Patients with primary biliary cholangitis (PBC) who receive linerixibat experience significantly less pruritis (itching) than those taking a placebo, according to recent findings of the GLISTEN trial published in The Lancet Gastroenterology and Hepatology.
Over 24 weeks of treatment, patients treated with linerixibat reported not only reduced itching but also fewer itching-related sleep difficulties.
What is pruritus?
Pruritus, or chronic itching, is a common and often debilitating symptom of primary biliary cholangitis (PBC). Pruritus can vary in intensity, affecting the quality of life by disrupting sleep and causing emotional distress. It is often one of the earliest symptoms of PBC and can appear before other signs of liver dysfunction.
The GLISTEN trial randomized 238 patients with PBC to receive linerixibat or a placebo for 24 weeks. For the remaining eight weeks, participants either stayed on their current treatment or switched to the opposite treatment.
All participants in the study had moderate-to-severe pruritis as measured using the Worst Itch Numerical Rating Scale (WI-NRS). Patients recorded their itching severity two times per day in an electronic diary, which was then used to assess changes over the study period. WI-NRS scores ranged from 0 to 10, with 10 indicating the worst itching a participant can imagine.
Read more about PBC signs and symptoms
By Week 24 of the study, patients receiving linerixibat had an estimated decrease in pruritis of 2.86 points, compared to 2.15 points among those taking the placebo.
Changes in pruritis score were also correlated with changes in sleep quality. In fact, participants taking linerixibat experienced significantly less sleep interference than those taking a placebo.
Participants who switched from a placebo to linerixibat in the second part of the study experienced improved pruritis, and those who switched from linerixibat to a placebo had worsened pruritis. Individuals who remained on their original treatment regimen reported no changes in itching.
“The findings support the potential of linerixibat as a treatment for pruritus in PBC, offering an alternative option to current therapies for patients globally, irrespective of ethnicity, race, or biochemical disease activity,” the authors concluded. “The results of this study could help change the care for patients living with PBC and pruritus.”
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