New Dupixent® (dupilumab) Data in Patients as Young as Six Years Old With Moderate-to-Severe Atopic Dermatitis to Be Presented at WCPD and EADV
More than 30 presentations reinforce the role of Dupixent in targeting IL-4 and IL-13, key drivers of the type 2 inflammation underlying atopic dermatitis in children, adolescents and adults
Results provide insight into the clinical and real-world experience of Dupixent on disease measures including itch, disease severity, sleep, and anxiety
Dupixent presentations include longest duration of data for any biologic medicine in adults with moderate-to-severe atopic dermatitis, with results up to 3.5 years
"Moderate-to-severe atopic dermatitis can severely affect people from infancy into adulthood, often causing a lifetime of debilitating symptoms like intense itch, skin lesions covering much of the body, impaired mental well-being and an increased risk of skin infections," said
Notable Dupixent presentations include long-term efficacy and safety data showing the impact of Dupixent on signs and symptoms of moderate-to-severe atopic dermatitis in children, adolescents and adults. More than 30 presentations highlight Dupixent results on skin lesions, itch and skin infections, as well as sleep and health-related quality of life, for patients and their families, such as in adults with a history of mental health disorders and in children with anxiety and depression. Real-world evidence will also be presented from observational registries and claims databases across multiple geographies.
Disease burden data to be presented at EADV include results from the Atopic Dermatitis Global Adolescent and Pediatric survey on how patients, caregivers and physicians view the full impact of moderate-to-severe atopic dermatitis, based on findings from more than 3,900 people across 13 countries. Data will also be shared from the Quality of Care in AD Initiative, which documents best practices from 32 atopic dermatitis centers across the world, focused on the value of patient education and communication.
Data to be presented at WCPD 2021
Clinical Efficacy and Safety of Dupixent in Atopic Dermatitis
- Oral presentation (
September 24, 3:40-3:50 pm BST):
- #SP42 Long-Term Efficacy and Safety Data for Dupilumab in a Phase 3, Open-Label Extension Trial (LIBERTY AD PED-OLE) in Patients Aged ≥ 6 to < 12 Years With Uncontrolled, Moderate-to-Severe Atopic Dermatitis (AD),
- Poster #P22: Efficacy and Safety of Dupilumab for up to 1 Year in a Phase 3 Open-Label Extension (OLE) Trial (LIBERTY AD PED-OLE) in Adolescents With Uncontrolled, Moderate-to-Severe Atopic Dermatitis (AD),
- Poster #P23: 52-Week Laboratory Safety Findings From an Open-Label Extension (OLE) Study of Dupilumab in Adolescent Patients With Atopic Dermatitis (LIBERTY AD PED-OLE),
- Poster #P33: Dupilumab Improved Itch in Children Aged 6–11 Years With Severe Atopic Dermatitis: Analysis From the LIBERTY AD PEDS Trial, Gil Yosipovitch
- Poster #P35: IGAxBSA: An Alternative to
EASIin Assessing Disease Severity and Response in Pediatric Patients With Moderate-to-Severe Atopic Dermatitis, Amy Paller
- Poster #P36: Dupilumab Induces Rapid and Sustained Improvement in Clinical Signs in Children With Severe Atopic Dermatitis,
- Poster #P38: Dupilumab Significantly Improves All POEM Components in Children Aged ≥6 to <12 Years With Severe Atopic Dermatitis,
- Poster #P40: Efficacy and Safety of Dupilumab in Children Aged ≥ 6 to < 18 Years With a History of Infection (LIBERTY AD PEDS, LIBERTY AD ADOL),
- Poster #P41: Dupilumab in Children Aged ≥6 to <12 Years Promotes Rapid and Sustained Improvement in Clinical Signs of Atopic Dermatitis (LIBERTY AD PEDS),
- Poster #P44: Dupilumab in Children Aged ≥6–<12 Years Significantly Improves Signs and Symptoms of Atopic Dermatitis Assessed by SCORAD, Sébastien Barbarot
Quality of Life Data in Atopic Dermatitis for Dupixent
- Poster #P30: Dupilumab Induces Clinically Meaningful Improvement in Symptoms of Anxiety and Depression in Children With Severe Atopic Dermatitis,
- Poster #P37: Dupilumab Treatment Improves Sleep in Children Aged ≥ 6 to < 12 Years With Severe Atopic Dermatitis,
- Poster #P46: Dupilumab Improves Family Quality of Life in Children Aged 6–11 Years With Severe Atopic Dermatitis (LIBERTY AD PEDS),
Dupixent Use and Vaccination
- Poster #P120: Dupilumab and Live-Attenuated Vaccines: Experience With Prior Dupilumab Use and Yellow Fever Vaccine in Patients With Severe Asthma From Brazil,
