STARS: Apraglutide shows efficacy in short bowel syndrome with intestinal failure

Apraglutide, a novel long-acting glucagon-like peptide-2 (GLP-2) analogue, significantly reduced parenteral support volume in participants with short bowel syndrome with intestinal failure (SBS-IF). Conducted across 73 centres in 18 countries, the STARS trial underscored the efficacy and safety of apraglutide in this challenging population.

The phase 3, double-blind, placebo-controlled STARS trial (NCT04627025) included 164 adults with SBS-IF, who were randomised in a 2:1 ratio to receive either once-weekly subcutaneous apraglutide or a placebo. Participants were stratified by intestinal anatomy (stoma or colon-in-continuity [CIC]) and received either 2.5 mg or 5 mg of apraglutide based on their weight. The primary endpoint was the relative change in weekly parenteral support volume at week 24. Secondary endpoints included additional days off parenteral support at weeks 24 and 48, and the total enteral autonomy at week 48. Prof. Francisca Joly (Hopital Beaujon, France) presented the findings [1].

The primary endpoint was met, with apraglutide-treated participants showing a significantly larger reduction in weekly parenteral support volume at week 24 compared with placebo (-25.5% vs -12.5%; P=0.001). This effect was evident as early as week 8 (see Figure). In the stoma subgroup, the reduction was more pronounced (-25.6% vs -7.8%; P<0.001). Although the CIC subgroup showed a numerical benefit, it did not reach statistical significance (-25.2% vs -17.6%; P=0.179). A significant proportion of participants on apraglutide achieved an additional day off parenteral support per week at week 24 (43% vs 27.5%; P=0.04).

Figure: Relative weekly reduction of parenteral support volume from baseline [1]



Moreover, apraglutide led to total enteral autonomy in a significant percentage of participants by week 24 (6.4% vs 0% in the placebo group; P=0.006), with sustained benefits observed at week 48 (12.5% vs 7.4% in the placebo group; P=0.387). Apraglutide was well tolerated, with a low discontinuation rate due to adverse events (3.6% vs 1.9%).

“Apraglutide is the first once-weekly GLP-2 analogue to show significant efficacy in reducing parenteral support volume in a phase 3 trial for participants with SBS-IF. The trial confirmed that apraglutide significantly reduces weekly parenteral support volume and increases days off parenteral support with a favourable safety profile,” Prof. Joly summarised.

1. 
   
   1. 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. 1057c, DDW 2024, 18–21 May, Washington, DC, USA.

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Posted on 11 July 202411 July 2024