Safety Consistent in Adolescents and Adults1

The safety profile of DUPIXENT in patients aged 12 to 17 years through Week 16 was similar to the safety profile from studies in adults with atopic dermatitis.

Adolescent Safety Demonstrated Up To Week 16

Adverse events in ≥2% of patients during the 16-week treatment period in
the adolescent trial and higher rate with DUPIXENT2
Adverse
events
DUPIXENT
200 mg or
300 mg Q2W
(n=82)
n (%)
Placebo
(n=85)
n (%)
Conjunctivitisa 8 (10) 4 (5)
Injection site reaction 7 (9) 3 (4)
Gastroenteritis viral 3 (4) 1 (1)
Pharyngitis streptococcal 2 (2) 0
Viral upper respiratory tract infection 2 (2) 1 (1)
Bronchitis 2 (2) 0
Sinusitis bacterial 2 (2) 0
Fatigue 2 (2) 0
Oropharyngeal pain 2 (2) 1 (1)
Nausea 2 (2) 1 (1)
Abdominal pain upper 2 (2) 1 (1)
Ligament sprain 2 (2) 0
Procedural pain 2 (2) 0

aIncludes atopic keratoconjunctivitis, conjunctivitis, conjunctivitis allergic, conjunctivitis bacterial, and conjunctivitis viral.

Fewer adolescent patients treated with DUPIXENT developed skin infections compared
with placebo in Trial 6 (11% vs 20%)2,3

Long-term Safety Observed in Adolescents

The long-term safety of DUPIXENT in adolescents was assessed in an open‑label extension trial (Trial 7) through Week 521

  • The safety profile of DUPIXENT through Week 16 and Week 52 observed in adolescents was consistent with that seen in adults with atopic dermatitis

Discontinuation rates in adolescents due to adverse events with DUPIXENT were comparable to those with placebo2,3

  • 0% of adolescent patients treated with DUPIXENT discontinued treatment through Week 16 vs 1.2% of adolescent patients treated with placebo discontinued through Week 16 (Trial 6)

Patients should discontinue DUPIXENT if a clinically significant hypersensitivity reaction occurs or until a parasitic (helminth) infection resolves in a patient who does not respond to anti-helminth treatment1

Avoid use of live vaccines in patients treated with DUPIXENT1

DUPIXENT clinical trial included adolescent patients with a history of systemic steroid use2

Trial 6 (history of systemic steroid use)

26%
of adolescent patients treated with DUPIXENT (n=82) had a history of using systemic steroids before starting DUPIXENT vs 25% with placebo (n=85)

Trial 6 (systemic steroid rescue medication use)

2%
of adolescent patients required systemic steroids as rescue medication while on DUPIXENT vs 6% with placebo through Week 16 in Trial 6b

In addition to systemic steroids, other agents were used as rescue treatment.2

  • In adolescent patients through Week 16, 21% of DUPIXENT patients required rescue therapy vs 59% of placebo patients

In this clinical trial, a numerically smaller proportion of DUPIXENT patients required systemic steroids as a rescue medication vs placebo2

bThese patients were considered nonresponders and their double-blind study medication was temporarily discontinued.2

NOT an immunosuppressant or a steroid1


According to the Prescribing Information

There is No Requirement for Initial Lab Testing or Ongoing Lab Monitoring1

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References:
  1. DUPIXENT Prescribing Information.
  2. Data on file, Regeneron Pharmaceuticals, Inc.
  3. Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: a phase 3 randomized clinical trial. JAMA Dermatol. 2020;156(1):44-56.