Frequently Asked Questions

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DUPIXENT basics

Per the indication for DUPIXENT, adult and pediatric patients aged 6 years and older with moderate-to-severe atopic dermatitis are considered uncontrolled when their disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.1

Itch reduction was evaluated as a key secondary endpoint in randomized, double-blind, placebo-controlled trials: 3 adult trials,
1 adolescent trial, and 1 trial in children.1 Click here for additional clinical trial design information.

Itch reduction with DUPIXENT was rapid and sustained in adults at 52 weeks. In SOLO 1, a significantly greater proportion of adult patients had improvement on the Peak Pruritus NRS score vs placebo (defined as at least a 4-point improvement) as early as Week 2 (9% of DUPIXENT patients achieved ≥4-point reduction in NRS score at Week 2 vs 3% with placebo [P=0.0097]).1,2

  • 41% of adult patients achieved a ≥4-point improvement in the Peak Pruritus Numerical Rating Scale (NRS) with DUPIXENT at Week 16 in SOLO 1 vs 12% with placebo1,3
  • 36% of adult patients achieved a ≥4-point improvement in the Peak Pruritus NRS with DUPIXENT at Week 16 in SOLO 2 vs 10% with placebo1,3

In addition, in CHRONOS1,4:

  • 59% of adult patients achieved a ≥4-point improvement in the Peak Pruritus NRS with DUPIXENT + TCS at Week 16 vs 20% in placebo + TCS
  • 51% of adult patients experienced rapid and sustained itch reduction at 52 weeks with DUPIXENT + TCS in CHRONOS vs 13% with placebo + TCS

A greater proportion of adolescents treated with DUPIXENT and children treated with DUPIXENT + TCS achieved an improvement in the Peak Pruritus NRS compared with placebo (defined as ≥4-point improvement as early as Week 4 in adolescents; 22% with DUPIXENT vs 5% with placebo).5

  • 37% of adolescent patients treated with DUPIXENT achieved a ≥4-point improvement in the Peak Pruritus NRS at Week 16 vs 5% with placebo (P<0.001)1,6
  • 54% of children treated with DUPIXENT 300 mg Q4W + TCS (<30 kg) achieved a ≥4-point improvement in the Peak Pruritus NRS at Week 16 vs 12% with placebo + TCS at Week 161,7
  • 61% of children treated with DUPIXENT 200 mg Q2W + TCS (≥30 kg) achieved a ≥4-point improvement in the Peak Pruritus NRS at Week 16 vs 13% with placebo + TCS at Week 161,7

Review Adult Peak Pruritus NRS Results Review Adolescent Peak Pruritus NRS Results Review the Peak Pruritus NRS Results in Children

DUPIXENT clinical trials

DUPIXENT has demonstrated results in 3 monotherapy trials that include adults and adolescents and 2 concomitant therapy trials for adults and children.1

A total of 917 adults in SOLO 1 and SOLO 2 (16 weeks each) with moderate-to-severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT or placebo. All patients who received DUPIXENT were given 300 mg Q2W after a 600 mg loading dose. Patients had an IGA score ≥3 (overall atopic dermatitis lesion severity scale of 0 to 4), an EASI score ≥16 on a scale of 0 to 72, and BSA involvement of ≥10%. At baseline, 51% had an IGA score of 3 (moderate), 49% had an IGA of 4 (severe), mean EASI score was 30, and weekly averaged Peak Pruritus NRS was 7.7 on a scale of 0 to 10.1

The primary endpoint was change from baseline in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement at Week 16 (37% of patients treated with DUPIXENT vs 9% with placebo in SOLO 1 and SOLO 2, P<0.001). Other endpoints included change from baseline in the proportion of subjects with EASI-75 at Week 16 (improvement of ≥75%; 48% of patients treated with DUPIXENT vs 13% with placebo in SOLO 1 and SOLO 2, P<0.001) and itch reduction defined by ≥4-point improvement in the Peak Pruritus NRS at Week 16 (38% of patients treated with DUPIXENT vs 11% with placebo in SOLO 1 and SOLO 2, P<0.001).1,6

