Safety

Revestive was well tolerated across multiple clinical trials in adults and children with short bowel syndrome-intestinal failure1

Adults1

Adverse reactions were retrieved from two placebo-controlled clinical studies.

109 patients with short bowel syndrome-intestinal failure were treated with doses of 0.05 mg/kg/day and 0.10 mg/kg/day (0.10 mg/kg/day is not a recommended dose) for up to 24 weeks.

Approximately 52% of the adults treated with Revestive experienced adverse reactions (vs. 36% of the adults given placebo).

The most common adverse events were:

  • Abdominal pain and distension (45%)
  • Respiratory tract infections (28%)
  • Nausea (26%)
  • Injection site reactions (26%)
  • Headache (16%)
  • Vomiting (14%)

Injection site reactions occurred in 26% of SBS-IF patients treated with Revestive compared with 5% of patients in the placebo arm:

  • The reactions included injection site haematoma, injection site erythema, injection site pain, injection site swelling, and injection site haemorrhage. The majority of reactions were moderate in severity, and no occurrences led to drug discontinuation

Consistent with the potentially immunogenic properties of medicinal products containing peptides, administration of Revestive may potentially trigger the development of antibodies. However, in Phase 3 studies antibody formation was not associated with clinically relevant safety findings, reduced efficacy, or changed pharmacokinetics of Revestive.

No new safety signals were identified in adult patients treated with Revestive 0.05 mg/kg/day for up to 30 months in the long-term STEPS-2 extension study2

Children2

In two completed clinical trials* in children aged 1–17 years-old with short bowel syndrome-intestinal failure treated with Revestive for up to 6 months:

  • No patient discontinued due to adverse events
  • Most treatment-emergent adverse events were mild to moderate in severity
  • The overall safety profile (type and frequency of events) was similar to that reported in adults

Long-term safety data are not yet available for the paediatric population.

Revestive was studied in a 12-week, open-label, clinical study in 42 paediatric patients aged 1 year through 14 years with SBS who were dependent on PN/IV. Three (3) doses of Revestive, 0.0125 mg/kg/day (n=8), 0.025 mg/kg/day (n=14), and 0.05 mg/kg/day (n=15), were investigated for 12 weeks.
Five (5) patients were enrolled in an SOC cohort. An additional 24-week, randomised, double-blind, multicentre study was conducted in 59 paediatric patients aged 1 year through 17 years who were dependent on PN/IV. Two (2) doses of Revestive were studied: 0.025 mg/kg/day (n=24) and 0.05 mg/ kg/day (n=26); nine (9) patients were enrolled in an SOC arm.


References

  1. Revestive (teduglutide) Summary of Product Characteristics. Shire Pharmaceuticals Ireland Limited, Dublin, Ireland. November 2017.
  2. Schwartz LK, O’Keefe SJD, Fujioka K, et al. Long-term safety and efficacy of teduglutide for the treatment of intestinal failure associated with short bowel syndrome. Clin Transl Gastroenterol. 2016;7:e142.
 
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