| PATIENTS WITH EVENT, n (%) | DUPIXENT 200 OR 300 MG Q2W (n=82) n (%) |
PLACEBO (n=85) n (%) |
|---|---|---|
| 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† | n (%) | n (%) |
| 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) |
| SAFETY OVERVIEW§ | DUPIXENT 2 MG KG-1 (n=17) |
DUPIXENT 4 MG KG-1 (n=19) |
|---|---|---|
| Total TEAEs | 161 | 253 |
| Total serious TEAEs | 3 | 0 |
| Total TEAEs related to DUPIXENT | 6 | 19 |
| Total serious TEAEs related to DUPIXENT | 0 | 0 |
| FULL TEAE PROFILE | n (%) | n (%) |
| Any infection (SOC) | 14 (82) | 17 (89) |
| Skin infection | 5 (29) | 8 (42) |
| Non-herpetic skin infections (adjudicated)|| | 3 (18) | 4 (21) |
| Herpes viral infections (HLT)¶ | 3 (18) | 4 (21) |
| Injection-site reactions (HLT)** | 3 (18) | 2 (11) |
| Conjunctivitis†† | 3 (18) | 3 (16) |
| MOST COMMON TEAES‡‡ | DUPIXENT 2 MG KG-1 (n=17) n (%) |
DUPIXENT 4 MG KG-1 (n=16) n (%) |
|---|---|---|
| Nasopharyngitis | 7 (41) | 9 (47) |
| Dermatitis atopic | 5 (29) | 8 (42) |
| Headache | 6 (35) | 5 (26) |
| Oropharyngeal pain | 4 (24) | 5 (26) |
| Tonsilitis | 1 (6) | 5 (26) |
| Upper respiratory tract infection | 4 (24) | 4 (21) |
| Diarrhoea | 4 (24) | 4 (21) |
| Oral Herpes | 3 (18) | 4 (21) |
| Cough | 4 (24) | 2 (11) |
| Vomiting | 3 (18) | 2 (11) |
| Pyrexia | 2 (12) | 2 (11) |
| Rhinitis allergic | 3 (18) | 1 (5) |
| Dermatitis infected | 0 | 1 (5) |
vs
No serious adverse events
reported with DUPIXENT2
Non-herpetic skin infections reported in:
vs
Most types of skin infections were less common
with DUPIXENT than with placebo2
vs
No discontinuation
due to adverse events with DUPIXENT2
| 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.
§Includes all TEAEs reported up to the first visit when patients switched from weight-based dosing (2 mg kg–1 or 4 mg kg–1) to a fixed dose regimen of 300 mg every 4 weeks.3 The licensed dose of DUPIXENT for the treatment of moderate-to-severe AD for adolescents aged 12 years and older is DUPIXENT 300 mg Q2W f or adolescents ≥60 kg, or 200 mg Q2W for adolescents <60 kg.1
||Includes MedDRA PTs angular cheilitis, bacterial disease carrier, dermatitis infected, folliculitis, hordeolum, molluscum contagiosum, skin bacterial infection, staphylococcal skin infections and tinea infections.
¶Includes MedDRA PTs herpes simplex, nasal herpes and oral herpes.
**Includes MedDRA PTs injection-site oedema, injection-site haemorrhage, injection-site induration, injection-site irritation, injection-site mass and injection-site swelling.
††Includes MedDRA PTs conjunctivitis, conjunctivitis allergic and conjunctivitis bacterial.
‡‡Includes all MedDRA PTs reported in ≥10% or ≥20% of patients in any treatment group of the Phase 3 OLE.3
AD, atopic dermatitis; MedDRA, Medical Dictionary for Regulatory Activities; MedDRA HLT, MedDRA high-level term; MedDRA PT, MedDRA Preferred Term; OLE, open-label extension; Q2W, once every two weeks; Q4W, once every four weeks; SOC, MedDRA system organ class; TCS, topical corticosteroids; TEAE, treatment-emergent adverse events.
References
