The investigational ileal bile acid transporter (IBAT) inhibitor volixibat delivered better itch relief than placebo in patients with primary sclerosing cholangitis (PSC), data from a phase II randomized clinical trial showed.
Among 111 patients with PSC and moderate to severe cholestatic pruritus, those randomized to volixibat had a mean 2.72-point reduction in their Adult Itch Reported Outcome (ItchRO) scores after 28 weeks, compared with a mean 1.08-point drop for those on placebo (P<0.0001).
More than half of volixibat patients (56%) saw at least a 2-point reduction in their itch scores -- defined as a meaningful improvement for patients -- compared with 26% of placebo patients (P=0.0019), while more than one-third of the volixibat group (37%) saw their scores drop by at least 3 points, a level achieved by only 11% of the placebo group (P=0.0011), reported Cynthia Levy, MD, of the University of Miami, at the European Association for the Study of the Liver annual meeting in Barcelona.
"Volixibat led to a rapid, sustained, and both clinically and statistically significant improvement in cholestatic pruritus," Levy said during her presentation. "There were also improvements in quality of life, especially in sleep disturbance, which deserve further evaluation."
