Using Digital Health Technology to Monitor Patients With Primary Biliary Cholangitis (PBC)

Characterizing Fatigue, Sleep and Activity in Patients Living With Primary Biliary Cholangitis (PBC) Using Digital Health Technology

The purpose of this study is to explore the use of digital health technology for measuring symptoms and daily health in people with primary biliary cholangitis (PBC). Biometric data captured with a wearable device will be compared to questionnaire responses (patient-reported outcomes, or PROs) and laboratory test results to test the hypothesis that changes in biometrics can be correlated to changes in disease activity.

Patients enrolled are intended to start a second-line therapy (2L) for control of their PBC - the choice of therapy will be at the discretion of the treating hepatologist. Once 2L therapy is initiated, the study will assess for correlations between changes in biochemistries (alkaline phosphatase, or ALP) with biometrics and PRO results.

• Inclusion Criteria:

  1. PBC diagnosis based on meeting 2 of 3 criteria:

     1. Cholestatic liver biochemistry at disease outset (defined as elevation in the serum ALP level or GGT).
     2. Associated autoantibody (AMA or PBC-associated antinuclear antibody by immune fluorescence or anti-PDC, anti-Gp210, or anti-Sp100) at a titer of greater than or equal to 1:40.
     3. Diagnostic or compatible liver biopsy.

  2. Ability to provide informed consent

  3. Ability to complete digital questionnaires

  4. Elevated alkaline phosphatase

• Abbreviations:

alkaline phosphatase [ALP] gamma-glutamyl-transferase [GGT] antimitochondrial antibody [AMA] Primary Biliary Cholangitis [PBC] Plasmacytoid dendritic cells [PDC] glycoprotein 210 [Gp210] Scleroderma 100 [Sp100]

Exclusion Criteria:

1. Uncontrolled chronic inflammatory condition that is likely to contribute to symptoms of poor fatigue and sleep and confound results.
2. Active malignancy requiring treatment