SAFETY DATA IN PATIENTS 12+ YEARS

^aThe asthma development program for patients aged 12 years and older included three randomized, double-blind, placebo-controlled, parallel-group, multicenter trials (DRI12544, QUEST, and VENTURE) of 24 to 52 weeks in treatment duration, which enrolled a total of 2888 subjects.

^bInjection site reactions cluster includes erythema, edema, pruritus, pain, and inflammation.

^cNone met the criteria for serious eosinophilic conditions.

• The safety population (DRI12544 and QUEST) was 12-87 years of age, of which 63% were female and 82% were White. DUPIXENT 200 mg or 300 mg was administered subcutaneously Q2W, following an initial dose of 400 mg or 600 mg, respectively
• In DRI12544 and QUEST, the proportion of subjects who discontinued treatment due to adverse events was 4% of the placebo + SOC group, 3% of the DUPIXENT 200 mg Q2W + SOC group, and 6% of the DUPIXENT 300 mg Q2W + SOC group
  

OLE, open-label extension; Q2W, once every 2 weeks; SOC, standard of care.

^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.