Table 3.
Clinical characteristics of the study population at ICI initiation
| irH | No irH | p-Value | |
|---|---|---|---|
| N = 97 | N = 194 | ||
| Single-agent ICI therapy | |||
| Atezolizumab | 4 (4.1%) | 4 (1.8%) | 0.070 |
| Avelumab | 0 (0%) | 1 (0.5%) | 0.580 |
| Cemiplimab | 2 (1.0%) | 0 (0%) | 0.010 |
| Durvalumab | 0 (0%) | 0 (0%) | N/A |
| Ipilimumab | 5 (5.1%) | 9 (6.0%) | 0.260 |
| Nivolumab | 13 (13.4%) | 85 (42.8%) | 0.002 |
| Pembrolizumab | 30 (30.9%) | 78 (40.2%) | 0.279 |
| Tremelimumab | 0 (0%) | 0 (0%) | N/A |
| Combination ICI Therapy | |||
| No | 54 (55.7%) | 177 (91.2%) | <0.001 |
| Yes | 43 (44.3%) | 17 (8.8%) | |
| ECOG Performance Score at ICI initiation | |||
| 0 and 1 | 71 (73.2%) | 129 (66.5%) | 0.054 |
| 2+ | 12 (12.4%) | 46 (23.7%) | |
| N/A | 14 (14.4%) | 19 (9.8%) | |
| Presence of metastases at ICI initiation | |||
| Any | 91 (93.8%) | 172 (88.7%) | 0.160 |
| Adrenal | 6 (6.2%) | 17 (8.8%) | 0.442 |
| Bladder/ureter/kidney | 6 (6.2%) | 12 (6.2%) | 1.00 |
| Bone | 26 (26.8%) | 53 (27.3%) | 0.926 |
| Bowel | 1 (1.0%) | 0 (0.0%) | 0.156 |
| Brain/CNS | 10 (10.3%) | 13 (6.7%) | 0.282 |
| Liver | 28 (28.9%) | 33 (17.0%) | 0.019 |
| Lung | 45 (46.4%) | 68 (35.1%) | 0.061 |
| Lymph node | 55 (56.7%) | 116 (59.8%) | 0.613 |
| Other | 5 (5.2%) | 19 (9.8%) | 0.175 |
| Peritoneum | 4 (4.1%) | 25 (12.9%) | 0.019 |
| Soft tissue | 19 (19.6%) | 28 (14.4%) | 0.260 |
| Vascular | 1 (1.0%) | 11 (5.7%) | 0.061 |
| Baseline liver tests | |||
| ALT | 18.0 [13.0–31.5] | 19.0 [11.0–34.5] | 0.641 |
| AST | 20.0 [17.0–26.5] | 19.0 [14.0–38.0] | 0.118 |
| AP | 69.0 [56.0–82.5] | 79.0 [61.0–133] | 0.009 |
| Total bilirubin | 0.50 [0.4–0.7] | 0.50 [0.4–0.6] | 0.325 |
| Albumin | 4.00 [3.7–4.3] | 3.80 [3.3–4.1] | 0.709 |
Descriptive categorical measures are expressed in as number (n) and percentage (%), quantitative metrics are expressed as median and IQR
Data unavailable by chart review were recorded as N/A. Case and control subsets were compared using chi-square- and t-tests
ALT alanine transaminase, AP alkaline phosphatase, AST aspartate transaminase, CNS central nervous system, ECOG Eastern Cooperative Oncology Group, ICI immune checkpoint inhibitor, IQR interquartile range, irH immune-related hepatitis, NA not applicable