Table 2.
Clinical Presentation and Outcomes of ICI-Treated Patients Presenting With Diarrhea by CDI Status
| Characteristic | Total Patients n (%) |
CDI-Positive n (%) |
CDI-Negative n (%) |
P Value |
|---|---|---|---|---|
| Total, n | 605 | 111 | 494 | |
| Time from ICI therapy initiation to diarrhea onset, median (IQR), d | 85 (28–196) | 92 (27–189) | 80 (29–196) | .7 |
| Presenting associated symptoms | ||||
| Abdominal pain | 241 (39.8) | 76 (68.5) | 165 (33.4) | <.001 |
| Fever | 154 (25.5) | 56 (50.5) | 98 (19.8) | <.001 |
| Bloody stools | 50 (8.3) | 26 (23.4) | 24 (4.9) | <.001 |
| Highest grade of diarrhea | .01 | |||
| I/II | 454 (75.0) | 73 (65.8) | 381 (77.1) | |
| III/IV | 151 (25.0) | 38 (34.2) | 113 (22.9) | |
| Highest grade of colitis | .05 | |||
| I/II | 492 (81.3) | 83 (74.8) | 409 (82.8) | |
| III/IV | 113 (18.7) | 28 (25.2) | 85 (17.2) | |
| Duration of diarrhea categories | .6 | |||
| Acute (<14 d) | 418 (69.1) | 81 (73.0) | 337 (68.2) | |
| Persistent (14–30 d) | 95 (15.7) | 16 (14.4) | 79 (16.0) | |
| Chronic (>30 d) | 92 (15.2) | 14 (12.6) | 78 (15.8) | |
| Underwent lower endoscopy | 133 (22.0) | 14 (12.6) | 119 (24.1) | .01 |
| Time to endoscopic assessment, median (IQR), d | 12 (3–31) | 16 (3–50) | 10 (3–31) | .7 |
| Mayo endoscopic score, N | 133 | 14 | 119 | <.01 |
| Score 0 | 24 (18.0) | 4 (28.6) | 20 (16.8) | |
| Score 1 | 65 (48.9) | 2 (14.3) | 63 (52.9) | |
| Score 2 | 36 (27.1) | 4 (28.6) | 32 (26.9) | |
| Score 3 | 8 (6.0) | 4 (28.6) | 4 (3.4) | |
| Colitis histologic subtype, N | 133 | 14 | 119 | .08 |
| Active colitis | 45 (33.8) | 5 (35.7) | 35 (29.4) | |
| Chronic active colitis | 40 (30.1) | 2 (14.3) | 43 (36.1) | |
| Microscopic colitis | 12 (9.0) | 0 (0.0) | 12 (10.1) | |
| GVHD-like (apoptosis) | 7 (5.3) | 2 (14.3) | 5 (4.2) | |
| Normal mucosa | 29 (21.8) | 5 (35.7) | 24 (20.2) | |
| Hospitalization for diarrhea | 225 (37.2) | 46 (41.4) | 179 (36.2) | .3 |
| Steroid treatment for concomitant irEC | 208 (34.4) | 27 (24.3) | 181 (36.6) | .01 |
| Duration of steroid treatment, median, (IQR), d | 41 (24–72) | 42 (24–95) | 41 (23–70) | .8 |
| Time from CDI testing to steroid initiation, median (IQR), d | 1 (0–6) | 2 (0–12) | 1 (0–6) | .7 |
| Second-line immunosuppressivesa | 90 (14.9) | 9 (8.1) | 81 (16.4) | .03 |
| Time to clinical response,b median (IQR), d | 7 (4–14) | 8 (4–13) | 7 (4–15) | .6 |
| Time to sustained response,c median (IQR), d | 8 (4–16) | 8 (4–20) | 8 (4–16) | .9 |
| Recurrence of ICI-related diarrhea | 55 (9.1) | 11 (9.9) | 44 (8.9) | .7 |
| Time from diarrhea onset to recurrence, median (IQR), d | 1 (0–6) | 2 (0–12) | 1 (0–6) | .7 |
Bold indicates statistically significant P value.
Abbreviations: CDI, Clostridioides difficile infection; ICI, immune checkpoint inhibitor; GVHD, graft-versus-host disease; irEC, immune-related enterocolitis.
a
Second-line immunosuppressive agents included infliximab and vedolizumab.
b
Clinical response defined as the first observed decrease to grade ≤1 symptoms with at least one grade decrease from initial diagnosis.
c
Sustained response defined as grade ≤1 symptoms for ≥30 consecutive days.