- For patients with primary biliary cholangitis (PBC), obeticholic acid (Ocaliva, Intercept Pharmaceuticals) leads to prompt and sustained improvement in cholestasis markers and hepatic enzymes.
- 2 additional studies of the drug are underway.
Why this matters
- Obeticholic acid may be helpful for patients who respond inadequately to ursodeoxycholic acid (Actigall, Allergan).
- About half of all patients had responded at both months 12 and 48.
- Obeticholic acid led to greater change to alkaline phosphatase vs baseline at all time points; for example:
- 12 months: −105.2 U/L; P<.0001.>
- 48 months: −95.6 U/L; P<.0001.>
- 3-year interim analysis of open-label extension of POISE trial (n=193).
- Trial randomly assigned adults with PBC to various obeticholic acid doses vs placebo.
- Outcome: changes vs baseline in laboratory measures.
- Funding: Intercept Pharmaceuticals.
- Outcomes were surrogates; clinical outcome rates were estimates.