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ADULT SAFETY PROFILE

In the treatment of adults with uncontrolled moderate-to-severe atopic dermatitis

Demonstrated long-term safety profile

The 52-week safety profile of DUPIXENT + TCS in adults was generally consistent
with the Week 16 adult safety profile1

Adverse reactions occurring in ≥1% of adult patients through Week 161
Injection site reaction
DUPIXENTc
(n=529) %		 10%
Placebo
(n=517) %		 5%
Conjunctivitisd
DUPIXENTc
(n=529) %		 10%
Placebo
(n=517) %		 2%
Blepharitis
DUPIXENTc
(n=529) %		 <1%
Placebo
(n=517) %		 <1%
Oral herpes
DUPIXENTc
(n=529) %		 4%
Placebo
(n=517) %		 2%
Keratitise
DUPIXENTc
(n=529) %		 <1%
Placebo
(n=517) %		 0%
Eye pruritus
DUPIXENTc
(n=529) %		 1%
Placebo
(n=517) %		 <1%
Other herpes simplex virus infectionf
DUPIXENTc
(n=529) %		 2%
Placebo
(n=517) %		 1%
Dry eye
DUPIXENTc
(n=529) %		 <1%
Placebo
(n=517) %		 0%
Injection site reaction
DUPIXENT + TCSc
(n=110) %		 10%
Placebo + TCS
(n=315) %		 6%
Conjunctivitisd
DUPIXENT + TCSc
(n=110) %		 9%
Placebo + TCS
(n=315) %		 5%
Blepharitis
DUPIXENT + TCSc
(n=110) %		 5%
Placebo + TCS
(n=315) %		 1%
Oral herpes
DUPIXENT + TCSc
(n=110) %		 3%
Placebo + TCS
(n=315) %		 2%
Keratitise
DUPIXENT + TCSc
(n=110) %		 4%
Placebo + TCS
(n=315) %		 0%
Eye pruritus
DUPIXENT + TCSc
(n=110) %		 2%
Placebo + TCS
(n=315) %		 1%
Other herpes simplex virus infectionf
DUPIXENT + TCSc
(n=110) %		 1%
Placebo + TCS
(n=315) %		 <1%
Dry eye
DUPIXENT + TCSc
(n=110) %		 2%
Placebo + TCS
(n=315) %		 <1%

Treatment-emergent eosinophilia (≥5,000 cells/mcL) was reported in1:

  • <3% of DUPIXENT-treated subjects and <0.5% of placebo-treated subjects (SOLO 1, SOLO 2, and AD-1021; DRI12544, QUEST, and VOYAGE; SINUS-24 and SINUS-52; PRIME and PRIME2)g
  • 8% of DUPIXENT-treated subjects and 0% of placebo-treated subjects (AD-1539)

The safety profile in AD-HAFT through Week 16 was consistent with the safety profile from studies in adult and pediatric subjects 6 months of age and older with moderate-to-severe atopic dermatitis.2

aPooled analysis of SOLO 1, SOLO 2, and AD-1021 (phase 2 dose-ranging study).1

bAnalysis of CHRONOS in which subjects were on background TCS therapy.1

cDUPIXENT 600 mg at Week 0, followed by 300 mg every 2 weeks.1

dConjunctivitis cluster includes conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye inflammation.1

eKeratitis cluster includes keratitis, ulcerative keratitis, allergic keratitis, atopic keratoconjunctivitis, and ophthalmic herpes simplex.1

fOther herpes simplex virus infection cluster includes herpes simplex, genital herpes, herpes simplex otitis externa, and herpes virus infection, but excludes eczema herpeticum.1

gDRI12544, QUEST, and VOYAGE are part of the asthma clinical trial program; SINUS-24 and SINUS-52 are part of the chronic rhinosinusitis with nasal polyposis clinical trial program; PRIME and PRIME2 are part of the prurigo nodularis clinical trial program.1

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
  • Most patients experiencing conjunctivitis recovered or were recovering during the treatment period1

Numerically fewer patients treated with DUPIXENT developed skin infections compared with
placebo2,h

  • 10.9% vs 17.8% of adults in CHRONOS, respectively

hData reflect adjudicated nonherpetic skin infections through Week 52.

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 (SOLO 1, SOLO 2, and AD-1021)
  • Similar discontinuation rates occurred at Week 52 in CHRONOS (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 treatment.1
Safety data collected from three phase 3 trials and one dose-ranging trial (AD‑1021) (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

Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT1
  • Avoid use of live vaccines during treatment with DUPIXENT1
DUPIXENT attributes and
considerations

NOT AN IMMUNOSUPPRESSANT
OR A STEROID1

NO INITIAL LAB TESTING OR
ONGOING
LAB MONITORING
according to the
Prescribing Information1

NO KNOWN DRUG-TO-DRUG
INTERACTIONS1

  • Not metabolized through the liver or excreted
    through the kidneys

NO BOXED WARNING1

Please see additional Warnings and
Precautions in the
Prescribing Information
and Important Safety Information below.

SELECT IMPORTANT
SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT

Please see additional Warnings and Precautions in the Prescribing Information and Important Safety Information below.

IN AN OPEN-LABEL EXTENSION (OLE) CLINICAL
TRIAL IN ADULTS

LONG-TERM SAFETY PROFILE THROUGH ≈5 YEARS WAS GENERALLY CONSISTENT WITH AD CONTROLLED STUDIES1

  • AD-1225 Study description: The OLE safety data in this open-label extension study reflect exposure to DUPIXENT 200 mg QW, 300 mg
    QW, and 300 mg Q2W in 2677 subjects who had varying lengths of treatment exposure (179 subjects exposed for at least 260 weeks).
    In DUPIXENT clinical trials, QW dosing did not demonstrate additional treatment benefit over Q2W dosing

QW, once weekly; Q2W, once every 2 weeks.

Dosage and administration

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