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New data presented at AAD showcase continued commitment to advance treatments for inflammatory dermatologic diseases
  • Positive Dupixent® (dupilumab) data provide new insights across a broad range of patients living with three chronic inflammatory skin diseases and include results from the longest study of a biologic for atopic dermatitis
  • Late-breaking 52-week Phase 2b efficacy and safety data for investigational amlitelimab, a novel anti-OX40-Ligand monoclonal antibody, in moderate-to-severe atopic dermatitis

Paris, March 8, 2024. Twenty-nine scientific abstracts across approved and investigational medicines will be presented at the American Academy of Dermatology (AAD) 2024 Annual Meeting from March 8 to 12. Abstracts include 26 evaluating Dupixent® (dupilumab), in collaboration with Regeneron, in atopic dermatitis (AD), prurigo nodularis (PN) and chronic spontaneous urticaria (CSU). In addition, three abstracts for investigational amlitelimab in AD will be presented.

Naimish Patel, M.D. 
Global Head of Development, Immunology and Inflammation at Sanofi  
“People living with chronic inflammatory skin diseases such as atopic dermatitis or prurigo nodularis suffer from persistent and unrelenting itch that can create a burden to their daily lives. Our scientific advancements in studying these diseases will be showcased at this year’s AAD Annual Meeting, where we will share long-term data across our growing portfolio in AD and additional data for Dupixent in PN, underscoring our unwavering commitment to advancing potential best-in-class therapies for patients with unmet needs.”

 

Notable presentations include:

Dupixent
Presentations underscore the importance of understanding how patients experience skin diseases and measuring outcomes in clinical and real-world studies that are meaningful to patients.

Clinical and long-term data in AD

  • LIBERTY AD-OLE trial: Findings across three abstracts from this open-label extension study will be presented including long-term data on Dupixent in AD for up to 5 years.
     
  • LIBERTY AD-HAFT: Positive Dupixent data will be presented during an oral presentation in patients with AD with moderate-to-severe hand and foot involvement. 
     
  • LIBERTY AD-PED-OLE trial: Positive Dupixent findings will be presented from an open-label extension pediatric study in patients aged 6 months to 17 years with AD.
     
  • PEDISTAD international study: Findings to be presented from this 10-year, ongoing observational study evaluating moderate-to-severe AD and its impact on growth in children aged <12 years. This abstract was awarded first place in the Annual Meeting Poster Awards.
     
  • PELISTAD pediatric open-label trial: Positive data from two oral presentations will be presented evaluating Dupixent and skin barrier function in children aged 6 to 11 years with moderate-to-severe AD.

Clinical data in PN

  • LIBERTY-PN PRIME and PRIME2 pivotal trials: Dupixent was associated with positive data in a pooled subgroup analysis in patients with PN regardless of patient body mass index (BMI).

The safety results of these trials were generally consistent with the known safety profile of Dupixent in its approved dermatological indications.

Amlitelimab
Three presentations show results for novel anti-OX40-Ligand monoclonal antibody amlitelimab for the treatment of AD. 

  • STREAM-AD: Up to 52-week Phase 2b efficacy and safety results for amlitelimab in patients with moderate-to-severe atopic dermatitis (AD).

Complete List of AAD 2024 Presentations

Presenting author 

Abstract title 

Presentation details 

Atopic Dermatitis 

Bissonnette 

Dupilumab Treatment for up to 5 Years Improves Eczema and Severity Index Score Across all Anatomical Regions in Adults with Moderate-to-Severe Atopic Dermatitis 

51573 

e-Poster 

 

Bissonnette 

Incidence of Injection-Site Reactions with Dupilumab Treatment in a 5-Year Open-Label Extension Study of Adults with Moderate-to-Severe Atopic Dermatitis 

52680 

Oral Presentation 

Friday, March 8 

10:55 PST 

Bissonnette 

Long-Term Safety Data for Dupilumab in a 5-Year Open-Label Extension Study of Adults with Moderate-to-Severe Atopic Dermatitis Trial 

52697 

e-Poster 

 

Cork 

Dupilumab Provides Sustained Normalization of Skin Barrier Function in Children with Moderate-to-Severe Atopic Dermatitis 

52273 

Oral Presentation 

Friday, March 8 

10:40 PST 

Cork 

Dupilumab Treatment Provides Sustained Improvement in Skin Barrier Function, Clinical Outcomes, and Patient-Reported Outcomes in Patients Aged 6 to 11 Years with Moderate-to-Severe Atopic Dermatitis 

53081 

Oral Presentation 

Friday, March 8 

8:40 PST 

Ferrucci 

Physician-Assessed Effectiveness and Safety in Adolescent and Adult Atopic Dermatitis Patients Treated with Dupilumab: Real-World Insights One Year into the GLOBOSTAD Multinational Prospective Observational Study 

52844 

e-Poster 

Kim 

Lower Total IgE After Dupilumab Treatment is Associated with a Reduction in Flares in Patients with Moderate-to-Severe Atopic Dermatitis 

53117 

Oral Presentation 

Friday, March 8 

11:15 PST 

Murrell 

Patient-Reported Outcomes and Safety in Adolescent and Adult Atopic Dermatitis Patients Treated with Dupilumab: Real-World Insights One Year into the GLOBOSTAD Multinational Prospective Observational Study 

53738 

e-Poster 

Paller 

Growth Analysis in Children Aged Less Than 12 Years with Moderate-to-Severe Atopic Dermatitis 

