Adult Peak Pruritus NRS Efficacy Results

Rapid itch relief after the first dose (as measured at Week 2) sustained for 1 year

See itch results from 3 pivotal, 16- and 52-week, randomized, placebo-controlled trials with adult patients with uncontrolled moderate‑to‑severe atopic dermatitis1

Rapid, sustained results

In 3 pivotal trials, adult patients with moderate-to-severe atopic dermatitis not adequately controlled with topical prescription treatments were randomized to DUPIXENT 300 mg Q2W or placebo. In Trial 3, concomitant TCS was used. An endpoint included the reduction in itch from baseline to Week 16 (all trials) and 52 (Trial 3), as defined by ≥4-point improvement in the Peak Pruritus numerical rating scale (NRS).1

18+ YEARS
Itch reduction sustained at 1 year (secondary endpoint)2,3,a-c
Trial 3: Concomitant Therapy With TCS

Significant itch reduction was also demonstrated with DUPIXENT in monotherapy trials (secondary endpoint)1,4,a,b

41%

of adults treated with DUPIXENT (n=213) achieved ≥4-point reduction in Peak Pruritus NRS vs 12% with placebo at Week 16 in Trial 1 (n=212; P<0.001)

36%

of adults treated with DUPIXENT (n=225) achieved ≥4-point reduction in Peak Pruritus NRS vs 10% with placebo at Week 16 in Trial 2 (n=221; P<0.001)

Change in Daily Peak Pruritus NRS with DUPIXENT in monotherapy trials in a post hoc analysis of Trials 1 and 25


18+ YEARS
Itch reduction at Day 15 (mean change from baseline in Peak Pruritus NRS)
Trials 1 and 2 (pooled): DUPIXENT Monotherapy
Limitations of analysis:
  • The prespecified itch endpoint in Trials 1 and 2 used weekly averaged Peak Pruritus NRS; this post hoc analysis is based on daily Peak Pruritus NRS5
  • Definitive conclusions cannot be made as this daily Peak Pruritus analysis (compared with weekly averaged analysis) was post hoc and was not statistically powered in these trials5

LSM, least squares mean.

aIn the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered nonresponders.

bFull Analysis Set includes all subjects randomized.

cIn Trial 3, as needed, subjects received topical calcineurin inhibitors for problem areas only, such as the face, neck, and intertriginous and genital areas.

dWeek 52 data were limited to patients completing 52 weeks as of the cutoff date.

eP<0.0001 vs placebo.

Itch reduction was also observed in adolescents and children at Week 161
Pruritus NRS assesses the average itch intensity over the previous 24 hours6

It is a patient-reported measure that uses a 0- to 10-point scale, with which patients are asked:


“On a scale of 0 to 10, how would you rate your itch overall (on average) during the previous 24 hours?”

0

None

1
2
3
4
5
6
7
8
9
10

The Worst Imaginable

A reduction of at least 4 points in pruritus NRS from baseline is a clinically meaningful change.1

References:

  1. DUPIXENT Prescribing Information.
  2. Data on file, Regeneron Pharmaceuticals, Inc.
  3. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287-2303.
  4. Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335-2348.
  5. Silverberg JI, Yosipovitch G, Simpson EL, et al. Dupilumab treatment results in early and sustained improvements in itch in adolescents and adults with moderate to severe atopic dermatitis: analysis of the randomized phase 3 studies SOLO 1 and SOLO 2, AD ADOL, and CHRONOS. J Am Acad Dermatol. 2020;82(6):1328-1336.
  6. Phan NQ, Blome C, Fritz F, et al. Assessment of pruritus intensity: prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus. Acta Derm Venereol. 2012:92(5):502-507.

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: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. Healthcare providers and patients may call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/ to enroll in or obtain information about the registry. 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.