Clinical usefulness of ursodeoxycholic acid for Japanese patients with autoimmune hepatitis

Table 1 Clinical features of the two groups classified according to the therapeutic agent

	Group U (n = 48)	Group P (n = 88)	P
Age (yr)	45 (17-74)	51 (15-78)	ns
Sex (female)	45 (93.8%)	65 (73.9%)	< 0.01
Acute presentation	5 (10.4%)	31 (36.5%)	< 0.01
Laboratory data
AST (IU/L)	104 (46-1234)	303 (31-2215)	< 0.001
ALT (IU/L)	149 (52-1000)	431 (38-2801)	< 0.001
T.Bil (mg/dL)	0.8 (0.3-18)	1.3 (0.4-19.3)	< 0.05
ALP (U/L)	300 (144-1184)	369 (145-4420)	ns
γ-GTP (U/L)	82 (13-875)	183 (12-1256)	< 0.05
IgG (mg/dL)	1954 (1096-3793)	2336 (1051-5776)	< 0.01
ANA (≥ 1 : 40)	46 (95.8%)	83 (94.3%)	ns
SMA (≥ 1 : 40)	11/23 (47.8%)	35/45 (77.8%)	< 0.05
HLA DR4	6/16 (37.5%)	33/57 (57.9%)	ns
Histological finding
Grading
A1	29 (60.4%)	25 (28.4%)	< 0.01
A2	18 (37.5%)	44 (50%)
A3	1 (2.1%)	19 (21.6%)
Staging
F1	35 (72.9%)	43 (48.9%)	< 0.05
F2	6 (12.5%)	28 (31.8%)
F3	6 (12.5%)	10 (11.4%)
F4	1 (2.1%)	7 (8.0%)
AIH score
Revised score	15 (10-20)	16 (7-23)	ns
Simplified score	6 (4-8)	6 (3-8)	ns

Continuous variables are expressed as median (range) values. The Mann-Whitney U test was used to evaluate differences in continuous variables between two groups. Dichotomous variables were compared by Pearson’s χ² test. Values of P < 0.05 were considered significant. ALT: Alanine aminotransferase; AIH: Autoimmune hepatitis; AST: Aspartate transaminase; HLA: Human leukocyte antigen; ANA: Antinuclear antibody; ALP: Alkaline phosphatase; γ-GTP: γ-glutamyltransferase; SMA: Smooth muscle antibody; ns: No significant difference; T.Bil: Total bilirubin; IgG: Immunoglobulin G.

Table 2 Clinical features of the two subgroups classified according to the effect of ursodeoxycholic acid

	Subgroup U11(n = 34)	Subgroup U22(n = 14)	P
Age (yr)	42 (17-74)	48 (21-66)	ns
Sex (female)	33 (97.1%)	12 (85.7%)	ns
Acute presentation	4 (11.8%)	1 (7.1%)	ns
Laboratory data
AST (IU/L)	93 (46-505)	144 (50-1234)	0.024
ALT (IU/L)	124 (52-742)	262 (65-1000)	0.023
T.Bil (mg/dL)	0.7 (0.3-18)	1.0 (0.3-2)	ns
ALP (U/L)	300 (144-1184)	300 (168-924)	ns
γ-GTP (U/L)	86 (16-875)	67 (13-405)	ns
IgG (mg/dL)	1959 (1096-3800)	1960 (1476-3793)	ns
ANA (≥ 1 : 40)	32 (94.1%)	14 (100%)	ns
SMA (≥ 1 : 40)	8/17 (47.1%)	3/6 (50%)	ns
HLA DR4	4/11 (36.4%)	2/5 (40%)	ns
Histological finding
Grading
A1	24 (70.6%)	5 (35.7%)	0.025
A2	10 (29.4%)	8 (57.1%)
A3	0 (0%)	1 (7.1%)
Staging
F1	25 (73.5%)	10 (71.4%)	ns
F2	4 (11.8%)	2 (14.3%)
F3	5 (14.7%)	1 (7.1%)
F4	0 (0%)	1 (7.1%)
AIH score
Revised score	15 (10-19)	17 (12-20)	ns
Simplified score	6 (4-8)	6 (6-7)	ns

¹Subgroup U1, normalized ALT and sustained remission;

²Subgroup U2, non-normalized ALT or relapse. Continuous variables are expressed as median (range) values. The Mann-Whitney U test was used to evaluate differences in continuous variables between two groups. Dichotomous variables were compared by Pearson’s χ² test. Values of P < 0.05 were considered significant. ALT: Alanine aminotransferase; AIH: Autoimmune hepatitis; AST: Aspartate transaminase; HLA: Human leukocyte antigen; ANA: Antinuclear antibody; ALP: Alkaline phosphatase; γ-GTP: γ-glutamyltransferase; SMA: Smooth muscle antibody; T.Bil: Total bilirubin; IgG: Immunoglobulin G; ns: No significant difference.

Table 3 Multivariate logistic regression analysis of factors associated with normalized alanine aminotransferase and sustained remission of ursodeoxycholic acid monotherapy in autoimmune hepatitis patients

Factor	Category	Odds ratio (95%CI)	P
ALT (IU/L)	> 200	1
	≤ 200	10.8 (1.64-71.0)	0.013
Age	> 50	1
	≤ 50	1.16 (0.21-6.38)	0.86
IgG	> 2000	1
	≤ 2000	0.65 (0.10-4.32)	0.66
Acute presentation	No	1
	Yes	4.13 (0.15-110.5)	0.4
Histological Grading	A2 or A3	1
	A1	0.76 (0.10-5.88)	0.8
Histological Staging	F2 or F3 or F4	1
	F1	0.41 (0.04-4.44)	0.46
AIH score	> 15	1
(International diagnostic criteria)	≤ 15	2.66 (0.43-16.48)	0.29
AIH score	> 6	1
(Simplified criteria)	≤ 6	5.46 (0.37-81.3)	0.22

ALT: Alanine aminotransferase; AIH: Autoimmune hepatitis.