Linerixibat Medication Review

Christina Hanson, FNP, and Dr. Marcelo Kugelmas of South Denver Gastroenterology review linerixibat, an ileal bile acid transporter (IBAT) inhibitor, and its role in managing cholestatic pruritus in primary biliary cholangitis (PBC). This medication review podcast explores how blocking bile acid reabsorption in the ileum targets a pathway involved in persistent itching. The discussion covers the phase 2 GLIMMER study and phase 3 GLISTEN trial, including findings on itch reduction, sleep interference, and treatment response in patients with moderate to severe pruritus. The speakers also examine safety and tolerability considerations, including diarrhea, abdominal pain, nausea, elevated liver enzymes, and treatment discontinuation. Additional topics include preliminary results from the linerixibat long-term safety and tolerability study (LLSAT), maintenance of itch relief, and the need for further research on combining linerixibat with PPAR agonists. Designed for nurse practitioners, physician assistants, and other gastroenterology and hepatology professionals, this episode offers a clinical perspective on IBAT inhibitor therapy, persistent PBC-related itching, and the balance between symptom improvement and treatment tolerability.

Clarifications and context within the video 👇

• Linerixibat, an IBAT inhibitor, is the first FDA approved treatment for cholestatic pruritus in adults with PBC.
• WI-NRS is used to assess itch severity on a scale of 0-10.
• At 6:43, correction regarding the diagnosis of cirrhosis: It was 10% in the placebo group and 11% in the linerixibat group.
• At 10:24, the primary endpoints of the LLSAT study are frequency and severity of adverse events.
• At 11:20, the LLSAT mean WI-NRS reduction of 4.87 is for patients assigned to linerixibat in GLISTEN Part A and Part B after 52 weeks of continuous treatment.