Approximately 60% of patients aged 12 years and older treated with Dupixent 300 mg weekly in the pivotal trial experienced histological disease remission; patients also significantly improved their ability to swallow compared to placebo
Dupixent is now an option for the approximately 50,000 adults and adolescents living with severe uncontrolled eosinophilic esophagitisin the European Union (EU)
Dupixent now approved to treat five diseases with underlying type 2 inflammation in the EU
TARRYTOWN, N.Y. and PARIS, Jan. 30, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) expanded the marketing authorization for Dupixent®(dupilumab) in the European Union (EU) to treat eosinophilic esophagitis (EoE) in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. With this approval, Dupixent is the first and only targeted medicine specifically indicated to treat EoE in Europe and the
“This latest approval establishes Dupixent as the only targeted medicine specifically indicated for eosinophilic esophagitis in the European Union. Dupixent is also the only biologic shown in pivotal trials to help patients achieve histological remission, reduce difficulty swallowing and improve health-related quality of life – all of which are crucial to reducing the burden of this debilitating disease,” saidGeorge D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent. “Since its first approval, Dupixent has redefined the treatment of certain chronic diseases with underlying type 2 inflammation and is now indicated for five conditions in the European Union. We remain committed to investigating Dupixent’s potential in additional diseases in which IL-4 and IL-13 may play a key role.”
“The impact of EoE on a patient’s daily life cannot be overstated – the narrowing and scarring of the esophagus can make something as simple as eating a painful and distressing experience, and may lead to choking and food impaction,” saidNaimish Patel,M.D., HeadofGlobal Development, Immunology and Inflammation atSanofi. “With this latest approval for Dupixent, adults and adolescents in the EU suffering from the chronic and often debilitating symptoms of EoE now have the first and only targeted treatment option clinically proven to reduce both esophageal inflammation and damage, as well as improve swallowing ability, pain and health-related quality of life.”
The EC decision is supported by 52-week data from a Phase 3 trial consisting of three parts (Part A, B and C). and investigated Dupixent 300 mg weekly (Part A n=42; Part B n=80) compared to placebo (Part A n=39; Part B n=79) for 24 weeks. Part C (n=188) observed patients who had continued on or switched to Dupixent from Parts A and B for an additional 28 weeks.
Dupixent patients in Parts A and B, respectively, experienced:
- An approximately 10 times higher rate of histological disease remission (60% and 59%), a co-primary endpoint, compared to placebo (5% and 6%).
- A 69% and 64% reduction in disease symptoms compared to 32% and 41% with placebo. Disease symptoms were measured using the Dysphagia Symptom Questionnaire (DSQ), on which Dupixent patients experienced a 21.9- and 23.8-point clinically meaningful improvement compared to a 9.6- and 13.9-point improvement for placebo, a co-primary endpoint. Swallowing improvement was observed as early as four weeks.
- A greater than seven-fold reduction in abnormal endoscopic findings from baseline (-3.2 and -4.5 points) compared to placebo (-0.3 and -0.6 points).
- Nominally significant improvements in swallowing-related pain and health-related quality of life, as well as less frequent non-swallowing symptoms.
Histological disease remission, swallowing improvement and reduction in abnormal endoscopic findings were consistent with the overall population in patients who were uncontrolled, or not responsive to or not eligible for swallowed topical corticosteroids. Longer term efficacy in Part C was similar to results observed in Parts A and B.
The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications. The most common side effects across indications were injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes and eosinophilia. Adverse events more commonly observed in EoE patients treated with Dupixent (n=122) compared to placebo (n=117) included infections (32% vs. 25%). An additional adverse reaction of injection site bruising was reported in the EoE trial. The safety profile through 52 weeks was generally consistent with the safety profile observed at 24 weeks.
About Eosinophilic Esophagitis
EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. The results seen with Dupixent in adults and adolescents with EoE demonstrate that interleukin-4 (IL-4) and interleukin-13 (IL-13) are key and central drivers of the type 2 inflammation underlying this disease. For people with EoE, swallowing even small amounts of food can be a painful and worrisome choking experience. They are often left to contend with the frustration and anxiety of a constantly evolving list of foods to avoid, a poor quality of life and a higher risk of depression. In cases where EoE causes the esophagus to narrow, forced and potentially painful dilation (physical expansion) of the esophagus may be needed. In severe cases, a feeding tube may be the only option to ensure proper caloric intake and adequate nutrition.In the EU, about 50,000 adults and adolescents live with severe uncontrolled EoE.
