Summary

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• Ocaliva (obeticholic acid) is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.
• This summary is based on the review of six systematic reviews/meta-analyses. ^[1-4]
• Primary Biliary Cholangitis (PBC): In PBC patients with an inadequate response to ursodeoxycholic acid (UDCA), obeticholic acid (OCA) combined with UDCA significantly improved liver enzymes and inflammatory markers, showing superior efficacy compared to UDCA monotherapy.
• Nonalcoholic Steatohepatitis (NASH): OCA at higher doses (25 mg) demonstrated significant efficacy in improving fibrosis in NASH patients but was associated with higher rates of adverse events and discontinuations compared to lower doses.
• Metabolic Dysfunction-Associated Steatohepatitis (MASH): OCA significantly improved primary and secondary outcomes in MASH patients, demonstrating superior efficacy compared to placebo.
• OCA treatment was associated with dose-dependent adverse events, including increased low-density lipoprotein cholesterol (LDL-C), decreased high-density lipoprotein cholesterol (HDL-C), and pruritus, particularly at higher doses in both PBC and NASH patients.
• In PBC, lower doses of OCA (5 mg) resulted in fewer adverse events compared to higher doses, whereas in NASH, higher doses (25 mg) led to more significant adverse events and higher discontinuation rates.
• PBC: Patients with an inadequate response to UDCA showed significant improvements with OCA, particularly when combined with UDCA; lower doses (5 mg) were effective and had fewer adverse events.
• NASH: Higher doses of OCA (25 mg) were more effective but led to higher rates of adverse events, suggesting careful dose management is necessary.
• MASH: Patients exhibited similar lipid profile changes and efficacy outcomes as PBC patients when treated with OCA.