The following is a summary of “Efficacy and Safety of Teduglutide in Infants and Children With Short Bowel Syndrome Dependent on Parenteral Support,” published in the September 2023 issue of Pediatrics by Chiba, et al.

For a study, researchers sought to assess both the short- and long-term safety and efficacy of teduglutide treatment in infants and children diagnosed with short bowel syndrome with intestinal failure (SBS-IF).

The investigation involved three open-label phase 3 studies, including one extension study, that evaluated the safety and efficacy of teduglutide administered at a dosage of 0.05 mg/kg/day in infants and children with SBS-IF: There was a 24-week study involving infants who were randomized to receive teduglutide or standard of care (SoC). A 24-week study encompassing infants and children, all of whom received teduglutide.

A 24-week extension study focused on completed patients, allowing them to receive up to 48 weeks of total teduglutide treatment.

The core studies included 12 infants and 8 children, with an additional 2 infants and 7 children participating in the extension study. After 24 weeks of teduglutide treatment, there was a reduction of ≥20% in parenteral support (PS) requirements from baseline for 4 infants (57.1%) and 4 children (66.7%) receiving teduglutide, as well as 2 infants receiving SoC (50.0%). After 48 weeks of treatment, 1 infant (50.0%) and 4 children (80.0%) maintained the ≥20% reduction in PS. Two children who received teduglutide achieved enteral autonomy after 12 and 28 weeks of treatment, respectively. Adverse events (AEs) were consistent with the known impacts of SBS-IF and adverse reactions to teduglutide. Only one serious AE (abdominal pain) was considered related to teduglutide.

Teduglutide treatment, both short- and long-term, led to clinically meaningful reductions in parenteral support requirements for infants and children with SBS-IF. Teduglutide was well tolerated, and its efficacy improved with prolonged treatment duration.

Source: journals.lww.com/jpgn/fulltext/2023/09000/efficacy_and_safety_of_teduglutide_in_infants_and.6.aspx