Table 3.
Clinical findings
| All patients, n (%) | Steroid-responsive, n (%) | Steroid-refractory, n (%) | |
|---|---|---|---|
| Total number of patients | 33 (100) | 11 (100) | 22 (100) |
| Colitis CTCAEa | |||
| Grade 3 | 27 (82) | 11 (100) | 16 (73) |
| Grade 4 | 6 (18) | 0 (0) | 6 (27) |
| Diarrhoea CTCAE | |||
| Grade 1 or 2 | 15 (45) | 4 (36) | 11 (50) |
| Grade 3 | 18 (55) | 7 (64) | 11 (50) |
| Further symptoms | |||
| Bloody stools | 14 (42) | 3 (27) | 11 (50) |
| Abdominal pain | 21 (64) | 7 (64) | 14 (64) |
| Peritoneal signs | 2 (6) | 0 (0) | 2 (9) |
| Emesis | 9 (27) | 2 (18) | 7 (32) |
| Fever, >38.2 °C | 6 (18) | 0 (0) | 6 (27) |
| <4 doses ICIb received at symptom onset | 23 (70) | 4 (36) | 19 (86) |
| Laboratory results | |||
| CRP,c mg/L, median (range) at first presentation | 17 (0.4–333) | 18 (1.5–246) | 16 (0.4–333) |
| Albumin, g/L, median (range) at first presentation | 37 (23–43) | 38.5 (33–43) | 37 (23–43) |
| Albumin <30 g/L at first presentation | 3/28 (11) | 0/8 (0) | 3/20 (15) |
| Initial stool test for enteric pathogens negative | 29/30 (97) | 9/9 (100) | 20/21 (95) |
| Endoscopic findings | |||
| Non-ulcerative | 15/27 (56) | 3/8 (38) | 12/19 (62) |
| Ulceration | 12/27 (44) | 5/8 (63) | 7/19 (37) |
| Extensive colitis, i.e., right and left colon | 14/25 (56) | 4/8 (50) | 10/17 (59) |
| Histological findings | |||
| Histology consistent with colitis | 25/27 (93) | 8/8 (100) | 17/19 (89) |
| Ulceration present | 7/27 (26) | 0 (0) | 7/19 (37) |
| Treatment characteristics | |||
| Hospitalization due to colitis | 29 (88) | 8 (73) | 21 (95) |
| High-dose prednisoned, oral or intravenous | 33 (100) | 11 (100) | 22 (100) |
| High-dose budesonidee | 7 (21) | 3 (27) | 4 (18) |
| Total days with steroids, median (range) | 64 (4–167) | 63 (4–151) | 69 (23–167) |
| Infliximabf | 20 (61) | 0 (0) | 20 (91) |
| Vedolizumabg | 1 (3) | 0 (0) | 1 (5) |
| Surgery | 4 (12) | 0 (0) | 4 (18) |
| Discontinuation of checkpoint inhibitor | 21 (64) | 4 (36) | 17 (77) |
| Complications | |||
| Colonic perforation | 2 (6) | 0 (0) | 2 (9) |
| Ruptured appendicitis | 1 (3) | 0 (0) | 1 (5) |
| Perianal abscess or fistula | 2 (6) | 0 (0) | 2 (9) |
| Superimposed Clostridium difficile colitish | 3 (9) | 1 (9) | 2 (9) |
| Bleeding resulting in anemia | 3 (9) | 0 (0) | 3 (14) |
Data presented as n (%), unless otherwise stated.
a
CTCAE, Common Terminology Criteria for Adverse Events.
b
ICI, immune checkpoint inhibitor.
c
CRP, C-reactive protein.
d
High-dose prednisone: >1 mg/kg body weight.
e
High-dose budesonide: >9 mg.
f
5 mg/kg body weight.
g
2 × 300 mg IV.
h
All successfully treated with metronidazole.