Early serum albumin changes in patients with ulcerative colitis treated with tacrolimus will predict clinical outcome

Table 1 Baseline characteristics of patients

Characteristics	n = 47
Age (yr), mean (range) ± SD	44.9 (16-78) ± 18.7
Male/female, n (%)	38/9 (80.9/10.6)
Disease duration (yr), mean (range) ± SD	3.2 (0.1-42) ± 7.0
Disease extent, n (%)
Extensive colitis	42 (89.4)
Left sided colitis	5 (10.6)
CAI (Rachmilewitz index) mean (range) ± SD	11.0 (7-17) ± 2.7
MES
MES 2	9 (19.1)
MES 3	38 (80.9)
Medication at study, n (%)
Oral 5-ASA	21 (44.7)
Suppository 5-ASA	7 (14.9)
Systemic steroids	28 (59.6)
Immunomodulators	10 (21.3)
Biologics	11 (23.4)
History of biologics, n (%)	12 (25.5)
Time to high trough level (d), mean (range) ± SD	8.1 (0-46) ± 7.5

5-ASA: 5-aminosalicylic acid; CAI: Clinical activity index; MES: Mayo endoscopic subscore.

Table 2 Comparison between the failure and remission groups before tacrolimus induction

Characteristics	Remission (n = 30)	Failure (n = 17)	P value
Age (yr), mean ± SD	41.33 ± 16.8	51.1 ± 20.7	0.084
Male/female, n (%)	23/7 (76.7 / 23.3)	15/2 (88.2/11.8)	0.455
Disease duration (yr), mean ± SD	2.0 ± 2.8	5.46 ± 10.9	0.098
Disease extent, n (%)
Extensive colitis	27 (90.0)	15 (88.2)	1
Left sided colitis	3 (10.0)	2 (11.8)
CAI (Rachmilewitz index), mean ± SD	10.7 ± 2.4	11.7 ± 2.9	0.221
MES
MES 2	6 (20.0)	3 (17.6)	1
MES 3	24 (80.0)	14 (82.4)
Medication at study, n (%)
Oral 5-ASA	16 (53.3)	5 (29.4)	0.138
Suppository 5-ASA	5 (16.7)	2 (11.8)	1
Systemic steroids	19 (63.3)	9 (52.9)	0.546
Immunomodulators	6 (20.0)	4 (23.5)	1
Biologics	6 (20.0)	5 (29.4)	0.493
History of biologics, n (%)	6 (20.0)	6 (35.3)	0.306
Time to high trough level (d), mean ± SD	7.9 ± 8.1	8.5 ± 6.4	0.773

5-ASA: 5-aminosalicylic acid; CAI: Clinical activity index; MES: Mayo endoscopic subscore.

Table 3 Comparison of biological data before and after tacrolimus induction

Biological data	Remission (n = 30)	Failure (n = 17)	P value
Serum Alb at week 0 (g/dL)	2.83 ± 0.68	2.81 ± 0.72	0.897
Serum Alb at week 1 (g/dL)	2.94 ± 0.61	2.85 ± 0.78	0.651
Serum Alb at week 2 (g/dL)	3.29 ± 0.57	2.81 ± 0.73	0.015
Serum CRP at week 0 (mg/dL)	5.58 ± 5.75	5.44 ± 5.45)	0.933
Serum CRP at week 1 (mg/dL)	0.88 ± 2.29	1.12 ± 1.51	0.696
Serum CRP at week 2 (mg/dL)	0.54 ± 1.50	1.17 ± 1.63	0.191
Hb at week 0 (g/dL)	11.2 ± 1.90	11.32 ± 2.06	0.871
Hb at week 1 (g/dL)	10.65 ± 1.60	11.15 ± 1.77	0.326
Hb at week 2 (g/dL)	10.78 ± 1.71	10.89 ± 1.88	0.837
WBC at week 0 (/μL)	8660.00 ± 4498.65	8846.47 ± 3876.21	0.887
WBC at week 1 (/μL)	5958.00 ± 2444.20	6618.24 ± 2201.22	0.362
WBC at week 2 (/μL)	5473.00 ± 2095.78	6672.35 ± 2154.37	0.069

Alb: Albumin; CRP: C-reactive protein; Hb: Hemoglobin; WBC: White blood cell. mean ± SD is shown.

Table 4 Comparison of biological data ratio after tacrolimus induction

Rate of biological data	Remission (n = 30)	Failure (n = 17)	P value
Week 1/week 0 Alb ratio	1.05 ± 0.14	1.02 ± 0.13	0.429
Week 2/week 0 Alb ratio	1.19 ± 0.20	1.02 ± 0.16	0.003
Week 1/week 0 CRP ratio	0.28 ± 0.49	1.28 ± 3.80	0.159
Week 2/week 0 CRP ratio	0.16 ± 0.23	1.42 ± 4.28	0.112
Week 1/week 0 Hb ratio	0.96 ± 0.13	1.01 ± 0.18	0.315
Week 2/week 0 Hb ratio	0.97 ± 0.13	0.98 ± 0.14	0.892
Week 1/week 0 WBC ratio	0.77 ± 0.32	0.84 ± 0.33	0.520
Week 2/week 0 WBC ratio	0.72 ± 0.30	0.86 ± 0.40	0.194

Alb: Albumin; CRP: C-reactive protein; Hb: Hemoglobin; WBC: White blood cell. mean ± SD is shown.

Table 5 Multivariate analysis for predicting failure during 3 mo after tacrolimus induction

Variable	Univariate analysis			Multivariate analysis
	HR	95%CI	P value	HR	95%CI	P value
Week 2/week 0 Alb ratio ≤ 1	3.632	1.396-9.445	0.008	7.195	2.011-25.74	0.002
Age	1.026	0.998-1.055	0.072	1.009	0.976-1.042	0.599
Sex (male)	2.139	0.489-9.362	0.313	2.420	0.435-13.45	0.313
Disease extent (extensive colitis)	1.062	0.243-4.640	0.937	4.665	0.554-39.30	0.157
MES 3	1.188	0.341-4.137	0.787	0.462	0.142-1.503	0.200
Medication
Oral 5-ASA	0.450	0.158-1.277	0.133	0.578	0.191-1.744	0.331
Suppository 5-ASA	0.652	0.149-2.853	0.570	0.247	0.035-1.744	0.161
Systemic steroids	0.729	0.281-1.890	0.515	0.636	0.193-2.094	0.457
Immunomodulators	1.152	0.375-3.543	0.805	1.516	0.391-5.885	0.548
Biologics	1.400	0.493-3.978	0.527	0.924	0.173-4.920	0.926

5-ASA: 5-aminosalicylic acid; Alb: Albumin; HR: Hazard ratio; MES: Mayo endoscopic subscore.