ADULT REAL-WORLD RESULTS

Clinical trial outcomes supported by real-world results

See DUPIXENT results from 2 real-world studies

CLINICAL TRIAL DESIGNS AND RESULTS IN ADULTS
Itch reduction was experienced by adult patients in Trial 3 and is supported by a real-world study1,3-5

IN TRIAL 3

59%
of adult patients treated with DUPIXENT + TCS (n=102) had ≥4-point improvement in Peak Pruritus NRS vs 20% with placebo + TCS (n=299) at Week 16 (secondary endpoint; P<0.0001)1-3

66%
of adult patients treated with DUPIXENT + TCS (n=105) had ≥3-point improvement in the Peak Pruritus NRS vs 28% with placebo + TCS (n=306) at Week 16 (secondary endpoint; P<0.0001)2

IN A REAL-WORLD STUDY

65%
of adult patients treated with DUPIXENT (n=89) achieved ≥3-point improvement in Peak Pruritus NRS, as recorded
≥4 months post-index5
  • In DUPIXENT clinical trials, clinically significant improvement in itch was defined as a ≥4-point improvement in Pruritus NRS. The real-world study defined improvement in itch as a ≥3-point improvement in Pruritus NRS1,5
In a real-world study

IGA results, as defined by a real-world study6

66%
of adult patients treated with DUPIXENT (n=187) achieved clear/minimal or mild lesion severity (IGA 0, 1, or 2), as recorded ≥4 months post-index6
  • In DUPIXENT clinical trials, IGA was examined on a 0- to 4-point scale rather than the 0- to 5-point IGA scale in this study. Responders in clinical trials were defined as subjects with IGA 0 or 1 (clear or almost-clear) and a reduction of ≥2-points on a 0- to 4-point IGA scale at Week 161,6

REAL-WORLD STUDY DESIGN

Modernizing Medicine’s electronic medical records (EMR) were evaluated and analyzed 2945 adult patients with ≥1 DUPIXENT prescription in the index period (between April 1, 2017 and November 30, 2017). The study period spanned from April 2016 to March 2018, and included data 12 months before the index date (baseline) and outcomes assessed at least 4 months after the index date (post-index).5,6

Limitations of analysis

Only a small proportion of patients treated with DUPIXENT had IGA and Pruritus NRS recorded in the EMR prior to, and after the initiation of, therapy with DUPIXENT.5,6 The cohort for itch assessed the real-world effectiveness of DUPIXENT in adult patients with moderate-to-severe itch, as defined by Pruritus NRS ≥3.5 The cohort for the IGA assessed the real-world effectiveness of DUPIXENT in adult patients with moderate-to-severe atopic dermatitis, as defined on the 0- to 5-point IGA scale (0=clear, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe). Clear/minimal lesion severity was defined as patients achieving a post-index IGA score of 0 or 1.6

High rate of real-world persistence demonstrated with DUPIXENT7
79%
of adult patients treated with DUPIXENT (n=1637) remained on therapy at 1 year7

REAL-WORLD STUDY DESIGN

From Truven Marketscan data, 1637 adults were identified with ≥1 DUPIXENT prescription between March 28, 2017 and January 31, 2018, with continuous enrollment during the baseline period. Patients were followed from their first prescription until July 31, 2018, or disenrollment.7

Limitations of analysis

Kaplan-Meier curves were used to estimate persistence at 6 and 12 months, using a 30-day grace period and assuming 14-day injection frequency. Limitations of this study may be the potential misclassification of persistence due to assumptions regarding injection frequency and grace period. Study includes early adopters of DUPIXENT, therefore as utilization in clinical practice increases over time, further analyses are recommended to confirm these findings.7

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. Guttman-Yassky E, Lio PA, Mallya UG, et al. Real-world effectiveness of dupilumab in atopic dermatitis: improvement in itch as assessed by the peak pruritus numerical rating scale (PNRS) in an electronic medical records dataset. Paper presented at: 24th World Congress of Dermatology (WCD); June 10-15, 2019; Milan, Italy.
  6. Eichenfield LF, Gadkari A, Armstrong AW, et al. Real-world effectiveness of dupilumab based on Investigator Global Assessment (IGA) scores and Peak Pruritus Numerical Rating Scale (PNRS) in an electronic medical records dataset. Poster presented at: 77th Annual Meeting of the Society for Investigative Dermatology (SID); May 8-11, 2019; Chicago, IL.
  7. Silverberg J, Guttman-Yassky E, Gadkari A, et al. Real-world persistence with dupilumab among adults with atopic dermatitis (AD). Poster presented at: 77th Annual Meeting of the Society for Investigative Dermatology (SID); May 8-11, 2019; Chicago, IL.

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.