Higher-dose upadacitinib reduces disease severity, prolongs clinical remission in UC
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CHARLOTTE, N.C. — A higher dose of upadacitinib decreased disease severity and induced clinical remission for a longer period among patients with active ulcerative colitis, according to a presenter at ACG Annual Scientific Meeting.
“Upadacitinib has been shown to be effective for both induction and maintenance therapy in ulcerative colitis. However, the relative benefits of a 30 mg dose vs. low 15 mg dose of upadacitinib as maintenance therapy remains to be established,” Brian G. Feagan, MD, senior scientific director at Alimentiv Inc. and gastroenterologist at Western University, told attendees. “The purpose of this study was to evaluate the proportion of patients in mild, moderate or severe disease per the Adaptive Mayo score between the two regimens and also assess the weeks in clinical remission per the Partial Adapted Mayo score.”
In a post-hoc analysis, Feagan and colleagues evaluated the benefits of upadacitinib (UPA) as a maintenance treatment in 451 patients with active UC. Included patients had a clinical response after an 8-week induction period with UPA 45 mg in the U-ACHIEVE maintenance trial.
Patients received either UPA 15 mg (n = 149), UPA 30 mg (n = 148) or placebo (n = 154) once daily for 52 weeks. Researchers analyzed clinical remission per Partial Adapted Mayo Score in subgroups of patients with mild, moderate or severe UC at weeks 0 and 52. For each dose of UPA, area under the curve analyses determined the number of weeks patients achieved clinical remission. Researchers also performed a sensitivity analysis for each dosage group (n = 135, 139 and 137, respectively) among patients aged younger than 65 years.
At baseline, Feagan noted “at least” 91% of patients had mild disease and there was no evidence of severe disease across treatment groups.
Following 52 weeks of maintenance, 19.7% more patients dosed with UPA 30 mg had lesser disease severity compared with patients dosed with UPA 15 mg. Further, clinical remission lasted for 15.8 weeks (95% CI, 12.2-19.5), 30.5 weeks (95% CI, 26.4-34.6) and 34.4 weeks (95% CI, 30.5-38.3) among patients dosed with placebo, UPA 15 mg and UPA 30 mg, respectively. Over a year of maintenance, patients in the UPA 30 mg arm were in clinical remission for an additional 3.8 weeks compared with patients in the UPA 15 mg arm.
Among patients in the sensitivity analysis, 26% more in the UPA 30 mg arm were in lesser disease severity compared with the UPA 15 mg arm and were in clinical remission for an additional 4.2 weeks over a year of maintenance therapy.
“After 52 weeks of maintenance, patients treated with upadacitinib 30 mg had less severe ulcerative colitis than those receiving 15 mg daily,” Feagan noted. “Over the 52-week maintenance period, patients in the 30 mg group were in clinical remission based on Partial Adapted Mayo Score for approximately one additional month in that year compared with patients in 15 mg group.”
He added, “This study demonstrates the important clinical benefit of high dose upadacitinib as maintenance therapy, and we’ve shown the relevance for patients younger than 65 where this effect, if anything, was slightly greater.”
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Feagan BG, et al. Abstract S712: Benefits of High versus Low Dose Upadacitinib as Maintenance Treatment in Ulcerative Colitis Patients Who Were Responders to 8-week Induction With Upadacitinib. Presented at: ACG Annual Scientific Meeting; Oct. 21-26, 2022; Charlotte, N.C. (hybrid meeting).
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