Table 1.
Demographics, Biochemical Response, and Clinical Outcomes of Treated and Untreated Patients
No Treatment (n = 51) |
UDCA (n = 236) |
PValue | |
---|---|---|---|
Demographics | |||
Age at PSC diagnosis | 12.6 | 11.1 | 0.026 |
Inflammatory bowel disease | 84% | 84% | 0.941 |
Ulcerative colitis phenotype | 88% | 84% | 0.479 |
Crohn’s disease phenotype | 12% | 16% | 0.479 |
Autoimmune hepatitis overlap | 45% | 38% | 0.327 |
Large duct involvement | 69% | 75% | 0.383 |
Laboratory studies at PSC diagnosis | |||
GGT (U/L) | 290 | 269 | 0.948 |
ALP (x ULN) | 1.2 | 1.3 | 0.583 |
ALT (U/L) | 175 | 238 | 0.162 |
APRI | 0.6 | 1.1 | 0.014 |
Total bilirubin (mg/dL) | 0.5 | 0.6 | 0.795 |
Laboratory studies at 1 year | |||
GGT (U/L) | 115 | 43 | < 0.001 |
ALP (x ULN) | 0.8 | 0.6 | 0.017 |
ALT (U/L) | 96 | 62 | 0.003 |
APRI | 0.5 | 0.4 | 0.031 |
Total bilirubin (mg/dL) | 0.5 | 0.6 | 0.235 |
Percentage decrease in laboratory studies from diagnosis to 1 year | |||
GGT (U/L) | 60% | 75% | 0.002 |
ALP (x ULN) | 12% | 44% | < 0.001 |
ALT (U/L) | 22% | 73% | < 0.001 |
APRI | 22% | 58% | < 0.001 |
Total bilirubin (mg/dL) | 0% | 9% | 0.322 |
Rate of liver outcomes within 5 years of diagnosis | |||
Portal hypertensive complications | 18% | 19% | 0.814 |
Biliary stricture requiring procedural intervention | 8% | 6% | 0.698 |
Liver transplantation | 12% | 11% | 0.807 |
Cholangiocarcinoma | 0% | 1% | 0.511 |
Death | 0% | 1% | 0.511 |
Any adverse outcome | 25% | 25% | 0.945 |
Abbreviation: ULN, upper limit of normal.