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DUPIXENT demonstrated a safety profile in clinical studies that was 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 atopic dermatitis (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 FREQUENCY ADVERSE REACTION
Infections and infestations ≥1% to <10% Conjunctivitis, oral herpes
Blood and lymphatic system disorders ≥1% to <10% Eosinophilia
Immune system disorders <0.01% Serum sickness/serum sickness-like reactions
Not known Anaphylactic reaction, Angiodema
Nervous system disorders ≥1% to <10% Headache
Eye disorders ≥1% to <10% Conjunctivitis allergic, eye pruritus, blepharitis
≥0.1% to 1% Keratitis, Ulcerative keratitis
Musculoskeletal and connective tissue disorders Not known Arthralgia
General disorders and administration site conditions Not known Injection site reactions
  • 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 placebo observed a similar safety profile to that seen for up to 52 weeks1,3

ADOLESCENT SAFETY PROFILE

*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
From post-marketing reporting.


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: December 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.