Per the indication for DUPIXENT, 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 3 randomized, double-blind, placebo-controlled trials that enrolled 2119 subjects, 18 years of age and older with moderate-to-severe atopic dermatitis not adequately controlled by topical prescription medication(s).1 Click here for additional clinical trial design information.
Itch reduction with DUPIXENT was rapid and sustained. In Trial 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
In addition, in Trial 31,3:
Itch reduction was evaluated as a key secondary endpoint in the adolescent trial that enrolled 251 subjects, aged 12 to 17 years with moderate-to-severe atopic dermatitis not adequately controlled by topical prescription medication(s).1
A greater proportion of subjects randomized to DUPIXENT achieved an improvement in the Peak Pruritus NRS compared with placebo (defined as ≥4-point improvement as early as Week 4; 22% with DUPIXENT vs 5% with placebo).1,2,4
Itch reduction was evaluated as a key secondary endpoint in the study in children that enrolled 367 subjects, aged 6 to 11 years with severe atopic dermatitis not adequately controlled by topical prescription medication(s).1
Trial 3 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
Trial 3 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.1-3
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.
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
In the adult 52-week trial1:
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 (Trial 7). The safety profile of DUPIXENT in adolescent subjects followed through Week 52 was similar to the safety profile observed at Week 16 in Trial 6. The long-term safety profile of DUPIXENT observed in adolescents was consistent with that seen in adults with atopic dermatitis.1Review 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 (Trial 7). Among subjects who entered this study, 110 (30%) had moderate and 72 (20%) had severe atopic dermatitis at the time of enrollment in Trial 7. The safety profile of DUPIXENT + TCS in children followed through Week 52 was similar to the safety profile observed at Week 16 in Trial 8. The long-term safety profile of DUPIXENT + TCS observed in children was consistent with that seen in adults and adolescents with atopic dermatitis.1Review 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:
The adolescent trial (Trial 6) was a 16-week monotherapy study with patients 12-17 years old with moderate-to-severe atopic dermatitis.
The trial in children (Trial 8) was a 16-week concomitant TCS use study with patients 6-11 years old with severe atopic dermatitis.See DUPIXENT Study Designs
The Modernizing Medicine study evaluated itch reduction and skin clearance in real-world adult DUPIXENT patients.5,6
Modernizing Medicine’s electronic medical records (EMR) were evaluated and analyzed 2945 adult patients with ≥1 DUPIXENT prescription in the index period (between April 1, 2017 and November 30, 2017). The study period spanned from April 2016 to March 2018, and included data 12 months before the index date (baseline) and outcomes assessed at least 4 months after the index date (post-index).5,6
Limitations of analysis:
Only a small proportion of patients treated with DUPIXENT had IGA and Pruritus NRS recorded in the EMR prior to, and after the initiation of, therapy with DUPIXENT. From this study, 2 cohorts were extrapolated5,6:
The cohort for itch assessed the real-world effectiveness of DUPIXENT in adult patients with moderate-to-severe itch, as defined by Pruritus NRS ≥3.5
The cohort for the IGA assessed the real-world effectiveness of DUPIXENT in adult patients with moderate-to-severe atopic dermatitis, as defined on the 0- to 5-point IGA scale (0=clear, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe). Clear/minimal lesion severity was defined as patients achieving a post-index IGA score of 0 or 1.6Explore Real-world Results
The Truven Marketscan study evaluated rates of persistence in real-world adult DUPIXENT patients.7
From Truven Marketscan data, 1637 adults were identified with ≥1 DUPIXENT prescription between March 28, 2017 and January 31, 2018, with continuous enrollment during the baseline period. Patients were followed from their first prescription until July 31, 2018, or disenrollment.7
Limitations of analysis:
Kaplan-Meier curves were used to estimate persistence at 6 and 12 months, using a 30-day grace period and assuming 14-day injection frequency. Limitations of this study may be the potential misclassification of persistence due to assumptions regarding injection frequency and grace period. Study includes early adopters of DUPIXENT, therefore as utilization in clinical practice increases over time, further analyses are recommended to confirm these findings.7
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) 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), 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.1Review Dosing and
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 52.1,3
Avoid use of live vaccines in patients treated with DUPIXENT.1
In studies of children (Trial 8) and adolescents (Trial 6), patients were excluded if they were treated with a live (attenuated) vaccine within 4 weeks before the baseline visit.2
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.2Non-live Vaccines
Immune responses to vaccination were assessed in a study in which 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.2,8
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 Trial 3, patients were permitted to use TCIs as needed.1
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.
The safety and efficacy of DUPIXENT have been established in pediatric patients 6 years of age and older with moderate-to-severe atopic dermatitis.1
Use of DUPIXENT in this age group is supported by Trial 8 which included 367 children ages 6 to 11 years old with severe atopic dermatitis. The safety and efficacy were generally consistent between pediatric and adult patients.1
Use is also supported by Trial 7, an open-label extension study that enrolled subjects who completed Trials 6 and 8. Trial 7 included 136 adolescents from Trial 6 and 110 children from Trial 8 with moderate atopic dermatitis at enrollment into the extension study. Trial 7 included 64 adolescents from Trial 6 and 72 children from Trial 8 with severe atopic dermatitis at enrollment. No new safety signals were identified in Trial 7.1
In the adult trials with DUPIXENT monotherapy (Trials 1 and 2) and with concomitant topical corticosteroids (Trial 3), as well as the adolescent trial (Trial 6), 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).
In the trial in children (Trial 8), the primary endpoint was the change in baseline to Week 16 in the proportion of subjects with an IGA 0 or 1 in patients with a baseline IGA of 4.
99% of US adult commercial patients are covered for DUPIXENT, with 76% of those lives having to fail only 1 or 2 prescription topical treatments. You'll have to check with your patients’ specific insurers to confirm their specific coverage.2,a
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.Click here for the information your patients can receive about pricing
A great place to start is with DUPIXENT MyWay, a patient support program providing guidance with the insurance approval process as well as patient-centric education.Look into DUPIXENT MyWay
You can use this guide to find out about the prior authorization request and appeal process for your patients appropriate for DUPIXENT.