Frequently Asked Questions

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), 1 trial in infants to preschoolers (6 months to 5 years of age) with uncontrolled moderate-to-severe atopic dermatitis, and 1 trial in atopic dermatitis patients (12 years and older) with uncontrolled moderate-to-severe hand and/or foot involvement.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 NRS with DUPIXENT at Week 16 in SOLO 1 vs 12% with placebo^1,3
• 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 placebo^1,3

In addition, in CHRONOS^1,4:

• 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

Improvement in Peak Pruritus NRS observed in adolescents treated with DUPIXENT (defined as ≥4-point improvement) as early as Week 4 (22% with DUPIXENT vs 5% with placebo; nominal P<0.001).⁵

Definitive conclusions cannot be made for time points earlier than Week 16 as those data were not multiplicity controlled and P value was nominal.

• 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 16^1,7
• 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 16^1,7

Improvement in Worst Scratch/Itch NRS observed in infants to preschoolers treated with DUPIXENT + TCS compared with placebo (defined as ≥4-point improvement) at Week 3 (22% with DUPIXENT + TCS vs 4% with placebo + TCS).^1,2

Definitive conclusions cannot be made for time points earlier than Week 16 as those data were not multiplicity controlled and P value was nominal.

• 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

A greater proportion of atopic dermatitis patients aged 12+ years with uncontrolled moderate-to-severe hand and/or foot involvement treated with DUPIXENT achieved an improvement in the hand and foot Peak Pruritus NRS at Week 16 compared with placebo (defined as ≥4-point improvement).^1,8

• 52% of adult and adolescent patients treated with DUPIXENT achieved a ≥4-point improvement in hand and foot Peak Pruritus NRS at Week 16 vs 14% with placebo (P<0.0001)

DUPIXENT has demonstrated results in 7 clinical trials in atopic dermatitis including¹:

• 3 monotherapy trials (2 trials with adult patients and 1 with adolescent patients)
• 3 concomitant TCS therapy trials (1 trial with adult patients, 1 trial with children [6‑11 years of age], and 1 with infants to preschoolers [6 months
  to 5 years of age])
• 1 clinical trial in adult and adolescent atopic dermatitis patients with uncontrolled moderate-to-severe hand and/or foot involvement (monotherapy treatment of hand/foot lesions)

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), median EASI score was 30, and weekly averaged Peak Pruritus NRS was 7.7 on a scale of 0 to 10.^1-3

At the end of SOLO 1 and SOLO 2 (Week 16), adult patients achieving IGA 0 or 1 and/or EASI-75 could enroll in SOLO CONTINUE, a double-blind phase 3 study. Patients who received DUPIXENT 300 mg Q2W in either parent study were randomized to DUPIXENT 300 mg Q2W (n=80), DUPIXENT 300 mg Q4W (n=41), DUPIXENT 300 mg Q8W (n=39), or placebo (n=39).¹¹

The primary endpoint was 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 the proportion of subjects with EASI-75 at Week 16 (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 ≥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

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 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 the proportion of subjects with EASI-75 at Week 16 (42% of patients treated with DUPIXENT vs 8% with placebo, P<0.001) and ≥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

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 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 the proportion of subjects with EASI-75 at Week 16 (69% of patients treated with DUPIXENT + TCS vs 23% with placebo + TCS in CHRONOS, P<0.0001) and ≥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

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 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 the proportion of subjects with EASI-75 at Week 16 (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 ≥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

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.^1,12

The primary endpoint was 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 the proportion of subjects with EASI-75 at Week 16 (53% of patients treated with DUPIXENT + TCS vs 11% with placebo + TCS, P<0.0001) and ≥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).^1,12

133 subjects aged 12 years and older in AD-HAFT (16 weeks) with atopic dermatitis with moderate-to-severe hand and/or foot involvement inadequately controlled with or intolerant to topical Rx therapies were randomized to DUPIXENT or placebo. Participants included subjects with both hand and foot involvement (n=71), foot-only involvement (n=4), and hand-only involvement (n=58). All DUPIXENT-treated adults and adolescents ≥60 kg received 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 hand and foot score ≥3 on a scale of 0 to 4. At baseline, 72% had an IGA hand and foot score of 3 (moderate), 28% had an IGA hand and foot score of 4 (severe), mean hand and foot Peak Pruritus NRS was 7.1 on a scale of 0 to 10, and mean HECSI score was 46.8 on a scale of 0 to 360.^1,8

