Established safety profile

A fully human monoclonal antibody

A total of 2,888 adult and adolescent patients with moderate-to-severe asthma were evaluated in 3 randomized, placebo-controlled, multicentre trials of 24 to 52 weeks duration (DRI12544, QUEST and VENTURE). Note: DUPIXENT® is not indicated in moderate disease. The safety pool consisted of patients from the DRI12544 and QUEST trials.

Adverse reactions occurring in ≥1% of the DUPIXENT® groups and greater than placebo (6-month safety pool)1

Table showing adverse reactions occurring in greater than or equal to 1% of the DUPIXENT groups and greater than placebo in a 6-month safety pool. The studies included in the safety pool were DRI12544 and QUEST. The table shows the rates of adverse events for DUPIXENT 200 mg every two weeks (n=779), DUPIXENT 300 mg every two weeks (n=788), and placebo (n=792). The percentage of patients experiencing injection site reactions in the DUPIXENT 200 mg Q2W group, DUPIXENT 300 mg Q2W group, and placebo group was: 14%, 18% and 6%, respectively. The percentage of patients experiencing oropharyngeal pain were 2%, 2% and 1%, respectively. The percentage of patients with eosinophilia were 2%, 2% and less than 1%. Please note that “injection-site reactions” is cross referenced to a footnote that states, “Injection-site reactions cluster includes erythema, edema, pruritus, pain, and inflammation.” “Eosinophilia” is also cross referenced to a footnote that states, “Eosinophilia is defined as blood eosinophils greater than or equal to 3,000 cells per microlitre or deemed by the investigator to be an adverse event. None met the criteria for serious eosinophilic conditions.”

Adapted from the Product Monograph.

Q2W=administered every other week.
* Injection site reactions cluster includes erythema, edema, pruritus, pain, and inflammation.
† Eosinophilia=blood eosinophils ≥3,000 cells/mcL, or deemed by the investigator to be an adverse event; 
   none met the criteria for serious eosinophilic conditions.

In the safety pool, the proportion of subjects who discontinued treatment due to adverse events was 3.2% in the DUPIXENT® 200 mg group, 6.1% of the DUPIXENT® 300 mg group and 4.3% of the combined placebo group. 

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MAT-CA-2300228
Last updated: 06/2023


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