DUPIXENT basics

Per the indication for DUPIXENT, adult and pediatric patients aged 6 months 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.1

Itch reduction was evaluated as a key secondary endpoint in randomized, double-blind, placebo-controlled trials: 3 adult trials, 1 trial in adolescents (12-17 years of age), 1 trial in children (6-11 years of age), and 1 trial in infants to preschoolers (6 months to 5 years of age).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 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) and as early as Week 4 in adolescents (22% with DUPIXENT vs 5% with placebo; nominal P<0.001).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

A greater proportion of infants to preschoolers treated with DUPIXENT + TCS had an improvement in Worst Scratch/Itch NRS compared with placebo (defined as ≥4-point improvement) at Week 3 (48% with DUPIXENT + TCS vs 9% with placebo + TCS).1,2

  • 48% of patients treated with DUPIXENT + TCS achieved ≥4-point improvement in Worst Scratch/Itch NRS vs 9% with placebo + TCS at Week 16, P<0.0001

Review Adult Peak Pruritus NRS Results

Review Adolescent Peak Pruritus NRS Results

Review the Peak Pruritus NRS Results in Children

Review the Worst Scratch/Itch NRS Results in Infants to Preschoolers

DUPIXENT clinical trials

DUPIXENT has demonstrated results in 3 monotherapy trials that include 2 trials with adult patients and one with adolescent patients, and 3 concomitant therapy trials that include 1 with adults, 1 with children (6-11 years of age), and 1 with infants to preschoolers (6 months to 5 years of age).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 on a 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 (38% of patients treated with DUPIXENT vs 10% with placebo in SOLO 1, P<0.001; and 36% of patients treated with DUPIXENT vs 9% with placebo in 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%; 51% of patients treated with DUPIXENT vs 15% with placebo in SOLO 1, P<0.001; and 44% of patients treated with DUPIXENT vs 12% with placebo in SOLO 2, P<0.001) and itch reduction defined by ≥4-point improvement in the Peak Pruritus NRS at Week 16 (41% of patients treated with DUPIXENT vs 12% with placebo in SOLO 1, P<0.001; and 36% of patients treated with DUPIXENT vs 10% with placebo in SOLO 2, P<0.001).1,3

A total of 251 adolescents (12-17 years) in AD-1526 (16 weeks) 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 on a 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).1,6

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 patients who received DUPIXENT were given 300 mg Q2W after a 600 mg loading dose with concomitant TCS. Patients had an IGA score ≥3 on a 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 7.7 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).1,4

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

A total of 162 infants to preschoolers (6 months to 5 years) in AD-1539 (16 weeks) with moderate-to-severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT + TCS or placebo + TCS. Patients 15 kg but <30 kg received 300 mg Q4W. Patients 5 kg but <15 kg received 200 mg Q4W. Patients had an IGA score ≥3 on a scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and BSA involvement of ≥10%. At baseline, 23% of infants to preschoolers had an IGA score of 3 (moderate), 77% had an IGA of 4 (severe), mean EASI score was 34.1, and weekly average of daily Worst Scratch/Itch NRS was 7.6 on a scale of 0 to 10.1,8

The primary endpoint was change from baseline in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) at Week 16 (28% of patients treated with DUPIXENT + TCS vs 4% with placebo + TCS, P<0.0001). Other endpoints included change from baseline in the proportion of subjects with EASI-75 at Week 16 (improvement of ≥75%; 53% of patients treated with DUPIXENT + TCS vs 11% with placebo + TCS, P<0.0001) and itch reduction defined by ≥4-point improvement in the Worst Scratch/Itch NRS at Week 16 (48% of patients treated with DUPIXENT + TCS vs 9% with placebo + TCS, P<0.0001).1,2

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) and ≥2-point improvement (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 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%) in patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia.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 was a 16-week trial.1

However, the long-term safety of DUPIXENT ± TCS was assessed in an open-label extension study of 180 infants to preschoolers 6 months to 5 years of age with atopic dermatitis (AD-1434). The majority of subjects were treated with DUPIXENT 300 mg every 4 weeks. The safety profile of DUPIXENT ± TCS in infants to preschoolers through Week 52 was similar to the safety profile observed through Week 16 in AD-1539. The long-term safety profile of DUPIXENT ± TCS observed in infants to preschoolers was consistent with that seen in adults, adolescents and children with atopic dermatitis. In AD-1434, hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) was reported in infants to preschoolers. These cases did not lead to study drug discontinuation.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 was a 16-week trial.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

The pivotal clinical trial evaluating the efficacy and safety of DUPIXENT ± TCS in infants to preschoolers aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis was a 16-week trial.

However, the long-term safety of DUPIXENT ± TCS was assessed in an open-label extension study of 180 infants to preschoolers 6 months to 5 years of age with atopic dermatitis (AD-1434). The majority of subjects were treated with DUPIXENT 300 mg every 4 weeks. The safety profile of DUPIXENT ± TCS in infants to preschoolers through Week 52 was similar to the safety profile observed through Week 16 in AD-1539. The long-term safety profile of DUPIXENT ± TCS observed in infants to preschoolers was consistent with that seen in adults, adolescents and children with atopic dermatitis. In AD-1434, hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) was reported in infants to preschoolers. These cases did not lead to study drug discontinuation.1

Review the Data in Infants to Preschoolers

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

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

Use of DUPIXENT in this age group (6-11 years of age) is supported by AD-1652, which included 367 children with severe atopic dermatitis.1

Use of DUPIXENT in this age group is supported by data from the following clinical trials:

