Adult Clinical Trial Safety Profile | DUPIXENT® (dupilumab)

Adverse reactions occurring in ≥1% of adult patients through Week 16¹

Adverse reaction	DUPIXENT 300 mg Q2W monotherapy^a		DUPIXENT 300 mg Q2W + TCS^b
Adverse reaction	DUPIXENT^c (n=529) %	Placebo (n=517) %	DUPIXENT + TCS^c (n=110) %	Placebo + TCS (n=315) %
Injection site reaction	10%	5%	10%	6%
Conjunctivitis^d	10%	2%	9%	5%
Blepharitis	<1%	<1%	5%	1%
Oral herpes	4%	2%	3%	2%
Keratitis^e	<1%	0%	4%	0%
Eye pruritus	1%	<1%	2%	1%
Oral herpes simplex virus infection^f	2%	1%	1%	<1%
Dry eye	<1%	0%	2%	<1%

DUPIXENT 300 mg
Q2W monotherapy^a

Injection site reaction
	DUPIXENT^c (n=529) %	10%
	Placebo (n=517) %	5%

Conjunctivitis^d
	DUPIXENT^c (n=529) %	10%
	Placebo (n=517) %	2%

Blepharitis
	DUPIXENT^c (n=529) %	<1%
	Placebo (n=517) %	<1%

Oral herpes
	DUPIXENT^c (n=529) %	4%
	Placebo (n=517) %	2%

Keratitis^e
	DUPIXENT^c (n=529) %	<1%
	Placebo (n=517) %	0%

Eye pruritus
	DUPIXENT^c (n=529) %	1%
	Placebo (n=517) %	<1%

Oral herpes simplex virus infection^f
	DUPIXENT^c (n=529) %	2%
	Placebo (n=517) %	1%

Dry eye
	DUPIXENT^c (n=529) %	<1%
	Placebo (n=517) %	0%

DUPIXENT 300 mg
Q2W + TCS^b

Injection site reaction
	DUPIXENT + TCS^c (n=110) %	10%
	Placebo + TCS (n=315) %	6%

Conjunctivitis^d
	DUPIXENT + TCS^c (n=110) %	9%
	Placebo + TCS (n=315) %	5%

Blepharitis
	DUPIXENT + TCS^c (n=110) %	5%
	Placebo + TCS (n=315) %	1%

Oral herpes
	DUPIXENT + TCS^c (n=110) %	3%
	Placebo + TCS (n=315) %	2%

Keratitis^e
	DUPIXENT + TCS^c (n=110) %	4%
	Placebo + TCS (n=315) %	0%

Eye pruritus
	DUPIXENT + TCS^c (n=110) %	2%
	Placebo + TCS (n=315) %	1%

Oral herpes simplex virus infection^f
	DUPIXENT + TCS^c (n=110) %	1%
	Placebo + TCS (n=315) %	<1%

Dry eye
	DUPIXENT + TCS^c (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)

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

^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.

^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

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

Numerically fewer patients treated with DUPIXENT developed skin infections
compared with placebo^2,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 in patients treated with DUPIXENT¹

NOT AN IMMUNOSUPPRESSANT¹

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

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.

Safety findings of DUPIXENT open-label extension (OLE) study in adults for ≈4 years (AD-1225)^1,3

The long-term safety profile observed in this trial up to 244 weeks (≈4 years) was generally consistent with that observed in 16- and 52-week controlled studies
3.7% of patients discontinued due to treatment emergent adverse events in the OLE study
- Study description: The safety data in this open-label extension study reflect exposure to DUPIXENT in 2677 subjects, including 2207 exposed for up to 52 weeks, 1065 exposed for up to 100 weeks, 557 exposed for up to 148 weeks, 352 exposed up to 204 weeks, and 202 exposed up to 244 weeks. 2677 patients were treated with 300 mg QW for up to 204 weeks. 226 of these patients transitioned to 300 mg Q2W with mean exposure of 46.7 ± 7.4 weeks at this dose
  In DUPIXENT clinical trials, DUPIXENT 300 mg QW did not demonstrate additional treatment benefit over DUPIXENT 300 mg Q2W.
- Limitations of this OLE study included, but were not limited to: the open-label design, the absence of a placebo arm, treatment interruptions because of protocol amendments, the smaller subset of patients who received Q2W dosing, the smaller subset of patients who transitioned from QW to Q2W dosing, and the smaller sample size at later timepoints, which was primarily because of study termination by the sponsor following regulatory approval of dupilumab in the enrollment country

QW, once weekly.

Dosage and Administration

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

Demonstrated long-term safety profile

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

DUPIXENT 300 mg
Q2W monotherapy^a

DUPIXENT 300 mg
Q2W + TCS^b

Numerically fewer patients treated with DUPIXENT developed skin infections
compared with placebo^2,h

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

Safety data collected from
three Phase 3 trials and one
dose-ranging trial (AD-1021)
(N=2304)^1,2

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

OTHER ATTRIBUTES &
IMPORTANT
CONSIDERATIONS

For the treatment of adults with uncontrolled moderate-to-severe atopic dermatitis Demonstrated long-term safety profile

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

DUPIXENT 300 mg Q2W monotherapya

DUPIXENT 300 mg Q2W + TCSb

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

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

Safety data collected from three Phase 3 trials and one dose-ranging trial (AD-1021) (N=2304)1,2

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

OTHER ATTRIBUTES & IMPORTANT CONSIDERATIONS

Are you sure you want to leave?

Are you sure you want to leave?

For 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

DUPIXENT 300 mg
Q2W monotherapy^a

DUPIXENT 300 mg
Q2W + TCS^b

Numerically fewer patients treated with DUPIXENT developed skin infections
compared with placebo^2,h

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

Safety data collected from
three Phase 3 trials and one
dose-ranging trial (AD-1021)
(N=2304)^1,2

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

OTHER ATTRIBUTES &
IMPORTANT
CONSIDERATIONS