62: Long-term safety analysis of teduglutide treatment in adult patients with short bowel syndrome and intestinal failure (SBS-IF): analysis from a prospective, multinational SBS-IF registry

Introduction: Randomized clinical trials have found teduglutide (TED) to improve intestinal absorption in patients with short bowel syndrome and intestinal failure (SBS-IF). The ongoing, prospective, multinational, observational, SBS-IF registry (NCT01990040) records real-world data on the long-term safety of TED in adults with SBS-IF. Methods: Safety data were compared between ‘ever-treated’ patients who received standard of care treatment (SOC) and TED, and ‘never-treated’ patients who received SOC and had never been exposed to TED. The never-treated patients had received parenteral nutrition and/or intravenous fluids for at least 6 months at study entry. Outcomes assessed include the occurrence and incidence rates (IRs) of colorectal cancer (CRC; primary safety outcome), new or worsening colorectal polyps, and adverse events (AEs). Cumulative data are reported for up to 5 years between enrollment and data cut-off (23/06/2014–30/06/2022). Baseline data were recorded at study enrollment. Results: At data cut-off, 1403 patients (669 ever-treated; 734 never-treated) were included in the analysis. Table 1 summarizes baseline data. The mean (standard deviation [SD]) cumulative TED exposure since baseline was 37.8 (29.0) months. No cases of CRC were reported in either group during the follow-up period. Colorectal polyps were reported more frequently in ever-treated patients than never-treated patients (IR, 30.4 vs 4.5/1000 patient-years [PY]). However, ever-treated patients underwent colonoscopies more frequently than never-treated patients (IR, 182.3 vs 64.6/1000 PY). Ever-treated patients had a lower rate of new or worsening diagnoses of any other type of malignancies than never-treated patients (IR, 16.7 vs 30.6/1000 PY). In addition, a lower proportion of ever-treated patients reported at least one AE or serious AE (SAE) than never-treated patients (Table 2). The most commonly reported AEs were abdominal pain, vascular device infection and device-related infection. Among ever-treated patients, 26.3% of AEs and 8.5% of SAEs were related to TED; 19.1% reported AEs led to treatment interruption or discontinuation. Overall, 59 SAEs associated with 49 (7.3%) deaths occurred in the ever-treated patients, while 112 SAEs associated with 98 (13.4%) deaths occurred in the never-treated patients; one fatal SAE (pancreatic carcinoma) was considered related to TED. Conclusions: During the 5-year follow-up period, no new CRC cases were reported in patients ever-treated or never-treated with TED. Ever-treated patients had more new or worsening polyps than never-treated patients but also had a greater proportion of colonoscopies. A lower proportion of ever-treated patients had fatal SAEs than never-treated patients.