Immune checkpoint inhibitor-mediated colitis is associated with cancer overall survival

Table 1 Baseline characteristics of patients with immune checkpoint inhibitor use

Clinical variables	All patients (n = 128)		Patients with IMC (n = 64)		Patients without IMC (n = 64)		P value
Age, yr (mean ± SD)1	66.6 (± 11.5)		67.4 (± 11.7)		65.8 (± 11.3)		0.420
Sex1
Male, n (%)	74	57.81%	37	57.81%	37	57.81%	1.000
Female, n (%)	54	42.19%	27	42.19%	27	42.19%
Race
White, n (%)	102	79.69%	52	81.25%	50	78.13%	0.660
Black, n (%)	4	3.13%	2	3.13%	2	3.13%	1.000
Asian, n (%)	9	7.03%	4	6.25%	5	7.81%	0.730
Type of malignancy1
Melanoma, n (%)	66	51.56%	33	51.56%	33	51.56%	1.000
RCC, n (%)	15	11.72%	8	12.50%	7	10.94%	0.783
NSCLC, n (%)	12	9.38%	6	9.38%	6	9.38%	1.000
Sarcoma, n (%)	11	8.59%	5	7.81%	6	9.38%	0.752
Head and neck SCC, n (%)	7	5.47%	3	4.69%	4	6.25%	0.697
Other, n (%)	17	13.28%	9	14.06%	8	12.50%	0.795
Stage IV malignancy, n (%)	114	89.07%	56	87.50%	58	90.63%	0.778
Type of immune checkpoint inhibitor1
Ipilimumab plus nivolumab, n (%)	48	37.50%	24	37.50%	24	37.50%	1.000
Ipilimumab, n (%)	22	17.19%	11	17.19%	11	17.19%	1.000
Nivolumab, n (%)	12	9.38%	6	9.38%	6	9.38%	1.000
Pembrolizumab, n (%)	38	29.69%	19	29.69%	19	29.69%	1.000
Atezolizumab, n (%)	8	6.25%	4	6.25%	4	6.25%	1.000
Number of Infusionsa (mean ± SD)1	6.91 (± 8.40)		6.09 (± 7.20)		7.73 (± 9.40)		0.268
Dose of ICI (mg/kg) (mean ± SD)	2.47 (± 1.30)		2.63 (± 1.60)		2.31 (± 1.00)		0.318
Prior ICI use1	19	14.84%	10	15.63%	9	14.06%	0.500
Medical history, n (%)
Non-liver, non-upper GI diseaseb, n (%)	28	21.88%	18	28.13%	10	15.63%	0.087
Personal history of autoimmune diseaseb, n (%)	30	23.44%	20	31.25%	10	15.63%	0.037
Prior irAEb, n (%)	8	12.50%	7	10.90%	1	1.56%	0.062
Family history of autoimmune diseaseb, n (%)	10	7.81%	8	12.50%	2	3.13%	0.048
Prior immune-enhancing therapyb, n (%)	11	8.59%	2	3.13%	9	14.06%	0.027
Prior interferon-γ therapy, n (%)	7	5.47%	1	1.56%	6	9.38%	0.115
Vitamin D use, n (%)	38	29.69%	25	39.06%	13	20.31%	0.020
Smoking (current or prior), n (%)	61	47.66%	33	51.56%	28	43.75%	0.376
NSAID use, n (%)	21	16.41%	10	15.63%	11	17.19%	0.811
Any vaccine, n (%)	25	19.53%	9	14.06%	16	25.00%	0.119
Flu vaccine, n (%)	19	14.84%	7	10.94%	12	18.75%	0.214
Pneumonia vaccine, n (%)	11	8.59%	4	6.25%	7	10.94%	0.344
Other vaccine, n (%)	2	1.56%	1	1.56%	1	1.56%	1.000
Weight at start of ICI (kg) (mean ± SD)	78.1 (± 17.4)		79.4 (± 16.9)		76.8 (± 17.9)		0.396
Medications
Steroid at start of ICI, n (%)	20	15.63%	11	17.19%	9	14.06%	0.626
Steroid duration (d)	N/A		107.7 (± 164.2)		N/A
Infliximab use, n (%)	N/A		10	15.63%	N/A
Vedolizumab use, n (%)	N/A		1	1.56%	N/A
Malignancy outcomes
Mean PFS (mo)	12.8 (± 15.3)		13.7 (± 14.9)		11.9 (± 15.8)		0.524
PFS > 6 mo, n (%)	63	49.22%	35	54.69%	28	43.75%	0.216
OS (mo)	21.0 (± 18.9)		24.3 (± 19.4)		17.7 (± 18.0)		0.050
OS > 12 mo, n (%)	72.0	56.25%	42	65.63%	30	46.88%	0.025
Death, n (%)	20	15.63%	6	9.38%	14	21.88%	0.051

¹Variable matched between cases and controls.

^aNumber of infusions of immune checkpoint inhibitor prior to immune checkpoint inhibitor-mediated colitis diagnosis (cases) or total (controls).

^bSee Supplementary Table 2.

IMC: Immune checkpoint inhibitor-mediated colitis; ICI: Immune checkpoint inhibitor; SD: Standard deviation; RCC: Renal cell carcinoma; NSCLC: Non-small cell lung cancer; SCC: Squamous cell carcinoma; PFS: Progression-Free Survival; irAE: Immune related adverse event; OS: Overall survival.