Regeneron Highlights Expanding Immunology Portfolio and Pipeline at AAAAI, Showcasing Novel Approaches to Treating Allergy
36 abstracts to be presented across
New Dupixent® (dupilumab) data highlight its clinical and real-world impact across dermatological, respiratory and gastrointestinal diseases, including analyses of food allergy sensitization in children with atopic dermatitis
TARRYTOWN, N.Y.,
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First-in-class potential for targeted antibody treatments in cat and birch allergies in “ocular challenge” a trials
Presented for the first time will be results from separate Phase 3 cat and birch allergen-challenge trials, which evaluated antibody cocktails that target the most dominant allergens—FelD1 for cat allergy and BetV1 for birch allergy. The trials assessed the ability of these therapies to reduce ocular allergic symptoms, such as ocular itch and conjunctival redness, in response to antigen challenge, as well as skin prick reactivity one week after treatment, compared to placebo. The results add to data from earlier trials demonstrating the effects of these cocktails on nasal, respiratory and skin endpoints in these patients.
Additional registration-enabling trials for both programs that evaluate similar endpoints but after longer follow-up are initiating this year. The cat and birch allergy programs are part of a broader allergy pipeline, which include innovative strategies with the goal of eliminating all IgE-mediated allergies. The safety and efficacy of these investigational medicines have not been evaluated by any regulatory authority.
New Dupixent insights on allergy sensitization, asthma treatment escalation and potential in AFRS
The impact of early and sustained Dupixent treatment on allergy sensitization in children will be shared in two new long-term analyses from a Phase 3 open-label extension trial in children with moderate-to-severe atopic dermatitis. In the separate analyses, IgE levels for common food and environmental allergies were measured throughout the course of Dupixent treatment for up to 1.5 years. These included IgE levels for egg white, peanut, cow’s milk, wheat, dust mite, plant or fungal/bacterial allergens.
In adults and adolescents with asthma, two real-world analyses will also be shared evaluating the potential of moving Dupixent earlier in the treatment paradigm. The analyses measured reduction of exacerbations and systemic corticosteroid use in patients uncontrolled on medium-dose inhaled corticosteroids (ICS), comparing the addition of Dupixent with escalating to high-dose inhaled corticosteroids or the addition of other biologics.
Additionally, late-breaking data from the Phase 3 AIMS trial in adults and children aged 6 years and older with allergic fungal rhinosinusitis (AFRS) will be presented. These data formed the basis for a supplemental Biologics License Application (sBLA) in the
The full list of
| Abstract Title | Presentation Number |
Presenting Author |
Presentation Date and Time (ET) |
| B cells accumulate in lung during allergic inflammation and play a role in tissue remodeling | 899 Oral Abstract Session |
Maloney, A. | |
| Immunological evaluation of cat allergic individuals living with or without a cat | 278 | Atanasio, A. | |
| Prediction of symptomatic relief in allergic individuals using a preclinical mouse model of allergic anaphylaxis | 279 | Atanasio, A. | |
| IL4Ra blockade reduces Oral Immunotherapy outcome-related adverse events through inhibition of Mast cell activity in a murine model of oral immunotherapy | 463 | Atanasio, A. | |
| A Single Prophylactic Dose of REGN1908-1909 Significantly Suppressed Cat-Allergen Induced Allergic Conjunctivitis Signs and Symptoms and Skin Test Reactivity | 746 | Gagnon, R. | |
| Utilizing an Indirect Basophil Activation Test to Interrogate the Potency of Bet v 1 and Related Allergens | 743 | Maloney, K. | |
| Multidimensional Burden In Cat Allergic Individuals Despite Allergen Avoidance Efforts | 677 | Schneider, S. | |
| Antibody Cocktail Targeting Bet v1 Reduces Signs and Symptoms of Allergic Conjunctivitis in Birch Allergic Individuals Undergoing Conjunctival Allergen Challenge | 742 | Torkildsen, G. |
The full list of
| Abstract Title | Presentation Number |
Presenting Author |
Presentation Date and Time (ET) |
| Atopic Dermatitis | |||
| Dupilumab Treatment up to 1 Year Reduces Allergen-Specific IgE in Young Children With Moderate-to-Severe Atopic Dermatitis | 016 | Beck, L.A. | |
| Progressive Reduction of Allergen-Specific IgE in Children Aged 6 to 11 Years With Moderate-to-Severe Atopic Dermatitis Treated With Dupilumab | 015 | Beck, L.A. | |
| Minimally Invasive Skin Tape Strip Proteomic Analysis Demonstrates Significant Inhibition of Epidermal Hyperplasia Protein Cluster in Pediatric Atopic Dermatitis Patients Treated With Dupilumab | 053 | Goleva, E. | |
| Systemic Treatments Outcomes for Moderate-to-Severe Atopic Dermatitis in Children Aged Less Than 12 Years: PEDISTAD 5-Year Results | 052 | Leung, D.Y.M. | |