About the Dupixent Eosinophilic Esophagitis Trial
The three-part Phase 3 randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in patients aged 12 years and older with EoE. All patients had previously not responded to proton pump inhibitors, and, across Parts A and B, 74% of patients were previously treated with swallowed topical corticosteroids.
At 24 weeks, the co-primary endpoints in Parts A and B assessed patient-reported measures of difficulty swallowing (change from baseline in the DSQ on a 0-84 scale) and esophageal inflammation (proportion of patients achieving histological disease remission, defined as peak esophageal intraepithelial eosinophil count of ≤6 eos/hpf).
Additional endpoints included abnormal endoscopic findings (EoE Endoscopic Reference Score [EoE-EREFS] on a 0-18 scale), swallowing-related pain (DSQ pain score), health-related quality of life (EoE Impact Questionnaire [EoE-IQ]) and frequency of other non-dysphagia symptoms (EoE Symptom Questionnaire [EoE-SQ]).
About Dupixent
Dupixent is an injection administered under the skin (subcutaneous injection) at different injection sites. In the EU for adolescents and adults with EoE, Dupixent is administered at 300 mg every week. It is available as both a pre-filled pen and pre-filled syringe at the 300 mg dose. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional.
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 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.
Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or 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 500,000 patients have been treated with Dupixent globally.
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 co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent, Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn).
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 pediatric EoE, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, 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.
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 12 years of age and older, who weigh at least 88 pounds (40 kg), with eosinophilic esophagitis (EoE). It is not known if DUPIXENT is safe and effective in children with eosinophilic esophagitis under 12 years of age and who weigh at least 88 pounds (40 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 .
- 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, 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 , 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 nottry 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 including Patient Information.
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 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous 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, pain, hematologic conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietaryVelociSuite®technologies, such asVelocImmune®,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, please visit or follow @Regeneron on Twitter.
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.
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These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron’s business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron’s and its collaborators’ ability to continue to conduct research and clinical programs, Regeneron’s ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron’s Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation Dupixent® (dupilumab) for the treatment of adults and adolescents with eosinophilic esophagitis (“EoE”); uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such asDupixent for the treatment of pediatric EoE, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, bullous pemphigoid, and other potential indications; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products (such as Dupixent) and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA®(aflibercept) Injection, Praluent®(alirocumab), and REGEN-COV® (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. 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FAQs
Is Dupixent FDA approved for EoE? ›
The Food and Drug Administration (FDA) has expanded approval for Dupixent (dupilumab) to include a new indication for the treatment of eosinophilic esophagitis (EoE) in patients 12 years and older weighing at least 40 kilograms (kg).
What is EoE disease? ›Eosinophilic esophagitis (EoE) is an inflammation of the esophagus (the tube connecting the mouth to the stomach), caused by a specific white blood cell – the eosinophil. Nearly three-quarters of affected cases occur in white males.
Who is the manufacturer for Dupixent? ›Contact Sanofi US or Regeneron Pharmaceuticals, Inc. or call 1-844-387-4936 to contact DUPIXENT MyWay®. DUPIXENT® and DUPIXENT MyWay® are registered trademarks of Sanofi Biotechnology.
When was Dupixent approved for EoE? ›Current management strategies follow the four D's paradigm of drugs, dietary elimination, dilation, and disease anxiety and hypervigilance therapy. On 20 May 2022, dupilumab was approved by FDA for EE.
What is the downside of Dupixent? ›The most common side effects of DUPIXENT include:
injection site reactions. eye and eyelid Inflammation, including redness, swelling, and itching, sometimes with blurred vision. cold sores in your mouth or on your lips. high count of a certain white blood cell (eosinophilia)
There is no cure for EoE. Treatments can manage your symptoms and prevent further damage. The two main types of treatments are medicines and diet.
