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Teduglutide

(Gattex®)

Teduglutide

Drug updated on 12/11/2024

Dosage FormInjection (subcutaneous; 5 mg)
Drug ClassGlucagon-like peptide 2 (GLP-2) analogs
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

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Summary
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  • This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
  • Teduglutide increased plasma citrulline levels in Short Bowel Syndrome (SBS) patients, with mean differences of 14.77 (95% confidence interval (CI), 10.20-19.33) at 0.1 mg/kg/day, 13.04 (95% CI, 9.79-16.2) at 0.05 mg/kg/day, and 7.84 (95% CI, 2.42-13.26) at 0.025 mg/kg/day.
  • Parenteral nutrition (PN) needs decreased with teduglutide in both pediatric and adult populations, with a pediatric enteral autonomy (EA) achievement rate of 36/223 over a median of 24 weeks (interquartile range (IQR): 24-48 weeks) and adult response rates (≥20% reduction in PN) at 6 months, 1 year, and ≥2 years of 64%, 77%, and 82%, respectively.
  • Comparative findings showed teduglutide to be more consistent in increasing citrulline levels and reducing PN needs relative to apraglutide and glepaglutide, although specific PN reduction data for these comparators were not detailed.
  • Safety outcomes showed no significant differences among teduglutide and apraglutide dose groups compared to control groups, with most adverse events (AEs) being mild to moderate in severity.
  • Gastrointestinal AEs, including abdominal pain, nausea, and abdominal distension, were commonly reported, particularly early in treatment. Catheter-related bloodstream infection was the most frequent AE associated with GLP-2 analogs, with teduglutide patients experiencing increased risks of abdominal distension and gastrointestinal stoma complications compared to placebo.
  • Both adult and pediatric populations with SBS experienced reductions in PN needs with teduglutide treatment, achieving enteral autonomy (EA) in 36 pediatric cases and PN independence in up to 21% of adults at ≥2 years; patients with Crohn's disease showed a non-significant trend toward higher response and weaning rates, while the presence of colon in continuity reduced response rate but increased weaning rate in adults.