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Table 2 Colitis outcomes

From: Budesonide treatment for microscopic colitis from immune checkpoint inhibitors

 

Overall

Microscopic colitis

Non-microscopic colitis

p-value

Interventions

 Budesonide

15/38 (39.5%)

12/13 (92.3%)

3/25 (12.0%)

< 0.001*

 Any systemic glucocorticoids

25/38 (65.8%)

3/13 (23.1%)

22/25 (88.0%)

< 0.001*

 Systemic glucocorticoids < 1 mg/kg/d

14/38 (36.8%)

2/13 (15.4%)

12/25 (48.0%)

0.077

 Systemic glucocorticoids ≥1 mg/kg/d

12/38 (31.2%)

1/13 (7.7%)

11/25 (44.0%)

0.030*

Time from symptom onset to initiation of glucocorticoids (days)

 Mean +/− SD

32.4 +/−  37.1

33.2 +/−  26.0

32.0 +/−  42.7

0.928

 Median

21.0

28.0

18.0

Proportion continuing CPI course

14/38 (36.8%)

10/13 (76.9%)

4/25 (16.0%)

< 0.001*

Proportion eventually discontinuing immunotherapy

29/38 (76.3%)

8/13 (61.5%)

21/25 (84.0%)

0.226

 Due to toxicity alone

22/38 (57.9%)

6/13 (46.2%)

16/25 (64.0%)

1.000

 Due to any progressive disease

7/38 (18.4%)

2/13 (15.4%)

5/25 (25.0%)

Average number of additional infusions#

3.0 +/− 5.7

5.8 +/− 6.8

1.6 +/− 4.5

0.030*

Additional irAEs after colitis

8/38 (21.1%)

3/13 (23.1%)

5/25 (20.0%)

1.000

Response to first line treatment

22/38 (67.9%)

9/13 (69.2%)

14/25 (56.0%)

0.429

Proportion of patients requiring second-line immunosuppression

23/38 (60.5%)

5/13 (38.5%)

18/25 (72.0%)

Not calculated

Proportion requiring TNFα inhibitor

16/38 (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