What foods to avoid if you have EoE? ›The six-food elimination diet (SFED) is the most frequently employed dietary therapy in patients with EoE. This diet typically trials the exclusion of wheat, milk, egg, nuts, soy, fish and shellfish. An upper endoscopy and biopsy is performed after six weeks of the SFED diet.
What autoimmune diseases cause high eosinophils? ›- Acute myelogenous leukemia (AML)
- Allergies.
- Ascariasis (a roundworm infection)
- Asthma.
- Atopic dermatitis (eczema)
- Cancer.
- Churg-Strauss syndrome.
- Crohn's disease.
Research shows a strong connection between food allergies and eosinophilic esophagitis (EOE). These six foods are most commonly associated with this allergic response: dairy, wheat, soy, eggs, nuts, and seafood/shellfish. Unfortunately, there is no accurate test to identify food allergies connected with EOE.
How long can you stay on Dupixent? ›Dupixent Safe, Effective Up to Four Years in Adults With Moderate-to-Severe Atopic Dermatitis. Safe and effective long-term treatment is important for stable disease control in atopic dermatitis.
Is weight loss a side effect of Dupixent? ›
Is weight gain or weight loss a side effect of Dupixent? No. Weight changes weren't reported as a side effect in clinical studies of Dupixent. For certain conditions, Dupixent may be used in combination with corticosteroids.
Does Dupixent lower your immune system? ›Dupixent isn't known to weaken your immune system in a way that makes it easier for you to get infections. Instead, the drug reduces inflammation signals in your immune system that can cause eczema, asthma, and chronic sinusitis. (These are conditions Dupixent is used to treat.)
Can Dupixent cause weight gain? ›It's unlikely you'll gain weight as a side effect of using Dupixent. People using the drug in its original clinical trials didn't report weight gain. Since the drug was approved, a very small study found a possible link between weight gain and Dupixent treatment in people with atopic dermatitis (eczema).
Are you on Dupixent forever? ›Because of the chronic (recurring) nature of atopic dermatitis, you must remain on Dupixent to continue the clinical benefits of the drug.
Is there a permanent cure for eosinophilia? ›This condition is chronic and recurring without a known cure. The current treatments and medications are meant to control the buildup of eosinophils and resulting symptoms. Talk with your doctor about the best plan for you. With the right treatment, you can reduce the discomfort in your throat.
Does Dupixent cause liver damage? ›There have been no published reports of clinically apparent acute liver injury attributed to dupilumab therapy, but it has had limited general clinical use. Thus, liver injury from dupilumab must be rare, if it occurs at all.
Can Dupixent cause heart problems? ›In the 1-year placebo-controlled trial in adult and pediatric subjects 12 years of age and older with asthma (QUEST), cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) were reported in 1 (0.2%) of the DUPIXENT 200 mg Q2W group, 4 (0.6%) of the DUPIXENT ...
Is Dupixent worth the risk? ›“Dupixent doesn't totally clear the risk of future eczema outbreaks, but it succeeds in managing symptoms,” he said. “Most of my patients experience less itching, a reduction in the rash, better sleep and a better quality of life overall.” But Dupixent isn't a cure, and it's not perfect.
What happens if eosinophilic esophagitis is left untreated? ›Complications. The long-term complications of EoE are not clearly understood. If left untreated, symptoms will continue and damage to the esophagus causing narrowing may happen.
What does an EoE flare up feel like? ›Adults: Difficulty swallowing, also called dysphagia. Food getting stuck in the esophagus after swallowing, also known as impaction. Chest pain that is often centrally located and does not respond to antacids.
Does EoE qualify as a disability? ›
With eosinophilic esophagitis, a veteran may be eligible if they are awarded the 60 percent rating, OR if their rating for eosinophilic esophagitis helps them reach a combined rating of 70 percent. Veterans who do not meet these qualifications may be eligible for extraschedular TDIU.
How can I lower my eosinophils naturally? ›Eat a healthy diet free of acidic foods: Both acid reflux and heartburn can raise your body's eosinophil count. To avoid these conditions, one must eat a balanced, healthy diet. Look for low-fat foods, including lean meats, whole grains, fresh fruits and vegetables, and whole-grain foods.
