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

Table 2 Demographics and clinical characteristics at diagnosis of the derivation and validation cohorts according to Ludwig Stage, n (%)

	Derivation cohort			Validation cohort
Variables	Early stage (n = 112)	Advanced stage (n = 78)	P value	Early stage (n = 43)	Advanced stage (n = 44)	P value
Female	99 (88.4)	72 (92.3)	0.376	37 (86.0)	37 (84.1)	0.798
Age at diagnosis (years)	48 (44-55)	56 (49-61)	< 0.001	51 (46-59)	54 (50-64)	0.049
UDCA-naïve,	82 (73.2)	44 (56.4)	0.016	28(65.1)	26 (59.1)	0.563
Comorbidity
Sjogren’s syndrome	5 (4.5)	3 (3.8)	1.000	2 (4.7)	3 (6.8)	1.000
Hashimoto’s thyroiditis	21 (18.8)	17 (21.8)	0.606	10 (23.3)	11 (25.0)	0.849
Diabetes	8 (7.1)	14 (17.9)	0.022	6 (14.0)	7 (15.9)	0.798
Hypertension	16 (14.3)	18 (23.1)	0.120	9 (20.9)	11 (25.0)	0.652
Total bilirubin (mg/dL)	0.8 (0.6-1.2)	1.1 (0.8-2.1)	< 0.001	0.7 (0.6-0.9)	1.3 (0.8-2.4)	< 0.001
Albumin (g/dL)	4.2 (4.0-4.5)	3.7 (3.4-4.2)	< 0.001	4.4 (4.1-4.7)	3.8 (3.2-4.0)	< 0.001
ALT (× ULN)	1.1 (0.6-1.9)	0.8 (0.5-1.6)	0.118	0.6 (0.4-1.4)	0.9 (0.5-1.6)	0.209
AST (× ULN)	1.2 (0.8-1.9)	1.4 (0.9-2.9)	0.035	0.7 (0.5-1.5)	1.5 (0.9-2.5)	< 0.001
ALP (× ULN)	1.4 (0.8-2.2)	1.3 (0.8-2.4)	0.761	0.8 (0.6-1.3)	1.6 (0.9-2.0)	0.002
GGT (× ULN)	3.1 (1.4-5.7)	2.1 (0.9-6.2)	0.484	1.9 (0.7-3.6)	3.4 (1.7-6.8)	0.012
IgG (g/L)	14.5 (12.3-16.9)	17.2 (13.7-22.2)	< 0.001	12.6 (11.3-15.3)	16.8 (13.9-23.9)	< 0.001
IgM (g/L)	3.19 (2.07-4.63)	3.01 (1.66-4.20)	0.734	2.2 (1.3-3.8)	2.9 (1.7-5.3)	0.094
Platelet count (× 109/L)	223 (173-285)	121 (88-165)	< 0.001	242 (195-293)	130 (93-189)	< 0.001
ANA	61 (54.5)	52 (66.7)	0.092	24 (55.8)	30 (68.2)	0.235
AMA/AMA-M2	68 (60.7)	49 (62.8)	0.769	23 (53.5)	30 (68.2)	0.160
Anti-gp210	28 (29.8)1	27 (38.0)2	0.266	12 (27.9)	19 (43.2)	0.137
Anti-sp100	16 (17.0)1	9 (12.7)2	0.441	4 (9.3)	7 (15.9)	0.354
Hyaluronic acid (ng/mL)	82.6 (62.5-122.1)	102.5 (78.5-132.1)	0.095	60.4 (31.0-87.4)	107.3 (77.2-276.6)	0.008
Serum fibrotic markers
FIB-4	1.49 (1.06-2.13)	4.17 (2.49-6.88)	< 0.001	1.20 (0.78-1.81)	4.27 (2.49-6.80)	< 0.001
APRI	0.59 (0.33-0.91)	1.25 (0.69-2.33)	< 0.001	0.30 (0.18-0.68)	1.23 (0.70-2.08)	< 0.001
AAR	0.91 (0.70-1.15)	1.29 (1.05-1.91)	< 0.001	0.90 (0.70-1.14)	1.32 (0.89-1.86)	< 0.001
GPR	1.98 (0.75-3.38)	2.28 (1.16-5.74)	0.019	1.02 (0.35-2.65)	3.59 (1.72-6.40)	< 0.001
MRS	3.82 (3.39-4.24)	4.81 (4.19-5.55)	< 0.001	3.71 (3.44-4.14)	4.90 (4.38-5.83)	< 0.001
LSM (kPa)	7.0 (5.7-9.1)	21.3 (14.1-30.8)	< 0.001	6.2 (5.1-7.8)	23.2 (16.5-43.6)	< 0.001
BMI (kg/m2)	22.9 (20.3-25.2)	22.0 (20.3-25.3)	0.653	22.9 (22.6-24.7)	21.4 (19.5-23.3)	0.008

¹Available in 94 patients.

²Available in 71 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.