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) |
Deaths | 0 | 0 |
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) |
vs
No serious adverse events
reported with DUPIXENT1
Non-herpetic skin infections reported in:
vs
Most types of skin infections were less common with DUPIXENT than with placebo1
vs
No discontinuation
due to adverse events with DUPIXENT1
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.
References