Long-Term Safety of Teduglutide Treatment for Patients With Intestinal Failure Associated With Short Bowel Syndrome

Abstract

Introduction: Teduglutide (TED) is approved for the treatment of adult patients with short bowel syndrome (SBS-IF) who are dependent on parenteral support (PS). The efficacy of TED was demonstrated by phase III randomized placebo-controlled studies that showed that TED significantly reduced PS volume requirements and the number of PS infusion days per week in patients with SBS-IF. Methods: Combined safety data were pooled from 4 TED clinical studies conducted in adult patients with SBS-IF: two 24-week, double-blind, placebo-controlled studies with 2 respective extensions of 28 weeks' and 2 years' duration. Results: Of 173 patients who received subcutaneous TED (0.05 mg/kg/d, 134; 0.10 mg/kg/d, 39), 140 (81%) were treated with TED for ≥6 months and 111 (64%) for ≥12 months; mean TED exposure duration was 67 weeks. At least 1 treatment-emergent adverse event (TEAE) was experienced by 97% of patients; the majority were mild (53%) or moderate (38%) in severity. TEAEs reported by ≥10% of patients are shown in Table 1. The incidence rates of the most commonly reported GI AEs and fluid overload decreased over time during the treatment period (Table 2). TEAEs that led to premature discontinuation occurred in 20% of patients (n=34), abdominal pain being the most common (5%; n=8). Serious TEAEs occurred in 58% of patients (n=101); catheter sepsis was the only event reported in ≥5% of patients (25%; n=43). As previously reported, 3 cases of malignant neoplasms were reported (metastatic adenocarcinoma, non-small-cell lung cancer, and squamous cell carcinoma); only metastatic adenocarcinoma was considered treatment related (patient had history of Hodgkin disease treated with chemotherapy and radiation). Conclusion: Findings from this pooled analysis demonstrate the safety of long-term TED treatment. TED was generally well tolerated with no new identified safety signals. The most commonly reported AEs tended to occur early in the treatment period and were consistent with the underlying condition and known mechanism of action of TED. This research was funded by NPS Pharmaceuticals, Inc., Bedminster, NJ.Figure 1