Table 1 Clinical features and management outcomes of patients with ICI-related colitis. p value in column denotes differences between Group A, Group B and Group C by Kruskal−Wallis test for continuous data or chi-square test for categorical data.

From: Immune checkpoint inhibitor-related colitis assessment and prognosis: can IBD scoring point the way?

 

Group A: Ipilimumab monotherapy

(n = 189)

Group B: Anti-PD-1 monotherapy

(n = 728)

Group C: Combination ipilimumab and nivolumab

(n = 157)

p value

Total

Patients with colitis (n, %)

42 (22)

41 (6)

51 (32)

2 × 10−23

134 (13)

Onset of colitis since start of treatment (median days, interquartile range)

64 (35–91)

69 (29–150)

40 (20–65)††, ‡

<0.05

60 (28–88)

Median age of colitis patients (years, interquartile range)

67 (57–76)

70 (58–76)

63 (56–68)

<0.05

66 (57–72)

Male sex in colitis patients (n, %)

28 (67)

23 (56)

30 (59)

0.95

81 (60)

Colitis patients with hospital admission

17 (40)

19 (46)

38 (75)

<0.0001

64 (48)

Days to first admission from onset of diarrhoea (Median, interquartile range)

4 (3–6)

3 (0–5)

5 (3–10)††

<0.05

4 (3–7)

Time from colitis onset to endoscopy (Median, interquartile range)

12 (4–18)

Length of first hospital stay in days for patients requiring admission (median, interquartile range)

4 (3–8)

5 (3–8)

6 (3–10)

0.37

5 (3–9)

Treatment

  Any steroids (n, %)

38 (90)

29 (71)

50 (98)

<0.001

117 (87)

  IV steroids (n, %)

12 (29)

14 (34)

38 (75)

<0.001

58 (43)

  Days of IV steroids in those receiving (median, interquartile range)

3 (2–4)

5 (3–8)

4 (3–6)

0.16

4 (3–6)

  Total days on any steroids (median, interquartile range)

59 (51–92)

60 (31–102)

66 (49–117)

0.53

62 (47–100)

  Infliximab (n, % total)

4 (10)

8 (20)

17 (33)

<0.01

29 (22)

  Colectomy (n, % total)

2 (5)

0 (0)

1 (2)

0.35

3 (2)

  1. Note patients who had anti-PD-1 therapy then anti-CTLA-4 therapy sequentially (or vice versa) because of progression on first-line treatment were recorded as monotherapy at the time of colitis.
  2. n/a not applicable.
  3. ††p< 0.01 compared with Group B by Mann−Whitney test.
  4. p < 0.03 compared with Group A by Mann−Whitney test with Bonferroni correction.