Highlights in Primary Biliary Cholangitis From the EASL 2020 Digital International Liver Congress, the ACG 2020 Virtual Annual Scientific Meeting, and the AASLD 2020 Liver Meeting Digital Experience: Commentary.

SUMMARY Efficacy and Tolerance of Obeticholic Acid in Patients With Primary Biliary Cholangitis and Inadequate Response to Ursodeoxycholic Acid in Real Life: Interim Analysis of the OCARELIFE Study The France-based OCARELIFE study is evaluating the efficacy and tolerability of OCA in the real-life setting. An interim analysis (EASL FRI180) assessed outcomes among the 50 patients treated for 12 months. Most patients were female, and the mean age was 56 years. The primary endpoint was ALP response according to the Paris 2 criteria (Corpechot et al. J Hepatol. 2011;55[6]:13611367). At baseline, 17.1% (95% CI, 8.6%-25.6%) of patients met this criteria; at month 12, the rate was 40% (95% CI, 26.4%-53.6%). Liver tests showed significant improvement after 1 year of treatment. At an 18-month follow-up, total bilirubin had also improved. Pruritus was the most common adverse event and had decreased at month 12 compared to baseline.

[1]  F. Nevens,et al.  Long-term efficacy and safety of obeticholic acid in patients with PBC from the POISE trial grouped biochemically by risk of disease progression , 2021 .

[2]  Primary Biliary Cholangitis: Patient Characteristics and the Health Care Economic Burden in the United States. , 2021, Gastroenterology & hepatology.

[3]  Long-Term Efficacy and Safety of Obeticholic Acid in Primary Biliary Cholangitis: Responder Analysis of More Than 5 Years of Treatment in the POISE Trial. , 2021, Gastroenterology & hepatology.

[4]  G. Hirschfield ENHANCE: Safety and Efficacy of Seladelpar in Patients With Primary Biliary Cholangitis-A Phase 3, International, Randomized, Placebo-Controlled Study. , 2021, Gastroenterology & hepatology.

[5]  GLIMMER Trial-A Randomized, Double-Blind, Placebo-Controlled Study of Linerixibat, an Inhibitor of the Ileal Bile Acid Transporter, in the Treatment of Cholestatic Pruritus in Primary Biliary Cholangitis. , 2021, Gastroenterology & hepatology.

[6]  Results of a Phase 2, Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Saroglitazar Magnesium in Patients With Primary Biliary Cholangitis (EPICS). , 2021, Gastroenterology & hepatology.

[7]  F. Carrat,et al.  Bezafibrate Add-On Therapy Improves Liver Transplantation-Free Survival in Patients With Primary Biliary Cholangitis: A Japanese Nationwide Cohort Study. , 2021, Gastroenterology & hepatology.

[8]  F. Nevens,et al.  Long-Term Efficacy and Safety of Obeticholic Acid in Patients With Primary Biliary Cholangitis: A Demographic Subgroup Analysis of 5-Year Results From the POISE Trial. , 2020, Gastroenterology & hepatology.

[9]  M. Trauner,et al.  687 DURABILITY OF BIOCHEMICAL IMPROVEMENTS THROUGH 6 YEARS OF OPEN-LABEL TREATMENT WITH OBETICHOLIC ACID IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS WHO DID NOT ACHIEVE THE POISE CRITERIA , 2020 .

[10]  G. Alexander,et al.  Pruritus Is Common and Undertreated in Patients With Primary Biliary Cholangitis in the United Kingdom. , 2019, Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association.

[11]  D. Magrez,et al.  LBO-02-Elafibranor, a peroxisome proliferator-activted receptor alpha and delta agonist demonstrates favourable efficacy and safety in patients with primary biliary cholangitis and inadequate response to ursodeoxycholic acid treatment , 2019, Journal of Hepatology.

[12]  Stuart Kendrick,et al.  Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluations Following Single Oral Doses of GSK2330672 in Healthy Japanese Volunteers , 2018, Clinical pharmacology in drug development.

[13]  W. Kim,et al.  Diagnosis and Management of Primary Biliary Cholangitis , 2019, The American Journal of Gastroenterology.

[14]  C. Levy,et al.  Cholestatic liver diseases: new targets, new therapies , 2018, Therapeutic advances in gastroenterology.

[15]  V. de Lédinghen,et al.  A Placebo‐Controlled Trial of Bezafibrate in Primary Biliary Cholangitis , 2018, The New England journal of medicine.

[16]  C. Bowlus,et al.  Update on New Drugs and Those in Development for the Treatment of Primary Biliary Cholangitis. , 2018, Gastroenterology & hepatology.

[17]  K. Lindor,et al.  Increasing Prevalence of Primary Biliary Cholangitis and Reduced Mortality With Treatment , 2017, Clinical Gastroenterology and Hepatology.

[18]  A. Parés Primary biliary cholangitis. , 2018, Medicina clinica.

[19]  David E. J. Jones,et al.  Effect of ileal bile acid transporter inhibitor GSK2330672 on pruritus in primary biliary cholangitis: a double-blind, randomised, placebo-controlled, crossover, phase 2a study , 2017, The Lancet.

[20]  J. Reguła,et al.  A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis. , 2016, The New England journal of medicine.

[21]  I. Mackay,et al.  Evolving Trends in Female to Male Incidence and Male Mortality of Primary Biliary Cholangitis , 2016, Scientific Reports.

[22]  Hwa Young Choi,et al.  Population‐based epidemiology of primary biliary cirrhosis in South Korea , 2016, Alimentary pharmacology & therapeutics.

[23]  T. Miyazaki,et al.  AUTOIMMUNE , CHOLESTATIC , AND BILIARY DISEASE Anticholestatic Effects of Bezafibrate in Patients with Primary Biliary Cirrhosis Treated with Ursodeoxycholic Acid , 2013 .

[24]  Y. Chrétien,et al.  Ten‐year survival in ursodeoxycholic acid–treated patients with primary biliary cirrhosis , 1999, Hepatology.

[25]  B. Balkau,et al.  A multicenter, controlled trial of ursodiol for the treatment of primary biliary cirrhosis. UDCA-PBC Study Group. , 1991, The New England journal of medicine.