbVie, Amgen, Arena, Biogen, Celltrion, Ferring, Galapagos, Gut Care, Janssen, Lilly, Mylan, Merck, NexBiome, Pfizer, Roche, and Takeda. Dr. Hanauer reported financial relationships with AbbVie, Amgen, Boehringer-Ingelheim, Bristol Myers Squibb, Celltrion, Genentech, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer, Progenity and Prometheus.