Table 4.
Summary of concomitant corticosteroid use for immune-mediated AEs.
| No corticosteroid | Low-dose corticosteroid (40 mg/day prednisone equivalent) | High-dose corticosteroid (≥ 40 mg/day prednisone equivalent) | |||||
|---|---|---|---|---|---|---|---|
|
|
|
|
|||||
| Episodes, n/N (%) | Episodes, n/N (%) | Starting dose, median (range), mg/day | Duration, median (range), days | Episodes, n/N (%) | Starting dose, median (range), mg/day | Duration, median (range), days | |
| Any immune-mediated AE | 1842/2657 (69.3) | 220/2657 (8.3) | 20 (1–38) | 8 (1–1239) | 592/2657 (22.3) | 75 (40–1250) | 7 (1–1607) |
| Adrenal insufficiencya | 12/72 (16.7) | 44/72 (61.1) | 8 (1–38) | 16 (1–504) | 15/72 (20.8) | 67 (40–126) | 2 (1–164) |
| Arthritis | 1/5 (20.0) | 1/5 (20.0) | 5 (5–5) | 120 (120–120) | 3/5 (60.0) | 53 (40–60) | 3 (2–5) |
| Colitisa | 59/184 (32.1) | 14/184 (7.6) | 28 (1–33) | 7 (2–31) | 110/184 (59.8) | 64 (40–625) | 7 (1–369) |
| Encephalitis | 2/7 (28.6) | 2/7 (28.6) | 2 (1–3) | 5 (4–5) | 3/7 (42.9) | 267 (80–1250) | 2 (1–3) |
| Guillain-Barré syndrome | 5/8 (62.5) | 0/8 (0) | – | – | 3/8 (37.5) | 90 (63–107) | 7 (1–421) |
| Hepatitis | 27/89 (30.3) | 6/89 (6.7) | 23 (10–27) | 8 (1–715) | 56/89 (62.9) | 80 (40–625) | 5 (1–66) |
| Hyperthyroidism | 354/370 (95.7) | 4/370 (1.1) | 18 (10–30) | 31 (13–44) | 12/370 (3.2) | 73 (40–100) | 6 (1–50) |
| Hypoparathyroidism | 5/5 (100) | 0/5 (0) | – | – | 0/5 (0) | – | – |
| Hypophysitis | 4/42 (9.5) | 25/42 (59.5) | 10 (3–25) | 60 (1–1239) | 13/42 (31.0) | 63 (40 –160) | 4 (1–29) |
| Hypothyroidism | 1001/1018 (98.3) | 9/1018 (0.9) | 10 (3–25) | 57 (1–296) | 8/1018 (0.8) | 60 (40–625) | 6 (2–22) |
| Myasthenic syndrome | 1/3 (33.3) | 0/3 (0) | – | – | 2/3 (66.7) | 675 (100–1250) | 5 (3–7) |
| Myelitis | 0/2 (0) | 1/2 (50.0) | 1 (1–1) | 3 (3–3) | 1/2 (50.0) | 142 (142–142) | 1 (1–1) |
| Myocarditis | 1/9 (11.1) | 2/9 (22.2) | 19 (4–33) | 4 (3–5) | 6/9 (66.7) | 103 (65–725) | 5 (1–9) |
| Myositis | 24/44 (54.5) | 7/44 (15.9) | 20 (5–27) | 15 (4–22) | 13/44 (29.5) | 80 (40–1000) | 9 (1–71) |
| Nephritis | 5/39 (12.8) | 2/39 (5.1) | 25 (20–30) | 29 (12–46) | 32/39 (82.1) | 73 (40–625) | 9 (1–121) |
| Optic neuritis | 0/1 (0) | 0/1 (0) | – | – | 1/1 (100) | 80 (80–80) | 10 (10–10) |
| Pancreatitis | 21/38 (55.3) | 3/38 (7.9) | 13 (10–20) | 7 (2–318) | 14/38 (36.8) | 78 (40–213) | 6 (1–1110) |
| Pneumonitisa | 120/423 (28.4) | 58/423 (13.7) | 25 (1–38) | 8 (1–168) | 244/423 (57.7) | 75 (40–1250) | 7 (1–1607) |
| Sarcoidosis | 4/5 (80.0) | 0/5 (0) | – | – | 1/5 (20.0) | 60 (60–60) | 36 (36–36) |
| Severe skin reactions | 74/155 (47.7) | 37/155 (23.9) | 20 (1–38) | 8 (1–198) | 44/155 (28.4) | 75 (40–267) | 7 (1–153) |
| Thyroiditis | 61/68 (89.7) | 3/68 (4.4) | 8 (5–8) | 5 (3–22) | 4/68 (5.9) | 74 (60–725) | 4 (1–22) |
| Type 1 diabetes mellitus | 36/38 (94.7) | 0/38 (0) | – | – | 2/38 (5.3) | 64 (60–69) | 4 (3–4) |
| Uveitis | 24/28 (85.7) | 2/28 (7.1) | 30 (30–30) | 6 (1–11) | 2/28 (7.1) | 50 (40–60) | 12 (7–17) |
| Vasculitis | 1/4 (25.0) | 0/4 (0) | – | – | 3/4 (75.0) | 60 (60–75) | 7 (6–29) |
AE, adverse event.
a
Starting dose missing for one episode.