Press Releases

PARIS – April 23, 2021 - New analyses from Dupixent^® (dupilumab) trials evaluated infection incidence reduction and reinforced the need for no laboratory monitoring in patients six years and older with moderate-to-severe atopic dermatitis. Additional analyses evaluated response rates across a broad population, and the impact of Dupixent on disease extent and severity, quality of life (QoL), and itch. These and other data from real-world settings and clinical trials, including the Dupixent open-label extension (OLE) trials, will be presented at the American Academy of Dermatology (AAD VMX 2021), April 23-25,  and at the 20^th European Society for Pediatric Dermatology Annual Meeting (ESPD 2021), May 12-14.

“The depth and breadth of data being presented at AAD and ESPD support the use of Dupixent in adults, adolescents and children six years and older, addressing multiple critical disease measures such as itch, disease extent and severity, and certain skin infections,” said Naimish Patel, M.D. Head of Global Development in Immunology and Inflammation at Sanofi. “In addition, our expanded efforts in research and development in the immunology space, including rilzabrutinib, underscores our long-term commitment to addressing serious dermatological conditions with unmet patient needs.”

Results from a subgroup analysis of the Phase 2 study evaluating rilzabrutinib, an investigational oral Bruton’s tyrosine kinase inhibitor (BTKi), for the treatment of pemphigus vulgaris (PV), include the rates of control of disease activity in patients with moderate-to-severe disease. These data will be presented as a late-breaking abstract oral presentation at AAD VMX 2021. PV is a rare, debilitating autoimmune disease that causes blistering of the skin and mucus membranes.

Abstracts to be presented at AAD VMX 2021

Pediatric efficacy and QoL data for Dupixent

• Abstract 27350: Dupilumab Improves Eczema Area and Severity Index Regional Scores Across All Anatomical Regions in Children Aged 6–11 Years with Severe Atopic Dermatitis (AD), Amy S. Paller
• Abstract 27375: Dupilumab Provides Early and Sustained Improvement of Sleep Disturbance in Children ≥ 6 Years With Severe Atopic Dermatitis (AD) and Adolescents With Moderate-to-Severe AD, Amy S. Paller
• Abstract 27389: Rapid and Sustained Improvement in Itch in Children Aged 6–11 Years With Severe Atopic Dermatitis (AD) Treated With Dupilumab: Analysis From the LIBERTY AD PEDS Phase 3 Trial, Amy S. Paller
• Abstract 27394: Dupilumab Provides Clinically Meaningful Improvement in Atopic Dermatitis (AD) Signs, Symptoms, and Quality of Life in Children With Severe AD: Results From the LIBERTY AD PEDS Phase 3 Clinical Trial, Amy S. Paller
• Abstract 27406: Dupilumab Improves Signs and Symptoms of Severe Atopic Dermatitis in Children Aged 6–11 Years With and Without Comorbid Asthma, Mark Boguniewicz
• Abstract 27406: Dupilumab Treatment Improves Health-Related Quality of Life in Children Aged ≥6 to <12 Years With Severe Atopic Dermatitis, Alan Irvine

Adult efficacy data for Dupixent

• Abstract 26839: Dupilumab With Topical Corticosteroids Results in Rapid and Sustained Improvement in Adults with Moderate-to-Severe Atopic Dermatitis Across All Anatomic Regions Over 52 Weeks, Andrew Blauvelt
• Abstract 27571: Dupilumab Provides Clinically Meaningful Responses in Adults With Moderate-To-Severe Atopic Dermatitis (AD): Results From LIBERTY AD CHRONOS Study, Jonathan I. Silverberg

Long-term data from Dupixent OLE studies, up to three years in adults and up to one year in adolescents (aged 12-17 years) and children (aged 6-11 years) with moderate-to-severe atopic dermatitis.

• Abstract 26313: 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), Andrew Blauvelt
• Abstract 26875: 52-Week Laboratory Safety Findings From an Open-Label Extension (OLE) Study of Dupilumab in Adolescent Patients With Atopic Dermatitis (LIBERTY AD PED-OLE), Michael J. Cork
• Abstract 26880: 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), Michael J. Cork
• Abstract 27419: Laboratory Safety of Long-Term Dupilumab Treatment in Adults With Moderate-to-Severe Atopic Dermatitis: Open-Label Extension (OLE) Study, Andrew Blauvelt
• Abstract 27424: Infections in Adults with Moderate-to-Severe Atopic Dermatitis Treated with Dupilumab: Long-Term Data from an Open-Label Extension (OLE) Study, Andrew Blauvelt

Real-world data for Dupixent

• Abstract 27434: Early Trends of Disease Improvement in Adult Patients With Atopic Dermatitis Treated With Dupilumab: Real-World Data From the PROSE Registry, Jerry Bagel

Abstracts presenting data on the burden and impact of atopic dermatitis include:

• Abstract 27430: Worldwide Survey Shows That Atopic Dermatitis Is Associated with a High Disease Burden in Children, Stephan Weidinger
• Abstract 27473: Worldwide Survey Shows That Atopic Dermatitis in Children is Associated with a Negative Impact on Their Families, Sebastien Barbarot
• Abstract 28081: Strategies to Improve Quality of Atopic Dermatitis Care in the North America: Results from the Atopic Dermatitis Quality of Care (ADQoC) Initiative, Peter Lio

