Table 2.
Baseline characteristics according to the presence of both positive antibodies.
| Variables | Both positive antibodies∗ (N = 460) |
||
|---|---|---|---|
| Yes (n = 36) | No (n = 424) | p value | |
| Demographics and comorbidities | |||
| Age (years) | 61 (55–67) | 58 (51–64) | 0.056 |
| Female sex | 19 (53) | 208 (49) | 0.668 |
| Arterial hypertension | 23 (64) | 258 (61) | 0.719 |
| Dyslipidemia | 23 (64) | 250 (59) | 0.563 |
| Type 2 diabetes mellitus | 21 (58) | 248 (59) | 0.985 |
| Obesity (BMI >30 kg/m2) | 26 (72) | 305 (74) | 0.813 |
| Immune-mediated diseases | 6 (17) | 102 (24) | 0.315 |
| Blood tests | |||
| AST (IU/L) | 41 (27–78) | 43 (30–65) | 0.949 |
| ALT (IU/L) | 41 (27–80) | 56 (36–87) | 0.138 |
| GGT (IU/L) | 74 (40–160) | 75 (43–146) | 0.995 |
| ALP (IU/L) | 98 (82–140) | 88 (70–110) | 0.052 |
| Bilirubin (mg/dl) | 0.6 (0.4–0.8) | 0.7 (0.5–0.9) | 0.030 |
| Albumin (g/L) | 45 (41–46) | 44 (42–46) | 0.577 |
| Platelets ( × 109) | 222 (158–250) | 211 (159–260) | 0.956 |
| INR | 1.04 (0.97–1.10) | 1.03 (0.97–1.09) | 0.384 |
| IgG ≥ULN† | 5 (14) | 58 (14) | 0.566 |
| Gamma globulins ≥ULN | 10 (28) | 84 (20) | 0.255 |
| Liver biopsy | |||
| Steatosis | 0.477 | ||
| No | 0 (0) | 25 (6) | |
| Low | 16 (44) | 194 (46) | |
| Moderate | 14 (39) | 145 (34) | |
| Severe | 6 (17) | 60 (14) | |
| Ballooning | 0.919 | ||
| No | 15 (42) | 167 (36) | |
| Moderate | 15 (42) | 175 (41) | |
| Severe | 6 (17) | 82 (19) | |
| Lobular inflammation | 0.132 | ||
| No | 8 (22) | 109 (26) | |
| ≤2 foci | 25 (69) | 249 (59) | |
| 2–4 foci | 2 (6) | 64 (15) | |
| ≥4 foci | 1 (3) | 2 (1) | |
| NAS score | 3.5 (2–4) | 3 (2–4) | 0.759 |
| Advanced fibrosis (F3–F4) | 14 (39) | 192 (45) | 0.459 |
| Interface hepatitis | 6 (17) | 81 (19) | 0.701 |
| Portal inflammation | 0.875 | ||
| Low | 20 (56) | 250 (59) | |
| Moderate | 4 (11) | 50 (12) | |
| Plasma cells clusters | 3 (8) | 45 (11) | 0.468 |
| Possible AIH based on “2022-AIH score”‡ | 3 (8) | 34 (8) | 0.570 |
| Baseline transient elastography | |||
| Liver stiffness (kPa) | 10 (7–14) | 12 (9–17) | 0.026 |
| CAP (dB/m) | 302 (259–340) | 333 (302–363) | <0.001 |
| Liver assessment | |||
| Baseline cACLD (n = 356)§ | 6 (19) | 111 (34) | 0.075 |
Qualitative variables are presented as n (%), and quantitative variables are presented as median (IQR). The Chi-square test or Fisher’s exact test was used for the comparison of qualitative variables, and the Mann–Whitney U test was used for the comparison of quantitative variables. Level of significance: p <0.05 (bold).
AIH, autoimmune hepatitis; ALP, alkaline phosphatase; ALT, alanine aminotransferase; ANA, antinuclear antibodies; ASMA, anti-smooth muscle antibodies; AST, aspartate aminotransferase; cACLD, compensated advanced chronic liver disease; CAP, controlled attenuation parameter; GGT, gamma-glutamyl transferase; IgG, immunoglobulin G; INR, international normalized ratio; NAS, non-alcoholic fatty liver disease activity score; ULN, upper limit of normal.
ANA ≥1/80 and ASMA ≥1/40 were considered positive.
The definition of ULN was different according to every center’s threshold: Hospital Clinic Barcelona: IgG ≥15.3 g/L and gamma globulin ≥18.8%; Hospital Vall d’Hebrón: IgG ≥16 g/L and gamma globulin ≥18.8%; Hospital Marqués de Valdecilla: IgG ≥14.8 g/L and gamma globulin ≥18.8%; and Hospital Ramón y Cajal: IgG ≥16 g/L and gamma globulin ≥17%.
According to the consensus recommendations for histological criteria of AIH from the International AIH Pathology Group.30
Baseline cACLD was defined based on liver biopsy when F4 or F3 had liver stiffness of ≥15 kPa.