Table 2.
Characteristic | Vedolizumab n=62 | Infliximab n=94 | P value |
Median length of ICI treatment, days (IQR), n=156 | 73 (28–247) | 70 (28–151) | 0.846 |
Median time from ICI initiation-IMDC onset, days (IQR), n=156 | 104 (53–212) | 96 (33–188) | 0.065 |
No of ICI treatments before IMDC, mean (SD) | 7 (8) | 7 (6) | 0.235 |
Diarrhea grade, no (%) | 0.583 | ||
1–2 | 20 (32) | 33 (35) | |
3–4 | 42 (68) | 61 (65) | |
Colitis grade, no (%) | 0.246 | ||
1–2 | 30 (48) | 57 (61) | |
3–4 | 32 (52) | 37 (39) | |
Median duration of initial IMDC symptoms, days (IQR), n=156 | 56 (27–80) | 50 (31–69) | 0.054 |
Endoscopy evaluation, no (%) | 60 (96) | 65 (69) | <0.001 |
Endoscopic presentation, no (%) | 0.265 | ||
Mucosal ulceration | 17 (28) | 19 (29) | |
Non-ulcerative inflammation | 32 (54) | 37 (57) | |
Normal | 11 (18) | 9 (14) | |
Histology features–no (%) | 0.105 | ||
Acute active colitis | 12 (20) | 24 (37) | |
Chronic active colitis | 35 (58) | 31 (48) | |
Microscopic colitis | 13 (22) | 10 (15) | |
IV steroids, no (%) | 36 (58) | 58 (62) | 0.237 |
Median duration of steroids for initial IMDC, days (IQR), n=156 | 35 (27–43) | 51 (41–68) | <0.001 |
No of steroid tapering attempts prior to SIT use, median (IQR), n=156 | 1 (1–3) | 2 (2–3) | 0.016 |
Median duration from IMDC to first dose of SIT- days (IQR), n=156 | 11 (9–48) | 23 (19–37) | <0.001 |
No of SIT doses (%) | <0.001 | ||
1–2 | 21 (34) | 77 (82) | |
≥3 | 41 (66) | 17 (18) | |
Doses of SIT, mean (SD) | 3 (2) | 2 (1) | <0.001 |
Median duration from first dose of SIT to symptom remission or improvement to grade 1, days (IQR), n=138 | 18 (10–40) | 13 (8–29) | 0.012 |
Hospitalization, no (%) | 40 (65) | 67 (71) | 0.367 |
Median duration of hospitalization, days (IQR), n=107 | 10 (5–15) | 14 (8–19.8) | 0.043 |
Multiple hospitalizations, no (%) | 10 (16) | 26 (28) | 0.005 |
Clinical remission, no (%) | 55 (89) | 83 (88) | 0.785 |
Recurrent IMDC, no. (%) | 8 (14) | 27 (29) | 0.007 |
Immunosuppressant-associated infection, no (%) | 12 (19) | 23 (25) | 0.184 |
ICI, immune checkpoint inhibitor; IMDC, immune-mediated diarrhea and colitis; IV, intravenous; SIT, selective immunosuppressive therapy.