A late-breaking abstract oral presentation for rilzabrutinib:

• Treatment with Rilzabrutinib Results in Rapid and Significant Decrease in Steroid Use and Improved Quality of Life in Patients with Chronic Relapsing Pemphigus: BELIEVE Phase 2 Study, Dedee F. Murrell

Abstracts to be presented at ESPD 2021

Abstracts related to data evaluating efficacy, safety and impact on health-related quality of life of Dupixent include:

Efficacy data

• ESPD21-0326: Dupilumab Provides Clinically Meaningful Improvement in Atopic Dermatitis (AD) Signs, Symptoms, and Quality of Life in Children With Severe AD, Stephan Weidinger
• ESPD21-0330: Dupilumab Improves EASI Regional Scores Across All Anatomical Regions in Children Aged ≥6–<12 Years With Severe Atopic Dermatitis, Michael J. Cork
• ESPD21-0331: Rapid Itch Improvement in Children With Severe Atopic Dermatitis Treated With Dupilumab: A Phase 3 Subset Analysis, Gil Yosipovitch
• ESPD21-0332: Dupilumab Significantly Improves Signs and Symptoms of Atopic Dermatitis Assessed by SCORAD in Children Aged ≥6 to <12 Years, Sebastien Barbarot
• ESPD21-0334: Dupilumab Treatment Improves Health-Related Quality of Life in Children Aged ≥6 to <12 Years With Severe Atopic Dermatitis, Alan Irvine
• ESPD21-0340: Dupilumab Improved Itch in Children Aged 6–11 Years With Severe Atopic Dermatitis: Analysis from the LIBERTY AD PEDS Trial, Amy S. Paller
• ESPD21-0341: Dupilumab Treatment Improves Sleep in Children Aged ≥6 to <12 Years With Severe Atopic Dermatitis, Amy S. Paller

Long-term data

• ESPD21-0335: Long-Term Efficacy and Safety of Dupilumab in a Phase 3, Open-Label Extension Trial in Children With Uncontrolled, Moderate-to-Severe Atopic Dermatitis, Michael J. Cork

Safety data

• ESPD21-0200: Increased Incidence of Conjunctivitis With Dupilumab Treatment in Adolescents Appears to be Specific to Atopic Dermatitis, Marjolein De Bruin-Weller
• ESPD21-0308: Laboratory Safety of Dupilumab in Children Aged ≥6–<12 Years With Severe Atopic Dermatitis: Results From a Phase 3 Trial, Andreas Wollenberg

Results from a qualitative survey on the impact of atopic dermatitis

• ESPD21-0322: AD-GAP: A Global, Cross-sectional, Qualitative Survey of Children/Adolescents Aged 6−17 Years With Moderate-to-Severe Atopic Dermatitis, Their Carers, and Physicians, Stephan Weidinger

About Dupixent
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and eosinophilic esophagitis.

Dupixent is approved in the U.S. to treat patients aged 6 years and older with moderate-to-severe atopic dermatitis that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies; for use with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in patients aged 12 years and older whose asthma is not controlled with their current asthma medicines; and for use with other medicines for the maintenance treatment of CRSwNP in adults whose disease is not controlled.

Outside of the U.S., Dupixent is approved for specific patients with moderate-to-severe atopic dermatitis and certain patients with asthma in a number of other countries around the world, including those in the EU and Japan. Dupixent is also approved in the EU and Japan to treat certain adults with severe CRSwNP. Across all approved indications globally, more than 260,000 patients have been treated with Dupixent.

Dupilumab Development Program
To date, dupilumab has been studied in more than 10,000 patients across 50 clinical trials in various chronic diseases driven in part by type 2 inflammation.

In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven in part 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) and food allergies (Phase 2). The use of dupilumab in these settings is currently under clinical investigation and its safety and efficacy have not been fully evaluated by any regulatory authority. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

U.S. INDICATIONS

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 U.S. PATIENTS

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.

About Rilzabrutinib
Rilzabrutinib is an oral, reversible covalent, Bruton’s tyrosine kinase (BTK) inhibitor being investigated for the treatment of immune mediated diseases.  BTK is involved in innate and adaptive immune responses and is a signaling molecule in immune mediated diseases. Rilzabrutinib pre-clinical data demonstrate an ability to help block inflammatory immune cells, eliminate autoantibody destructive signaling, and prevent new autoantibody production without depleting B cells. Rilzabrutinib has the potential to target the underlying disease pathogenesis and has not been shown to alter platelet aggregation. The clinical significance of this data is under investigation. Rilzabrutinib is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. 

Editor’s Note: Rilzabrutinib has been granted orphan drug designation by the FDA for both pemphigus vulgaris (and from the European Commission for the treatment of pemphigus vulgaris and pemphigus foliaceus) and for its investigational use in immune thrombocytopenia (ITP). In November 2020, we announced that rilzabrutinib was granted FDA Fast Track Designation for ITP.