VIDEO: Greater reduction in parenteral support with apraglutide vs. placebo in SBS-IF
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Key takeaways:
- Apraglutide met the primary endpoint of relative reduction in weekly parenteral support volume vs. placebo (–25.5% vs. –12.5%).
- More patients on apraglutide achieved at least 1, 2 and 3 days off support.
WASHINGTON — In a Healio video, Kishore R. Iyer, MBBS, shares results from the STARS study, in which weekly apraglutide significantly reduced parenteral support volume in patients with short bowel syndrome and intestinal failure.
“Apraglutide is the first once-weekly glucagon-like peptide-2 analog to show efficacy in a phase 3 trial in patients with short bowel syndrome-related intestinal failure,” Iyer, director of adult and pediatric intestinal rehabilitation and transplantation at Mount Sinai Hospital and professor of surgery, pediatrics and global health at the Icahn School of Medicine, told Healio. “Efficacy with once-weekly dosing demonstrated a significantly larger relative reduction in parenteral support volume observed from week 8 onward.”
In the phase 3, double-blind, placebo-controlled STARS study, Iyer and colleagues randomly assigned 163 adult patients with short bowel syndrome and intestinal failure 2:1 to subcutaneous once-weekly apraglutide (n = 110; mean age, 51.1 years; 44% men) or placebo (n = 53; mean age, 52.3 years; 50.9% men). Patients were further stratified by stoma (n = 80) or colon in continuity (CIC; n = 83).
The primary endpoint was relative reduction in parenteral support (PS) volume in the overall population, while secondary endpoints included days off PS and relative reduction in PS volume among patients with stoma vs. CIC.
According to results presented at Digestive Disease Week, there was a significantly greater relative reduction in weekly PS volume at week 24 among patients treated with apraglutide (–25.5%) vs. placebo (–12.5%).
“The primary endpoint in the overall population was met for apraglutide,” Iyer said.
In addition, those with stoma had significantly greater relative reduction in weekly PS volume at week 24 (–25.6% vs. –7.8%). Although the reduction was not significant among patients with CIC (–25.2% vs. –17.6%), these patients had “a numerically greater reduction in PS volume,” Iyer noted.
Further, more patients treated with apraglutide in the overall population achieved at least 1 day (43% vs. 27.5%), 2 days (24.5% vs. 11.3%) and 3 days (11.8% vs. 1.9%) off PS support per week, as well as enteral autonomy, which included patients with stoma and CIC.
Apraglutide also was “well-tolerated, with no new safety signals identified,” Iyer noted, which “was consistent with prior studies.”
“What this trial has shown is that patients meaningfully achieved days off PS,” Iyer said. “Each day off parenteral support is a good day for a patient with intestinal failure.”
He added, “And for the patients who achieved complete freedom from parental support, that is the holy grail of care. The impact that they do not have to be dependent on support day in and day out cannot be stated emphatically enough.”
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Joly F, et al. Efficacy and safety of apraglutide once-weekly in patients with short bowel syndrome and intestinal failure (SBS-IF): Results from the STARS study, a global phase 3 double-blind, randomized, placebo-controlled trial. Presented at: Digestive Disease Week; May 18-21, 2024; Washington (hybrid).
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