What is the most common trigger for EoE? ›The foods that most commonly cause an allergic reaction leading to EoE include milk, eggs, wheat, soy, peanuts or tree nuts and fish or shellfish. You may have a combination of allergies that increase the risk of EoE.
Can tomatoes cause EoE? ›Peanut, soybean, egg white, cow's milk and tree nuts [14] , as well as wheat, tomato, carrot and onion [15] , were identified as common food allergens in adult EoE patients.
Should I worry about high eosinophils? ›A high eosinophil count typically isn't a cause for alarm. Your healthcare provider may order additional tests to find out why your eosinophil levels are unusually high.
What cancers cause high eosinophils? ›Eosinophilia is uncommon in healthy individuals, however, it is associated with allergies, helminth infections and some inflammatory states. Eosinophilia has also been observed in cancer, including colorectal, breast, ovarian, cervical, oral squamous, Hodgkin's lymphoma and prostate cancer.
Why would my eosinophils be high? ›Eosinophilia (e-o-sin-o-FILL-e-uh) is a higher than normal level of eosinophils. Eosinophils are a type of disease-fighting white blood cell. This condition most often indicates a parasitic infection, an allergic reaction or cancer.
What foods heal esophagitis? ›Use high protein, thick liquids and higher calorie items, such as milkshakes, custard, pudding, macaroni and cheese, etc. Some other soft or liquid-‐type foods are applesauce, cooked cereals, strained cream soup, mashed potatoes, Jello, rice pudding, etc.
Is oatmeal good for EoE? ›In many cases, people who have EoE are allergic to one or more foods. The most common food triggers for EoE include milk, eggs, wheat, soy, peanuts, corn, potato, rice, oat, barley and meat (beef, chicken, and pork).
What vitamin is deficient in EoE? ›When the researchers examined a cohort of patients with EoE, they found that many of these patients had a vitamin D deficiency, Rothenberg said. Biopsies revealed that the severity of their disease, including eosinophil levels, histological changes and other features, were inversely proportional to vitamin D levels.
Does Dupixent cause eye problems? ›
Advice for healthcare professionals: dupilumab is commonly associated with cases of conjunctivitis and allergic conjunctivitis, eye pruritus, blepharitis, and dry eye and with infrequent cases of keratitis and ulcerative keratitis, especially in patients with atopic dermatitis.
Can you drink alcohol while on Dupixent? ›by Drugs.com
Dupixent has not been reported to have a drug interaction with alcohol.
Experts aren't sure exactly why Dupixent causes joint pain, but suspect that in certain people, by preferentially inhibiting the interleukins IL‐4 and IL‐13, Dupixent may enhance IL‐17‐mediated inflammation, particularly in the joints.
What is the success rate of Dupixent? ›Clear or almost clear skin was reported in 37% of patients taking Dupixent compared to 9% of those not using the drug, a four-fold increase. Nearly half of adult patients (48%) saw a 75% skin improvement, and some saw a 90% improvement, compared to those not using Dupixent (13%).
Can Dupixent cause thyroid issues? ›However, dupilumab is an IL-4 and IL-13 inhibitor and is not recognized as a risk factor for thyroiditis or any endocrine disease.
Can Dupixent cause lymphoma? ›In recent years, studies have associated dupilumab with unmasking or progression of cutaneous T-cell lymphoma (CTCL). The objective of this study was to synthesize reported cases of CTCL in the setting of dupilumab use.
Why can't you get vaccinated on Dupixent? ›The prescribing information for dupixent does not recommend live virus vaccines during treatment but provides no references as to why. There is a theoretical concern that inhibition of IL-4 and IL-13 may impair immune response, probably more likely humoral response but also may affect T cell responses.
Can Dupixent cause rheumatoid arthritis? ›Reports of inflammatory arthritis and enthesitis in patients on dupilumab are starting to appear. deWijs et al detailed a 38- year-old woman who developed severe joint pain and morning stiffness in one ankle, followed by symptoms of her knees, hips, and elbows, starting within days of her first dupilumab injection.
