Unmet Needs for Pruritus Management in PBC

While the primary biliary cholangitis (PBC) treatment landscape has long been limited to just a handful of agents with limited efficacy, 2024 saw a major shift in PBC management with the addition of 2 new second-line therapies.

Seladelpar (Livdelzi), a proliferator-activated receptor (PPAR) delta agonist, was one of these recent additions to the PBC treatment armamentarium and was a major topic of discussion at The Liver Meeting 2024 from the American Association for the Study of Liver Diseases (AASLD) in San Diego, California.

Along with a late-breaking presentation highlighting seladelpar’s sustained efficacy and long-term safety in a 2.5-year interim analysis of the ongoing open-label phase 3 ASSURE study, another abstract presentation focused on the agent’s impact on pruritus in the RESPONSE trial.

In this segment, which is part 2 of a 4-part series, Andreas Kremer, MD, PhD, MHBA, head of hepatology at University Hospital Zurich, explains current unmet needs for pruritus care in PBC management.

Kremer calls attention to a critical gap in managing pruritus in patients with PBC, highlighting the unmet need for therapies that address both the underlying disease and symptom burden. He notes that current in-label treatments, such as ursodeoxycholic acid and obeticholic acid, have not demonstrated efficacy in alleviating pruritus, and in some cases, these therapies may even exacerbate the symptom despite their proven ability to reduce cholestasis.

Kremer stresses the importance of developing new, in-label drugs that are not only effective but also safe and well-tolerated for long-term use. He expresses optimism about ongoing advancements, noting promising developments in the pharmaceutical pipeline targeting rare liver diseases that offer hope for more comprehensive treatment strategies that address both the clinical and symptom-related aspects of PBC.

Editors’ note: Kremer has relevant disclosures with AbbVie, AstraZeneca, Bayer, CymaBay, Gilead, GlaxoSmithKline, Intercept, Mirum, Takeda, Ipsen, and others.

References

1. ^{Brooks A. FDA Grants Accelerated Approval to Seladelpar (Livdelzi) for Primary Biliary Cholangitis. HCPLive. August 14, 2024. Accessed December 6, 2024. https://www.hcplive.com/view/fda-grants-accelerated-approval-to-seladelpar-livdelzi-for-primary-biliary-cholangitis}
2. ^{Brooks A. Seladelpar (Livdelzi) Demonstrates Long-Term Benefit for Primary Biliary Cholangitis. HCPLive. November 15, 2024. Accessed December 6, 2024. https://www.hcplive.com/view/seladelpar-livdelzi-demonstrates-long-term-benefit-primary-biliary-cholangitis}