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
  • An analysis of nearly 5,000 patients with PBC demonstrated that lowering alkaline phosphatase is associated with increased transplant-free survival3
  • 85% of patients in the study 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

  • It is widely reported in the literature that approximately 40% of patients who are currently being treated with UDCA may have an inadequate response to treatment3,a
  • PBC progression is highly variable—extensive fibrosis may occur after 2 years of inadequate treatment.6,7,9

  • Risk factors for disease progression should be evaluated in all patients, even those with only slight elevations in alkaline phosphatase4,5
    • Elevated bilirubin6
    • Development of fibrosis7
    • Gender/age: Men of any age and women <45 years of age are at the greatest risk8

PBC progression is highly variable—extensive fibrosis may occur after 2 years of inadequate treatment.6,7,9

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. Lammers WJ, Kowdley KV, van Buuren HR. Predicting outcome in primary biliary cirrhosis. Ann Hepatol. 2014;13(4):316-326.
  7. Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ. Primary biliary cirrhosis. Hepatology. 2009;50(1):291-308.
  8. 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.
  9. 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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