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Demonstrated Safety in Adults

Three randomized, double-blind, placebo-controlled, multicenter trials (Trial 1, Trial 2, and Trial 3) and one dose-ranging trial (Trial 4) evaluated the safety of DUPIXENT in adults with moderate-to-severe atopic dermatitis. Trials 1, 2, and 4 compared the safety of DUPIXENT monotherapy to placebo through Week 16. Trial 3 compared the safety of DUPIXENT + TCS to placebo + TCS through Week 16 and Week 52.1

Safety data collected from three phase 3 trials and one dose-ranging trial (Trial 4) (N=2304)1,2

  • 49% had allergic rhinitis
  • 37% had food allergy
  • 27% had allergic conjunctivitis

Safety and efficacy of DUPIXENT have not been established in the treatment of these conditions.1

Demonstrated safety across 52 weeks in adults

The Week 52 safety profile of DUPIXENT + TCS in adults was generally consistent with the Week 16 adult safety profile.1

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on Adverse Reactions

Adverse reactions occurring in ≥1% of adult patients through Week 161
Adverse reaction DUPIXENT 300 mg Q2W monotherapya DUPIXENT 300 mg Q2W + TCSb
DUPIXENTc
(n=529)
n (%)		 Placebo
(n=517)
n (%)		 DUPIXENT + TCSc
(n=110)
n (%)		 Placebo + TCS
(n=315)
n (%)
Injection site reaction 51 (10) 28 (5) 11 (10) 18 (6)
Conjunctivitisd 51 (10) 12 (2) 10 (9) 15 (5)
Blepharitis 2 (<1) 1 (<1) 5 (5) 2 (1)
Oral herpes 20 (4) 8 (2) 3 (3) 5 (2)
Keratitise 1 (<1) 0 4 (4) 0
Eye pruritus 3 (1) 1 (<1) 2 (2) 2 (1)
Oral herpes simplex virus infectionf 10 (2) 6 (1) 1 (1) 1 (<1)
Dry eye 1 (<1) 0 2 (2) 1 (<1)
  1. Pooled analysis of Trials 1, 2, and 4 (phase 2 dose-ranging study).
  2. Analysis of Trial 3 in which subjects were on background TCS therapy.
  3. DUPIXENT 600 mg at Week 0, followed by 300 mg every 2 weeks.
  4. Conjunctivitis cluster includes conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye inflammation.
  5. Keratitis cluster includes keratitis, ulcerative keratitis, allergic keratitis, atopic keratoconjunctivitis, and ophthalmic herpes simplex.
  6. Other herpes simplex virus infection cluster includes herpes simplex, genital herpes, herpes simplex otitis externa, and herpes virus infection, but excludes eczema herpeticum.
  • Most patients experiencing conjunctivitis recovered or were recovering during the treatment period1

Select adverse events in the 52-week trial in adults

  • The rate of serious adverse events with DUPIXENT + TCS was comparable to placebo + TCS (4% vs 5%, respectively)2
  • Keratitis was reported in 4% of the DUPIXENT + TCS group and in 0% of the placebo + TCS group1
  • Conjunctivitis was reported in 16% of the DUPIXENT + TCS group and in 9% of the placebo + TCS group1

Fewer patients treated with DUPIXENT developed skin infections
compared with placebo2

  • 11% vs 18% of adults in Trial 3, respectively

Discontinuation rates in adults due to adverse events with DUPIXENT
with or without TCS were comparable to those with placebo1

1.9% of patients treated with DUPIXENT discontinued treatment through Week 16 vs 1.9% of patients treated with placebo through Week 16 (Trials 1, 2, and 4)
  • Similar discontinuation rates occurred at Week 52 in Trial 3 (1.8% with DUPIXENT + TCS vs 7.6% with placebo + TCS)

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 trials included adult patients with a history of systemic steroid use2

Trial 3 (history of systemic steroid use)

38%
of adult patients treated with DUPIXENT + TCS (n=110) or comparator (n=315) had a history of using systemic steroids

Trial 3 (systemic steroid rescue medication use)

8%
of adult patients required systemic steroids as rescue medication while on DUPIXENT + TCS vs 11% with placebo + TCS through Week 52 during Trial 3g

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

  • Overall, in adult patients through Week 52, 16% of DUPIXENT + TCS patients required rescue therapy vs 38% of placebo + TCS patients
In this clinical trial, a numerically smaller proportion of DUPIXENT + TCS patients required systemic steroids as a rescue medication vs placebo + TCS2

aThese 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

See the Adolescent (12 to 17 Years)
Safety Profile
See the Child (6 to 11 Years)
Safety Profile
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References:
  1. DUPIXENT Prescribing Information.
  2. Data on file, Regeneron Pharmaceuticals, Inc.