In monotherapy AD-1526 (16 weeks), a total of 251 adolescents with moderate-to-severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT or placebo. Adolescents ≥60 kg received DUPIXENT 300 mg Q2W after a 600 mg loading dose, and adolescents <60 kg received 200 mg Q2W after a 400 mg loading dose. Patients had an IGA score ≥3 (overall lesion severity scale of 0 to 4), an EASI score ≥16 on a scale of 0 to 72, and BSA involvement of ≥10%. At baseline, 46% had an IGA score of 3 (moderate), 54% had an IGA of 4 (severe), mean EASI score was 36, and weekly averaged Peak Pruritus NRS was 8 on a scale of 0 to 10.1

The primary endpoint was change from baseline in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement at Week 16 (24% of patients treated with DUPIXENT vs 2% with placebo, P<0.001). Other endpoints included change from baseline in the proportion of subjects with EASI-75 at Week 16 (improvement of ≥75%; 42% of patients treated with DUPIXENT vs 8% with placebo, P<0.001) and itch reduction defined by ≥4-point improvement in the Peak Pruritus NRS at Week 16 (37% of patients treated with DUPIXENT vs 5% with placebo, P<0.001).1,4

A total of 421 adults in CHRONOS (52 weeks) with moderate-to-severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT + TCS or placebo + TCS. All DUPIXENT patients received 300 mg Q2W after a 600 mg loading dose. Patients had an IGA score ≥3 (overall atopic dermatitis lesion severity scale of 0 to 4), an EASI score ≥16 on a scale of 0 to 72, and BSA involvement of ≥10%. At baseline, 50% had an IGA score of 3 (moderate), 50% had an IGA of 4 (severe), mean EASI score was 31, and weekly averaged Peak Pruritus NRS was 8 on a scale of 0 to 10.1,4

The primary endpoint was change from baseline in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement at Week 16 (39% of patients treated with DUPIXENT + TCS vs 12% with placebo + TCS in CHRONOS, P<0.0001). Other endpoints included change from baseline in the proportion of subjects with EASI-75 at Week 16 (improvement of ≥75%; 69% of patients treated with DUPIXENT + TCS vs 23% with placebo + TCS in CHRONOS, P<0.0001) and itch reduction defined by ≥4-point improvement in the Peak Pruritus NRS at Week 16 (59% of patients treated with DUPIXENT + TCS vs 20% with placebo + TCS in CHRONOS, P<0.0001).1,3

A total of 367 children (6-11 years of age) in AD-1652 (16 weeks) with severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT + TCS or placebo + TCS. Patients ≥30 kg but <60 kg received 200 mg Q2W after a 400 mg loading dose. Patients 15 kg but <30 kg received 300 mg Q4W after a 600 mg loading dose. Patients had an IGA score of 4, an EASI score ≥21, and BSA involvement ≥15%. Mean EASI score was 37.9 and weekly averaged Peak Pruritus NRS was 7.8 on a scale of 0 to 10.1

The primary endpoint was change from baseline in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) at Week 16 (39% of patients ≥30 kg treated with DUPIXENT + TCS vs 10% with placebo + TCS, and 30% of patients <30 kg treated with DUPIXENT + TCS vs 13% with placebo + TCS). Other endpoints included change from baseline in the proportion of subjects with EASI-75 at Week 16 (improvement of ≥75%; 75% of patients ≥30 kg treated with DUPIXENT + TCS vs 26% with placebo + TCS, and 75% of patients <30 kg treated with DUPIXENT + TCS vs 28% with placebo + TCS) and itch reduction defined by ≥4-point improvement in the Peak Pruritus NRS at Week 16 (61% of patients ≥30 kg treated with DUPIXENT + TCS vs 13% with placebo + TCS, and 54% of patients <30 kg treated with DUPIXENT + TCS vs 12% with placebo + TCS).1,7

SEE OVERVIEW OF CLINICAL TRIALS

CHRONOS was a 52-week pivotal clinical trial evaluating the efficacy and safety of DUPIXENT in adult patients with uncontrolled moderate-to-severe atopic dermatitis. 421 adult patients were randomized to DUPIXENT + TCS or placebo + TCS.1

