UC patients achieve symptomatic improvement ‘as early as day 2’ with etrasimod
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Key takeaways:
- Patients treated with etrasimod achieved symptomatic response and remission by days 2 and 11, respectively.
- Stool frequency normalization and rectal bleeding remission “reached significance” at days 3 and 15.
VANCOUVER, British Columbia — A post hoc analysis of the ELEVATE UC trials demonstrated “rapid treatment effect” with early symptomatic response among patients treated with etrasimod for ulcerative colitis, according to a presenter.
“What was shown already and published was the efficacy and safety of etrasimod in both ELEVATE UC 52 and ELEVATE UC 12,” Marla C. Dubinsky, MD, a pediatric gastroenterologist at Mount Sinai Kravis Children’s Hospital, said at the ACG Annual Scientific Meeting. “More patients treated with etrasimod vs. placebo achieved clinical remission and response during the 12-week induction period for both ELEVATE UC 52 and ELEVATE UC 12.”
In a post-hoc analysis, Dubinsky and colleagues evaluated daily e-diary entries from 787 patients with moderate to severe UC who received etrasimod 2 mg (n = 527) or placebo (n = 260) in the ELEVATE UC program.
Using patient responses, researchers calculated daily Mayo rectal bleeding and stool frequency subscores, partial modified Mayo score (pMMS) and change from baseline in the first 28 days of treatment. Symptomatic response was defined as at least a 30% decrease in pMMS from baseline, while symptomatic remission was defined as a rectal bleeding subscore of 0 and a stool frequency subscore of 0 or 1, with at least a 1-point improvement from baseline.
At baseline, mean rectal bleeding and stool frequency subscores were 1.6 and 2.4, respectively, across both treatment and placebo groups, and mean pMMS was 4.
According to results, 16.83% of patients in the etrasimod group achieved symptomatic response by day 2 vs. 11.16% in the placebo group (adjusted difference = 5.56; 95% CI, 0.79-10.33) and 13.59% vs. 8.71%, respectively, achieved symptomatic remission (adjusted difference = 4.69; 95% CI, 0.36-9.03) by day 11.
In addition, stool frequency normalization occurred “as early as” day 3 in the treatment group (6.19%) vs. placebo (2.45%; adjusted difference = 3.51; 95% CI, 0.87-6.14), with rectal bleeding remission reported by day 15 (31.35% vs. 25.21%; adjusted difference = 6.33; 95% CI, 0.14-12.51).
“In the phase 3 ELEVATE UC trial program, within the first 28 days there were clinically relevant symptomatic improvements seen in patients treated with etrasimod vs. placebo as early as day 2, particularly as it relates to stool frequency as well as the response,” Dubinsky concluded. “These findings suggest that etrasimod has a rapid treatment effect with early symptomatic response.”
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Dubinsky MC, et al. Symptomatic improvement observed within 2 days of etrasimod induction therapy: Results from ELEVATE UC 52 and ELEVATE UC 12 studies in patients with ulcerative colitis. Presented at: ACG Annual Scientific Meeting; Oct. 20-25, 2023; Vancouver, British Columbia (hybrid meeting).
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