Real-world predictive model for immune checkpoint inhibitor-induced hepatitis using baseline cytotoxic T-lymphocyte counts

doi:10.3748/wjg.121501

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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Copyright: ©Author(s) 2026. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.

World J Gastroenterol. Dec 21, 2026; 32(47): 121501
Published online Dec 21, 2026. doi: 10.3748/wjg.121501

Table 1 Demographic and clinical characteristics of patients with or without immune-mediated hepatitis, n (%)/median interquartile ranges (P25, P75)

Variables	Total (n = 544)	No-IMH (n = 308)	IMH (n = 236)	P value
Gender				< 0.001
Female	144 (26.47)	64 (20.78)	80 (33.90)
Male	400 (73.53)	244 (79.22)	156 (66.10)
Primary cancer type				< 0.001
Malignant melanoma	9 (1.65)	5 (1.62)	4 (1.69)
Hepatocellular carcinoma	25 (4.60)	4 (1.30)	21 (8.90)
Lung cancer	297 (54.60)	188 (61.04)	109 (46.19)
Cholangiocarcinoma	19 (3.49)	8 (2.60)	11 (4.66)
Lymphoma	27 (4.96)	16 (5.19)	11 (4.66)
Head and neck cancer	29 (5.33)	25 (8.12)	4 (1.69)
Gastrointestinal cancer	90 (16.54)	40 (12.99)	50 (21.19)
Urologic cancer	7 (1.29)	4 (1.30)	3 (1.27)
Other types of tumors	41 (7.54)	18 (5.84)	23 (9.75)
ICI agent type				0.027
Anti PD-1	482 (88.60)	263 (85.39)	219 (92.80)
Anti PD-L1	60 (11.03)	44 (14.29)	16 (6.78)
Combination of anti PD-1 and anti CTLA-4	2 (0.377)	1 (0.32)	1 (0.42)
ICI treatment regimen				0.079
ICI monotherapy	58 (10.66)	36 (11.69)	22 (9.32)
ICI + targeted therapy	122 (22.43)	73 (23.70)	49 (20.76)
ICI + chemotherapy	245 (45.04)	124 (40.26)	121 (51.27)
ICI + chemotherapy + targeted therapy	119 (21.88)	75 (24.35)	44 (18.64)
Grade
Grade 1			177 (75.00)
Grade 2			26 (11.02)
Grade 3			26 (11.02)
Grade 4			7 (2.97)
Age (years)	59.00 (52.00, 66.00)	59.00 (54.00, 66.00)	57.00 (49.00, 66.00)	0.006
WBC (10⁹/L)	5.80 (4.50, 7.80)	6.20 (4.60, 7.90)	5.60 (4.50, 7.60)	0.148
HB (g/L)	120.50 (106.00, 132.00)	119.00 (106.00, 132.00)	122.00 (108.00, 132.00)	0.476
PLT (10⁹/L)	212.50 (163.00, 282.00)	218.50 (171.50, 280.25)	208.50 (152.00, 287.25)	0.163
N (10⁹/L)	3.70 (2.80, 5.43)	4.05 (2.90, 5.60)	3.65 (2.70, 5.20)	0.238
LYM (10⁹/L)	1.20 (0.90, 1.60)	1.20 (0.90, 1.60)	1.20 (0.80, 1.60)	0.518
MONO (10⁹/L)	0.60 (0.40, 0.80)	0.60 (0.40, 0.80)	0.50 (0.40, 0.70)	0.050
ALB (g/L)	39.35 (36.18, 42.30)	39.10 (36.27, 41.92)	39.50 (35.90, 42.62)	0.688
GLB (g/L)	29.60 (26.40, 33.50)	30.05 (26.67, 33.23)	29.50 (25.90, 33.65)	0.524
TBIL (μmol/L)	8.50 (6.20, 11.60)	8.00 (5.97, 10.80)	9.10 (6.60, 12.62)	0.004
DBIL (μmol/L)	3.00 (2.20, 4.40)	2.80 (2.00, 4.03)	3.40 (2.40, 5.00)	< 0.001
TBA (μmol/L)	4.45 (2.60, 7.30)	4.25 (2.60, 7.10)	4.70 (2.60, 7.93)	0.555
ALT (U/L)	22.05 (15.00, 31.52)	17.95 (13.28, 27.22)	27.35 (20.65, 36.75)	< 0.001
AST (U/L)	23.85 (19.00, 32.32)	21.75 (17.78, 29.40)	26.85 (21.17, 36.40)	< 0.001
AKP (U/L)	93.00 (76.00, 127.60)	91.20 (74.00, 126.00)	94.30 (77.38, 134.43)	0.575
GGT (U/L)	39.80 (24.20, 79.00)	36.50 (23.40, 71.80)	42.65 (26.05, 87.68)	0.306
CRP (mg/dL)	9.70 (2.96, 29.84)	10.65 (3.28, 30.41)	8.80 (2.46, 26.70)	0.295
C4 (mg/L)	257.00 (207.00, 314.00)	273.00 (231.00, 331.00)	237.00 (179.00, 292.25)	< 0.001
C3 (mg/L)	999.00 (848.00, 1160.00)	1040.00 (864.00, 1170.00)	978.00 (828.00, 1150.00)	0.195
IgG (g/L)	12.80 (10.85, 15.40)	12.70 (10.80, 15.30)	13.00 (11.20, 16.00)	0.402
IgA (mg/L)	2570.00 (1737.50, 3157.50)	2350.00 (1730.00, 3130.00)	2780.00 (1760.00, 3210.00)	0.340
IgM (mg/L)	960.00 (676.25, 1287.50)	953.00 (684.00, 1260.00)	983.00 (676.00, 1350.00)	0.927
CD3+ CD4+ T cells (cells/μL)	475.00 (328.75, 625.50)	461.50 (314.75, 593.50)	499.00 (344.00, 771.00)	< 0.001
CD3+ CD8+ T cells (cells/μL)	326.50 (224.75, 495.75)	287.50 (203.00, 429.50)	396.50 (275.75, 649.25)	< 0.001
Th/Ts ratio	1.42 (0.97, 1.89)	1.56 (1.01, 2.15)	1.25 (0.92, 1.58)	< 0.001