The primary endpoint was the proportion of subjects with an IGA hand and foot 0 (clear) or 1 (almost clear) at Week 16 (40% of patients treated with DUPIXENT vs 17% with placebo, P=0.0030). Other endpoints included the proportion of subjects with a ≥4-point improvement in hand and foot Peak Pruritus NRS at Week 16 (52% of patients treated with DUPIXENT vs 14% with placebo, P<0.0001) and the proportion of subjects with ≥75% improvement in HECSI (HECSI-75) at Week 16 (47% of patients treated with DUPIXENT vs 22% with placebo, P=0.0028). All DUPIXENT-treated patients in AD-HAFT received DUPIXENT monotherapy for their hand and/or foot lesions.^1,8

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.^1,4

• 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)

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

The long-term safety of DUPIXENT was assessed in an open-label extension study that included adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis (AD-1434). The safety profile of DUPIXENT in 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 pediatric subjects 12 to 17 years of age 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 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.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 Data in Infants to Preschoolers

AD-HAFT was a 16-week randomized trial of 133 AD patients 12 years and older with uncontrolled moderate-to severe hand and/or foot involvement; therefore, there are currently no long-term safety data available.¹

REVIEW THE DATA IN AD PATIENTS WITH HAND AND/OR FOOT INVOLVEMENT (12+ YEARS)

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 trials¹:

• 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 162 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%) were reported in infants to preschoolers. These cases did not lead to study drug discontinuation.¹

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%) were 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%) were 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

Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT. Avoid use of live vaccines during treatment 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 of the type 2 cytokines that contribute to 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 (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%) were 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%) were 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, acute generalized exanthematous pustulosis (AGEP), serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. A case of AGEP was reported in an adult subject who participated in the bullous pemphigoid development program. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

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.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 (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%) were 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.

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=857; data presented include 55 adolescents aged ≥12 to <18 years). Data presented here are from an interim analysis.^14,15

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.^14,15

EXPLORE REAL-WORLD
PATIENT RESULTS

The study was a retrospective, multicenter, Italian dynamic cohort study conducted on 2576 adult patients with moderate-to-severe atopic dermatitis treated with DUPIXENT were collected from 24 dermatological centers from June 2018 to July 2022. Data are from patients observed at 4 months (N=2364), 12 months (N=2066), 24 months (N=1291), 36 months (N=601), and 48 months (N=110).¹⁶

Limitations of analysis:

Limitations include the retrospective nature of the study and dynamic cohort design that hindered considerations regarding drug survival. Patients were also treated with other atopic dermatitis medications.¹⁶

EXPLORE REAL-WORLD
PATIENT RESULTS

RELIEVE-AD is a single-arm, prospective, observational study in patients with moderate-to-severe atopic dermatitis enrolled in DUPIXENT MyWay^® prior to initiating treatment with DUPIXENT. Patients completed multiple surveys over 60 months. At Month 60, participants that responded to the survey at Month 33 and/or Month 48 were recontacted for Month 60 follow-up.^2,17

Limitations of analysis:

This patient population was self-selected; those who maintain long-term efficacy and safety may be more likely to participate in such surveys. Similarly, patients were recruited through a DUPIXENT patient support program, which may influence patient perceptions of treatment benefit.^2,17

Explore Real-world
ADULT PATIENT Results

The IBM MarketScan study evaluated rates of persistence in real-world adult DUPIXENT patients.¹⁸

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.¹⁸

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 Diseases (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.¹⁸

Explore Real-world
ADULT PATIENT Results

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) followed by 300 mg (1 SC injection) 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

99% of commercial AD patients (6+ months of age) nationally are covered for DUPIXENT, with 90% of commercial AD patient lives having to fail only 1 or 2 prescription topical treatments.^2,a

^a MMIT Analysis, June 2025.

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 1-844-DUPIXEN(T) (1-844-387-4936) 1-844-DUPIXEN(T) (1-844-387-4936) 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.