ADULT REAL-WORLD RESULTS

Results from 2 real-world studies in adults

These real-world studies of DUPIXENT assessed use of concomitant prescription treatment categories, patient satisfaction, and persistence

CLINICAL TRIAL DESIGNS AND RESULTS IN ADULTS
Use of concomitant prescription treatment categories4
86%
of adult patients treated with DUPIXENT required
none or only 1 concomitant prescription treatment category at 6 months
Patient satisfaction based on a survey of adult patients4
86%
of adult patients treated with DUPIXENT were
very/extremely/somewhat satisfied with their overall atopic dermatitis treatment at 6 months
vs 18% before starting

REAL-WORLD STUDY DESIGN

Based on results from a prospective, observational, longitudinal patient survey of 674 adult patients who had not been treated with DUPIXENT prior to this study. Surveys were completed at baseline (prior to DUPIXENT treatment) and at Months 1, 2, 3, 6, 9, and 12 after initiation of DUPIXENT. Data are from an interim analysis of patients who had completed surveys through 1 month (n=538) and through 6 months (n=206). The use of concomitant prescription treatment categories was measured using the percentage of patients that required atopic dermatitis treatment categories (excluding DUPIXENT for Month 1 to 6); the recall period for use of atopic dermatitis therapies was during the past 4 weeks. Concomitant treatment categories were defined as prescription topicals (topical corticosteroid, topical calcineurin inhibitors), PDE4 inhibitor, systemic corticosteroids, systemic immunosuppressants, and phototherapy. Patient-reported satisfaction with current atopic dermatitis treatment was evaluated using the question “How satisfied are you with your current treatment(s) for atopic dermatitis?”, with responses on a 7-point Likert scale that ranged from “extremely satisfied” to “extremely dissatisfied.”4

Limitations of analysis

The survey data were collected from patients who enrolled in the DUPIXENT patient support program, and these patients may have different characteristics and perspectives vs those who did not enroll. Patients who continue to respond to long-term surveys may be self-selecting for favorable effectiveness and safety. “As observed” data may bias results. Safety and tolerability data were not collected.4

Persistency: High rate at 1 year5
77%
of adult patients treated with DUPIXENT
remained on therapy at 1 year
Of the 329 patients who discontinued therapy,
≈8 of 10 patients returned to DUPIXENT treatment within 4 months

REAL-WORLD STUDY DESIGN

From IBM MarketScan Commercial and Medicare supplemental databases, 1963 adults were identified who initiated DUPIXENT between March 28, 2017 and March 31, 2018, and followed until September 30, 2018, or disenrollment.5

Limitations of analysis

Kaplan-Meier analysis was used to estimate persistence at 6 and 12 months, assuming a 14-day injection frequency. Limitations of this study may be the potential misclassification of patients in claims-based analyses that rely on International Classification of Disease (ICD) diagnostic codes for population identification. Study included only early initiators of DUPIXENT, which likely reflects more severe patients, potentially reducing generalizability since persistence may be different in a more diverse population of patients who initiate DUPIXENT. Duration of treatment and persistence was based on assumptions about whether and how patients take their treatment, and such assumptions may result in misclassification that could potentially over- or underestimate persistence.5

References:

  1. DUPIXENT Prescribing Information.
  2. 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.
  3. 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.
  4. Kimball AB, Mallya UG, Yang M, et al. Dupilumab improves treatment satisfaction and reduces treatment burden in adults with atopic dermatitis: results from the RELIEVE-AD study. Poster presented at: 28th European Academy of Dermatology and Venereology Congress (EADV 2019); October 9-13, 2019; Madrid, Spain.
  5. Silverberg JI, Guttman-Yassky E, Gadkari A, et al. Real-world persistence with dupilumab among adults with atopic dermatitis. Ann Allergy Asthma Immunol. 2021;126(1):40-45.

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.