Disease severity was defined by an IGA score ≥3 in the overall assessment of atopic dermatitis lesions on a severity scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and a minimum body surface area involvement of ≥10%.1

CHRONOS results demonstrated significant improvement with DUPIXENT + TCS in achieving clear (IGA 0) or almost-clear skin (IGA 1) (the primary endpoint at 16 weeks) and lesion extent and severity (EASI) at Weeks 16 and 52 vs placebo + TCS.1,2,4

  • 39% of adult patients treated with DUPIXENT + TCS achieved clear or almost-clear skin at 16 weeks vs 12% with placebo + TCS (P<0.0001)
  • 36% of adult patients achieved clear or almost-clear skin (IGA 0 or 1) with DUPIXENT + TCS at 52 weeks vs 13% with placebo + TCS in CHRONOS (P<0.0001)
  • 69% and 65% of adult patients treated with DUPIXENT + TCS demonstrated improvement in EASI-75 at 16 weeks and 52 weeks vs 23% and 22% with placebo + TCS, respectively (P<0.0001)

View Adult IGA Results

Explore Adult EASI Results

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.1

Additionally, the adult safety profile of DUPIXENT + TCS through Week 52 was generally consistent with the safety profile observed at Week 16 in adults.1

The pivotal clinical trial evaluating the efficacy and safety of DUPIXENT in adolescent patients aged 12 to 17 years with uncontrolled moderate-to-severe atopic dermatitis lasted for 16 weeks.1

However, the long-term safety of DUPIXENT in adolescent patients with moderate-to-severe atopic dermatitis who had participated in previous clinical trials of DUPIXENT was assessed in an open-label extension trial (AD-1434). The safety profile of DUPIXENT in adolescent subjects followed through Week 52 was similar to the safety profile observed at Week 16 in AD-1526. The long-term safety profile of DUPIXENT observed in adolescents was consistent with that seen in adults with atopic dermatitis.1

Review the adolescent data

The pivotal clinical trial evaluating the efficacy and safety of DUPIXENT + TCS in children aged 6 to 11 years with uncontrolled severe atopic dermatitis lasted for 16 weeks.1

However, the long-term safety of DUPIXENT + TCS was assessed in an open-label extension study of 368 subjects 6 to 11 years of age with atopic dermatitis (AD-1434). Among subjects who entered this study, 110 (30%) had moderate and 72 (20%) had severe atopic dermatitis at the time of enrollment in AD-1434. The safety profile of DUPIXENT + TCS in children followed through Week 52 was similar to the safety profile observed at Week 16 in AD-1652. The long-term safety profile of DUPIXENT + TCS observed in children was consistent with that seen in adults and adolescents with atopic dermatitis.1

Review the data in children

Atopic dermatitis is a chronic inflammatory skin disease, which you may consider treating continuously based on your clinical judgment.

The LIBERTY Atopic Dermatitis clinical trial program was designed to evaluate the safety and efficacy of dupilumab for the treatment of uncontrolled moderate-to-severe atopic dermatitis. The LIBERTY Atopic Dermatitis clinical trial program included the following trials2:

  • SOLO 1 (AD-1334): a Phase 3, 16-week monotherapy study in adults
  • SOLO 2 (AD-1416): a Phase 3, 16-week monotherapy study in adults
  • CHRONOS (AD-1224): a Phase 3 efficacy and long-term safety study in adults of 52-week concomitant therapy with topical corticosteroids
  • R668-AD-1021: a randomized Phase 2 dose-ranging study in adults
  • SOLO-Continue (AD-1415): a Phase 3 maintenance study for adult patients who completed SOLO 1 or SOLO 2 and achieved an IGA of 0 or 1 or EASI-75
  • R668-AD-1526 a Phase 3, 16-week monotherapy study in adolescent patients
  • R668-AD-1434 Open Label Extension (OLE): a Phase 3 OLE study assessing the long-term safety of dupilumab in adolescent patients 12 to 17 years of age and children 6 to 11 years of age
  • R668-AD-1652: a Phase 3 efficacy and safety study in children 6 to 11 years of age with 16-week concomitant therapy with topical corticosteroids
  • R668-AD-1225: a Phase 3 OLE study assessing the long-term safety of repeat doses of dupilumab in adults with moderate-to-severe atopic dermatitis

