Table 2.
Characteristics of the immune-related adverse events
| irAEs (n*) | Initial irAE(s)† (n=191) |
Second irAEs after ICI rechallenge‡ (n=77) |
||||||
| Initial irAEs (%) | Grade | Systemic corticosteroids |
Second irAEs (%) | Grade | Systemic corticosteroids |
|||
| 2 | 3/4 | 2 | 3/4 | |||||
| Gastrointestinal disorders (71) | 24.6 | 17 | 30 | 35§ | 31.2 | 15 | 9 | 20¶ |
| Colitis (57) | 19.4 | 13 | 24 | 30 | 26.0 | 12 | 8 | 17 |
| Pancreatic disorders (13) | 4.7 | 3 | 6 | 5 | 5.2 | 3 | 1 | 3 |
| Gastritis (1) | 0.5 | 1 | – | – | – | – | – | – |
| Endocrine disorders (41) | 17.8 | 23 | 11 | 4 | 9.1 | 4 | 3 | 1 |
| Hyperthyroidism (13) | 6.3 | 10 | 2 | 4 | 1.3 | 1 | – | 1 |
| Hypophysitis (10) | 4.7 | 5 | 4 | – | 1.3 | 1 | – | – |
| Diabetes (8) | 2.1 | 2 | 2 | – | 5.2 | 1 | 3 | – |
| Hypothyroidism (5) | 2.6 | 4 | 1 | – | 1.3 | – | – | – |
| Adrenal insufficiency (5) | 2.1 | 2 | 2 | – | 1.3 | 1 | – | – |
| Hepatitis (39) | 16.2 | 12 | 19 | 17§ | 10.4 | 2 | 6 | 7 |
| Respiratory disorders (28) | 11.0 | 15 | 6 | 15 | 9.1 | 5 | 2 | 4 |
| Pneumonitis (24) | 9.4 | 12 | 6 | 15 | 7.8 | 4 | 2 | 4 |
| Pulmonary sarcoidosis (2) | 1.0 | 2 | – | – | – | – | – | – |
| Pulmonary embolism (2) | 0.5 | 1 | – | – | 1.3 | 1 | – | – |
| Skin disorders (28) | 9.4 | 9 | 9 | 8§ | 13.0 | 6 | 4 | 6 |
| Musculoskeletal disorders (17) | 5.8 | 8 | 3 | 11§ | 7.8 | 5 | 1 | 3¶ |
| Arthritis/arthralgia (14) | 4.7 | 6 | 3 | 9 | 6.5 | 5 | – | 2 |
| Myositis (3) | 1.0 | 2 | – | 2 | 1.3 | – | 1 | 1 |
| Renal and urinary disorders (16) | 5.2 | 6 | 4 | 5 | 7.8 | 6 | – | 6 |
| Neurological disorders (8) | 3.1 | 4 | 2 | 5 | 2.6 | 1 | 1 | 1 |
| Hematological disorders (8) | 3.1 | 2 | 4 | 4 | 2.6 | 2 | – | – |
| Ocular disorders (7) | 2.6 | 3 | 2 | 1 | 2.6 | 2 | – | 2 |
| Cardiac disorders (5) | 1.0 | – | 2 | – | 3.9 | 2 | 1 | 2 |
| Total (268) | 100.0 | 99 | 92 | 105** | 100.0 | 50 | 27 | 52†† |
Detailed data on recurrent irAEs are shown in online supplemental table.
The bold values refer to organ involvement. Non bold values refer to more precise diseases.
*Including initial and second irAEs.
†191 grade ≥2 irAEs led to discontinuation in 180 patients.
‡77 recurrent and/or new onset irAEs occurred in 70 patients.
§Immunosuppressive drugs were required in 11 initial irAEs (nine patients): colitis (n=5), hepatitis (n=3), arthritis (n=2) and lichenoid dermatitis (n=1).
¶Immunosuppressive drugs were required in 6 second irAEs (six patients): colitis (n=5) and arthritis (n=1).
**Missing data in four initial irAEs.
††Missing data in 13 second irAEs.
ICI, immune checkpoint inhibitor; IrAE, immune-related adverse event.