Positive Dupixent® (dupilumab) Data Across Five Diseases with Underlying Type 2 Inflammation to be Presented at 2022 AAAAI Annual Meeting
Late-breaking pivotal data show significant disease improvements in eosinophilic esophagitis and also in chronic spontaneous urticaria
18 abstracts add to body of evidence that IL-4 and IL-13 pathways inhibited by Dupixent are key drivers of the type 2 inflammation underlying certain diseases, accounting for the impact of Dupixent in its approved and investigational indications
The five diseases include eosinophilic esophagitis (EoE), chronic spontaneous urticaria (CSU), asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and atopic dermatitis. Additionally, positive results from two Phase 3 trials in a sixth indication, prurigo nodularis, were recently announced and will be presented at a separate medical meeting later this year.
Abstracts being presented at the AAAAI meeting have been published in an online supplement to
New pivotal data showing significant disease improvements in EoE and CSU will be presented for the first time. The use of Dupixent in these diseases is currently under clinical investigation and its safety and efficacy have not been fully evaluated by any regulatory authority.
- Oral Presentation L01 (
February 26, 2:00-3:15 pm MST): Dupilumab Significantly Reduces Itch and Hives in Patients with Chronic Spontaneous Urticaria: Results from a Phase 3 Trial (LIBERTY-CSU CUPID Study A), Marcus Maurer
- Oral Presentation L02 (
February 26, 2:00-3:15 pm MST): Dupilumab Improves Clinical and Histologic Aspects of Disease in Adult and Adolescent Patients with Eosinophilic Esophagitis at Week 24: Results from Part B of the 3-Part LIBERTY EoE TREET Study, Marc Rothenbergand Evan Dellon
New analyses evaluate Dupixent in patients aged six years and older with moderate-to-severe asthma. These include analyses in patients characterized by different type 2 inflammatory biomarkers and comorbidities, as well as those with seasonal exacerbations.
- Oral Presentation 189 (
February 26, 2:00-3:15 pm MST): Long-Term Efficacy of Dupilumab in Patients with Asthma with and without Comorbid Chronic Rhinosinusitis/Nasal Polyposis, Andrew Menzies-Gow
- Oral Presentation 190 (
February 26, 2:00-3:15 pm MST): Efficacy of Dupilumab in the Prevention of Seasonal Exacerbations in Patients with and without Evidence of an Allergic Asthma Phenotype, Anju Peters
- Poster 42 (
February 26, 9:45-10:45 am MST): Dupilumab Efficacy in LIBERTY ASTHMA QUEST Patients with Uncontrolled, Moderate-to-Severe Asthma by Allergen Sensitization Status, Jonathan Corren
- Poster 50 (
February 26, 9:45-10:45 am MST): Efficacy of Dupilumab in Quadrants of Elevated- vs Low- Type 2 Biomarkers in Children with Uncontrolled, Moderate-to-Severe Asthma: LIBERTY ASTHMA VOYAGE, Leonard Bacharier
- Poster 409 (
February 27, 2:00-3:15 pm MST): Dupilumab Improves Asthma Control, and Allergic Rhinitis-Related Health-Related Quality of Life in Children with Uncontrolled Persistent Asthma with Comorbid Allergic Rhinitis, Alessandro Fiocchi
- Poster 571 (
February 28, 9:45-10:45 am MST): Long-Term Efficacy of Dupilumab in Quadrants of Elevated- vs Low- Type 2 Biomarker Patients with Uncontrolled, Moderate-to-Severe Asthma: LIBERTY ASTHMA TRAVERSE, Michael Wechsler
New analyses assess Dupixent in reducing the burden of disease for patients with CRSwNP. These include assessments on the reduction of systemic corticosteroid use and symptoms, such as loss of sense of smell and nasal congestion, as well as the increase in days with no symptoms.
