Table 1.
Clinical Characteristics of the Study Population
| Biochemical Tests | |
| ALT (IU/L) (n = 965) | 25.0 (4.0‐1315.0) |
| ALT:ULN ratio | 0.6 (0.1‐35.0) |
| IgG (g/L) (n = 742) | 12.5 (2.1‐51.1) |
| IgG:ULN ratio | 0.8 (0.2‐3.2) |
| Biochemical Remission | |
| Normal ALT only (according to each site’s ULN [n = 965]) | 758 (78.5) |
| Normal ALT and IgG (n = 736) | 449 (61.0) |
| Normal ALT and IgG with no documented flares last 12 months (used in regression analysis [n = 990]) | 558 (56.4) |
| Therapy and Dose per day (n = 990) | |
| Prednisolone | 499 (50.4) |
| Dose, mg | 5 (0.2‐60) |
| Budesonide | 47 (4.7) |
| Dose, mg | 3 (0.4‐9) |
| Azathioprine | 581 (58.7) |
| Dose, mg | 100 (25‐250) |
| Dose/weight, mg/kg | 1.1 (0.2‐2.8) |
| 6‐Mercaptopurine | 48 (4.8) |
| Dose, mg | 50 (12‐150) |
| Dose/weight, mg/kg | 0.7 (0.1‐2.0) |
| Mycophenolate (MMF/MA) | 166 (16.8%) |
| Dose, mg | 1,000 (200‐3,000) |
| Tacrolimus | 41 (4.1) |
| Dose, mg | 2 (0.5‐9) |
| Cyclosporine | 6 (0.6) |
| Dose, mg | 125 (50‐300) |
| Self‐reported comorbidities (n = 956) | |
| Primary biliary cholangitis | 64 (6.7) |
| Primary sclerosing cholangitis | 22 (2.3) |
| Ulcerative colitis/Crohn’s | 48 (5.0) |
| Rheumatoid arthritis | 60 (6.3) |
| Osteoporosis | 147 (15.4) |
Note: Data are presented as n (%) or median (range), unless noted otherwise.