Francisca Joly, MD, PhD: Apraglutide in Short Bowel Syndrome with Intestinal Failure

New data from the phase 3 STARS trial evaluating the safety and efficacy of once-weekly subcutaneous apraglutide in patients with short bowel syndrome with intestinal failure (SBS-IF) were presented in a late-breaking session at Digestive Disease Week (DDW) 2024 in Washington, DC.

Results showed significantly more patients treated with the long-acting synthetic GLP-2 analog gained additional days off from parenteral support per week and were clinical responders or clinical high responders, building upon previous positive topline data announced earlier in 2024.

“In terms of quality of life, it’s very complicated,” Francisca Joly, MD, PhD, professor of nutrition and gastroenterologist at Beaujon Hospital, explained to HCPLive as she described the burden of parenteral support in patients with SBS-IF. “The patient feels that they’ve lost freedom due to the impact of parenteral support.”

A multicenter, double-blind, randomized, placebo-controlled trial, STARS was conducted in 18 countries with enrollment from 68 study sites and is the largest global SBS-IF clinical trial to date, including a total of 164 patients who were randomly assigned in a 2:1 ratio to receive once weekly apraglutide or placebo. The primary endpoint was relative change from baseline in actual weekly parenteral support volume at week 24, along with multiple secondary endpoints assessing the reduction in days on parenteral support and volume of parenteral support from baseline as well as enteral autonomy.

Data presented at DDW showed significantly more apraglutide patients gained additional days off from parenteral support per week at week 24 versus placebo (≥2 days, 24.5% vs 11.3%; P = .021 and ≥3 days, 11.8% vs 1.9%; P = .006), and significantly more patients treated with apraglutide were clinical responders and clinical high responders, defined as ≥20% and ≥40% parenteral support volume reduction, respectively, at both weeks 20 and 24 versus placebo. Investigators pointed out this was consistent across both the overall (Clinical responders, 42.7% vs 20.8%; P = .003; Clinical high responders, 22.7% vs 9.4%; P = .018) and the stoma populations (Clinical responders, 40.7% vs 15.4%; P = .02; Clinical high responders, 20.4% vs 0%; P = .009).

Additionally, enteral autonomy was achieved by 7 apraglutide-treated patients by week 24, including 3 in the stoma subpopulation and 4 in the colon-in-continuity subpopulation (6.4% apraglutide vs 0% placebo; P = .006), something Joly described as a “dream” for these patients. By week 48, an additional 3 colon-in-continuity patients achieved enteral autonomy (12.5% apraglutide vs 7.4% placebo; P = .387).

Joly has relevant disclosures with Takeda, AbbVie, Jaansen, and others.

Reference:

Brooks, A. STARS: Apraglutide Reduces Parenteral Support in Patients with Stoma, Colon-In-Continuity. HCPLive. May 21, 2024. Accessed May 21, 2024. https://www.hcplive.com/view/stars-apraglutide-reduces-parenteral-support-in-patients-with-stoma-colon-in-continuity