Drug updated on 11/1/2024
| Dosage Form | Injection (subcutaneous; 5 mg) |
| Drug Class | Glucagon-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.
Latest News
Summary
- 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% CI (confidence interval), 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 (IQR (Interquartile range): 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 Short Bowel Syndrome (SBS) experienced reductions in parenteral nutrition (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.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Gattex (teduglutide) Prescribing Information. | 2024 | Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and safety of glucagon-like peptide 2 in patients with short bowel syndrome: a systematic review and network meta-analysis | 2024 | Journal of Gastrointestinal Surgery |
| Use of Teduglutide in Children With Intestinal Failure: A Systematic Review | 2022 | Frontiers in Nutrition |
| Efficacy of Teduglutide for Parenteral Support Reduction in Patients with Short Bowel Syndrome: A Systematic Review and Meta-Analysis | 2022 | Nutrients |
| The Role of Dipeptidyl Peptidase 4 as a Therapeutic Target and Serum Biomarker in Inflammatory Bowel Disease: A Systematic Review | 2021 | Inflammatory Bowel Diseases |
| Teduglutide for the treatment of adults with intestinal failure associated with short bowel syndrome: pooled safety data from four clinical trials | 2020 | Therapeutic Advances in Gastroenterology |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Teduglutide for short bowel syndrome in adults, assessment and monitoring. | 2023 | NHS Greater Glasgow and Clyde |
| ESPEN practical guideline: Clinical nutrition in chronic intestinal failure | 2021 | Clinical Nutrition |
| Evidence-based recommendations of the Andalusian Group for Nutrition Reflection and Investigation (GARIN) for the management of adult patients with short bowel syndrome | 2021 | Nutricion Hospitalaria |