Abstracts presenting research on the burden of atopic dermatitis include:
- Poster #P29: Pediatric Patients With Atopic Dermatitis (AD) Have a High Burden of Atopic Comorbidities: Results From a
Large Worldwide Survey, Jonathan Silverberg
Data to be presented at EADV 2021
Long-Term Efficacy and Safety of Dupixent in Atopic Dermatitis
- Oral Presentation (
September 30, 10:00-11:00 am CEST):
- #2008 Long-Term Efficacy of Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis: Results From an Open-Label Extension Trial up to 172 Weeks,
- Poster #P0258: Dupilumab Provides Long-Term Improvement in Pruritus in Children With Severe Atopic Dermatitis, and Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis,
- Poster #P0723: Patient Well-Being and Perception of Treatment Effect With Long-Term Dupilumab Monotherapy in Adults With Moderate-to-Severe Atopic Dermatitis,
- Poster #P0726: Safety of Long-Term Dupilumab Treatment in Adults With Moderate-to-Severe Atopic Dermatitis: Results From an Open-Label Extension Trial up to 172 Weeks,
- Poster #P0727: Dupilumab Provides Long-Term Efficacy Over 2.5 Years in Adults With Moderate-to-Severe Atopic Dermatitis,
- Poster #P0729: Dupilumab Monotherapy Provides Long-Term Control and Prevents Flares in Adults With Moderate-to-Severe Atopic Dermatitis Optimally Responding at Week 16,
Quality of Life Data for Dupixent in Atopic Dermatitis
- Poster #P0239: Dupilumab Improves Family Quality of Life in Children Aged 6-11 Years With Severe Atopic Dermatitis: An Analysis From the Phase 3 LIBERTY AD PEDS Trial,
- Poster #P0252: Dupilumab Provides Long-Term Improvement of Sleep Loss in Children, Adolescents, and Adults With Atopic Dermatitis,
- Poster #P0722: Dupilumab Monotherapy Provides Long-Term Improvement in Quality of Life in Adults With Moderate-to-Severe Atopic Dermatitis Optimally Responding at Week 16, Carlos Ferrándiz
Additional Efficacy and Safety Analyses of Dupixent in Atopic Dermatitis
- Poster #P0230: Dupilumab Treatment in Adult Patients Is Efficacious Regardless of Age at Atopic Dermatitis Onset,
- Poster #P0231: Dupilumab in Children Aged ≥ 6 to < 12 Years Promotes Rapid Improvement in Clinical Signs of Atopic Dermatitis,
- Poster #P0251: Infections in Dupilumab Pediatric Clinical Trials in Atopic Dermatitis — A Pooled Analysis,
- Poster #P0255: Dupilumab Significantly Improves Treatment Response in Children With Severe Atopic Dermatitis From the Patient's Perspective and by Clinical Assessments of Signs, Symptoms, and Quality of Life: Results From the LIBERTY AD PEDS Phase 3 Clinical Trial,
- Poster #P0256: Dupilumab Treatment Is Efficacious in Adult Atopic Dermatitis Patients Independent of History of Mental Health Disorders: A Post Hoc Analysis of Pooled Phase 3 Trials,
- Poster #P0260: Dupilumab Treatment Is Efficacious in Adult Atopic Dermatitis Patients Regardless of History of Infection: A Pooled Analysis of Four Phase 3 Trials,
- Poster #P0733: Dupilumab Monotherapy Provides 1 Year Sustained Response in Adults With Moderate-to-Severe Atopic Dermatitis Optimally Responding at Week 16, With No Need of Concomitant Topical Steroids,
- Poster #P0257: Improvement in Disease Severity and Quality of Life in Patients With Atopic Dermatitis Treated With Dupilumab for up to 18 Months: Real-World Data From the PROSE Registry,
- Poster #P0259: Use of Systemic Therapies in Adults With Atopic Dermatitis: 18-Month Results From the European Prospective Observational Study in Patients Eligible for Systemic Therapy for Atopic Dermatitis (EUROSTAD),
Marjolein De Bruin-Weller
- Poster #P0272: Real-World Use of Dupilumab Among Adults With Atopic Dermatitis and Its Impact on Healthcare Utilization in
Japan, Ken Igawa
Abstracts presenting research on patient education, health-related quality of life and burden of disease in atopic dermatitis include:
- Poster #P0208: The Importance of Patient Education and Communication: Results from the Atopic Dermatitis Quality of Care Initiative,
- Poster #P0254: Relative Importance of Distinct Aspects of Quality of Life for Patients Aged 6–11 and 12–17 Years Old With Atopic Dermatitis, Caregivers, and Physicians (AD-GAP),
- Poster #P0271: Prevalence and Characteristics of Prurigo Nodules in Adults With Moderate-to-Severe Atopic Dermatitis in
Japan: Results From a 2-Year Observational Study, Yoko Kataoka
