Rationale: Teduglutide is indicated for the treatment of patients with short bowel syndrome (SBS) who are dependent on parenteral support (PS). This study evaluated longer-term teduglutide effectiveness and safety in Canadian patients diagnosed with SBS dependent on PS using Real-World Evidence.
Methods: This was an observational, retrospective study, using data from the national Canadian Takeda patient support program, and included adults with SBS. Data were collected 6 months before teduglutide initiation and from initiation to Dec-01-2023, death, or loss of follow-up. Descriptive statistics characterized the population and treatment-emergent adverse events (TEAEs). Changes in parenteral nutrition/intravenous fluid supply (PN/IV) were assessed based on decreases in PN/IV volume from baseline. Statistical significance was set at p<0.05.
Results: 52 patients (60% women) were included in this study. Median age (range) was 54 (22–81) and 50% had Crohn’s disease as their etiology of SBS. At 6 months, median (range) absolute and percentage reduction from baseline in PN/IV volume was 3,900 mL/week (-6,960–26,784; p<0.001), and 28.1% (-82.9–100). At 24 months, median (range) absolute reduction from baseline was 6,650 mL/week (-4,400–26,850; p=0.003), and the proportion of patients who achieved ≥20% reduction in weekly PN/IV was 66.7%. Over the study, 27% achieved independence from PN/IV. TEAEs were reported in 51 (98%) patients (83% were serious TEAEs) during the study period, the 3 most common were weight changes, diarrhoea, and fatigue.
Conclusion: Patients showed significant decreases in PN/IV volumes after initiating teduglutide, with no unexpected safety findings. This study demonstrates real-world, longer-term effectiveness and safety of teduglutide in Canadian patients with SBS, complimenting previous clinical trials, and real-world studies.
Conflicts of interest: Funding of this study is from Takeda Canada Inc. JPA: honorarium from Takeda for speaker and advisory board; research support from Zealand pharmaceutical and OMS Inc. DCD: Dane Christina Daoud has received a sponsorship grant from Shire (Takeda) to pursue a fellowship in intestinal failure; MR: reports speaker fees and grant funding from Lupin, Takeda, Pfizer, Janssen, and Fresenius Kabi; LD and JHC were employees of Takeda Canada Inc. and owns stock/stock options in Takeda at the time of this study; MN and JW were employees at Pentavere Research Group Inc, Toronto, ON, Canada at the time of this study; JJ and LG has no relevant COIs to declare.
