CONFERENCE UPDATE: AASLD 2025

Sustained improvement in pruritus among patients with PBC treated with seladelpar: Results from the 30-month ASSURE Study

GASTROENTEROLOGY & HEPATOLOGY
18 Mar 2026

STUDY DESIGN

Primary biliary cholangitis (PBC) is a chronic, progressive, autoimmune cholestatic liver condition that mainly affects women over the age of 40.1 Many patients—up to 80%—experience cholestatic pruritus, a symptom that can severely diminish quality of life and, in extreme cases, prompt consideration of liver transplantation even when liver function is still preserved.1 Conventional treatments such as bile acid sequestrants, antihistamines, and off-label rifampin often provide incomplete or inconsistent symptom relief, highlighting the need for better therapeutic options.1 Seladelpar, a first-in-class selective PPARδ agonist, previously demonstrated notable improvements in pruritus and biochemical markers in the pivotal RESPONSE study.1

During the presentation, long-term pruritus outcomes from the phase 3 RESPONSE study of seladelpar in adults with PBC and interim results from its ongoing open-label ASSURE studywere shown.1 In the RESPONSE study, pruritus scores using the numeric rating scale (NRS) were gathered daily for the first six months, followed by weekly collections for one week each month over a span of twelve months.1 After transitioning to the ASSURE phase, NRS was recorded daily for another six months and during scheduled clinic appointments thereafter.1 Additional assessments included the PBC-40 and 5-D Itch questionnaires.1 As of January 312025, patients exhibiting moderate to severe pruritus (NRS ≥4) at baseline were evaluated based on their randomization to either seladelpar 10mg or placebo in the RESPONSE phase and were subsequently categorized as continuous or crossover seladelpar 10mg groups in ASSURE.1 Baseline characteristics were well-balanced between the seladelpar (n=49) and placebo (n=23) arms in patients with moderate to severe pruritus.1
Outcomes assessed included changes in pruritus measured by the NRS, the 5-D Itch scale, and the PBC-40 itch domain over 30 months of treatment.1 The percentage of patients achieving a clinically meaningful improvement of ≥3 points on the NRS was also evaluated, along with comparisons between single-visit NRS scores and weekly averages in the ASSURE phase.1

FINDINGS

Change in pruritus:
  • Change in pruritus was assessed by pruritus NRS, 5D Itch, and PBC-40 itch domain from baseline up to 30 months of treatment1
  • NRS: Seladelpar produced persistent reductions in mean NRS among patients with baseline NRS ≥4. Improvements seen in RESPONSE study through month 12 and sustained in ASSURE to month 301
  • 5D itch: Total scores improved, and the benefit persisted across long-term follow-up to 30 months with seladelpar1
  • PBC-40 itch: The itch score improved and remained sustained through month 30, indicating durable symptom and quality-of-life gains with seladelpar1

Clinically meaningful improvement in the NRS (≥3-point change):
  • ‑In patients with moderate to severe pruritus (baseline NRS ≥4), ≥50% achieved a ≥3 point NRS reduction at multiple timepoints, with rates ranging approximately 25%-63% in the continuous seladelpar group and 5%-72% in the crossover group over months 1-301

Comparability of single-visit NRS and weekly averaged NRS in ASSURE:
  • Single visit NRS closely matched weekly averaged NRS from baseline to month 6, demonstrating strong correlation (Spearman r=0.93; 95% CI: 0.90-0.95) and close agreement over time1

 


“Seladelpar led to sustained, clinically meaningful improvement in pruritus in ASSURE with up to 30 months of treatment”

Dr. Gideon Hirschfield
The Autoimmune and Rare Liver Disease Programme,
Toronto General Hospital, Toronto, Canada

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