|PATIENTS WITH EVENT, N (%)||DUPIXENT 200 OR 300 MG Q2W (N=82)||PLACEBO (N=85)|
|TEAEs||59 (72.0)||59 (69.4)|
|TEAEs (leading to permanent discontinuation)||0||1 (1.2)|
|Serious TEAEs||0||1 (1.2)|
|Most common TEAEs†|
|Dermatitis atopic (MedDRA PT)||15 (18.3)||21 (24.7)|
|Skin infection (adjudicated)||9 (11.0)||17 (20.0)|
|Skin infections excluding herpetic skin infections (adjudicated)||8 (9.8)||16 (18.8)|
|Upper respiratory tract infection (MedDRA PT)||10 (12.2)||15 (17.6)|
|Headache (MedDRA PT)||9 (11.0)||9 (10.6)|
|Conjunctivitis‡||8 (9.8)||4 (4.7)|
|Infections and infestation||34 (41.5)||37 (43.5)|
|Injection site reactions (MedDRA HLT)||7 (8.5)||3 (3.5)|
Non-herpetic skin infections reported in:
|Systemic Hypersensitivity||If a systemic hypersensitivity reaction (immediate or delayed) occurs, DUPIXENT should be discontinued immediately and appropriate therapy initiated.1|
|Conjunctivitis||Patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis should undergo ophthalmological examination, as appropriate.1|
|Asthma||Patients with comorbid asthma should not adjust or stop their asthma treatments without consulting their physicians. Monitor patients with comorbid asthma carefully following discontinuation of DUPIXENT.1|
|Helminth Infections||Patients with pre-existing helminth infections should be treated before initiating DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, DUPIXENT should be discontinued until infection resolves.1|
*One patient in the DUPIXENT Q4W group was randomised but did not receive treatment.
†By MedDRA PT, in ≥5% of patients in any treatment group.
‡Includes atopic keratoconjunctivitis, conjunctivitis, conjunctivitis allergic, conjunctivitis bacterial, and conjunctivitis viral.
AD, atopic dermatitis; AE, adverse events; MedDRA, Medical Dictionary for Regulatory Activities; MedDRA PT, MedDRA Preferred Term; Q2W, once every two weeks; Q4W, once every four weeks; SAE, serious adverse events; TCS, topical corticosteroids; TEAE, treatment-emergent adverse events.