P395 Short-term clinical efficacy and safety of teduglutide for Crohn’s disease patients with short bowel syndrome
Kaku, K.(1)*;Sato, T.(1);Takeuchi, J.(2);Uchino , M.(3);Fujihira, Y.(1); Shimizu, K.(1);Yokoyama, K.(1);Yagi , S.(1);Takashima, Y.(1);Ikenouchi, M.(1);Kojima, K.(1);Kawai, M.(1); Nagase , K.(1);Kamikozuru, K.(1);Yokoyama , Y.(1);Takagawa, T.(1); Ikeuchi, H.(3);Watanabe, K.(1);Shinzaki , S.(1);
(1)Hyogo Medical University, Division of Gastroenterology and Hepatology- Department of Internal Medicine, Hyogo, Japan;(2)Hyogo Medical University, Department of Clinical Epidemiology, Hyogo, Japan;(3)Hyogo Medical University, Division of Surgery- Department of Inflammatory Bowel Disease, Hyogo, Japan;
Background
The short-term effects of teduglutide (TED) for short bowel syndrome with chronic intestinal failure (SBS–IF) in patients with Crohn’s disease (CD) remain unknown and real-world data have not been scarce. This study aimed to investigate the short-term efficacy and safety of TED in CD patients on parenteral support (PS) for SBS–IF.
Methods
We retrospectively investigated the medical records of CD patients with SBS–IF who initiated TED between January 2020 and October 2022 in Hyogo Medical University hospital. The primary outcomes were the change in PS volume and proportion of patients with a reduction of PS volume by ≥20% at week 4. Secondary outcomes were the changes in body mass index (BMI), estimated glomerular filtration rate (eGFR), albumin, hematocrit (Ht), PS calorie requirements, withdrawal from PS, and adverse events during the observation period.
Results
Of 605 CD patients, 23 who underwent home PS for SBS–IF were included in this study. Twenty patients continued TED throughout the observation period. The median PS duration was 11.6 (range 1.0-20.0) years and the observation period after starting TED was 48.0 (7.0-60.0) weeks. TED significantly reduced the PS volume from 17989(570-49000) mL/week to 14257(0-42000) mL/week at week 4 (p = 0.0013), and the PS volume decreased by ≥20% in 8 patients (40.0%) at week 4 and in 16 patients (80.0%) during the observation period after TED administration. The BMI significantly increased from 17.9 (12.9–23.9) kg/m2 before TED administration and 18.9 (14.6–25.4) kg/m2 after TED administration (p = 0.014). Although there were no significant differences in albumin (p = 0.53), eGFR (p = 0.66), and Ht (p = 0.089), the PS calorie /week was significantly decreased from 6581 (244–14000) kcal to 3747(0– 8820) kcal after TED administration (p = 0.0001). Ten patients (50.0%) experienced gastrointestinal stoma complications, including stoma swelling and/or prolapse during the observation period. Abdominal pain occurred in 7 cases (35.0%), catheter-related infection in five patients (25.0%), oedema in 4 patients (20.0%), nausea in 2 patients (10.0%), abdominal distension in 3 patients (15.0%), and upper respiratory tract infection in 1 patient (5.0%). All the symptoms were transient and tolerable. Although 3 patients discontinued TED due to nausea and abdominal pain and were excluded from this analysis, these symptoms improved after the discontinuation.
Conclusion
TED reduced PS volume at week 4 in CD patients with SBS–IF, and the BMI and the PS calorie requirement were improved during the observational period without serious adverse events.