The adolescent trial (AD-1526) was a 16-week monotherapy study with patients 12-17 years of age with moderate-to-severe atopic dermatitis.1

The trial in children (AD-1652) was a 16-week concomitant TCS use study with patients 6-11 years of age with severe atopic dermatitis.1

See DUPIXENT Study
Designs

The safety and efficacy of DUPIXENT have been established in pediatric patients 6 to 17 years of age with moderate-to-severe atopic dermatitis.1

Use of DUPIXENT in this age group is supported by AD-1652, which included 367 children ages 6 to 11 years of age with severe atopic dermatitis. The safety and efficacy were generally consistent between pediatric and adult patients.1

Use of DUPIXENT is also supported by AD-1434, an open-label extension study that enrolled subjects who completed AD-1526 and AD-1652. AD-1434 included 136 adolescents from AD-1526 and 110 children from AD-1652 with moderate atopic dermatitis at enrollment into the extension study. AD-1434 included 64 adolescents from AD-1526 and 72 children from AD-1652 with severe atopic dermatitis at enrollment.1

In the adult trials with DUPIXENT monotherapy (SOLO 1 and SOLO 2) and with concomitant topical corticosteroids (CHRONOS), as well as the adolescent trial (AD-1526), the primary endpoint was the change in baseline to Week 16 in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and a ≥2-point improvement in patients with a baseline IGA of 3 (moderate) or 4 (severe).1

In the trial in children (AD-1652), the primary endpoint was the change in baseline at Week 16 in the proportion of subjects with an IGA 0 or 1 in patients with a baseline IGA of 4.1

DUPIXENT safety profile

In adults, the most common adverse reactions (incidence ≥1% at Week 16) were injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye. The safety profile of DUPIXENT in pediatric patients 6 to 17 years of age through Week 16 was similar to the safety profile from studies in adults with atopic dermatitis. In an open-label extension study, the safety profile of DUPIXENT in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis.1

Explore the Dupixent Safety Profile

Other attributes/
considerations

DUPIXENT is not an immunosuppressant and avoids broad immunosuppression. It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with preexisting 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. DUPIXENT is a human monoclonal antibody that inhibits the signaling of IL-4 and IL-13, two type 2 cytokines that contribute to the type 2 inflammation in atopic dermatitis.1

In the DUPIXENT pivotal clinical trials, the most common adverse reactions (incidence ≥1% at Week 16) in adults were injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye. The safety profile of DUPIXENT in pediatric patients 6 to 17 years of age through Week 16 was similar to the safety profile from studies in adults with atopic dermatitis. In an open-label extension study, the safety profile of DUPIXENT in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis.1

Explore the DUPIXENT Safety Profile

DUPIXENT does not have a boxed warning. In the DUPIXENT pivotal clinical trials, the most common adverse reactions (incidence ≥1% at Week 16) in adults were injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye. The safety profile of DUPIXENT in pediatric patients 6 to 17 years of age through Week 16 was similar to the safety profile from studies in adults with atopic dermatitis. The 52-week safety profile of DUPIXENT + TCS in adults was generally consistent with the Week 16 adult safety profile. In an open-label extension study, the safety profile of DUPIXENT in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis.1

Note: 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.1 Please see additional Warnings and Precautions in the Prescribing Information and Important Safety Information below.

Explore the DUPIXENT Safety Profile

DUPIXENT does NOT have any known drug-to-drug interactions. DUPIXENT is NOT metabolized through the liver or excreted through the kidneys.1

In the DUPIXENT pivotal clinical trials, the most common adverse reactions (incidence ≥1% at Week 16) in adults were injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye. The safety profile of DUPIXENT in pediatric patients 6 to 17 years of age through Week 16 was similar to the safety profile from studies in adults with atopic dermatitis. In an open-label extension study, the safety profile of DUPIXENT in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis.1

Please see additional Warnings and Precautions in the Prescribing Information and Important Safety Information throughout.

