tract infection
DUPIXENT demonstrated safety data in asthma patients requiring OCS2
Adverse events occurring in ≥5% of patients in either group in VENTUREd
DUPIXENT 300 mg
Q2W + SOC
(n=103) n (%)
tract infection
9 (9)
Bronchitis
7 (7)
7 (7)
3 (3)
14 (14)
9 (9)
eosinophil count >3000 cells/μL
13 (13)
PLACEBO + SOC (n=107) n (%)
tract infection
19 (18)
Bronchitis
6 (6)
4 (4)
6 (6)
1 (1)
4 (4)
eosinophil count >3000 cells/μL
1 (1)
dAdverse events in this category were reported according to preferred terms in the Medical Dictionary for Regulatory Activities (MedDRA), version 20.0.
eThe adverse event of eosinophilia in this table is a combination of the preferred items of eosinophil count increase (in 7% of the patients in the DUPIXENT group vs no patients in the placebo group) and eosinophilia (7% vs 1%).
fInjection site reaction is a high-level term in MedDRA.
-
The safety population (VENTURE) included all patients who received at least 1 dose or a partial
dose
of DUPIXENT or placebo; data were analyzed according to the regimen received
OCS, oral corticosteroid; OLE, open-label extension; Q2W, once every 2
weeks;
SOC, standard of care.