Assessing Response in Primary Biliary Cholangitis (PBC)

Inadequate Response to UDCA Indicates Ongoing Disease Activity and Progression1-3

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

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

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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