Long-term efficacy and safety of elafibranor in primary biliary cholangitis: Interim results from the open-label extension of the ELATIVE trial up to 3 years
Bibliographic record
Abstract
Background: Elafibranor (ELA) significantly improved biomarkers of cholestasis at Week (W)52 in patients (pts) with primary biliary cholangitis (PBC) in the phase III ELATIVE trial (NCT04526665). Aim: To report up to 3-year interim results from the ongoing ELATIVE open-label extension (OLE). Method: Pts completing the ELATIVE double-blind period (DBP) were eligible to enter the OLE receiving ELA 80 mg daily. For pts who received placebo (PBO) in the DBP, baseline (BL) was set as the last non-missing value before the first OLE ELA dose; for pts who received ELA in the DBP, BL was the DBP start. Endpoints reported include biochemical response (alkaline phosphatase [ALP]<1.67xULN, with≥15% reduction from BL and total bilirubin [TB]≤ULN), ALP normalization, change in liver stiffness measurement (LSM) and enhanced liver fibrosis (ELF) score, and change in pruritus (PBC Worst Itch Numeric Rating Scale [WI-NRS], PBC-40 Itch, and 5-D Itch) in those with moderate-to-severe pruritus at BL (PBC WI-NRS≥4). Results presented descriptively;safety analyses evaluated events in the OLE. Result: At data cutoff (June 2024), 153 pts had received ELA; 108 received ELA and 45 received PBO in the DBP. 138 pts entered the OLE. Pts receiving continuous ELA had data up to W156. At BL for each group, pts crossing over from PBO had increased mean ALP and TB vs pts receiving continuous ELA (335.8U/L vs 321.3U/L; 0.64mg/dL vs 0.57mg/dL).In pts receiving continuous ELA, 34/61(56%) at W104 and 11/13(85%) at W156 had biochemical response; ALP normalization occurred in 8/61(13%) at W104 and 5/13(39%) at W156. In pts crossing over from PBO, 21/41(51%) had biochemical response and 9/41(22%) had ALP normalization at W52. LSM and ELF scores showed a trend for stability in pts receiving continuous ELA for≥104 weeks (median change from BL in LSM: W104:−0.2 kPa[n=48],W156:−0.5 kPa[n=11];ELF:W104:0.0[n=41],W156:−0.6[n=9]).Improvement in pruritus was sustained in pts with moderate-to-severe pruritus at BL receiving continuous ELA (mean change from BL in PBC WI-NRS:W104:−3.1[n=21], W156:−4.4[n=5]; PBC-40 Itch: W104:−3.0[n=22],W156:−4.6[n=5]; 5-D Itch:W104:−5.0[n=22], W156:−7.0[n=5]). No new safety signals were identified. Conclusion: In the ongoing ELATIVE OLE, ELA led to sustained improvements in biomarkers of cholestasis and pruritus and stabilization of fibrosis up to W156 and remained well tolerated. Pts crossing over from PBO had similar results at W52 to those who received ELA in the DBP. Publication History Article published online: 04 September 2025 © 2025. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.008 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.004 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.003 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".