Achievements

Teduglutide has been shown to "potentially demonstrate early efficacy in patients with short bowel syndrome complicated by Crohn's disease"

A research group led by Shinichiro Niizaki, Professor Chair of the Department of Gastroenterology Hyogo Medical University (Location: Nishinomiya City, Hyogo Prefecture; President: Keiichiro Suzuki), has revealed that teduglutide "may show early efficacy in treating short bowel syndrome complicated by Crohn's disease."

Topic

Short-term clinical evaluation of teduglutide for patients with Crohn's disease on home parental support for postoperative short bowel syndrome with intestinal failure

Author of the paper

Sato, Toshiyuki; Uchino, Motoi; Takeuchi, Jiro; Tohei, Yūtarō; Shimizu, Kōma; Yokoyama, Kōko; Yagi, Sōichi; Kaku, Kōji; Takashima, Yūsuke; Ikenouchi, Mōko; Kojima, Kōtaro; Kawai, Kōtaro; Nagase, Kōji; Kamikozuru, Kōji; Yokoyama, Yōko; Takagawa, Tōya; Ikeuchi, Hōki; Watanabe, Kōji; and Nizaki, Sōichiro.

Research Summary

This study is the first to provide detailed information on the potential short-term effectiveness of teduglutide for short bowel syndrome associated with Crohn's disease.
Our research group confirmed the efficacy of teduglutide at 8 weeks, as shown in clinical trials, and also demonstrated efficacy at 4 weeks, suggesting that one of the factors contributing to this was the lack of colonic continuity.

Research Background

Patients with short bowel syndrome are unable to eat or drink enough, so they must receive nutrition through infusions at home for the rest of their lives. Infusions at home not only significantly reduce the patient's quality of life, but can also cause fatal complications such as catheter infections.

Teduglutide, a GLP-2 analog, improves diet and fluid intake by promoting the growth of intestinal villi, and has made it possible to reduce or eliminate the amount of infusion at home in clinical trials in Europe, the United States, and Japan. It was approved for insurance coverage in Japan in 2021, but because short bowel syndrome is a rare disease, the clinical trial data includes various diseases other than Crohn's disease as causative diseases, and there have been no reports of short-term outcomes in Crohn's disease alone. In addition, although it was theoretically known that early effectiveness could be expected in cases without colonic continuity, it was unclear at what point the effect would appear in Crohn's disease alone.

Research Methods and Results

A retrospective cohort study was conducted on patients with Crohn's short bowel syndrome who were administered teduglutide from 2020 to 2021. The primary outcome was reduction in infusion dose at 8 weeks, and the secondary outcome was reduction in infusion dose depending on whether or not there was colonic continuity.

As a result, a significant reduction in the amount of infusion was achieved 8 weeks after administration of teduglutide. Furthermore, in cases with colonic continuity, a significant reduction in the amount of infusion was confirmed not only at 8 weeks, but also at 4 weeks, making it possible to reduce the amount of infusion earlier than the data shown in clinical trials.

Future challenges

Teduglutide showed early efficacy in patients with Crohn's disease and short bowel syndrome. However, there is little data on long-term outcomes, and it is unclear why early efficacy was confirmed in Crohn's disease. Although this study is a rare disease, it was limited by the fact that it was a single-center study with a small sample size. Since teduglutide is a drug that has issues with cost-effectiveness, we would like to increase the sample size through multicenter collaborative studies in the future, clarify efficacy predictors and long-term prognosis, and identify optimal cases for drug introduction.

Publication

https://www.clinicalnutritionjournal.com/article/S0261-5614(23)00092-4/fulltext