| Asthma | |||
| Dupilumab With Medium-Dose Inhaled Corticosteroids Versus Omalizumab With High-Dose Inhaled Corticosteroids Improves Clinical Outcomes In Patients With Coexisting Chronic Rhinosinusitis With Nasal Polyps And Uncontrolled Asthma | L03 | Wagenmann, M. | |
| Baseline Predictors of Clinical Remission in Children With Uncontrolled, Moderate-To-Severe Asthma Treated With Dupilumab: A Post Hoc Analysis of the VOYAGE Study | 130 | Bacharier, L.B. | |
| Dupilumab Improves Lung Function and Reduces Total and Specific IgE Levels in Patients With Asthma and Allergic Bronchopulmonary Aspergillosis: The Phase 2 LIBERTY ABPA AIRED Study | 828 | Corren, J. | |
| Systemic Corticosteroid Use Before Biologic Initiation Among Pediatric Patients With Asthma in |
138 |
Guilbert, T.W. | |
| Systemic Corticosteroid Use Among Pediatric Patients With Uncontrolled Moderate-to-Severe Asthma in |
119 |
Jackson, D.J. | |
| Escalation to High-Dose ICS Versus Dupilumab Initiation in Uncontrolled Asthma Patients on Medium-Dose ICS: A Matched Analysis of Administrative Claims | 125 |
Katial, R. | |
| Utility of Spirometry-Derived Ratios to Detect Changes in Large and Small Airways With Dupilumab in Moderate-to-Severe Asthma | 643 | Lipworth, B. | |
| Real-World Outcomes Following Asthma Treatment Escalation From Medium-Dose ICS to high-Dose ICS or Biologics | 133 | ||
| Patient-Reported Burden of Coexisting Type 2 Inflammatory Conditions in Patients Initiating Dupilumab for Asthma: Baseline Data From the REVEAL Registry | 634 | Maspero, J.F. | |
| Improved Quality of Life Over 1 Year in Patients With Asthma who Initiate Dupilumab in a Real-World Clinical Setting: The RAPID Registry | 143 | Peters, A.T. | |
| Children With Asthma Receiving Dupilumab had Reduced Exacerbations and Improved Asthma Control Versus Placebo, Regardless of Asthma Duration | 118 | Phipatanakul, W. | |
| CRSwNP | |||
| Dupilumab for Treatment of Allergic Fungal Rhinosinusitis in Adults and Children Aged 6 and Over: Results From LIBERTY-AIMS Study | L40 Late Breaking Poster Presentation |
Han, J. | |
| Comparative Efficacy of Dupilumab and Tezepelumab in Patients With Chronic Rhinosinusitis With Nasal Polyps: An Anchored Matching-adjusted Indirect Comparison | L78 Late Breaking Poster Presentation |
Lipworth, B. | |
| Dupilumab Led to Rapid Improvements in Nasal Congestion and Loss of Smell in Patients With Chronic Rhinosinusitis With Nasal Polyps: Results from the Global AROMA Registry | 244 | Buchheit, K. | |
| Efficacy of Dupilumab vs Omalizumab in Patients With Severe Chronic Rhinosinusitis With Nasal Polyps Coexisting With Asthma and Allergic Rhinitis: Results From the Head-to-Head, Prospective, Randomized EVEREST study | 241 | Oppenheimer, J. | |
| Dupilumab Improved Work Productivity in Patients With CRSwNP: Results From the Global AROMA Registry | 237 | Peters, A.T. | |
| Concurrent Improvement in Nasal Polyp Score and Forced Expiratory Volume in One Second With Dupilumab vs Omalizumab in Patients With Severe CRSwNP and Coexisting Asthma: Results From the EVEREST Study | 238 | Peters, A.T. | |
| Real-World Dupilumab Effectiveness Through 18 Months in Patients With CRSwNP and Coexisting Allergic Rhinitis: Results From the Global AROMA Registry | 245 | White, A. | |
| COPD | |||
| Evaluating Fractional Exhaled Nitric Oxide as a Predictor of Clinical Outcomes in Patients With Chronic Obstructive Pulmonary Disease With Type 2 Inflammation | 652 | Soliman, M. | |
| EoE | |||
| Dupilumab Leads to Sustained Treatment Response up to 52 Weeks in Dysphagia and Odynophagia Associated With Eosinophilic Esophagitis in Adults and Adolescents: Post-Hoc Analysis of the LIBERTY EoE TREET Study | 180 | Cianferoni, A. | |
| Dupilumab Maintains Histologic and Endoscopic Improvements Across Age Subgroups in Pediatric Patients With Eosinophilic Esophagitis (EoE) Over 52 Weeks: Pooled Analysis From Two Phase 3 Studies (EoE KIDS and LIBERTY EoE TREET) | 172 | McGown, E. | |
| CSU | |||
| Dupilumab Reduced Itch and Urticaria Activity in Chronic Spontaneous Urticaria Patient Subpopulations | 001 | Casale, T.B. | |
| Dupilumab Efficacy in Pooled LIBERTY-CSU CUPID Study A and Study C Regardless of Baseline Serum Total IgE Levels | 023 | Saini, S.S. | |
| Cross-Franchise | |||
| Serum Total IgE Reductions With Dupilumab Treatment in Pediatric Patients With Atopic Dermatitis, Asthma or Eosinophilic Esophagitis and their Relationship to Clinical Improvement | 014 | Beck, L.A. | |
About
DUPIXENT is a prescription medicine used:
- to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) 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 AD under 6 months 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. 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 polyps (CRSwNP) in adults and children 12 years of age and older whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with CRSwNP under 12 years of age.
