Table 1.
Overall all Cohort N=15 | HLA- A *33:01(+) N= 11 HLA |
HLA- A *33:01 (−) N=4 | p-value | |
---|---|---|---|---|
Median Age (years) | 56.6 (40– 74.8) | 57.5 (43.7– 4.8) | 46 (40– 68) | 0.30 |
% Female | 53% | 55% | 50% | >0.99 |
Race | ||||
% European | 73% | 91% | 25% | 0.017 |
% African | 7% | 9 | 0% | |
% East Asian | 13% | 0 | 50% | |
% Multiracial | 7% | 0 | 25% | |
% Hispanic | 13% | 0 | 50% | 0.06 |
Median BMI (kg/m2) | 24.2 (19.8– 37.6) | 23.8 (19.8– 29.6) | 28.0 (20.9– 37.6) | 0.30 |
Medical history | ||||
%Drug allergies | 33% | 18% | 75% | 0.08 |
% Diabetes | 20% | 18% | 25% | >0.99 |
% Alcohol use | 60% | 73% | 25% | 0.24 |
Symptoms | ||||
% Jaundice | 80% | 73% | 100% | 0.52 |
% Pruritus | 73% | 82% | 50% | 0.52 |
% Rash | 20% | 18% | 25% | >0.99 |
% Fever | 7% | 0% | 25% | 0.27 |
Duration of use prior to DILI onset (days) | 38 (24–114) | 38 (28– 114) | 39 (24–48) | 0.74 |
Labs at DILI onset | ||||
ALT (U/L) | 448 (131–1071) | 419 (131–1071) | 546 (293–778) | 0.79 |
ALP (U/L) | 333 (143–452) | 333 (203– 433) | 303 (143–452) | 0.79 |
Bilirubin (mg/dL) | 6.6 (0.7–23.7) | 6.6 (0.7–14.9) | 7.3 (2.2–23.7) | 0.60 |
% ANA (+) | 21% | 20% | 25% | > 0.99 |
% SmAb (+) | 8% | 0% | 25% | 0.38 |
% Hepatocellular | 33% | 27% | 50% | 0.77 |
% Mixed | 47% | 55% | 25% | |
% Cholestatic | 20% | 18% | 25% | |
Peak labs | ||||
ALT (U/L) | 709 (131–1133) | 709 (131–1133) | 613 (372–912) | 0.70 |
ALP (U/L) | 375 (143.0– 677.0) | 366 (311– 667) | 480 (143–677) | 0.43 |
Bilirubin (mg/dL) | 12.9 (3.8– 29.5) | 11.0 (4.0– 20.8) | 17.3 (3.8–29.5) | 0.43 |
Treatment | ||||
% Corticosteroids | 40% | 36% | 50% | >0.99 |
% Ursodiol | 27% | 36% | 0% | 0.52 |
Chronic injury at 6 months | 7/13 (54%) | 6/10 (60%) | 1/3 (33%) | 0.56 |
Data presented as Median (range).