Overall (n=115)* | PD1 (n=35) | IPI+ PD1 (n=80) | P value | |
Time to colitis (weeks) | <0.001 | |||
Median (range) | 6.2 (0.5, 201.5) | 25.7 (1.5, 201.5) | 6.3 (0.5, 57.6) | |
Cycles of immunotherapy to colitis, n (%) | <0.0001 | |||
Median (range) | 2 (1,46) | 8 (1,46) | 1 (1,6) | |
Colitis grade, n (%) | <0.001 | |||
G1 and G2 | 51 (44.3) | 24 (68.6) | 27 (33.8) | |
G3 and G4 | 64 (55.7) | 11 (31.4) | 53 (66.3) | |
Endoscopic and histopathological features, n (%)† | 64 (56%) | 20 (57%) | 44 (55%) | |
Type of endoscopy, n (%) | 0.97 | |||
Colonoscopy | 29 (45.3) | 9 (45.0) | 20 (45.0) | |
Sigmoidoscopy | 35 (54.7) | 11 (55.0) | 24 (54.5) | |
Time to endoscopy (days) | 0.11 | |||
Median(range) | 10 (0–91) | 10 (0–37) | 13.5 (1–91) | |
Treatment before endoscopy | 0.04 | |||
Oral steroid only | 38 (59.4) | 17 (85.0) | 21 (47.7) | |
Oral + intravenous steroid | 20 (31.3) | 2 (10.0) | 18 (40.9) | |
Steroid + infliximab | 2 (3.1) | 0 (0.0) | 2 (4.5) | |
None | 4 (6.3) | 1 (5.0) | 3 (6.8) | |
Area of colon affected, n (%) | 0.42 | |||
Rectum only | 4 (6.3) | 1 (5.3%) | 3 (6.8) | |
Sigmoid colon only | 14 (22.2) | 7 (36.8) | 7 (15.9) | |
Left colon (sigmoid + rectum) | 15 (23.4) | 4 (20.0) | 11 (25.0) | |
Right colon (includes ileum) | 3 (4.8) | 2 (10.5) | 1 (2.3) | |
Pancolon | 15 (23.8) | 2 (10.5) | 13 (29.5) | |
None | 13 (20.6) | 4 (21.1) | 9 (20.5) | |
Intraepithelial neutrophilic infiltrate, n (%) | 0.03 | |||
Absent | 19 (29.7) | 10 (50.0) | 9 (20.5) | |
<5% crypts involved | 22 (34.4) | 7 (35.0) | 15 (34.1) | |
<50% crypts involved | 13 (20.3) | 3 (15.0) | 10 (22.7) | |
>50% crypts involved | 10 (15.6) | 0 (0.0) | 10 (22.7) | |
Intraepithelial lymphocytosis, grade | 0.01 | |||
Absent | 43 (67.2) | 9 (45.0) | 34 (77.3) | |
Borderline (1–20/100 HPF) | 13 (20.3) | 5 (25.0) | 8 (18.2) | |
Severe (>20/100 HPF) | 8 (12.5) | 6 (30.0) | 2 (4.5) | |
Location of intraepithelial lymphocytosis, n (%) | <0.01 | |||
Absent | 43 (67.2) | 9 (45.0) | 34 (77.3) | |
Crypt predominant | 12 (18.8) | 4 (20.0) | 8 (18.2) | |
Crypt and superficial | 9 (14.1) | 7 (35.0) | 2 (4.50) | |
Erosion, n (%) | 0.04 | |||
Absent | 51 (79.7) | 19 (95.0) | 32 (72.7) | |
Present | 13 (20.3) | 1 (5.0) | 12 (27.3) |
*Excluding three patients with ipilimumab only.
†Endoscopic and histolopathological data available on 64/115 patients (56%); 20 (20/35 57%) in PD1 and 44 (44/80, 55%) in IPI+PD1 cohort.
HPF, High power field; IPI, ipilimumab; PD1, programmed cell death protein 1.