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: Higher rate with DUPIXENT2,3
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 long-term safety profile of DUPIXENT 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 and/or until a parasitic (helminth)
infection resolves in a patient who does not respond to anti-helminth treatment.1

In clinical trials, patients were less likely to use rescue medication with
DUPIXENT vs placebo2,3

DUPIXENT clinical trials included adult and adolescent patients with a history of immunosuppressant use2,3

24%
of adolescent patients treated with DUPIXENT + TCS had a history of using immunosuppressantsa
0%
of adolescent patients required immunosuppressants as a rescue medication while on DUPIXENT in Trial 6b

DUPIXENT is not a steroid treatment or an immunosuppressant1

There is no requirement for initial lab testing or ongoing lab monitoring according to the Prescribing Information1

Avoid use of live vaccines with DUPIXENT2

aRefers to systemic nonsteroidal immunosuppressants.

bThese patients were considered nonresponders.

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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 [published online November 6, 2019]. JAMA Dermatol. doi:10.1001/jamadermatol.2019.3336