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  2. Atopic Dermatitis
  3. Safety and tolerability
  4. Adolescent safety and tolerability

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

  • Adolescent safety was measured 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) 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)
  • 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

The Adolescent 16-week trial showed:

0%

DUPIXENT

vs

1.2%

Placebo

No serious adverse events
reported with DUPIXENT1

Non-herpetic skin infections reported in:

10%

DUPIXENT

vs

19%

Placebo

Most types of skin infections were less common with DUPIXENT than with placebo1

0%

DUPIXENT

vs

1.2%

Placebo

No discontinuation
due to adverse events with DUPIXENT1

DUPIXENT:

  • Does not require routine laboratory monitoring1
  • Is a targeted immunomodulator, not a broad immunosuppressant or steroid tertament1,2
  • 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
  • The safety profile at Week 52 was similar to the safety profile observed at Week 16 in the AD-1526 trial1

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

Adult trial design

Learn more about how the adult trials have been designed.

Find out more

Adult Safety profile

Learn more about the safety profile of DUPIXENT in adults.

Find out more

Adolescent trial design

Learn more about how the adolescent trial has been designed.

Find out more

*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

  1. DUPIXENT Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/8553/smpc. Date accessed: December 2020.
  2. Paller A, et al. Dupilumab for Adolescents With Moderate-to-Severe Atopic Dermatitis: Results From a Phase 3, Randomized, Double-Blinded Trial (Poster 10051) presented at the 77th annual meeting of the American Academy of Dermatology, Washington, DC, USA, March 1–5 2019.