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Table 1 Baseline characteristics

From: Budesonide treatment for microscopic colitis from immune checkpoint inhibitors

 

Overall

Microscopic colitis

Non-microscopic colitis

p-value

Number of patients

38

13

25

1.000

Age in years

 Mean +/− SD

62.3 +/− 8.9

62.4 +/− 8.6

62.2 +/− 9.2

0.952

 Median

62.5

62.0

64.0

Sex (M:F)

17:21

7:6

14:11

0.899

CPI regimen

 α-CTLA-4

3/38 (7.9%)

1/13 (7.7%)

2/25 (8.0%)

0.281

 α-PD-(L)1

27/38 (71.1%)

11/13 (84.6%)

16/25 (64.0%)

 Combination CPI

8/38 (21.1%)

1/13 (7.7%)

7/25 (28.0%)

Tumor type

 Melanoma

21/38 (55.3%)

6/13 (46.2%)

15/25 (60.0%)

0.415

 NSCLC

7/38 (18.4%)

3/13 (23.1%)

4/25 (16.0%)

0.672

 Other

10/38 (26.3%)

4/13 (30.8%)

6/25 (24.0%)

0.709

Prior irAE

14/38 (36.8%)

5/13 (38.5%)

11/25 (44.0%)

0.743

Prior medications

 Antibiotics within 3 months

9/38 (23.7%)

2/13 (15.4%)

7/25 (28.0%)

0.456

 PPI

14/38 (36.8%)

7/13 (53.9%)

7/25 (28.0%)

0.163

 SSRI/SNRI

10/38 (26.3%)

4/13 (30.8%)

6/25 (24.0%)

0.709

 Estrogen

3/35 (7.9%)

2/13 (15.4%)

1/25 (4.0%)

0.265

Time from first CPI infusion to symptom onset (days)

 Mean +/− SD

139.5 +/−  153.9

225.0 +/−  214.9

95.1 +/−  86.1

0.011*

 Median

72.5

150.0

68.0

CTCAE symptom grade: median (IQR)

2 (1–3)

2 (1–3)

2 (1–3)

1.000

  1. The p-value was calculated by ANOVA for numerical covariates and chi-square test or Fisher’s exact for categorical covariates, where appropriate. Combination CPI: all patients received a PD-(L)1 inhibitor in combination with ipilimumab either as standard of care or on an investigational protocol. SD: standard deviation. CPI: immune checkpoint inhibitor. PD-(L)1: programmed cell death receptor (ligand)-1. NSCLC: non-small cell lung cancer. Other tumor types: breast cancer (n = 1); colorectal cancer (n = 1); cutaneous squamous cell cancer (n = 1); squamous cell cancer of the head and neck (n = 1); diffuse large B-cell lymphoma (n = 2); multiple myeloma (n = 1); ovarian adenocarcinoma (n = 2); renal cell cancer (n = 1). PPI: proton-pump inhibitor. SSRI/SNRI: selective serotonin reuptake inhibitor/serotonin and norepinephrine reuptake inhibitor. Prior medications were within one year of symptoms unless otherwise specified. CTCAE: Common Terminology Criteria for Adverse Events. IQR: interquartile range. *statistically significant at significance of 0.05
  2. All of the boldfaced numbers should be statistically signficant