Adult Clinical Study Designs| DUPIXENT® (dupilumab)

The Largest Clinical Development Program
in Atopic Dermatitis

A total of 917 adult patients in Trials 1 and 2 (16‑week trials) and 421 adult patients in Trial 3 (52‑week trial) with moderate‑to‑severe atopic dermatitis not adequately controlled with topical prescription treatments were randomized to DUPIXENT 300 mg Q2W or placebo. For all patients in Trial 3, lesions were treated with concomitant TCS.¹

	Adult (18+ years of age)^1-3
Number of patients	>2100
Pivotal trials^b	2 Monotherapy (Trials 1 and 2) 1 Concomitant TCS (Trial 3)
Dosing^c	A loading dose of 600 mg (2 x 300 mg SC injections) of DUPIXENT at Week 0 followed by 300 mg (1 SC injection) Q2W^d
Disease severity at baseline Moderate atopic dermatitis (IGA 3)	52%
Severe atopic dermatitis (IGA 4)	48%
Disease extent at baseline Mean EASI score	33 out of 72
Mean body surface area involvement	55%
Itch severity at baseline^e Peak Pruritus NRS	7 out of 10

Adult
(18+ years of age)^1-3

Number of patients

>2100

Pivotal trials^b

2 Monotherapy (Trials 1 and 2)
1 Concomitant TCS (Trial 3)

Dosing^c

A loading dose of
600 mg (2 x 300 mg SC injections)
of DUPIXENT at Week 0 followed by
300 mg (1 SC injection) Q2W^d

Disease severity at baseline
Moderate atopic dermatitis (IGA 3)

52%

Severe atopic dermatitis (IGA 4)

48%

Disease extent at baseline
Mean EASI score

33 out of 72

Mean body surface area involvement

55%

Itch severity at baseline^e
Peak Pruritus NRS

7 out of 10

^aThese baseline characteristics are not meant for comparison.

^bTrial 4 was a dose‑ranging trial to evaluate the safety of DUPIXENT monotherapy through Week 16. Trial 5 evaluated multiple DUPIXENT monotherapy dose regimens for maintaining treatment response for 36 weeks.

^cEmollient background regimen was required.

^dStudied vs placebo.

^eWeekly averaged Peak Pruritus NRS score (10 indicates the most severe).

^fSubgroup analysis was based on all 3 adult trials.

Important Safety Information
and Indication

CONTRAINDICATION: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Hypersensitivity reactions, including generalized urticaria, rash, erythema nodosum, anaphylaxis and serum sickness or serum sickness‑like reactions, were reported in <1% of subjects who received DUPIXENT in clinical trials. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Advise patients to report new onset or worsening eye symptoms to their healthcare provider

Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical or inhaled corticosteroids abruptly upon initiation with DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Atopic Dermatitis Patients with Comorbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.

Parasitic (Helminth) Infections: It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with pre‑existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti‑helminth treatment, discontinue treatment with DUPIXENT until the infection resolves.

ADVERSE REACTIONS: The most common adverse reactions (incidence ≥1% at Week 16) in adult patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye. The safety profile in children and adolescents through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT in adolescents and children observed through Week 52 was consistent with that seen in adults with atopic dermatitis.

DRUG INTERACTIONS: Avoid use of live vaccines in patients treated with DUPIXENT.

USE IN SPECIFIC POPULATIONS

Pregnancy: Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug‑associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.
Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.

Please see accompanying full Prescribing Information

Indication

DUPIXENT is indicated for the treatment of patients aged 6 years and older with moderate‑to‑severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

ADULT STUDY DESIGNS

The Largest Clinical Development Program
in Atopic Dermatitis

DUPIXENT was evaluated in adult patients whose moderate-to-severe atopic dermatitis
was inadequately controlled on topical Rx therapies.¹

References:

ADULT STUDY DESIGNS

The Largest Clinical Development Program in Atopic Dermatitis

DUPIXENT was evaluated in adult patients whose moderate-to-severe atopic dermatitis was inadequately controlled on topical Rx therapies.1

References:

The Largest Clinical Development Program
in Atopic Dermatitis

DUPIXENT was evaluated in adult patients whose moderate-to-severe atopic dermatitis
was inadequately controlled on topical Rx therapies.¹