Skip to main content

Table 2 Colitis outcomes

From: Budesonide treatment for microscopic colitis from immune checkpoint inhibitors

 OverallMicroscopic colitisNon-microscopic colitisp-value
Interventions
 Budesonide15/38 (39.5%)12/13 (92.3%)3/25 (12.0%)< 0.001*
 Any systemic glucocorticoids25/38 (65.8%)3/13 (23.1%)22/25 (88.0%)< 0.001*
 Systemic glucocorticoids < 1 mg/kg/d14/38 (36.8%)2/13 (15.4%)12/25 (48.0%)0.077
 Systemic glucocorticoids ≥1 mg/kg/d12/38 (31.2%)1/13 (7.7%)11/25 (44.0%)0.030*
Time from symptom onset to initiation of glucocorticoids (days)
 Mean +/− SD32.4 +/−  37.133.2 +/−  26.032.0 +/−  42.70.928
 Median21.028.018.0
Proportion continuing CPI course14/38 (36.8%)10/13 (76.9%)4/25 (16.0%)< 0.001*
Proportion eventually discontinuing immunotherapy29/38 (76.3%)8/13 (61.5%)21/25 (84.0%)0.226
 Due to toxicity alone22/38 (57.9%)6/13 (46.2%)16/25 (64.0%)1.000
 Due to any progressive disease7/38 (18.4%)2/13 (15.4%)5/25 (25.0%)
Average number of additional infusions#3.0 +/− 5.75.8 +/− 6.81.6 +/− 4.50.030*
Additional irAEs after colitis8/38 (21.1%)3/13 (23.1%)5/25 (20.0%)1.000
Response to first line treatment22/38 (67.9%)9/13 (69.2%)14/25 (56.0%)0.429
Proportion of patients requiring second-line immunosuppression23/38 (60.5%)5/13 (38.5%)18/25 (72.0%)Not calculated
Proportion requiring TNFα inhibitor16/38 (42.1%)4/13 (30.8%)11/25 (44.0%)0.429
  1. The p-value was calculated by ANOVA for numerical covariates and chi-square test or Fisher’s exact for categorical covariates, where appropriate. TNFα: tumor necrosis factor α. CPI: immune checkpoint inhibitor. SD: standard deviation. irAE: immune-related adverse event. #calculated among patients who continued CPIs. *denotes statistical significance at p = 0.05. Second-line immune suppression includes exposure to different glucocorticoids in the microscopic colitis cohort
  2. All of the boldfaced numbers should be statistically signficant