Patients treated with obeticholic acid for primary biliary cholangitis were significantly more likely to achieve a GLOBE score of 0.3 or lower compared with placebo, according to a presentation at the World Congress of Gastroenterology at ACG 2017.
Marlyn J. Mayo
According to Marlyn J. Mayo, MD, a GLOBE score of 0.3 or lower is correlated with liver transplant-free survival like that of sex- and age-matched normal population, whereas a score above 0.3 is correlated with significantly diminished liver transplant-free survival.
To assess the efficacy of obeticholic acid for PBC treatment, Mayo and colleagues enrolled 216 patients into the POISE phase 3 study.
Seventy-three patients received placebo, 70 patients received 5 mg to 10 mg of obeticholic acid daily (titrated at 6 months based on response or tolerability), and 73 patients received 10 mg of obeticholic acid daily. The study included a similar number of patients with GLOBE scores higher or lower than 0.3 across treatment groups.
At 12 months, patients who received 5 mg to 10 mg of obeticholic acid daily were significantly more likely to shift to GLOBE score lower than 0.3 compared with the placebo group (27% vs. 6%; P < .05). Comparatively, those in the placebo group were significantly more likely to progress to a GLOBE score higher than 0.3 vs. those who received 10 mg of obeticholic acid (33% vs. 3%; P < .01), with a non-significant trend for the titrated group (33% vs 13%).
Mayo and colleagues concluded that their results indicate 12 months of treatment with obeticholic acid may effectively delay disease progression in patients with PBC who have had insufficient response with ursodeoxycholic acid. – by Talitha Bennett
Harms MH, et al. Abstract 60. Presented at: World Congress of Gastroenterology at American College of Gastroenterology Annual Scientific Meeting; Oct. 13-18, 2017; Orlando, FL.
Disclosure: Mayo reports she received grant or research support from Cymabay, Gilead, Intercept Pharmaceuticals, NGM and Shire.