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Adolescent 16-week safety profile is consistent with adults1,2

  • Adolescent safety was evaluated in a randomised, placebo-controlled, double-blind, parallel-group, multi-centre, Phase 3 trial of moderate-to-severe atopic dermatitis (AD) adolescents whose disease was inadequately controlled by TCS
  • Patients were randomised to receive either a) 200/300 mg DUPIXENT Q2W (n=82) (licensed dose), b) 300 mg DUPIXENT Q4W (n=84) or c) placebo Q2W (n=85) for 16 weeks*

Adverse events in ≥5% of patients during the 16-week treatment period in the adolescent trial*1,2

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)
  • There were no study discontinuations due to TEAEs in any of the DUPIXENT groups, one patient in the placebo group discontinued study treatment due to TEAEs (unrelated to study drug)2
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)

The Adolescent 16-week trial showed:

0%

DUPIXENT

vs

1.2%

Placebo

No serious adverse events
reported with DUPIXENT2

Non-herpetic skin infections reported in:

10%

DUPIXENT

vs

19%

Placebo

Most types of skin infections were less common
with DUPIXENT than with placebo2

0%

DUPIXENT

vs

1.2%

Placebo

No discontinuation
due to adverse events with DUPIXENT2

DUPIXENT:

  • Does not require routine laboratory monitoring1
  • Is a targeted immunomodulator1
  • Is not associated with increased overall risk of infections, including serious and opportunistic1
  • Antibody response to non-live vaccines were similar to placebo groups1

52 Weeks

  • The long-term safety of DUPIXENT was assessed in an open-label extension trial (AD-1434) up to 52 weeks in adolescents (aged 12–17)1,3
  • The safety profile at Week 52 was similar to the safety profile observed at Week 16 in adults and adolescents1

Precautions for use1

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

  1. DUPIXENT Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/8553/smpc. Date accessed: February 2021.
  2. Simpson EL, et al. JAMA Dermatol. 2020;156(1):44–56.
  3. Cork MJ, et al. Br J Dermatol. 2020;182(1):85–96.