Dupixent, which was invented using Regeneron's proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. Dupixent is not an immunosuppressant and does not require lab monitoring. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).
Dupixent is currently approved in the
Dupilumab Development Program
To date, dupilumab has been studied across 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.
Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes, including pediatric asthma (6 to 11 years of age, Phase 3), chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), eosinophilic esophagitis (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), chronic inducible urticaria-cold (Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), allergic fungal rhinosinusitis (Phase 3), allergic bronchopulmonary aspergillosis (Phase 3) and peanut allergy (Phase 2). These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
About Regeneron's VelocImmune® Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's President and Chief Scientific Officer
DUPIXENT is a prescription medicine used:
- to treat people aged 6 years and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 years of age.
- with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. DUPIXENT is not used to treat sudden breathing problems. It is not known if DUPIXENT is safe and effective in children with asthma under 12 years of age.
- with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyposis under 18 years of age.
IMPORTANT SAFETY INFORMATION FOR
Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®.
Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you:
- have eye problems
- have a parasitic (helminth) infection
- are scheduled to receive any vaccinations. You should not receive a "live vaccine" if you are treated with DUPIXENT.
- are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby.
- There is a pregnancy exposure registry for women who take DUPIXENT during pregnancy to collect information about the health of you and your baby. Your healthcare provider can enroll you or you may enroll yourself. To get more information about the registry call 1–877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/.
- are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have atopic dermatitis or CRSwNP, and also have asthma. Do not change or stop your corticosteroid medicine or other asthma medicine without talking to your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine or other asthma medicine to come back.
DUPIXENT can cause serious side effects, including:
- Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following symptoms: breathing problems, fever, general ill feeling, swollen lymph nodes, swelling of the face, mouth and tongue, hives, itching, fainting, dizziness, feeling lightheaded (low blood pressure), joint pain, or skin rash.
- Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.
- Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by DUPIXENT. Tell your healthcare provider right away if you have: rash, shortness of breath, persistent fever, chest pain, or a feeling of pins and needles or numbness of your arms or legs.
The most common side effects by indication are as follows:
- Atopic dermatitis: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, and cold sores in your mouth or on your lips.
- Asthma: injection site reactions, pain in the throat (oropharyngeal pain), and high count of a certain white blood cell (eosinophilia).
- Chronic rhinosinusitis with nasal polyposis: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, high count of a certain white blood cell (eosinophilia), trouble sleeping (insomnia), toothache, gastritis, and joint pain (arthralgia).
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed. Your healthcare provider will tell you how much DUPIXENT to inject and how often to inject it. DUPIXENT is an injection given under the skin (subcutaneous injection). If your healthcare provider decides that you or a caregiver can give DUPIXENT injections, you or your caregiver should receive training on the right way to prepare and inject DUPIXENT. Do not try to inject DUPIXENT until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that DUPIXENT be administered by or under supervision of an adult. In children younger than 12 years of age, DUPIXENT should be given by a caregiver.
Please see accompanying full Prescribing Information including Patient Information.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
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