Safety Consistent in Children, Adolescents, and Adults

The most common adverse reactions (incidence ≥1% at Week 16) in adult patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye.1

The safety profile of DUPIXENT + TCS in patients aged 6 to 11 years through Week 16 was similar to the safety profile from studies in adults and adolescents with atopic dermatitis.1

Safety in Children Demonstrated Up to Week 162

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on Adverse Reactions

Adverse reactions occurring in ≥2% of children through Week 16 and higher rate with DUPIXENT
Adverse reaction <30 kg: 300 mg Q4W ≥30 kg: 200 mg Q2W
DUPIXENT 300 mg
Q4W + TCS
(n=60)
n (%)
Placebo + TCS

(n=60)
n (%)
DUPIXENT 200 mg
Q2W + TCS
(n=59)
n (%)
Placebo + TCS

(n=60)
n (%)
Upper respiratory tract infection 9 (15) 5 (8.3) 5 (8.5) 7 (11.7)
Injection site reaction 6 (10) 4 (6.7) 8 (13.6) 3 (5)
Nasopharyngitis 6 (10) 2 (3.3) 2 (3.4) 6 (10)
Conjunctivitisa 4 (6.7) 2 (3.3) 5 (5.5) 3 (5)
Vomiting 3 (5) 4 (6.7) 4 (6.8) 4 (6.7)
Pyrexia 3 (5) 4 (6.7) 1 (1.7) 0
Abdominal Pain 1 (1.7) 2 (3.3) 2 (3.4) 1 (1.7)
Diarrhea 1 (1.7) 1 (1.7) 2 (3.4) 1 (1.7)
Molluscum contagiosum 1 (1.7) 0 2 (3.4) 1 (1.7)
Bronchitis 1 (1.7) 0 2 (3.4) 0
Pharyngitis streptococcal 0 2 (3.3) 2 (3.4) 1 (1.7)
Erythema 2 (3.3) 0 1 (1.7) 0
Alopecia 2 (3.3) 0 0 0
Skin papilloma 2 (3.3) 0 0 0
  1. Conjunctivitis cluster includes conjunctivitis bacterial, conjunctivitis, conjunctivitis allergic, conjunctivitis viral, and eye irritation

Long-term Safety Observed in Children

The long-term safety of DUPIXENT + TCS in children was assessed in an open-label extension study (Trial 7)1

  • The safety profile through Week 52 was similar to the safety profile observed through Week 16 in Trial 8
  • The long-term safety profile of DUPIXENT + TCS in children was consistent with that seen in adults and adolescents

Discontinuation rates due to adverse events in children treated with DUPIXENT + TCS were comparable to those with placebo + TCS2,b

  • 0.8% of children treated with DUPIXENT + TCS (n=242) discontinued treatment through Week 16 vs 1.7% of children treated with placebo + TCS (n=120) discontinued treatment through Week 16 (Trial 8)

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 treatment.1

Avoid use of live vaccines in patients treated with DUPIXENT.1

DUPIXENT clinical trials included children with a history of systemic steroid use2,b

Trial 8 (history of systemic steroid use)

23%
of children treated with DUPIXENT + TCS (n=242) vs 14% with placebo + TCS (n=120) had a history of using systemic steroids

Trial 8 (systemic steroid rescue medication use)

0%
of children required systemic steroids as a rescue medication while on DUPIXENT + (n=242) vs 5% with placebo + TCS (n=120) through Week 16 in Trial 8c

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

  • Overall, in children through Week 16, 3% of all DUPIXENT patients required some rescue therapy vs 20% of all placebo patients

In this clinical trial, a numerically smaller proportion of DUPIXENT patients required systemic steroids as a rescue medication vs placebo + TCS2

bAnalysis done in overall study population.

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

NOT an immunosuppressant or a steroid1

According to the Prescribing Information

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

DUPIXENT demonstrated a generally consistent safety profile across multiple age populations, including patients aged as young as 6 years1

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References:
  1. DUPIXENT Prescribing Information.
  2. Data on file, Regeneron Pharmaceuticals, Inc.