The effects of elafibranor in people with primary biliary cholangitis: a plain language summary

Plain Language SummaryWhat is this summary about?This is a plain language summary describing the phase 3 clinical trial called ‘ELATIVE®’. Primary biliary cholangitis (PBC) is a rare disease of the liver that can get worse over time and can be potentially life threatening. Living with PBC can also reduce a person’s quality of life. There are currently not many treatment options available for PBC. The ELATIVE® clinical trial tested how well a potential new treatment called ‘elafibranor’ works in treating people with PBC.What was done?The ELATIVE® clinical trial aimed to find out how well elafibranor works in treating PBC for people who did not get better with the current first-line treatment, called ‘ursodeoxycholic acid’ (UDCA). The trial also looked at what the side effects of elafibranor might be. 161 people with PBC took part in ELATIVE® worldwide. People were randomly split into 2 groups: 1 group took an elafibranor tablet and the other group took a tablet with no medicine, called ‘placebo’. Both tablets were taken once a day for at least a year. Most people were taking UDCA before the clinical trial started, and they continued to take this medication with elafibranor or placebo during the clinical trial.What were the results?Researchers looked at 2 substances produced by the liver and found in the blood, called alkaline phosphatase and bilirubin. People with higher amounts of these substances in their blood have worse liver health. After a year of treatment, more people taking elafibranor had lower levels of these substances in their blood than people taking placebo. This suggests that their liver condition had improved.People with PBC often experience symptoms of itchy skin (often called ‘pruritus’) and tiredness, and current treatments do not always improve these symptoms. The effect of elafibranor on itch was looked at in people who had uncontrollable itch at the start of the clinical trial. Elafibranor treatment did not worsen pruritus. However, the ‘Worst Itch Numeric Rating Scale (NRS)’ was not able to demonstrate that itch improved more in people who were taking elafibranor compared with people taking the placebo. Yet, elafibranor seemed to reduce symptoms of itch when looking at the results of 2 other questionnaires, called the ‘PBC-40’ (itch section) and ‘5-dimensional (5-D) Itch’ questionnaires.A similar percentage of people taking elafibranor and taking placebo had side effects. The most common side effects of elafibranor were linked to the digestive system and included stomach pain, diarrhea, nausea, and vomiting. These side effects were experienced by about 1 in every 10 people taking elafibranor and were mostly easy to control.What do the results mean?The results from this clinical trial indicate that elafibranor may be a promising treatment option for people with PBC who do not get better with the current first-line treatment. A continuation of this clinical trial, and another clinical trial called ‘ELFIDENCE’, are testing the effects of elafibranor over a longer time period.How to say (download PDF and double click sound icon to play sound)…Primary biliary cholangitis: prai-muh-ree bi-lee-ur-ee ko-lan-jai-tusElafibranor: ell-uh-fib-rah-norUrsodeoxycholic acid: ur-soh-dee-ox-ee-koh-lik ah-sidPruritus: proo-rye-tusDiarrhea: dye-uh-ree-uhNausea: naw-zee-uhCreatinine: kree-ah-tuh-neenCreatine phosphokinase: kree-uh-teen fos-foh-ky-nayzObeticholic acid: oh-beh-tih-koh-lik ah-sidPhase 3 clinical trial: A study that tests the benefits and risks of a potential new treatment in people with a specific disease. It follows similar studies where the treatment has been tested in smaller groups of people.Quality of life: In medical terms, a measure of how a person feels about their own physical and mental health. This takes into account how a person’s daily life and wellbeing is affected by their disease, and is a useful tool for researchers who are developing potential new treatments.First-line treatment: The first therapy that is recommended for a specific disease.Side effect: Any unexplained or unintended effect of a medical treatment.Placebo: A treatment that looks very similar to the treatment being tested, except it has no active ingredients. This means that the placebo should not bring about any effect on a person’s disease or symptoms.Alkaline phosphatase: A substance that can be measured in the blood. People with PBC have higher amounts of alkaline phosphatase in their blood.Bilirubin: A substance found in the blood when red blood cells are broken down. People with liver disease have higher amounts of bilirubin in their blood.This is an abstract of the Plain Language Summary of Publication article.View the full Plain Language Summary PDF of this article to read the full-textLink to original article here

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