- Results provide new insights into ability of Dupixent to improve lung function by inhibiting IL-4 and IL-13, key drivers of type 2 inflammation
- Largest global-scale trial to use novel functional respiratory imaging (FRI) to assess the effect of a biologic on airway inflammation and mucus plugging in adults with uncontrolled moderate-to-severe asthma
- Data reinforces Sanofi’s commitment to advancements in Immunology and Inflammation
Paris, February 24, 2024. Topline results from the VESTIGE Phase 4 clinical trial evaluating the effect of Dupixent® (dupilumab) on airway remodeling parameters through the use of functional respiratory imaging (FRI) in adults with uncontrolled moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid dependent asthma will be presented in collaboration with Regeneron in a late-breaking poster session at the 2024 American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting. The study, the largest of its kind to utilize FRI to evaluate a biologic’s impact on the lungs, found that patients taking Dupixent achieved a significant reduction in airway inflammation, and had numerically greater reductions in mucus plug (mucus buildup in the lungs) scores and numerically greater improvements in airway volume and flow, indicating improvements in their ability to breathe more normally.
Mucus plugs in patients with asthma and other respiratory conditions are associated with type 2 inflammation and play a role in airflow obstruction, sometimes leading to persistent symptoms. Further utilization of novel FRI technologies has the potential to more accurately measure a biologic’s effect on mucus plugging in at-risk patients across multiple respiratory diseases.
Njira Lugogo, MD, MS, Division of Pulmonary & Critical Care Medicine's Asthma Program Director, University of Michigan
“By using functional respiratory imaging to produce 3D visualizations, we were able to track asthma disease progression and the biologic's efficacy with much greater accuracy than with traditional methods like spirometry. These findings reinforce the efficacy of dupilumab in improving airflow in the lungs, and the importance of reducing mucus plugging when managing asthma. These data show the impact of dupilumab on the lungs of patients with moderate-to-severe asthma and further add to its ability to effectively treat respiratory diseases.”
Data presented at the 2024 AAAAI Annual Meeting showed that patients treated with Dupixent experienced the following changes compared to placebo at Week 24:
- 56.9% of patients taking Dupixent achieved a significant reduction in airway inflammation as measured by fractional exhaled nitric oxide (FeNO) <25 parts per billion (ppb) compared to 10.8% of patients on placebo (P <0.001), a primary endpoint
- Numerically greater reductions in mucus plug scores compared to placebo in which Dupixent reduced mucus scores while an increase was observed in patients on placebo. The difference between Dupixent and placebo was -4.9 (nominal P<0.001)
- Dupixent also reduced mucus volume by Week 24 vs placebo: −0.107 mL (p<0·001). The reductions in mucus plug count and volume are also clearly visible in the computed tomography
- Numerically greater improvements in lung function from baseline compared to placebo as defined by in airway volumes ([s]iVaw) at total lung capacity (TLC), the other primary endpoint, and airway resistance ([s]iRaw) at TLC, were also achieved
The safety results were generally consistent with the known safety profile of Dupixent in moderate-to-severe asthma. The most common adverse events (AEs) observed with Dupixent (≥1%) compared to placebo included cardiac disorders (Dupixent n=1/72, placebo n=2/37), vascular disorders (Dupixent n=3/72, placebo n=0/37), infections and infestations (Dupixent n=13/72, placebo n=10/37), injection site reaction (Dupixent n=7/72, placebo 2/37) and COVID-19 (Dupixent n=7/72, placebo n=2/37).
About the VESTIGE Clinical Trial
The Phase 4 randomized, double-blind, placebo-controlled trial evaluated the efficacy of Dupixent on lung inflammation and structural/functional changes in airway volume using novel imaging technology along with safety among 109 adult patients aged 21 to 70 years with uncontrolled moderate-to-severe asthma and raised type 2 biomarkers (blood eosinophils ≥300 cells/µL and FeNO ≥25 ppb). During the 24-week treatment period, patients were randomized 2:1 to receive 300 mg of Dupixent (n=72) or matched placebo (n=37) every two weeks.
The study’s primary endpoints were the proportion of patients achieving FeNO <25 ppb and the percent change from baseline at 24 weeks in airway volumes ([s]iVaw) at total lung capacity (TLC). Main secondary endpoints included percent change from baseline at 24 weeks in untrimmed distal airway resistance corrected for lung volume ([s]iRaw) at TLC and change from baseline at 24 weeks in global lung mucus score (University of California, San Francisco [UCSF] mucus scoring).
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, EoE and chronic spontaneous urticaria (CSU) (in Japan).
In the U.S., Dupixent is indicated as an add-on maintenance treatment for adults and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.
In the EU, Dupixent is approved in children aged 6 to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised FeNO, who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. For adolescents and adults 12 years and older with severe asthma with type 2 inflammation, patients must be inadequately controlled with high dose ICS plus another medicinal product for maintenance treatment.
Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE, prurigo nodularis and CSU 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 Regeneron and Sanofi 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, Regeneron and Sanofi 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.
IMPORTANT SAFETY INFORMATION & INDICATIONS
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.
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.
About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for over 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all 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, hematologic conditions, infectious diseases and rare diseases.
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 more information about Regeneron, please visit www.Regeneron.com or follow Regeneron on LinkedIn.
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