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April 8, 2026Liver International2 citationsOpen Access

Baseline Alkaline Phosphatase Impacts Response Rates in Primary Biliary Cholangitis: Exploring Response to Elafibranor in ELATIVE

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CLCynthia LevyCBChristopher L. BowlusELEric Lawitz

Key Points

  • This research aims to investigate how baseline alkaline phosphatase levels influence treatment responses to elafibranor in primary biliary cholangitis.
  • Grouped patients by baseline alkaline phosphatase levels
  • Assessed biochemical response and ALP normalization
  • Examined ALP change from baseline
  • Evaluated transplant-free survival using GLOBE score
  • Biochemical response rates varied by baseline ALP, reaching up to 86.7% in lower levels with elafibranor
  • ALP normalization was significantly associated with elafibranor treatment
  • Mean ALP reductions were consistent across elafibranor subgroups
  • Risk of liver transplant and liver-related mortality was similarly reduced among elafibranor recipients, regardless of initial ALP levels
  • Placebo group showed no substantial biochemical benefits

Abstract

ABSTRACT Background among patients receiving placebo, reduced risk was only predicted in responders (−1.5%). Conclusions In ELATIVE, lower baseline ALP correlated with higher biochemical response and ALP normalization rates with elafibranor. However, among patients receiving elafibranor, relative reductions in risk scores and ALP were consistent regardless of biochemical response and pre‐treatment ALP, indicating treatment benefit. Similar biochemical benefits were not observed among patients receiving placebo. These results support evaluating continuous measures and prognostic scores alongside dichotomous criteria to comprehensively assess efficacy. Trial Registration : NCT04526665

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Cite This Study

Levy et al. (2026) studied this question.

synapsesocial.com/papers/69d5f09e74eaea4b11a79f9ahttps://doi.org/10.1111/liv.70630
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Population Pharmacokinetics and Pharmacokinetics‐Pharmacodynamics Analyses of Elafibranor to Support Dose Selection in Primary Biliary Cholangitis2026
  2. 2Long-term efficacy and safety of elafibranor in primary biliary cholangitis: Interim results from the open-label extension of the ELATIVE trial up to 3 years2025
  3. 3P31 Elafibranor impacts inflammatory, fibrotic and symptom-associated markers in patients with primary biliary cholangitis (PBC): proteomic results from the ELATIVE® trial2025
  4. 4Alkaline phosphatase changes with seladelpar across subgroups of primary biliary cholangitis patients in the response trial2025
  5. 5Effectiveness and tolerability of bezafibrate in primary biliary cholangitis – a nationwide real-world study2025