Table 3.
Summary of immune-mediated AEs and infusion reactions.
| 31-trial pooled safety dataset | Label safety dataset [1] | |||
|---|---|---|---|---|
| N = 8937 | N = 2799 | |||
|
| ||||
| Immune-mediated AEs or infusion reactions | 2121 (23.7) | 601 (21.5) | ||
| Grade 3–5 AEs | 563 (6.3) | 155 (5.5) | ||
| Serious AEs | 538 (6.0) | 162 (5.8) | ||
| Led to discontinuation | 326 (3.6) | 86 (3.1) | ||
| Led to death | 22 (0.2)a | 4 (0.1)b | ||
| Any immune-mediated AE or infusion reaction | Any grade | Grade 3–5 | Any grade | Grade 3–5 |
| Hypothyroidism | 939 (10.5) | 11 (0.1) | 237 (8.5) | 3 (0.1) |
| Pneumonitis | 375 (4.2) | 125 (1.4) | 94 (3.4) | 36 (1.3) |
| Hyperthyroidism | 356 (4.0) | 8 (0.1) | 96 (3.4) | 4 (0.1) |
| Infusion reactions | 183 (2.0) | 16 (0.2) | 70 (2.5) | 6 (0.2) |
| Colitis | 165 (1.8) | 95 (1.1) | 48 (1.7) | 32 (1.1) |
| Severe skin reactions | 142 (1.6) | 109 (1.2) | 39 (1.4) | 30 (1.1) |
| Hepatitis | 86 (1.0) | 68 (0.8) | 18 (0.6) | 13 (0.5) |
| Adrenal insufficiency | 69 (0.8) | 36 (0.4) | 22 (0.8) | 10 (0.4) |
| Thyroiditis | 65 (0.7) | 4 (< 0.1) | 16 (0.6) | 0 |
| Hypophysitis | 41 (0.5) | 23 (0.3) | 17 (0.6) | 9 (0.3) |
| Myositis | 39 (0.4) | 11 (0.1) | 11 (0.4) | 1 (< 0.1) |
| Nephritis | 39 (0.4) | 20 (0.2) | 9 (0.3) | 5 (0.2) |
| Pancreatitis | 35 (0.4) | 22 (0.2) | 9 (0.3) | 6 (0.2) |
| Type 1 diabetes mellitus | 29 (0.3) | 26 (0.3) | 6 (0.2) | 5 (0.2) |
| Uveitis | 27 (0.3) | 3 (< 0.1) | 14 (0.5) | 1 (< 0.1) |
| Myocarditis | 9 (0.1) | 8 (0.1) | 0 | 0 |
| Guillain-Barré syndrome | 8 (0.1) | 6 (0.1) | 2 (0.1) | 1 (< 0.1) |
| Encephalitis | 7 (0.1) | 6 (0.1) | 1 (< 0.1) | 1 (< 0.1) |
| Hypoparathyroidism | 5 (0.1) | 0 | 1 (< 0.1) | 0 |
| Sarcoidosis | 5 (0.1) | 0 | 2 (0.1) | 0 |
| Arthritis | 4 (< 0.1) | 4 (< 0.1) | 0 | 0 |
| Vasculitis | 4 (< 0.1) | 3 (< 0.1) | 2 (0.1) | 1 (< 0.1) |
| Myasthenic syndrome | 3 (< 0.1) | 2 (< 0.1) | 2 (0.1) | 1 (< 0.1) |
| Myelitis | 2 (< 0.1) | 2 (< 0.1) | 1 (< 0.1) | 1 (< 0.1) |
| Optic neuritis | 1 (< 0.1) | 0 | 1 (< 0.1) | 0 |
AE, adverse event.
Data are n (%).
a
A total of 22 patients (0.2%) in the 31-trial pooled safety dataset died due to an immune-mediated AE (pneumonitis, n = 15; colitis, n = 2; myocarditis, n = 2; Guillain-Barré syndrome, n = 1; myositis, n = 1; severe skin reaction, n = 1).
b
Four patients (0.1%) in the label safety dataset died due to an immune-mediated AE (pneumonitis, n = 4).