- Oral Presentation 430 (
February 27, 2:05-2:15 pm MST): Dupilumab Achieves Durable Reduction in Severity of Symptoms Rated Most Important by Patients with Chronic Rhinosinusitis with Nasal Polyps, Claire Hopkins
- Oral Presentation 431 (
February 27, 2:15-2:25 pm MST): Dupilumab Improves Objective, Subjective, and Health-Related Quality of Life Outcomes in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), Regardless of BMI ≥30 kg/m2 or Weight ≥90 kg: Post-hoc Analysis of the SINUS-24 and SINUS-52 Studies, Seong Cho
- Oral Presentation 432 (
February 27, 2:25-2:35 pm MST): Symptom Free Days in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps Treated with Dupilumab, Claus Bachert
- Oral Presentation 434 (
February 27, 2:45-2:55 pm MST): Dupilumab Leads to Reduction of Anosmia in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps, Andrew Lane
- Poster 145 (
February 26, 9:45-10:45 am MST): EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients: The EVEREST Trial, Lucia De Prado Gomez
- Poster 377 (
February 27, 9:45-10:45 am MST): Dupilumab Reduces Asthma Disease Burden and Recurrent SCS Use in Patients with CRSwNP and Coexisting Asthma, Mark Gurnell
In addition to the late-breaking abstract, a new analysis assesses the impact of Dupixent treatment on biomarkers of type 2 inflammation in patients with EoE. The use of Dupixent in EoE is investigational and has not been approved by any regulatory authority.
- Oral Presentation 633 (
February 28, 9:45-10:45 am MST): Dupilumab Reduces Biomarkers of Type 2 Inflammation in Adult and Adolescent Patients with Eosinophilic Esophagitis: Results from Parts A and C of a Three-Part, Phase 3 LIBERTY EoE TREET Study, Mark Rothenberg
New data from a trial that evaluated improvements in skin barrier function for adults and adolescents with moderate-to-severe atopic dermatitis treated with Dupixent, as well as long-term safety results of Dupixent in adults, will be shared.
- Poster 29 (
February 26, 9:45-10:45 am MST): Dupilumab Treatment Significantly Improves Skin Barrier Function in Adult and Adolescent Patients with Moderate to Severe Atopic Dermatitis, Evgeny Berdyshev
- Poster 30 (
February 26, 9:45-10:45 am MST): Safety of Long-Term Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis up to 172 Weeks: Results from an Open-Label Extension (OLE) Trial, Andreas Wollenberg
In addition, results from an observational study highlight the disease burden of moderate-to-severe atopic dermatitis and unmet need in children.
- Poster 22 (
February 26, 9:45-10:45 am MST): The Patient Burdenof Moderate-to-Severe Atopic Dermatitis (AD) in Children Aged <12 Years: Results From 732 Patients in the PEDIatric STudy in Atopic Dermatitis (PEDISTAD) Observational Study, Amy Paller
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 CRSwNP.
Dupixent is currently approved in the
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
Dupilumab Development Program
Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. 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.
In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes, including pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), eosinophilic esophagitis (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), bullous pemphigoid (Phase 3), chronic inducible urticaria-cold (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.
DUPIXENT is a prescription medicine used:
- to treat adults and children 6 years of age 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 adults and children 6 years of age 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 6 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" right before and during treatment with DUPIXENT.
- are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby.
- A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. To enroll or get more information 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. DUPIXENT can cause allergic reactions that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing, swelling of the face, lips, mouth, tongue or throat, fainting, dizziness, feeling lightheaded, fast pulse, fever, hives, joint pain, general ill feeling, itching, skin rash, swollen lymph nodes, nausea or vomiting, or cramps in your stomach-area.
- Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an exam if needed.
- 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, chest pain, worsening shortness of breath, a feeling of pins and needles or numbness of your arms or legs, or persistent fever.
- Joint aches and pain. Some people who use DUPIXENT have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop DUPIXENT if you develop joint symptoms
The most common side effects include:
- Atopic dermatitis: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, and cold sores in your mouth or on your lips.
- Asthma: injection site reactions, pain in the throat (oropharyngeal pain), high count of a certain white blood cell (eosinophilia), and parasitic (helminth) infections.
- Chronic rhinosinusitis with nasal polyposis: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, 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 by your healthcare provider. It's an injection given under the skin (subcutaneous injection). Your healthcare provider will decide if you or your caregiver can inject DUPIXENT. Do not try to prepare and inject DUPIXENT until you or your caregiver have been trained by your healthcare provider. In children 12 years of age and older, it's recommended DUPIXENT be administered by or under supervision of an adult. In children under 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.
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