Table 4.
Number (percentage) of patients with ophthalmic adverse events consistent with or suggestive of conjunctivitis, by severity in all patients
| Preferred term | Placebo ± TCS (n = 598) | Dupilumab | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 300 mg q2w ± TCS (n = 403) | 300 mg qw ± TCS (n = 596) | |||||||||||
| Mild | Moderate | Severe | Any severity | Mild | Moderate | Severe | Any severity | Mild | Moderate | Severe | Any severity | |
| Any class | 31 (5·2) | 15 (2·5) | 2 (0·3) | 47 (7·9) | 40 (9·9) | 29 (7·2) | 2 (0·5) | 64 (15·9) | 88 (14·8) | 58 (9·7) | 6 (1·0) | 130 (21·8) |
| Atopic keratoconjunctivitis | 0 | 1 (0·2) | 0 | 1 (0·2) | 0 | 0 | 0 | 0 | 2 (0·3) | 2 (0·3) | 0 | 4 (0·7) |
| Blepharitis | 2 (0·3) | 2 (0·3) | 0 | 4 (0·7) | 5 (1·2) | 2 (0·5) | 0 | 7 (1·7) | 10 (1·7) | 8 (1·3) | 1 (0·2) | 15 (2·5) |
| Conjunctival hyperaemia | 1 (0·2) | 0 | 0 | 1 (0·2) | 0 | 0 | 0 | 0 | 1 (0·2) | 0 | 0 | 1 (0·2) |
| Conjunctivitis | 4 (0·7) | 4 (0·7) | 0 | 8 (1·3) | 8 (2·0) | 7 (1·7) | 1 (0·2) | 14 (3·5) | 13 (2·2) | 10 (1·7) | 0 | 22 (3·7) |
| Conjunctivitis allergic | 16 (2·7) | 5 (0·8) | 1 (0·2) | 22 (3·7) | 15 (3·7) | 13 (3·2) | 1 (0·2) | 26 (6·5) | 37 (6·2) | 25 (4·2) | 3 (0·5) | 59 (9·9) |
| Conjunctivitis bacterial | 2 (0·3) | 4 (0·7) | 0 | 6 (1·0) | 1 (0·2) | 4 (1·0) | 0 | 5 (1·2) | 5 (0·8) | 12 (2·0) | 1 (0·2) | 14 (2·3) |
| Conjunctivitis viral | 0 | 0 | 0 | 0 | 2 (0·5) | 0 | 0 | 2 (0·5) | 1 (0·2) | 0 | 0 | 1 (0·2) |
| Dry eye | 4 (0·7) | 0 | 0 | 4 (0·7) | 2 (0·5) | 1 (0·2) | 0 | 3 (0·7) | 6 (1·0) | 4 (0·7) | 0 | 10 (1·7) |
| Eye discharge | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0·2) | 0 | 1 (0·2) |
| Eye irritation | 1 (0·2) | 0 | 1 (0·2) | 2 (0·3) | 4 (1·0) | 0 | 0 | 4 (1·0) | 5 (0·8) | 1 (0·2) | 1 (0·2) | 7 (1·2) |
| Eye pruritus | 5 (0·8) | 0 | 0 | 5 (0·8) | 3 (0·7) | 1 (0·2) | 0 | 4 (1·0) | 12 (2·0) | 3 (0·5) | 0 | 14 (2·3) |
| Foreign‐body sensation in eyes | 0 | 0 | 0 | 0 | 1 (0·2) | 0 | 0 | 1 (0·2) | 0 | 0 | 0 | 0 |
| Lacrimation increased | 2 (0·3) | 0 | 0 | 2 (0·3) | 1 (0·2) | 0 | 0 | 1 (0·2) | 4 (0·7) | 2 (0·3) | 0 | 5 (0·8) |
| Ocular hyperaemia | 1 (0·2) | 0 | 0 | 1 (0·2) | 2 (0·5) | 1 (0·2) | 0 | 3 (0·7) | 2 (0·3) | 2 (0·3) | 0 | 4 (0·7) |
| Photophobia | 0 | 0 | 0 | 0 | 1 (0·2) | 1 (0·2) | 0 | 2 (0·5) | 2 (0·3) | 0 | 0 | 2 (0·3) |
AD‐1021 and SOLO 1 data include those collected during the 16‐week treatment duration and follow‐up period; CHRONOS data include those collected during the 52‐week treatment duration and follow‐up period. If a patient developed multiple conjunctivitis events of one type of severity, the event count for that severity is one. If a patient developed multiple conjunctivitis events of different types of severity, the event count for each severity is one. qw, weekly; q2w, every 2 weeks; TCS, topical corticosteroids.