Explore the DUPIXENT Safety Profile

No. Tuberculosis testing is not required with DUPIXENT according to the Prescribing Information

Explore the DUPIXENT Safety Profile

DUPIXENT real-world data

This study was 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.8

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.8

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.8

Explore Real-world ADULT PATIENT Results

This study was 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.8

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). 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.”8

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.8

Explore Real-world ADULT PATIENT Results

The IBM MarketScan study evaluated rates of persistence in real-world adult DUPIXENT patients.9

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.9

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.9

Explore Real-world ADULT PATIENT Results

Using DUPIXENT

The dosing for adolescents and children is weight tiered. For your adolescent patients (12 to 17 years of age) who weigh ≥60 kg (132 lb), the dosing will be the same as patients aged 18 years and older. Specifically, a loading dose of 600 mg (2 x 300 mg subcutaneous [SC] injections in different injection sites) given every other week.1

For your pediatric patients (6 to 17 years of age) who weigh 30 kg (66 lb) to less than 60 kg (132 lb), the recommended dose is a loading dose of 400 mg (2 x 200 mg SC injections in different injection sites) followed by 200 mg (1 SC injection) given every other week. For patients who weigh 15 kg (33 lb) to less than 30 kg (66 lb), a loading dose of 600 mg (2 x 300 mg SC injections in different injection sites) followed by 300 mg (1 SC injection) given every 4 weeks.1

DUPIXENT can be used with or without TCS.1

Review Dosage and
Administration

DUPIXENT can be used with or without TCS. 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.

The 52-week adult study was designed to evaluate therapy with DUPIXENT in combination with TCS at Week 16 and long-term efficacy and safety at Week 52.1,4

Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT. It is unknown if administration of live vaccines during DUPIXENT treatment will impact the safety or effectiveness of these vaccines.1

In studies of children (AD-1652) and adolescents (AD-1526), patients were excluded if they were treated with a live (attenuated) vaccine within 4 weeks before the baseline visit.2

  • Patients for whom administration of a live (attenuated) vaccine could be safely postponed until after the study were eligible to enroll in the study
  • Patients who had their vaccination preponed (given prior to the study) could enroll in the trial only after a gap of 4 weeks following administration of the vaccine

In the adult dupilumab clinical studies, treatment with a live vaccine within 12 weeks before the baseline visit was prohibited. Subjects who received a live vaccine during the clinical study were immediately discontinued from the study treatment. Subjects who completed the study treatment were advised not to administer live vaccines for approximately 3 months after stopping dupilumab.2,10

Nonlive vaccines

Limited data are available regarding coadministration of DUPIXENT with non-live vaccines.

Immune responses to vaccination were assessed in a study in which adult subjects with atopic dermatitis were treated once weekly for 16 weeks with 300 mg of dupilumab (twice the recommended dosing frequency). After 12 weeks of DUPIXENT administration, subjects were vaccinated with a Tdap vaccine (Adacel®) and a meningococcal polysaccharide vaccine (Menomune®). Antibody responses to tetanus toxoid and serogroup C meningococcal polysaccharide were assessed 4 weeks later. Antibody responses to both tetanus vaccine and meningococcal polysaccharide vaccine were similar in dupilumab-treated and placebo-treated subjects. Immune responses to the other active components of the Adacel and Menomune vaccines were not assessed.1,10

Yes, DUPIXENT can be used concomitantly with topical calcineurin inhibitors (TCIs), but, as stated in the DUPIXENT label, they should be reserved for problem areas only, such as the face, neck, and intertriginous and genital areas.1

In the adult 52-week CHRONOS, patients were permitted to use TCIs as needed.1

Review Dosage and
Administration

Because DUPIXENT may be used with or without topical medications, continuing with or stopping concomitant use is at your discretion based on your patient’s condition. Do not discontinue topical 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.1

Atopic dermatitis is a chronic disease, and you may consider treating continuously with DUPIXENT based on your clinical judgment. Individual patient responses may vary.

Access and support

99% of commercial patients nationally are covered for DUPIXENT, with 82% of adult and adolescent patients having to fail only 1 or 2 prescription topical treatments, and 79% of children ages 6 to 11 years having to fail only 1 or 2 topical treatments. You’ll have to check with your patients’ insurers to confirm their coverage.2,a

a MMIT Analysis, October 2021.