51363 

Oral Presentation  

Friday, March 8 

8:30 PST 

Shi 

Rates of Viral Non-Respiratory Infections in Patients with Moderate-to-Severe Atopic Dermatitis in the US: A Retrospective Study of Administrative Claims 

53040 

e-Poster 

Siegfried 

Dupilumab Treatment Provides Long-Term Disease Control in Pediatric Patients with Moderate-to-Severe Atopic Dermatitis Over 1 Year 

53713  
e-Poster 

Siegfried 

Dupilumab Treatment Shows Rapid and Consistent Improvement in Atopic Dermatitis in All Anatomical Regions in Patients Aged 6 Months to 17 Years: Results from an Open-Label Extension Study  

52650 

e-Poster 

Simpson 

Dupilumab Treatment in Patients with Atopic Hand and Foot Dermatitis: Results from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial 

53710 

Oral Presentation 

Friday, March 8 

11:30 PST 

Simpson 

Real-World Effectiveness of Dupilumab in Adult and Adolescent Patients with Atopic Dermatitis: 3-Year Data from the PROSE Registry 

51777 

e-Poster 

Wang 

Dupilumab Improves Health-Related Quality of Life and Work Productivity Among Adults with Moderate-to-Severe Atopic Dermatitis in Clinical Practice: 4-Year Follow-up Results From the RELIEVE-AD Study 

52842 

e-Poster 

Zink 

Influence of Biological Sex on Clinical Manifestation in Moderate-to-Severe Atopic Dermatitis and on Dupilumab Treatment Effectiveness 

52284 

e-Poster 

Weidinger

Efficacy and safety of amlitelimab (an OX40 Ligand antibody) in patients with moderate-to-severe atopic dermatitis: 52-week results from a Phase 2b trial (STREAM-AD)

Late-breaking oral presentation

Sunday, March 10

1:30 PST

Weidinger

Amlitelimab improves extent and severity of disease in adults with moderate-to-severe atopic dermatitis (AD): 24-week results from a Phase 2b trial (STREAM-AD)​

53907

e-poster

Friday, March 8

8:55 PST​

Blauvelt

Improvements on patient-reported outcome (PRO) measures with 24 weeks of amlitelimab treatment in adults with moderate-to-severe atopic dermatitis: results from a Phase 2b trial (STREAM-AD)​

53997

e-poster

Prurigo Nodularis 

Kim 

Dupilumab Shows Improvements in Adult Patients with Prurigo Nodularis Regardless of Their Body Mass Index 

51600 

e-Poster 

Kwatra 

Work and Productivity Impairment in Patients with Prurigo Nodularis: Results from the PN – paTient Reported burden of sicKness (PN-TREK) Study 

53674 

e-Poster 

Kwatra 

Quality of Life in Patients with Prurigo Nodularis: Results from the PN – paTient Reported burden of sicKness (PN-TREK) Study 

53510 

e-Poster 

Chronic Spontaneous Urticaria 

Giménez-Arnau 

Dupilumab Improves Emotional Burden in Patients with Chronic Spontaneous Urticaria Uncontrolled by H1 Antihistamines   

53693 

e-Poster 

Giménez-Arnau 

Dupilumab Improves Self-Perception and Relationships among Patients with Chronic Spontaneous Urticaria Uncontrolled by H1 Antihistamines 

53474 

e-Poster 

 

Guillemin 

Patient Experience of Chronic Spontaneous Urticaria: Conceptual Model Development and Identification of Available Patient-Reported Outcome Measures 

50328 

e-Poster 

 

Yosipovitch 

Dupilumab Improves Activity and Work Productivity Among Patients with Chronic Spontaneous Urticaria Inadequately Controlled with H1 Antihistamines   

53763 

Oral Presentation 

Friday, March 8 

14:45 PST 

Yosipovitch 

Dupilumab Improves Sleep Quality in Patients with Chronic Spontaneous Urticaria Inadequately Controlled with H1 Antihistamines   

53782 

Oral Presentation 

Friday, March 8 

14:50 PST 

Yosipovitch 

Dupilumab Improves the Burden of Itch in Patients with CSU 

51598 

e-Poster 

Yosipovitch 

Dupilumab Reduces Itch in Atopic Dermatitis, Prurigo Nodularis, And Chronic Spontaneous Urticaria 

51072 

e-Poster 

 

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. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and EoE, and chronic spontaneous urticaria (CSU) (in Japan).  

Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE, and prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 800,000 patients are being treated with Dupixent globally. 

Dupilumab Development Program 
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 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, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic pruritus of unknown origin, chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation, and bullous pemphigoid. 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. 

About Amlitelimab
Amlitelimab is a fully human, non-T cell  non-depleting monoclonal antibody that binds to OX40-Ligand, a key immune regulator, and has the potential to be a first-in-class treatment for a range of immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis (Phase 3), asthma (Phase 2), hidradenitis suppurativa (Phase 2), scleroderma, celiac disease, and alopecia (Phase 2 studies to be initiated in 2024). By targeting OX40-Ligand, amlitelimab aims to restore balance between pro-inflammatory and regulatory T cells.

Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

U.S. INDICATIONS 

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 atopic dermatitis 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. 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.
  • 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 eosinophilic esophagitis 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 prurigo nodularis under 18 years of age.

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 atopic dermatitis, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, or prurigo nodularis 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:

  • Eczema: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, dry eye, 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 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), 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 and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, herpes virus infections, common cold symptoms (nasopharyngitis), dizziness, muscle pain, and diarrhea.

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 Sanofi
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