Update

2018 AASLD guidance recommends OCALIVA as the only approved second-line treatment option for PBC3 SEE THE GUIDELINES

Assessing Response in Primary Biliary Cholangitis (PBC)

~40% of Patients Are at an Increased Risk of Disease Progression Due to an Inadequate Response to UDCA5,12,a

As Alkaline Phosphatase Increases, so Does
the Risk of Transplantation or Death3

Alkaline phosphatase level and risk of transplantation or death Alkaline phosphatase level and risk of transplantation or death
  • When alkaline phosphatase is >1x ULN, patients are twice as likely to reach transplant or death than patients whose alkaline phosphatase is <1x ULN3,a
  • Patients with bilirubin >1x ULN are 5 times more likely to reach transplant or death than patients with bilirubin <1x ULN3,a
  • Based on an analysis of nearly 5,000 patients with PBC, 85% of whom were treated with UDCA3

This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Elevated alkaline phosphatase is a primary marker of inadequate response in PBC1,3

  • The Global PBC Study Group supports that approximately 40% of patients are at increased risk of disease progression due to an inadequate response to UDCA3

Risk factors for disease progression should be evaluated in all patients, even those with only slight elevations in alkaline phosphatase4-6

PBC progression is highly variable and may occur sooner than expected7,10

Other factors associated with PBC disease progression:

  • Elevated bilirubin6,7
  • Development of fibrosis6,8
  • Gender/age (males of any age and females <45 are at the
    greatest risk)9
  • Risk factors for disease progression should be evaluated in all patients,
    even those with only slight elevations in alkaline phosphatase4-6

PBC progression is highly variable and may occur sooner than expected7,10

UDCA, ursodeoxycholic acid; ULN, upper limit of normal.

References:

  1. Poupon R. Primary biliary cirrhosis: a 2010 update. J Hepatol. 2010;52(5):745-758.
  2. Dyson JK, Hirschfield GM, Adams DH, et al. Novel therapeutic targets in primary biliary cirrhosis. Nat Rev Gastroenterol Hepatol. 2015;12(3):147-158.
  3. Lammers WJ, van Buuren HR, Hirschfield GM, et al; on behalf of the Global PBC Study Group. Levels of alkaline phosphatase and bilirubin are surrogate end points of outcomes of patients with primary biliary cirrhosis: an international follow-up study. Gastroenterology. 2014;147(6):1338-1349.
  4. Brostoff JM, Rashid S, McCrea D. Primary biliary cirrhosis with a normal alkaline phosphatase: a case report. Cases J. 2008;1(1):33.
  5. Parés A, Rodés J. Natural history of primary biliary cirrhosis. Clin Liver Dis. 2003;7(4):779-794.
  6. European Association for the Study of the Liver. EASL clinical practice guidelines: the diagnosis and management of patients with primary biliary cholangitis. J Hepatol. 2017;67(1):145-172.
  7. Lammers WJ, Kowdley KV, van Buuren HR. Predicting outcome in primary biliary cirrhosis. Ann Hepatol. 2014;13(4):316-326.
  8. Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ. Primary biliary cirrhosis. Hepatology. 2009;50(1):291-308.
  9. Carbone M, Mells GF, Pells G, et al. Sex and age are determinants of the clinical phenotype of primary biliary cirrhosis and response to ursodeoxycholic acid. Gastroenterology. 2013;144(3):560-569.
  10. Sclair SN, Little E, Levy C. Current concepts in primary biliary cirrhosis and primary sclerosing cholangitis. Clin Transl Gastroenterol. 2015;6:e109. doi:10.1038/ctg.2015.33.
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