Lower dose of Ocaliva may reduce pruritus occurrence in PBC
BARCELONA — In this exclusive video interview at International Liver Congress, Marlyn J. Mayo, MD, hepatologist at UT Southwestern Medical Center, Texas, discusses results from an analysis of the POISE clinical trials, where a titration strategy for initiating low dose of obeticholic acid, or Ocaliva, was found as efficacious as starting with a higher dose but with lower rates of pruritus in patients with primary biliary cholangitis.
“This is a side effect that should be discussed with patients before starting them on the medication. ... These data show pruritus is very mild and rarely leads to the need for discontinuation of the drug and can be managed effectively with certain strategies,” Mayo told Healio.com/Hepatology.
In this analysis, the titration strategy — initiating Ocaliva (obeticholic acid, Intercept Pharmaceuticals) at 5 mg and titrating up to 10 mg based on clinical response at 6 months — helped reduce the incidence and severity of pruritus.
“In earlier phase 2 trials, the major side effect seen was pruritus and there was definitely a dose-response relationship where patients on a 50 mg dose experienced pruritus, but then in the 10 mg group there was less pruritus and almost the same therapeutic effect,” Mayo said.
Rates of pruritus were improved in the POISE trial, with patients in the 10 mg group with a 70% rate of pruritus and patients who received 5mg then titrated to 10mg had a 56% rate.
“That may sound high but [the 56% rate] is not that different from the placebo, which was 38%,” Mayo said. “This data is important because we anticipate obeticholic acid to be on the market soon.”
Only one patient discontinued obeticholic use in the titration group over 1 year of treatment, according to the poster. In addition, patient-reported pruritus severity improved over the course of the study, despite an early increase at 2 weeks.
The Gastrointestinal Drugs Advisory Committee recently recommended the FDA approve obeticholic acid for use as monotherapy or in combination with ursodeoxycholic acid for the treatment of adults with PBC.
Disclosure: Mayo reports grant support from Intercept Pharmaceuticals, Gilead Sciences, Lumena, NGM and Salix.