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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 monotherapya DUPIXENT + 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 group + TCS group1

Discontinuation rates in adults due to adverse events with DUPIXENT
with or without TCS were comparable to those with placebo1,2

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 and/or until a parasitic (helminth) infection resolves in a patient who does not respond to anti-helminth treatment.

Avoid use of live vaccines with DUPIXENT.1,3

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

DUPIXENT clinical trials included adult and adolescent patients with a history of immunosuppressant use.2,4

41%
of adult patients treated with DUPIXENT + TCS had a history of using immunosuppressantsa
2%
of adult patients required immunosuppressants as a rescue medication while on DUPIXENT during Trial 3b

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

aRefers to systemic nonsteroidal immunosuppressants.

bThese patients were considered nonresponders.

See the Adolescent Safety Profile
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References:
  1. DUPIXENT Prescribing Information.
  2. Data on file, Regeneron Pharmaceuticals, Inc.
  3. Blauvelt A, Simpson EL, Tyring SK, et al. Dupilumab does not affect correlates of vaccine-induced immunity: a randomised, placebo-controlled trial in adults with moderate-to-severe atopic dermatitis. J Am Acad Dermatol. 2019;80(1):158-167.
  4. 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