- to treat adults and children 1 year of age and older with eosinophilic esophagitis (EoE), who weigh at least 33 pounds (15 kg). It is not known if DUPIXENT is safe and effective in children with EoE under 1 year of age, or who weigh less than 33 pounds (15 kg).
- to treat adults with prurigo nodularis (PN). It is not known if DUPIXENT is safe and effective in children with PN under 18 years of age.
- with other medicines for the maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and a high number of blood eosinophils (a type of white blood cell that may contribute to your COPD). DUPIXENT is used to reduce the number of flare-ups (the worsening of your COPD symptoms for several days) and can improve your breathing. It is not known if DUPIXENT is safe and effective in children with COPD under 18 years of age.
- to treat adults and children 12 years of age and older with chronic spontaneous urticaria (CSU) who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if DUPIXENT is safe and effective in children with CSU under 12 years of age, or who weigh less than 66 pounds (30 kg).
- to treat adults with bullous pemphigoid (BP). It is not known if DUPIXENT is safe and effective in children with BP under 18 years of age.
DUPIXENT is not used to relieve sudden breathing problems and will not replace an inhaled rescue medicine or to treat any other forms of hives (urticaria).
IMPORTANT SAFETY INFORMATION
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 AD, CRSwNP, EoE, PN, COPD, CSU, or BP and also have asthma. Do not change or stop your other medicines, including corticosteroid medicine or other asthma medicine, without talking to your healthcare provider. This may cause other symptoms that were controlled by those medicines to come back.
DUPIXENT can cause serious side effects, including:
- Allergic reactions. DUPIXENT can cause allergic reactions, including skin 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, skin rash, including rash that looks like a bullseye, painful red or blue bumps under the skin, or red pus-filled spots on the skin, general ill feeling, itching, swollen lymph nodes, nausea or vomiting, joint pain, 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. Tell your healthcare provider right away if you get: rash, chest pain, worsening shortness of breath, brown or dark colored urine, persistent fever, or a feeling of pins and needles or numbness of your arms or legs.
- Psoriasis. This can happen in people with atopic dermatitis and asthma who receive DUPIXENT. Tell your healthcare provider about any new skin symptoms. Your healthcare provider may send you to a dermatologist for an examination if needed.
- 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:
- Eczema: injection site reactions, eye problems, including eye and eyelid inflammation, redness, swelling, itching, eye infection, dry eye, and blurred vision, cold sores in your mouth or on your lips, and high count of a certain white blood cell (eosinophilia).
- Asthma: injection site reactions, high count of a certain white blood cell (eosinophilia), pain in the throat (oropharyngeal pain), and parasitic (helminth) infections.
- Chronic Rhinosinusitis with Nasal Polyps: injection site reactions, eye problems, including eye and eyelid inflammation, redness, swelling, itching, eye infection, and blurred vision, high count of a certain white blood cell (eosinophilia), stomach problems (gastritis), joint pain (arthralgia), trouble sleeping (insomnia), and toothache.
- Eosinophilic Esophagitis: injection site reactions, upper respiratory tract infections, cold sores in your mouth or on your lips, and joint pain (arthralgia).
- Prurigo Nodularis: eye problems, including eye and eyelid inflammation, redness, swelling, itching, and blurred vision, herpes virus infections, common cold symptoms (nasopharyngitis), dizziness, muscle pain, and diarrhea.
- Chronic Obstructive Pulmonary Disease: injection site reactions, common cold symptoms (nasopharyngitis), high count of a certain white blood cell (eosinophilia), viral infection, back pain, inflammation inside the nose (rhinitis), diarrhea, stomach problems (gastritis), joint pain (arthralgia), toothache, headache, and urinary tract infection.
- Chronic Spontaneous Urticaria: injection site reactions.
- Bullous Pemphigoid: joint pain (arthralgia), eye problems, including eye and eyelid inflammation, redness, swelling, itching, and blurred vision, and herpes virus infections.
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 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver.
Please see accompanying full Prescribing Information including Patient Information.
About
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.
For more information, please visit www.Regeneron.com or follow
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a The conjunctival allergen challenge was conducted with the Ora Conjunctival Challenge Model (Ora-CAC®).
Source: Regeneron Pharmaceuticals, Inc.