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Table 1 Baseline characteristics

From: Budesonide treatment for microscopic colitis from immune checkpoint inhibitors

 OverallMicroscopic colitisNon-microscopic colitisp-value
Number of patients3813251.000
Age in years
 Mean +/− SD62.3 +/− 8.962.4 +/− 8.662.2 +/− 9.20.952
 Median62.562.064.0
Sex (M:F)17:217:614:110.899
CPI regimen
 α-CTLA-43/38 (7.9%)1/13 (7.7%)2/25 (8.0%)0.281
 α-PD-(L)127/38 (71.1%)11/13 (84.6%)16/25 (64.0%)
 Combination CPI8/38 (21.1%)1/13 (7.7%)7/25 (28.0%)
Tumor type
 Melanoma21/38 (55.3%)6/13 (46.2%)15/25 (60.0%)0.415
 NSCLC7/38 (18.4%)3/13 (23.1%)4/25 (16.0%)0.672
 Other10/38 (26.3%)4/13 (30.8%)6/25 (24.0%)0.709
Prior irAE14/38 (36.8%)5/13 (38.5%)11/25 (44.0%)0.743
Prior medications
 Antibiotics within 3 months9/38 (23.7%)2/13 (15.4%)7/25 (28.0%)0.456
 PPI14/38 (36.8%)7/13 (53.9%)7/25 (28.0%)0.163
 SSRI/SNRI10/38 (26.3%)4/13 (30.8%)6/25 (24.0%)0.709
 Estrogen3/35 (7.9%)2/13 (15.4%)1/25 (4.0%)0.265
Time from first CPI infusion to symptom onset (days)
 Mean +/− SD139.5 +/−  153.9225.0 +/−  214.995.1 +/−  86.10.011*
 Median72.5150.068.0
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