Table 1.

Baseline characteristics

	Overall n=3902	UDCA-treated n=3529	Untreated n=373	P value
Age at diagnosis, years*	52.3 (11.9)	52.1 (11.7)	54.1 (13.4)	<0.001
Female, n (%)	3552/3902 (91.0)	3209/3529 (90.9)	343/373 (92.0)	0.510
AMA-positive, n (%)	3507/3862 (90.8)	3175/3491 (90.9)	332/371 (89.5)	0.418
Year of diagnosis†	1996 (1990–2003)	1997 (1990–2003)	1992 (1982–2000)	<0.001
Histological disease stage, n (%)‡				<0.001
Stage I	784/2173 (36.1)	739/2076 (35.6)	45/97 (46.4)
Stage II	671/2173 (30.9)	657/2076 (31.6)	14/97 (14.4)
Stage III	365/2173 (16.8)	351/2076 (16.9)	14/97 (14.4)
Stage IV	353/2173 (16.2)	329/2076 (15.8)	24/97 (24.7)
Serum bilirubin (ULN)†	0.63 (0.44–1.00)	0.62 (0.44–1.00)	0.65 (0.43–1.38)	0.081
Serum ALP (ULN)†	2.29 (1.41–3.95)	2.32 (1.46–4.00)	1.94 (1.11–3.51)	<0.001
Serum AST (ULN)†	1.53 (1.03–2.31)	1.56 (1.05–2.34)	1.25 (0.75–2.00)	<0.001
Serum ALT (ULN)†	1.68 (1.05–2.63)	1.71 (1.09–2.68)	1.20 (0.75–1.83)	<0.001
Serum albumin (LLN)†	1.15 (1.06–1.25)	1.15 (1.06–1.25)	1.15 (1.03–1.26)	0.840
Platelet count (x 109/L)†	245 (190–300)	248 (195–303)	217 (146–271)	<0.001
Biochemical disease stage, n (%)§				<0.001
Early	1576/2296 (68.6)	1376/1980 (69.5)	200/316 (63.3)
Advanced	559/2296 (24.3)	484/1980 (24.4)	75/316 (23.7)
Severe	161/2296 (7.0)	120/1980 (6.1)	41/316 (13.0)

Serum bilirubin was missing for 1020 (26%) patients, serum ALP for 1069 (27%), serum AST for 1175 (30%), serum ALT for 1294 (33%), serum albumin for 1533 (39%) and platelet count for 1720 (44%). AMA status was missing for 40 (1.9%) patients.

*Data are expressed as mean and SD.

†Data are expressed as median and IQR.

‡Histological disease stage according to Ludwig and Scheuer’s classification.²⁸

§Biochemical disease stage according to Rotterdam criteria.²⁹

ALP, alkaline phosphatase; ALT, alanine aminotransferase;AMA, antimitochondrial antibodies; AST, aspartate aminotransferase; LLN, lower limit of normal; UDCA, ursodeoxycholic acid; ULN, upper limit of normal.