The upper limit of normal for alanine transaminase is 40 U/L per the laboratory reference range. IMH: Immune-mediated hepatitis; ICI: Immune checkpoint inhibitor; PD-1: Programmed cell death-1; PD-L1: Programmed cell death ligand-1; CTLA-4: Cytotoxic T-lymphocyte-associated protein 4; WBC: White blood cells; HB: Hemoglobin; PLT: Platelet; N: Neutrophil; LYM: Lymphocyte; MONO: Monocyte; ALB: Albumin; GLB: Globulin; TBIL: Total bilirubin; DBIL: Direct bilirubin; TBA: Total bile acid; ALT: Alanine transaminase; AST: Aspartate transaminase; AKP: Alkaline phosphatase; GGT: Gamma-glutamyl transferase; CRP: C-reactive protein; C4: Complement 4; C3: Complement 3; IgG: Immunoglobulin G; IgA: Immunoglobulin A; IgM: Immunoglobulin M; Th/Ts: T helper cell/T suppressor cell (cluster of differentiation 3+ cluster of differentiation 4+/cluster of differentiation 3+ cluster of differentiation 8+); CD: Cluster of differentiation.

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Citation: Peng WT, Yang FL, Peng SF, Fu L. Real-world predictive model for immune checkpoint inhibitor-induced hepatitis using baseline cytotoxic T-lymphocyte counts. World J Gastroenterol 2026; 32(47): 121501
URL: https://www.wjgnet.com/1007-9327/full/v32/i47/121501.htm
DOI: https://dx.doi.org/10.3748/wjg.121501

Peng WT, Yang FL, Peng SF, Fu L. Real-world predictive model for immune checkpoint inhibitor-induced hepatitis using baseline cytotoxic T-lymphocyte counts. World J Gastroenterol 2026; 32(47): 121501 [DOI: 10.3748/wjg.121501]

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