Seladelpar’s Impact on Pruritus

Author(s):

Key Takeaways

Seladelpar, a PPAR delta agonist, is a new addition to PBC treatment, showing sustained efficacy and safety in recent studies.
The ASSURE and RESPONSE trials highlight seladelpar's significant impact on reducing pruritus severity in PBC patients.
Seladelpar prevented new-onset pruritus in patients without baseline symptoms, unlike placebo, indicating its antipruritic efficacy.
These findings suggest seladelpar's potential to improve PBC management and patient quality of life.

Andreas Kremer, MD, PhD, MHBA, explains seladelpar’s impact on pruritus in PBC based on findings from a posthoc analysis of the RESPONSE trial.

EP: 1.Understanding Pruritus in Primary Biliary Cholangitis

EP: 2.Unmet Needs for Pruritus Management in PBC

EP: 3.Emerging Second-Line Therapies in PBC

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EP: 4.Seladelpar’s Impact on Pruritus

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 the final installment of a 4-part series, Andreas Kremer, MD, PhD, MHBA, head of hepatology at University Hospital Zurich, explains seladelpar’s impact on pruritus symptoms in patients with PBC.

Kremer delves into the promising outcomes of recent studies on seladelpar and its potential to alleviate pruritus in PBC, specifically focusing on a posthoc analysis revealing that patients with moderate to severe pruritus who were treated with seladelpar achieved a significant reduction on the numeric rating scale (NRS) for symptom severity.

In addition to improvements in pruritus among patients who reported itch at baseline, Kremer pointed out patients who reported no pruritus at baseline who were treated with seladelpar did not report any new-onset pruritus, whereas 25% of those on placebo developed pruritus during the same period. In totality, the findings underscore the potential antipruritic efficacy of seladelpar alongside its primary anti-cholestatic and anti-inflammatory properties.

Kremer points to an exciting future for PBC management, with new therapies on the horizon poised to improve both disease outcomes and quality of life for patients.

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

References

^{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}
^{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}