Trial reportLiver international : official journal of the International Association for the Study of the Liver2026
Baseline Alkaline Phosphatase Impacts Response Rates in Primary Biliary Cholangitis: Exploring Response to Elafibranor in ELATIVE.
Trial report in Liver international : official journal of the International Association for the Study of the Liver, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04526665 (A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic Acid), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic Acid
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Baseline Alkaline Phosphatase Impacts Response Rates in Primary Biliary Cholangitis: Exploring Response to Elafibranor in ELATIVE.Liver international : official journal of the International Association for the Study of the Liver · 2026Trial
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
BACKGROUND &
aimsBaseline alkaline phosphatase (ALP) levels can influence the likelihood of achieving dichotomous biochemical response criteria in primary biliary cholangitis (PBC). This concept was explored using Week 52 data from the phase III ELATIVE trial (NCT04526665), which assessed elafibranor, a peroxisome proliferator-activated receptor α/δ agonist approved as a second-line treatment for PBC.
methodsPatients were grouped by baseline ALP. Outcomes assessed: biochemical response, ALP normalization, ALP change from baseline (CfB), transplant-free survival (using GLOBE score).
resultsAt Week 52, biochemical response was achieved across all subgroups receiving elafibranor (≤ 2× upper limit of normal [ULN]: 86.7%, > 2-≤ 2.5× ULN: 80.0%, > 2.5-≤ 3× ULN: 52.0%, > 3-≤ 4× ULN: 22.2%, > 4× ULN: 18.8%), and one subgroup receiving placebo (≤ 2× ULN: 13.3%). ALP normalization occurred only with elafibranor (≤ 2× ULN: 53.3%, > 2-≤ 2.5× ULN: 12.0%, > 2.5-≤ 3× ULN: 12.0%, > 4× ULN: 12.5%). Mean ALP reductions were consistent across subgroups receiving elafibranor (overall CfB: -38.9%). Patients receiving elafibranor, regardless of biochemical response, had similar reductions in risk of liver transplant and/or liver-related mortality within 15 years (-4.0% to -4.5%); among patients receiving placebo, reduced risk was only predicted in responders (-1.5%).
conclusionsIn 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 registrationNCT04526665.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.