How much does Dupixent cost per year? ›The average monthly retail price of Dupixent is $4,910 per 2, 2 mL of 300 mg/2 mL prefilled syringes. Depending on the dose, uninsured patients can expect to pay up to $59,000 per year for Dupixent treatment. Dupixent is the only monoclonal antibody approved by the FDA to treat atopic dermatitis and eczema.
Can Dupixent cause neuropathy? ›Dupilumab improved asthma symptoms, but it was discontinued owing to sustained peripheral neuropathy. Numbness resolved 6 months after withdrawal of dupilumab. The clinical course of our patient clearly suggests a direct association between the development of peripheral neuropathy and administration of dupilumab.
Can Dupixent cause blurry vision? ›
Common side effects of Dupixent include the following: Injection site reactions. Eye or eyelid inflammation. New or worsening eye problems, including eye pain, blurred vision, or changes in vision.
Can you take ibuprofen with Dupixent? ›6. Can you take Ibuprofen along with Dupixent? Dupilumab is also used together with other medications to treat moderate-to-severe asthma that is not controlled with other asthma medicines. No interactions have been found between Dupixent and ibuprofen.
What does Dupixent do to your body? ›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.
What level of eosinophils indicate leukemia? ›The main criteria for diagnosing eosinophilic leukemia are: An eosinophil count in the blood of 1.5 x 109 /L or higher that lasts over time. No parasitic infection, allergic reaction, or other causes of eosinophilia. Problems with the functioning of a person's organs because of the eosinophilia.
Can high eosinophils make you tired? ›According to the American Partnership for Eosinophilic Disorders (APED), intense wheezing, coughing, trouble breathing (shortness of breath), and chest tightness are all common with eosinophilic asthma. Fatigue is also very common, Parikh says.
Which food is not good for eosinophilia? ›Avoid all forms of fish and shellfish including fish sauce and oyster sauce. Read food labels and avoid foods that 'may contain' fish or shellfish. The following tables will show you what you can and can't eat while on the 6FED, avoiding wheat (W), milk (M), eggs (E), soy (S), nuts (N) and fish/shellfish (F).
What is the approved medication for EoE? ›Sanofi's Dupixent scores big as the first FDA-approved treatment for eosinophilic esophagitis. Already on a roll, Sanofi and Regeneron's Dupixent just scored a big FDA win by nabbing a new indication as the first and only medicine approved to treat eosinophilic esophagitis (EoE).
Does Dupixent treat eosinophilic esophagitis? ›Eosinophilic Esophagitis: DUPIXENT is indicated for the treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE).
What is Dupixent FDA-approved for? ›Dupixent is FDA-approved for multiple indications, including treatment of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis. Dupixent comes as a single-dose pre-filled syringe with needle shield or as a pre-filled pen and is given as an injection under the skin.
What is the best medication for EoE? ›Corticosteroids, which control inflammation, are effective medications for treating EoE. They help control inflammation in the esophagus. Fluticasone comes in an inhaler, like those used for asthma. It is sprayed into the mouth and then swallowed.
How long can you live EoE? ›
Straumann and colleagues described the clinical course of 30 adult EoE patients who were followed for an average of 7.2 years. The authors found no cases of esophageal malignancy or death from any cause (8). Another study followed 13 EoE patients for an average of 13.6 years.
What are the side effects of EoE Dupixent? ›The most common side effects associated with Dupixent include injection site reactions, upper respiratory tract infections, joint pain, and herpes viral infections. Dupixent is contraindicated in patients with known hypersensitivity to dupilumab or any of its inactive ingredients.
Is Dupixent an autoimmune drug? ›No, Dupixent is not an immunosuppressant. Instead, it's a monoclonal antibody drug, which works on very specific targets within your immune system.
How long do people stay on Dupixent? ›Dupixent Safe, Effective Up to Four Years in Adults With Moderate-to-Severe Atopic Dermatitis. Safe and effective long-term treatment is important for stable disease control in atopic dermatitis.
Do I have to take Dupixent for life? ›How long do I have to take Dupixent? Because of the chronic (recurring) nature of atopic dermatitis, you must remain on Dupixent to continue the clinical benefits of the drug.
What is the most common cause of eosinophilic esophagitis? ›Causes. EoE is caused by an allergic reaction to certain foods or environmental allergens.