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DUPIXENT demonstrated a safety profile in clinical studies that is consistent in both adults and adolescents

  • DUPIXENT has a long-term safety and tolerability profile that has been investigated up to 3 years in clinical trials in adults1,2
  • The long-term safety profile seen in adults is similar to the safety profile of adolescents in a 16-week, Phase 3 trial1,3

Adverse reactions to DUPIXENT in interventional AD clinical trials in adults*1

  • The safety of DUPIXENT was evaluated in four randomised, double-blind, placebo-controlled trials and one dose-ranging trial in adult patients with moderate-to-severe AD1
  • In these five trials, 1,689 subjects were treated with subcutaneous injections of DUPIXENT, with or without concomitant TCS1
  • In these five trials, a total of 305 patients were treated with DUPIXENT for at least 1 year1
  • DUPIXENT was monitored in adolescents with moderate-to-severe AD (12–17 years old) in a 16-week trial that had a similar safety profile to the adult trials1
SYSTEM ORGAN CLASS ADVERSE REACTION FREQUENCY
General disorders and administration site conditions Injection site reactions Very common (≥10%)
Infections and infestations Conjunctivitis, oral herpes Common (≥1% to <10%)
Blood and lymphatic system disorders Eosinophilia Common (≥1% to <10%)
Nervous system disorders Headache Common (≥1% to <10%)
Eye disorders Allergic conjunctivitis, eye pruritus, blepharitis Common (≥1% to <10%)
Immune system disorders Serum sickness/serum-sickness-like reactions Very rare (0 to <0.0001%)
  • The safety profile of DUPIXENT in adolescents was explored further for up to 1 year
    in which the results were similar to the 16-week adolescent trial1

Adults

2,677 adult moderate-to-severe AD patients investigated for up to 3 years with DUPIXENT in an open label extension (OLE) trial1,2

ADULT SAFETY PROFILE

Not an actual patient.

Not an actual patient.

Adolescents

251 adolescent moderate-to-severe AD patients investigated for up to 16 weeks with DUPIXENT compared to placebo1,3

ADOLESCENT SAFETY PROFILE

Adult trial design

Learn more about how the adult trials have been designed.

Find out more

Dosing

Learn more about how DUPIXENT can be administered.

Find out more

Adolescent trial design

Learn more about how the adolescent trial has been designed.

Find out more

*Pooled data from placebo-controlled monotherapy clinical studies and placebo-controlled concomitant therapy with TCS study; patients exposed to DUPIXENT 300 mg QW or 300 mg Q2W.1

AD, atopic dermatitis; OLE, open label extension; QW, once weekly; Q2W, once every two weeks; TCS, topical corticosteroids.

References

  1. DUPIXENT Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/8553/smpc. Date accessed: March 2020.
  2. Thaçi D, et al. Favorable Safety and Sustained Efficacy With Long-Term Dupilumab Treatment in Adults With Moderate-to-Severe Atopic Dermatitis: An Analysis up to 3 Years (LIBERTY AD OLE) presented at the 20th Annual Las Vegas Dermatology Seminar, Nevada, USA, November 7–9 2019.
  3. 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.
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