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. 2021 Oct 1;77(4):1231–1244. doi: 10.1111/all.15067

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.