)
ADVERSE REACTIONS REPORTED IN THE BOREAS AND NOTUS TRIALS
Adverse reactions that occurred in ≥2% of adult subjects with COPD treated with DUPIXENT
and greater than placebo1
| Adverse reaction |
BOREAS and NOTUS | |
|---|---|---|
| DUPIXENT 300 mg Q2W n=938 n (%) |
Placebo n=934 n (%) |
|
| Viral infectiona | 133 (14.2) | 115 (12.3) |
| Headache | 73 (7.8) | 62 (6.6) |
| Nasopharyngitis | 73 (7.8) | 69 (7.4) |
| Back pain | 42 (4.5) | 29 (3.1) |
| Diarrheaa | 35 (3.7) | 30 (3.2) |
| Arthralgia | 29 (3.1) | 25 (2.7) |
| Urinary tract infection | 28 (3.0) | 18 (1.9) |
| Local administration reactions | 26 (2.8) | 6 (0.6) |
| Injection site reactions | 11 (1.2) | 2 (0.2) |
| Rhinitis | 24 (2.6) | 17 (1.8) |
| Eosinophiliab | 22 (2.3) | 7 (0.7) |
| Toothache | 20 (2.1) | 11 (1.2) |
| Gastritis | 19 (2) | 7 (0.7) |
aConsists of multiple similar terms.
bEosinophilia was defined as blood eosinophils ≥3000 cells/μL or deemed by the investigator to be an adverse event. None met the criteria for serious eosinophilic conditions.
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