The safety profile of DUPIXENT + TCS in infants to preschoolers through Week 16 was similar to that in adults with atopic dermatitis1

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%
Oral 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%
Oral 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 in2:

  • <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)

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

b Analysis of CHRONOS in which subjects were on background TCS therapy.

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

d Conjunctivitis cluster includes conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye inflammation.

e Keratitis cluster includes keratitis, ulcerative keratitis, allergic keratitis, atopic keratoconjunctivitis, and ophthalmic herpes simplex.

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

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.

  • The 52-week safety profile of DUPIXENT + TCS in adults was generally consistent with the Week 16 adult safety profile1
  • Treatment-emergent eosinophilia (≥5,000 cells/mcL) was reported in <3% of DUPIXENT-treated subjects and <0.5% placebo-treated subjects (adult monotherapy studies)1
  • In AD-1539 (6 months to years of age), treatment-emergent eosinophilia (≥5,000 cells/mcL) was reported in 8% of DUPIXENT-treated subjects and 0% in placebo-treated subjects1

Numerically fewer infants to preschoolers treated with DUPIXENT + TCS developed skin infections compared with placebo + TCS in AD-1539h

  • 12% of infants to preschoolers treated with DUPIXENT + TCS vs 24% with placebo + TCS

hData reflect adjudicated nonherpetic skin infections through Week 16.

Long-term safety profile observed in infants to preschoolers

The long-term safety of DUPIXENT ± TCS in infants to preschoolers was assessed in an open-label extension study (AD-1434)1

  • The safety profile through Week 52 was similar to the safety profile observed through Week 16 in AD-1539
  • The long-term safety profile of DUPIXENT ± TCS in infants to preschoolers was consistent with that seen in adults, adolescents, and children
    • In AD-1434, hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) was reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation

DUPIXENT demonstrated a generally consistent safety profile through Week 16 across multiple age populations as young as 6 months

Discontinuation rates due to adverse events in infants to preschoolers treated with DUPIXENT + TCS were comparable to those with placebo + TCSh

  • 1% of infants to preschoolers treated with DUPIXENT + TCS (n=83) and placebo + TCS (n=78) discontinued treatment through Week 16

hAnalysis done in overall study population.

 

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.

Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT1

  • Avoid use of live vaccines in patients treated with DUPIXENT

Important considerations

NO BOXED WARNING1
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

NOT METABOLIZED THROUGH THE LIVER
OR EXCRETED THROUGH THE KIDNEYS1

  • No known drug-to-drug interactions

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

Other attributes1

DUPIXENT IS NOT AN
IMMUNOSUPPRESSANT OR A STEROID,
AND AVOIDS BROAD
IMMUNOSUPPRESSION

  • It is unknown if DUPIXENT will influence the immune response against helminth infections

NO REQUIREMENT FOR INITIAL LAB
TESTING OR ONGOING LAB MONITORING,
according to the Prescribing Information

Dosage and
Administration
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