Table 1.
Clinical Characteristics of Patients With ICI Myocarditis and Control Subjects
| Patients With Myocarditis (n = 27) | Control Subjects (n = 2,579) | P Value | |
|---|---|---|---|
| Demographics | |||
| Age at the start of ICI, y | 67.4 ± 17.5 | 63.5 ± 13.2 | 0.016 |
| Male | 20 (74.1) | 1,560 (60.5) | 0.043 |
| Race | 0.92 | ||
| Caucasian | 27 (100.0) | 2,348 (91.0) | |
| African American | 0 (0.0) | 104 (4.0) | |
| Asian | 0 (0.0) | 37 (1.4) | |
| American Indian or Alaska Native | 0 (0.0) | 7 (0.3) | |
| Other | 0 (0.0) | 53 (2.1) | |
| Unknown | 0 (0.0) | 22 (0.9) | |
| Ethnicity | 0.92 | ||
| Non-Hispanic or Latino | 27 (100.0) | 2,490 (96.5) | |
| Hispanic or Latino | 0 (0.0) | 32 (1.2) | |
| Unknown | 0 (0.0) | 56 (2.1) | |
| Past medical history | |||
| Hypertension | 15 (55.6) | 1,603 (62.2) | 0.78 |
| Hyperlipidemia | 14 (51.9) | 1,158 (44.9) | 0.77 |
| Type 2 diabetes mellitus | 7 (25.9) | 590 (22.9) | 0.93 |
| Peripheral vascular disease | 3 (11.1) | 161 (6.2) | 0.58 |
| Coronary artery disease | 12 (44.4) | 490 (19.0) | 0.004 |
| Heart failure | 8 (29.6) | 253 (9.8) | 0.003 |
| Stroke | 4 (14.8) | 238 (9.2) | 0.61 |
| Atrial flutter/fibrillation | 7 (25.9) | 366 (14.2) | 0.22 |
| Cardiovascular risk factors | |||
| History of smoking | 17 (63.0) | 1,330 (51.6) | 0.57 |
| BMI, kg/m2 | 29.1 ± 6.4 | 28.1 ± 6.4 | 0.84 |
| Cancer diagnoses | |||
| Melanoma | 13 (48.1) | 1,040 (40.3) | 0.41 |
| Lung cancer | 6 (22.2) | 632 (24.5) | 0.78 |
| Urothelial | 3 (11.1) | 400 (15.5) | 0.53 |
| Kidney | 1 (3.7) | 218 (8.5) | 0.38 |
| Gastric | 1 (3.7) | 44 (1.7) | 0.42 |
| Hepatocellular carcinoma | 1 (3.7) | 81 (3.1) | 0.87 |
| Other | 3 (11.1) | 158 (6.1) | 0.28 |
| Treatment | |||
| Ipilimumab + nivolumab | 5 (18.5) | 375 (14.5) | 0.58 |
| Ipilimumab | 0 (0.0) | 151 (6.2) | 0.40 |
| Pembrolizumab | 16 (59.3) | 1,294 (51.6) | 0.44 |
| Nivolumab | 5 (18.5) | 568 (30.4) | 0.82 |
| Atezolizumab | 0 (0.0) | 255 (10.0) | 0.10 |
| Durvalumab | 1 (3.7) | 72 (2.8) | 0.55 |
| Avelumab | 0 (0.0) | 0 (0.0) | 0.99 |
| Cemiplimab | 0 (0.0) | 0 (0.0) | 0.99 |
| Number of ICI infusions | 2.41 ± 2.32 | 8.71 ± 9.55 | <0.001 |
| ICI dose, total mg | |||
| Ipilimumab | 400 (340-1,040) | 1,023 (633.5-1,600) | 0.10 |
| Pembrolizumab | 400 (200-600) | 1,000 (400-2,400) | <0.001 |
| Nivolumab | 480 (240-720) | 1,200 (675-2,400) | 0.013 |
| Atezolizumab | — | 4,800 (2,400-9,600) | — |
| Durvalumab | 1,480 (1,480-1,480) | 7,820 (3,915-16,120) | 0.13 |
| Baseline laboratory values | |||
| CPK, IU/L | 74 (46-127) | 69 (44-120) | 0.25 |
| ALT, IU/L | 22 (16-33) | 23 (18-33) | 0.96 |
| AST, IU/L | 25 (20-33) | 22 (21-28) | 0.47 |
| LDH, IU/L | 287 (207-361) | 209 (175-275) | 0.09 |
Values are mean ± SD, n (%), median (IQR). Control subjects are defined as patients who did not develop myocarditis before death or censoring at last known follow-up. All therapies are included in counts; patients could have received more than 1 type of therapy.
ALT = alanine aminotransferase; AST = aspartate aminotransferase; BMI = body mass index; CPK = creatine phosphokinase; ICI = immune checkpoint inhibitor; LDH = lactate dehydrogenase.