Markers of Response in Primary Biliary Cholangitis (PBC)

Alkaline Phosphatase and Bilirubin Are Important Markers in PBC1,2

chart

Alkaline phosphatase: An early and ongoing indicator of progression in PBC1

  • Elevations in alkaline phosphatase are associated with cholestasis, ongoing bile duct destruction, and disease progression1,3,4
  • Lowering alkaline phosphatase is associated with longer transplant-free survival2
  • Intervention in the early disease stages has been shown to lower alkaline phosphatase levels1,5
liver

Bilirubin: Even slight elevations can be concerning2,5

  • Bilirubin is an important predictor of survival in PBC1,2,5
    • Bilirubin elevations usually occur late in the disease, when treatment options are limited1,5
  • While bilirubin doesn’t normally become elevated during the early stages of PBC, even mild elevations put patients at risk for developing extensive fibrosis or cirrhosis1,5

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.

References:

  1. Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ. Primary biliary cirrhosis. Hepatology. 2009;50(1):291-308.
  2. 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.
  3. Poupon R. Liver alkaline phosphatase: a missing link between choleresis and biliary inflammation. Hepatology. 2015;61(6):2080-2090.
  4. Bonheur JL. Biliary obstruction workup: laboratory studies, imaging studies, procedures. http://emedicine.medscape.com/article/187001-workup. Updated November 27, 2016. Accessed May 9, 2017.
  5. Poupon R. Primary biliary cirrhosis: a 2010 update. J Hepatol. 2010;52(5):745-758.
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