Oral odevixibat well tolerated, effective in patients with cholestatic liver disease
Oral odevixibat reduced serum bile acids pediatric and improved pruritus in patients with cholestatic liver disease and pruritus were evaluated, according to the results of a Phase 2 study.
In this phase 2, open-label, multicenter study, 20 patients, including 13 with progressive familial intrahepatic cholestasis (3 re-entries), 6 with Alagille syndrome, 3 with biliary atresia, and 2 with other intrahepatic cholestasis causes (1 re-entry), received 10‒200 μg/kg oral odevixibat daily for 4 weeks.
Mean baseline serum bile acid levels were high and were reduced in most patients.
Improvements in pruritus and sleep were reported by patients. A reduction in pruritus was correlated significantly with a reduction in serum bile acids. Significant correlations between autotaxin levels and pruritus were also noted.
Baumann U, Sturm E, Lacaille F, et al. Effects of odevixibat on pruritus and bile acids in children with cholestatic liver disease: Phase 2 study. Clin Res Hepatol Gastroenterol. 2021;45(5):101751. doi: 10.1016/j.clinre.2021.101751. Epub ahead of print. PMID: 34182185.