Kris Kowdley, MD: Elafibranor Improves Long-Term Transplant-Free Survival in PBC

New research is reinforcing the beneficial effects of second-line treatment with elafibranor (Iqirvo) for primary biliary cholangitis (PBC), suggesting its positive impact on long-term transplant-free survival based on improvements in GLOBE and UK-PBC prognostic scores.

The analysis of the phase 3 ELATIVE trial was presented at The Liver Meeting 2024 from the American Association for the Study of Liver Diseases (AASLD) in San Diego, California, by Kris Kowdley, MD, director of Liver Institute Northwest. Results showed improvements in predicted transplant-free survival as early as week 4 of treatment with elafibranor and continued improvement through 52 weeks.

“What's exciting about these prognostic scores is that they're based on calculations that you can get from just routine laboratory tests and clinical features, and they predict transplant-free survival going out to 10 or 15 years,” Kowdley explained to HCPLive, describing reductions in alkaline phosphatase (ALP) observed in patients treated with elafibranor in the ELATIVE trial and the presumed impact on long-term survival based on ALP being a validated surrogate endpoint.

At baseline, the mean GLOBE and UK-PBC scores were −0.63 (Standard deviation [SD], 0.67) and −0.74 (SD, 0.90) in the elafibranor group compared with −0.73 (SD, 0.73) and −0.80 (SD, 0.86) in the placebo group, respectively. After 1 year of treatment, the mean change from baseline in GLOBE and UK-PBC scores were −0.36 (SD, 0.40) and −0.27 (SD, 0.53) in the elafibranor group compared with 0.13 (SD, 0.45) and 0.05 (SD, 0.63) in the placebo group, respectively.

“Just as we expect, there was a significant improvement in GLOBE scores and in the UK-PBC score suggesting significantly improved transplant-free survival for patients treated with elafibranor compared to placebo,” Kowdley said. “Obviously, it's indirect information about long-term prognosis, but it does show that the change in alkaline phosphatase is associated with a shift in the GLOBE and UK-PBC score that should be clinically meaningful in terms of us being able to counsel our patients as to how has this impacts their probability of long-term transplant-free survival.”

Editors’ note: Kowdley has relevant disclosures with Intercept Pharmaceuticals, Genfit, Ipsen, Gilead Sciences Mirum, GSK, and Zydus.

Reference

^{Brooks, A. Elafibranor Improves Predicted Transplant-Free Survival Based on GLOBE, UK-PBC Scores. HCPLive. November 16, 2024. Accessed November 17, 2024. https://www.hcplive.com/view/elafibranor-improves-predicted-transplant-free-survival-globe-uk-pbc-scores}