Table 1.

Criteria for Predicting Outcomes in Primary Biliary Cholangitis Patients: Biochemical Response to UDCA and Risk Stratification

Biochemical Response to Treatment
Qualitative Definition	Number of Patients	Time to Assessment	Responder Criteria
Rochester-I32	180	6 months	ALP ≤2-fold ULN
Barcelona*33	192	1 year	ALP decreases greater than 40% of baseline values or normal levels after 1 year of treatment.
Paris-I*6	291	1 year	Bilirubin level ≤1.0 mg/dL ALP ≤3-fold ULN AST ≤2-fold ULN
Rotterdam34	375	1 year	Normalization of bilirubin and/or albumin levels
Toronto*35	69	2 years	ALP ≤1.67-fold ULN
Ehime36	83	6 months	Normal GGT levels or ≥70% decrease in pre-treatment levels
Paris-II37	165	1 year	ALP and AST ≤1.5-fold ULN with a normal bilirubin level
Rochester-II4	73	1 year	ALP ≤1.67-fold ULN and bilirubin ≤1 mg/dL
Global PBC38	4845	1 year	ALP ≤2-fold ULN and bilirubin ≤1-fold ULN
Risk Stratification Scores
Quantitative scores	Number of patients	Time to assessment	Included parameters
APRI-r1 (± biochemical response)39	386	1 year	Aspartate aminotransferase (AST) and platelet count at 1 year of treatment APRI ≤0.54 ±biochemical response (defined by Barcelona, Paris I/II, or Toronto criteria)
GLOBE score40	4119	1 year	Age at start of UDCA ALP, bilirubin, albumin, and platelet count at 12 months
UK-PBC score41	3165	1 year	Baseline albumin and platelet count ALP, bilirubin, and AST (or ALT) at 12 months of treatment.

ALBI, albumin-bilirubin; ALP, alkaline phosphatase; ALT, alanine aminotransferase; APRI-r1, AST/platelet ratio index at 1 year of treatment; AST, aspartate aminotransferase; GGT, gamma-glutamyl transferase; PBC, primary biliary cholangitis; ULN, upper limit of normal.

*Considered the best predictability of transplant-free survival as validated in large studies.