Real-world performance of transient elastography in assessing advanced fibrosis in Chinese patients with primary biliary cholangitis

Table 1 Demographics and clinical characteristics of the derivation and validation cohorts, n (%)

Variables	Derivation cohort (n = 190)	Validation cohort (n = 87)	P value
Year of diagnosis	2011-2019	2020-2021	-
Female gender	171 (90.0)	74 (85.1)	0.232
Age at diagnosis (years)	51 (45-58)	53 (47-61)	0.127
UDCA-naïve	126 (66.3)	54 (62.1)	0.492
Comorbidity
Sjogren’s syndrome	8 (4.2)	5 (5.7)	0.575
Hashimoto’s thyroiditis	38 (20.0)	21 (24.1)	0.435
Diabetes	22 (11.6)	13 (14.9)	0.434
Hypertension	34 (17.9)	20 (23.0)	0.321
Total bilirubin (mg/dL)	0.9 (0.6-1.4)	0.9 (0.6-1.4)	0.944
Albumin (g/dL)	4.1 (3.7-4.4)	4.1 (3.6-4.5)	0.947
ALT (× ULN)	1.0 (0.5-1.8)	0.7 (0.4-1.6)	0.086
AST (× ULN)	1.3 (0.8-2.1)	1.1 (0.7-1.8)	0.121
ALP (× ULN)	1.4 (0.8-2.3)	1.2 (0.7-1.8)	0.038
GGT (× ULN)	2.7 (1.1-5.9)	2.6 (1.1-2.8)	0.627
IgG (g/L)	15.2 (12.6-18.6)	14.7 (12.0-17.9)	0.396
IgM (g/L)	3.15 (1.93-4.45)	2.65 (1.42-4.19)	0.103
Platelet count (× 109/L)	187 (121-258)	190 (127-253)	0.900
ANA+	113 (59.5)	54 (62.1)	0.682
AMA/AMA-M2+	117 (61.6)	53 (60.9)	0.917
Anti-gp210+	55 (33.3)1	31 (35.6)	0.714
Anti-sp100+	25 (15.2)1	11 (12.6)	0.589
Hyaluronic acid (ng/mL)	90.0 (66.4-126.1)	84.1 (49.4-144.4)	0.759
Serum fibrotic markers
FIB-4	1.97 (1.23-4.30)	1.98 (1.13-4.61)	0.889
APRI	0.73 (0.44-1.44)	0.69 (0.29-1.33)	0.373
AAR	1.07 (0.79-1.44)	1.10 (0.78-1.47)	0.750
GPR	2.09 (0.94-4.24)	2.07 (0.62-4.49)	0.846
MRS	4.16 (3.62-4.80)	4.25 (3.65-4.96)	0.455
Ludwig stage			0.060
Stage I	60 (31.6)	29 (33.3)
Stage II	52 (27.4)	14 (16.1)
Stage III	19 (10.0)	17 (19.5)
Stage IV	59 (31.0)	27 (31.0)
LSM (kPa)	10.0 (6.6-18.6)	10.2 (6.2-24.0)	0.587
Mix-Max	2.8-75.0	3.2-75.0
IQR/Median	0.15 (0.11-0.20)	0.16 (0.11-0.23)	0.124
IQR/Median			0.647
Very reliable (≤ 0.1)	44 (23.2)	18 (20.7)
Reliable (0.1-0.3)	146 (76.8)	69 (79.3)
Poorly reliable (> 0.3)	0 (0)	0 (0)
BMI (kg/m2)	22.9 (20.3-25.2)	22.6 (20.5-23.4)	0.239

¹Available in 165 patients.

Variables are presented as median (IQR) for continuous variables and total n (%) for categorical variables. UDCA: Ursodeoxycholic acid; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; ALP: Alkaline phosphatase; GGT: Gamma-glutamyl-transferase; IgG: Immunoglobulin G; IgM: Immunoglobulin M; ANA: Antinuclear antibodies; AMA: Antimitochondrial antibody; FIB-4: Fibrosis-4; APRI: Aspartate aminotransferase to platelet ratio index; AAR: Alanine aminotransferase ratio; GPR: Gamma-glutamyl transpeptidase to platelet ratio; MRS: Mayo risk score; LSM: Liver stiffness measurement; IQR: Interquartile range; BMI: Body mass index.