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ELATIVE trial shows pruritus benefits with elafibranor in PBC

By Lucy Piper, medwireNews reporter

medwireNews: Elafibranor reduces the severity of pruritus symptoms in patients with primary biliary cholangitis (PBC), lessening its impact on their quality of life (QoL), suggest the latest findings from the phase 3 ELATIVE trial.

The effect of elafibranor on pruritus after 52 weeks of treatment was measured using two patient-reported questionnaires – the 5-D Itch and PBC-40. The 5-D itch ranges from a score of 5 points (no pruritus) to 25 points (most severe pruritus) and the PBC-40 includes an itch domain consisting of 3 items to give a score from 0 points (no pruritus) to 15 points (most severe pruritus).

As previously reported, elafibranor treatment did not significantly impact the secondary endpoint of moderate-to-severe pruritus according to the PBC Worst Itch Numeric Rating Scale (PBC-WI-NRS) at week 52.

But presenting the most recent findings in a late-breaking poster at the EASL Congress 2024 in Milan, Italy, the researchers note that in addition to measuring pruritus severity, 5-D Itch and PBC-40 “assess the impact on patients’ QoL.”

Specifically, the least squares mean difference in the reduction in 5-D itch score from baseline was a significant 1.3 points lower for the 108 patients randomly assigned to receive the dual PPAR delta and alpha agonist for 52 weeks compared with the 53 patients assigned to receive placebo. Similarly, the corresponding least squares mean difference for the PBC-40 was a significant 1.2 points lower with elafibranor versus placebo.

Andreas Kremer (University of Zurich, Switzerland) and colleagues note that the impact of treatment on itch symptoms was greater among the 66 (41%) patients who had moderate-to-severe pruritus at baseline, defined as a score of at least 4 points on the PBC-WI-NRS. Of these patients, 44 were in the elafibranor group and 22 were in the placebo group.

For these patients, the least squares mean difference in the reductions in 5-D itch and PBC-40 scores from baseline were a respective 3.0 points and 2.3 points lower with elafibranor than placebo, a significant difference in both cases.

The patients with moderate-to-severe pruritus at baseline were balanced between those receiving elafibranor and those receiving placebo, with the average age 53–55 years, 91–96% women, and a mean PBC-WI-NRS score of 6.2–6.3 points.

Looking at changes in each of the 5-D itch and PBC-40 domains for patients with moderate-to-severe pruritus, Kremer et al found that for the 5-D itch questionnaire, most of the elafibranor-treated patients improved with regard to severity of itch (66.7 vs 38.9% with placebo), direction of improvement (64.3 vs 3.3%), and disability (66.7 vs 44.4%).

They point out that for the sleep element of this last domain, specifically, the mean reduction in score from baseline to week 52 was 1.2 points with elafibranor versus 0.2 points with placebo. For the duration and distribution domains on the 5-D itch, the majority of elafibranor patients were spread almost equally between either improvement or no change.

For the PBC-40 domains, the majority of elafibranor-treated patients improved on the domain “I scratched so much I made my skin raw,” at 61.9% versus 22.2% of placebo-treated patients, and for “Itching disturbed my sleep” and “I felt embarrassed because of the itching,” improvement was seen with elafibranor in 50.0% and 35.7% of patients versus 33.3% and 27.8% of those treated with placebo, respectively. The majority of patients in the elafibranor group who did not improve in these domains saw no change.

The investigators conclude: “In patients with PBC in ELATIVE, treatment with elafibranor resulted in improvements in 5-D Itch and clinically meaningful improvements in PBC-40 Itch, emphasising the potential of elafibranor to reduce both the severity and impact on QoL, and address an important unmet need.”

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2024 Springer Healthcare Ltd, part of the Springer Nature Group

EASL Congress; Milan, Italy: June 5–8, 2024

https://easl.eu/event/easl-congress-2024/

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