The amount your patients pay for DUPIXENT will largely depend on whether they have insurance, the type of insurance they have, whether their insurance provider considers the medication to be preferred or not preferred, and whether they’ve met their deductible.

GET PRICING INFORMATION YOU CAN SHARE WITH YOUR PATIENTS

A great place to start is with DUPIXENT MyWay®, a patient support program that provides guidance with the insurance approval process as well as patient-centric education.

Look into DUPIXENT MyWay®

The DUPIXENT MyWay® Interim Access Program assists eligible, commercially insured patients who previously started DUPIXENT and are experiencing a specific, short-term lapse in therapy. It temporarily provides eligible patients DUPIXENT at no cost, subject to program terms and conditions. You or your patients can contact DUPIXENT MyWay at to learn more.

You can use this guide to find out about the prior authorization request and appeal process for your patients appropriate for DUPIXENT.

IGA, Investigator’s Global Assessment; EASI, Eczema Area and Severity Index; NRS, numerical rating scale; Q2W, once every 2 weeks; Q4W, once every 4 weeks; SC, subcutaneous; TCI, topical calcineurin inhibitors; TCS, topical corticosteroids.

References:

  1. DUPIXENT Prescribing Information.
  2. Data on file, Regeneron Pharmaceuticals, Inc.
  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. 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.
  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;82:1328-1336.
  6. Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: a phase 3 randomized clinical trial. JAMA Dermatol. 2020;156(1):44-56.
  7. Paller AS, Siegfried EC, Thaçi D, et al. Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: a randomized, double-blinded, placebo-controlled phase 3 trial. J Am Acad Dermatol. 2020;83(5):1282-1293.
  8. 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.
  9. 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.
  10. Blauvelt A, Simpson EL, Tyring SK, et al. Dupilumab does not affect correlates of vaccine-induced immunity: a randomized, placebo-controlled trial in adults with moderate-to-severe atopic dermatitis. J Am Acad Dermatol. 2019;80(1):158-167.
Important Safety
Information and Indications

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

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.

Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT compared to those who received placebo, with conjunctivitis being the most frequently reported eye disorder. Conjunctivitis also occurred more frequently in chronic rhinosinusitis with nasal polyposis subjects who received DUPIXENT compared to those who received placebo. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g. blurred vision) associated with conjunctivitis or keratitis. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.

Eosinophilic Conditions: Patients being treated for asthma may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis (EGPA), conditions which are often treated with systemic corticosteroid therapy. These events may be associated with the reduction of oral corticosteroid therapy. Healthcare providers should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia. Cases of eosinophilic pneumonia were reported in adult subjects who participated in the asthma development program and cases of vasculitis consistent with EGPA have been reported with DUPIXENT in adult subjects who participated in the asthma development program as well as in adult subjects with co-morbid asthma in the CRSwNP development program. A causal association between DUPIXENT and these conditions has not been established.

Acute Asthma Symptoms or Deteriorating Disease: Do not use DUPIXENT to treat acute asthma symptoms, acute exacerbations, acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of DUPIXENT.

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

Patients with Co-morbid Asthma: Advise patients with atopic dermatitis or CRSwNP who have co-morbid asthma not to adjust or stop their asthma treatments without consultation with their physicians.

Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.

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. Helminth infections (5 cases of enterobiasis and 1 case of ascariasis) were reported in pediatric patients 6 to 11 years old in the pediatric asthma development program.

Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT.

ADVERSE REACTIONS:
  • Atopic dermatitis: The most common adverse reactions (incidence ≥1% at Week 16) in adult patients 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.
  • Asthma: The most common adverse reactions (incidence ≥1%) are injection site reactions, oropharyngeal pain, and eosinophilia.
  • Chronic rhinosinusitis with nasal polyposis: The most common adverse reactions (incidence ≥1%) are injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.
USE IN SPECIFIC POPULATIONS
  • Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. 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.


Indications

Atopic Dermatitis: DUPIXENT is indicated for the treatment of adult and pediatric 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.

Asthma: DUPIXENT is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.

Chronic rhinosinusitis with nasal polyposis (CRSwNP): DUPIXENT is indicated as an add-on maintenance treatment in adult patients with inadequately controlled CRSwNP.