  • AD-1526 which included 251 adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis treated with DUPIXENT
  • AD-1652 which included 367 children 6 to 11 years of age with severe atopic dermatitis treated with DUPIXENT + TCS
  • AD-1539 which included 161 infants to preschoolers 6 months to 5 years of age with moderate-to-severe atopic dermatitis treated with DUPIXENT + TCS
  • AD-1434, an open-label extension study that enrolled 275 adolescents 12 to 17 years of age treated with DUPIXENT, 368 children 6 to 11 years of age treated with DUPIXENT ± TCS, and 180 infants to preschoolers 6 months to 5 years of age treated with DUPIXENT ± TCS

The safety and effectiveness were generally consistent between pediatric and adult patients. In AD-1434, hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) was reported in infants to preschoolers. These cases did not lead to study drug discontinuation.1

DUPIXENT safety profile

The most common adverse reactions (incidence ≥1%) were injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile of DUPIXENT in pediatric patients 6 months 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 (AD-1434), the safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis. In AD-1434, hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) was reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.1

Explore the Dupixent Safety Profile

The safety profile of DUPIXENT in adults and pediatric patients 6 months to 17 years of age through Week 16 was similar. The long-term safety profile of DUPIXENT ± TCS across multiple age groups was assessed in an open-label extension study (AD-1434). DUPIXENT demonstrated a generally consistent safety profile across infants to preschoolers, children, adolescents, and adults. In AD-1434, hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) was reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.1

Explore the DUPIXENT Safety Profile

Other attributes/
considerations

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.1

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 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. 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%) in patients with atopic dermatitis were injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile of DUPIXENT in pediatric patients 6 months 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, study (AD-1434), the safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis. In AD-1434, hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) was reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.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%) in patients with atopic dermatitis were injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile of DUPIXENT in pediatric patients 6 months 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 (AD-1434), the safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis. In AD-1434, hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) was reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.1

Note: Select 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.1 DUPIXENT is NOT metabolized through the liver or excreted through the kidneys.

In the DUPIXENT pivotal clinical trials, the most common adverse reactions (incidence ≥1%) in patients with atopic dermatitis were injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile of DUPIXENT in pediatric patients 6 months 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 (AD-1434), the safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis. In AD-1434, hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) was reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.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

PROSE is an ongoing, longitudinal, prospective, observational registry in the USA and Canada (NCT03428646) of patients aged ≥12 years with moderate-to-severe atopic dermatitis, treated with DUPIXENT in accordance with approved prescribing information (N=563; data presented include 28 adolescents aged ≥12 to <18 years). The results were measured by mean improvement in Peak Pruritus NRS and EASI scores from baseline. Data presented here are from the safety analysis set with a cutoff date of October 2020.9

Limitations of analysis:

Patients were also treated with other atopic dermatitis medications. While the initial prescription for DUPIXENT had to be in accordance with approved prescribing information, physicians were free thereafter to make any treatment decisions they deemed appropriate. Also, there could be a bias toward better outcomes in patients who continue providing data in this real-world study.9

Explore Real-world ADULT PATIENT Results

This study was a prospective, observational, longitudinal patient survey of 699 adult patients who had not been treated with DUPIXENT prior to this study.10,11

Surveys were completed at baseline (prior to DUPIXENT treatment) and at Months 1, 2, 3, 6, 9, 12, and 30-36 after initiation of DUPIXENT. Data are from an interim analysis of patients who had completed surveys through 1 month (n=632) and through 30-36 months (n=425). 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."10,11

Limitations of analysis:

The survey data were collected from patients who enrolled in the DUPIXENT patient support program, and these patients may have different perceptions of DUPIXENT 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.11

Explore Real-world ADULT PATIENT Results

The IBM MarketScan study evaluated rates of persistence in real-world adult DUPIXENT patients.12

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. Patients received a mean of 8.6 DUPIXENT dispensations from initiation to first discontinuation.12

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.12

Explore Real-world ADULT PATIENT Results

This study was a prospective, observational, longitudinal patient survey of 698 adult patients prescribed DUPIXENT and enrolled in the patient support program.13,14

Surveys were completed at baseline (prior to DUPIXENT treatment) and at Months 1, 2, 3, 6, 9, 12, and 30-36 after initiation of DUPIXENT. Data are from an analysis of patients who had completed surveys through 1 month (n=631) and through 30-36 months (n=425). The use of concomitant prescription treatment categories was measured using the percentage of patients that required atopic dermatitis treatment categories (excluding DUPIXENT for Months 1 to 30-36); 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 inhibitors, systemic corticosteroids, systemic immunosuppressants, and phototherapy.13,14

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.14

Explore Real-world ADULT PATIENT Results

Prescribing DUPIXENT

The dosing for adolescents, children, and infants to preschoolers 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), the recommended dose is 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

For your pediatric patients (6 months to 5 years) who weigh 15 kg (33 lb) to less than 30 kg (66 lb), the recommended dose is 300 mg (1 SC injection) given every 4 weeks. For patients who weigh 5 kg (11 lb) to less than 15 kg (33 lb), the recommended dose is 200 mg (1 SC injection) given every 4 weeks. No initial loading dose is recommended for patients aged 6 months to 5 years.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 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.1

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

Yes, DUPIXENT can be used concomitantly with 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 trial, 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 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.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 (6+ years of age) nationally are covered for DUPIXENT, with 83% of commercial patient lives having to fail only 1 or 2 prescription topical treatments.2,a

a MMIT Analysis, July 2022.

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.

NAVIGATING PRIOR AUTHORIZATIONS
AND APPEALS FOR DUPIXENT

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