Table 5.
Safety Assessment
| Placebo (n = 25) | Dupilumab (n = 26) | SCIT (n = 26) | SCIT+dupilumab (n = 26) | |
|---|---|---|---|---|
| Patients with ≥1 TEAE, n (%) | 21 (84.0) | 18 (69.2) | 24 (92.3) | 22 (84.6) |
| Patients with ≥1 serious TEAE, n (%) | 1 (4.0) | 1 (3.8) | 1 (3.8) | 2 (7.7) |
| Maximum intensity of TEAE, severe, n (%) | 1 (4.0) | 1 (3.8) | 1 (3.8) | 2 (7.7) |
| Deaths | 0 | 0 | 0 | 0 |
| TEAE leading to discontinuation of study drug | ||||
| Any TEAE leading to discontinuation of study drug (dupilumab/dupilumab placebo) permanently, n (%) |
0 | 2 (7.7) | 4 (15.4) | 1 (3.8) |
| Any TEAE leading to discontinuation of study drug (SCIT/SCIT placebo) permanently, n (%) |
0 | 1 (3.8) | 5 (19.2) | 1 (3.8) |
| Any TEAE leading to discontinuation of study drug (dupilumab/dupilumab placebo or SCIT/SCIT placebo) permanently, n (%) |
0 | 2 (7.7) | 5 (19.2) | 1 (3.8) |
| Injection site reactions (HLT), n (%) | 12 (48.0) | 9 (34.6) | 18 (69.2) | 18 (69.2) |
| Patients with TEAE (≥10% by PT), n (%) | ||||
| Injection site reaction | 8 (32.0) | 8 (30.8) | 11 (42.3) | 16 (61.5) |
| Injection site erythema | 1 (4.0) | 1 (3.8) | 2 (7.7) | 4 (15.4) |
| Injection site induration | 1 (4.0) | 0 | 5 (19.2) | 4 (15.4) |
| Injection site pruritus | 1 (4.0) | 0 | 4 (15.4) | 3 (11.5) |
| Injection site swelling | 1 (4.0) | 0 | 3 (11.5) | 2 (7.7) |
| Injection site urticaria | 1 (4.0) | 0 | 3 (11.5) | 2 (7.7) |
| Nasopharyngitis | 5 (20.0) | 5 (19.2) | 1 (3.8) | 10 (38.5) |
| Viral upper respiratory tract infection | 3 (12.0) | 0 | 0 | 1 (3.8) |
| Upper respiratory tract infection | 5 (20.0) | 4 (15.4) | 1 (3.8) | 0 |
| Hypersensitivity | 0 | 0 | 5 (19.2) | 8 (30.8) |
| Headache | 3 (12.0) | 1 (3.8) | 1 (3.8) | 1 (3.8) |
| Nausea | 3 (12.0) | 0 | 2 (7.7) | 2 (7.7) |
| Nasal congestion | 1 (4.0) | 1 (3.8) | 3 (11.5) | 0 |
| Patients with ≥1 rescue medication for allergic reaction to SCIT during study, n (%) | 0 | 2 (7.7) | 14 (53.8) | 14 (53.8) |
| Patients with ≥1 epinephrine dose, n (%) | 0 | 1 (3.8) | 5 (19.2) | 2 (7.7) |
| Patients with ≥1 oral antihistamine dose, n (%) | 0 | 2 (7.7) | 12 (46.2) | 12 (46.2) |
| Patients with ≥1 oral steroid, n (%) | 0 | 0 | 5 (19.2) | 2 (7.7) |
| Patients with ≥1 topical steroid, n (%) | 0 | 0 | 2 (7.7) | 1 (3.8) |
| Patients with ≥1 SABA, n (%) | 0 | 0 | 2 (7.7) | 4 (15.4) |
| Patients achieving maintenance dose of SCIT during 16-week treatment period, n (%) | N/A | N/A | 12 (46.2) | 16 (61.5) |
Abbreviations: HLT, MedDRA high-level term; MedDRA, Medical Dictionary for Regulatory Activities; N/A, not applicable; PT, MedDRA preferred-term; SABA, short-acting beta agonist; SCIT, subcutaneous immunotherapy; TEAE, treatment-emergent adverse event.