Table 3.
Clinical Presentation and Outcomes of CDI-Positive Patients Treated With Antibiotics and Steroids Versus Antibiotics Alone
| Characteristic | Total CDI-Positive Patients n (%) |
Antibiotics + Steroids n (%) |
Antibiotics Alone n (%) |
P Value |
|---|---|---|---|---|
| Total | 111 | 27 | 84 | |
| Time from ICI therapy initiation to diarrhea onset, median (IQR), d | 92.3 (168.3) | 122.7 (158.2) | 88.2 (151.6) | .62 |
| Presenting associated symptoms | ||||
| Abdominal pain | 76 (68.5) | 24 (88.9) | 52 (61.9) | .01 |
| Fever | 56 (50.5) | 15 (55.6) | 41 (48.8) | .5 |
| Bloody stools | 26 (23.4) | 13 (48.2) | 13 (15.5) | <.01 |
| Highest grade of diarrhea | <.01 | |||
| I/II | 73 (65.8) | 9 (33.3) | 64 (76.2) | |
| III/IV | 38 (34.2) | 18 (66.7) | 20 (23.8) | |
| Highest grade of colitis | <.01 | |||
| I/II | 83 (74.8) | 8 (29.6) | 75 (89.3) | |
| III/IV | 28 (25.2) | 19 (70.4) | 9 (10.7) | |
| Duration of diarrhea categories | <.01 | |||
| Acute (<14 d) | 81 (73.0) | 10 (37.0) | 71 (84.5) | |
| Persistent (14–30 d) | 16 (14.4) | 6 (22.2) | 10 (11.9) | |
| Chronic (>30 d) | 14 (12.6) | 11 (40.8) | 3 (3.6) | |
| Underwent lower endoscopy | 14 (12.6) | 10 (24.3) | 4 (4.8) | <.01 |
| Time to endoscopic assessment, median (IQR), d | 17 (3–56) | 7 (1–140) | 35 (9–56) | .67 |
| Mayo endoscopic score | 14 | 10 | 4 | .14 |
| Score 0 | 4 (28.6) | 1 (10.0) | 3 (75.0) | |
| Score 1 | 2 (14.3) | 2 (20.0) | 0 (0) | |
| Score 2 | 4 (28.6) | 3 (30.0) | 1 (25.0) | |
| Score 3 | 4 (28.6) | 4 (40.0) | 0 (0) | |
| Colitis histologic subtype | 14 | 10 | 4 | .2 |
| Active colitis | 2 (14.3) | 1 (10.0) | 1 (25.0) | |
| Chronic active colitis | 5 (35.7) | 5 (50.0) | 0 (0) | |
| GVHD-like (apoptosis) | 2 (14.3) | 1 (10.0) | 1 (25.0) | |
| Normal mucosa | 5 (35.7) | 3 (30.0) | 2 (50.0) | |
| Hospitalization for diarrhea | 46 (41.4) | 19 (70.4) | 27 (32.1) | <.01 |
| Second-line immunosuppressives | 9 (8.1) | 9 (33.3) | 0 (0) | <.01 |
| Clostridioides difficile strain | 93 | 23 | 70 | .09 |
| Hypervirulenta | 8 (8.6) | 0 (0) | 8 (11.4) | |
| Other | 85 (91.4) | 23 (100) | 62 (88.6) | |
| Threshold cycle value, median (IQR) | 27.4 (24.4–33.2) | 26.2 (23.9–33.5) | 27.7 (24.5–33.2) | .73 |
| Severe CDI | 34 (30.6) | 9 (33.3) | 25 (29.8) | .73 |
| Fulminant CDI | 11 (9.9) | 2 (7.4) | 9 (10.7) | .62 |
| Initial CDI antibiotic treatment regimen | .84 | |||
| Vancomycin monotherapy | 61 (55.0) | 14 (51.9) | 47 (56.0) | |
| Metronidazole monotherapy | 17 (15.3) | 4 (14.8) | 13 (15.4) | |
| Vancomycin + metronidazole | 31 (27.9) | 8 (29.6) | 23 (27.4) | |
| Vancomycin + fidaxomicin | 2 (1.8) | 1 (3.7) | 1 (1.2) | |
| Time to clinical response, median (IQR), d | 8 (4–13) | 13 (8–26) | 6 (3–10) | <.01 |
| Time to sustained clinical response, median (IQR), d | 8 (4–20) | 25 (10–63) | 6 (3–11) | <.01 |
| Recurrence of CDI | 22 (19.8) | 5 (18.5) | 17 (20.2) | .85 |
| Recurrent CDI treatment regimen | .45 | |||
| Vancomycin monotherapy | 14 (63.6) | 2 (40.0) | 12 (70.6) | |
| Metronidazole monotherapy | 1 (4.6) | 0 (0) | 1 (5.9) | |
| Vancomycin + metronidazole | 4 (18.2) | 2 (40.0) | 2 (11.8) | |
| No antibiotics | 2 (9.1) | 1 (20.0) | 1 (5.9) | |
| Fecal microbiota transplant | 1 (4.6) | 0 (0) | 1 (5.9) |
Abbreviations: CDI, Clostridioides difficile infection; GVHD, graft-versus-host disease; ICI, immune checkpoint inhibitor; irEC, immune-related enterocolitis.
a
Defined as Clostridioides difficile ST-1 and ST-11.