Chimaobi Anugwom, MD1, Ahmed Dirweesh, MD2, Dupinder Singh, MD1, Cynthia Levy, MD3, Shahnaz Sultan, MD, MHSc2
1University of Minnesota Medical School, Minneapolis, MN; 2University of Minnesota, Minneapolis, MN; 3University of Miami Miller School of Medicine, Miami, FL
Introduction: Obeticholic acid (OCA), a farnesoid-X receptor agonist, has been approved for the management of PBC since 2016. It has been shown to significantly decrease serum alkaline phosphatase (ALP) and total bilirubin levels in patients with primary biliary cholangitis (PBC), either alone or in combination with ursodiol. Data on the efficacy of OCA in PBC is limited. We conducted a systematic review and meta-analysis to evaluate the efficacy of OCA in patients with PBC
Methods: We searched PubMed, Cochrane and Embase databases for randomized control trials (RCTs) comparing OCA to placebo in the management of PBC through 2019. The Cochrane Risk of Bias tool was used to assess the quality of the RCTs. We estimated odds ratio (OR) with 95% confidence interval (CI) for each outcome using a random effects model. The quality of the evidence was assessed using the GRADE approach.
Results: A total of 3 randomized controlled trials including 440 patients were identified. The mean age of patients was 54 and follow up ranged from 3-12 months. The studies varied with respect to whether OCA was used as monotherapy or added to standard of care (ursodiol). Compared to placebo, OCA resulted in reduction of ALP to < 1.67X the ULN with an OR of 5.92 (CI 2.98 – 11.94, p< 0.00001); and 1.76X the ULN with an OR of 5.95 (CI 3.25 – 10.93; p< 0.00001). Across the three studies, patients on OCA experienced higher rates of pruritus as compared with placebo. The overall certainty of evidence was moderate. Data on clinical endpoints such as quality of life, progression to cirrhosis or liver transplantation, and mortality were lacking
Discussion: Obeticholic acid is superior to placebo in reducing ALP in patients with PBC. An important limitation in these studies is the lack of data on clinical endpoints however, ALP levels have been shown to correlate with risk of liver transplantation and death. More RCT data with longer follow up is needed to fully assess the net benefits and harms of OCA in patients with PBC.
Citation: Chimaobi Anugwom, MD; Ahmed Dirweesh, MD; Dupinder Singh, MD; Cynthia Levy, MD; Shahnaz Sultan, MD, MHSc. P2430 - USE OF OBETICHOLIC ACID IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS: A SYSTEMATIC REVIEW AND META-ANALYSIS. Program No. P2430. ACG 2019 Annual Scientific Meeting Abstracts. San Antonio, Texas: American College of Gastroenterology.