TABLE 5.
Overview of treatment‐emergent adverse events: pooled analysis of SINUS‐24/SINUS‐52 up to week 24*
| No surgery | ≥1 prior surgery | |||
|---|---|---|---|---|
| Parameter |
Placebo (n = 97) |
Dupilumab 300 mg q2w (n = 167) |
Placebo (n = 185) |
Dupilumab 300 mg q2w (n = 273) |
| TEAEs, n (%) | ||||
| Any TEAE | 68 (70.1) | 110 (65.9) | 140 (75.7) | 195 (71.4) |
| Any serious TEAE | 3 (3.1) | 6 (3.6) | 13 (7.0) | 9 (3.3) |
| Any TEAE leading to death | 0 | 0 | 0 | 0 |
| Any TEAE leading to permanent treatment discontinuation | 5 (5.2) | 2 (1.2) | 10 (5.4) | 9 (3.3) |
| TEAEs occurring in ≥5% of patients in both subgroups, n (%)a | ||||
| Nasopharyngitis | 13 (13.4) | 20 (12.0) | 28 (15.1) | 35 (12.8) |
| Nasal polyps | 14 (14.4) | 5 (3.0) | 19 (10.3) | 7 (2.6) |
| Injection‐site erythema | 4 (4.1) | 10 (6.0) | 18 (9.7) | 18 (6.6) |
| Headache | 9 (9.3) | 9 (5.4) | 15 (8.1) | 23 (8.4) |
| Asthma | 6 (6.2) | 3 (1.8) | 14 (7.6) | 4 (1.5) |
| Epistaxis | 7 (7.2) | 10 (6.0) | 13 (7.0) | 15 (5.5) |
*Data are presented for the safety population (all patients who received ≥1 dose of a study drug).
a
According to MedDRA 21.0; nasal polyps refers to a worsening of nasal polyps, leading to surgery or systemic glucocorticoid use, and asthma refers to a worsening of asthma.
q2w = every 2 weeks; MedDRA = Medical Dictionary of Regulatory Activities; TEAE = treatment‐emergent adverse event.