TABLE 3.
Summary of safety over 24 weeks among patients with CRSwNP with and without NSAID‐ERD
| Patients with CRSwNP with NSAID‐ERD a | Patients with CRSwNP without NSAID‐ERD a | |||
|---|---|---|---|---|
| Patients, n (%) |
Placebo (n = 82) |
Dupilumab 300 mg q2w (n = 121) |
Placebo (n = 200) |
Dupilumab 300 mg q2w (n = 319) |
| Any TEAE | 65 (79.3) | 85 (70.2) | 143 (71.5) | 220 (69.0) |
| Any serious TEAE | 5 (6.1) | 6 (5.0) | 11 (5.5) | 9 (2.8) |
| Any TEAE leading to death | 0 | 0 | 0 | 0 |
| Any TEAE leading to permanent treatment discontinuation | 4 (4.9) | 4 (3.3) | 11 (5.5) | 7 (2.2) |
| TEAEs occurring in ≥5% of patients (MedDRA PT), n (%) | ||||
| Nasopharyngitis | 12 (14.6) | 19 (15.7) | 29 (14.5) | 36 (11.3) |
| Upper respiratory tract infection | 5 (6.1) | 2 (1.7) | NA | NA |
| Headache | 10 (12.2) | 8 (6.6) | 14 (7.0) | 24 (7.5) |
| Asthma | 10 (12.2) | 5 (4.1) | 10 (5.0) | 2 (0.6) |
| Nasal polyps | 12 (14.6) | 4 (3.3) | 21 (10.5) | 8 (2.5) |
| Arthralgia | 0 | 8 (6.6) | NA | NA |
| Acute sinusitis | NA | NA | 11 (5.5) | 5 (1.6) |
| Epistaxis | NA | NA | 16 (8.0) | 21 (6.6) |
| Injection‐site erythema | 9 (11.0) | 13 (10.7) | 13 (6.5) | 15 (4.7) |
Abbreviations: CRSwNP, chronic rhinosinusitis with nasal polyps; MedDRA, Medical Dictionary for Regulatory Activities; NA, not available; NSAID‐ERD, non‐steroidal anti‐inflammatory drug‐exacerbated disease; PT, Preferred Term; q2w, every 2 weeks; TEAE, treatment‐emergent adverse event.
a
One patient in each patient group (with NSAID‐ERD, without NSAID‐ERD) was randomized but not treated.