Detailed results from the NIH-sponsored Phase III OUtMATCH study showed treatment with Xolair increased the amount of peanuts, tree nuts, egg, milk and wheat that people as young as 1 year consumed without an allergic reaction Allergic reactions can be life-threatening and it is estimated that food-related anaphylaxis results in 30,000 medical events treated in emergency rooms in the US each year1-3 EAST HANOVER, N.J., Feb. 25, 2024 /PRNewswire/ -- Novartis announced today data from Stage 1 of the National Institutes of Health (NIH)-sponsored pivotal Phase III OUtMATCH study evaluating the efficacy and safety of Xolair® (omalizumab) in patients allergic to peanuts and at least two other common foods were published in the New England Journal of Medicine (NEJM) and featured in a late-breaking symposium at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The study showed treatment with Xolair increased the amount of peanuts, milk, egg, wheat and tree nuts (cashew, hazelnut and walnut) that it took to cause moderate to severe allergic reactions in multi-food allergic people as young as 1 year. Safety findings were consistent with the known safety profile of Xolair across its approved indications and in previous clinical trials4. The US Food and Drug Administration (FDA) recently approved the expanded use of Xolair in children and adults with IgE-mediated food allergies based on the OUtMATCH data. "Over the past 35 years, I have seen how debilitating food allergies can be for patients and their loved ones, as they are consumed by the fear of accidental exposure," said Robert Wood, M.D., Director of the Eudowood Division of Allergy, Immunology and Rheumatology at Johns Hopkins Children's Center, and principal investigator of the OUtMATCH study. "While allergic reactions to exposures are common and often severe, there have been limited treatment advancements for food allergy. The results of the OUtMATCH study showed that anti-IgE therapy could significantly reduce the occurrence of allergic reactions across multiple foods in the event of an accidental exposure." "Living with food allergies has a profound impact on patients and their families, causing significant stress and requiring constant vigilance," said R. Sharon Chinthrajah, M.D., Associate Professor of Medicine, Stanford School of Medicine, Sean N. Parker Center for Allergy and Asthma ResearchAllergy and Asthma Research and OUtMATCH co-lead study investigator. "The OUtMATCH study demonstrated that anti-IgE therapy increased most patients' threshold for an allergic reaction. This presents an important new treatment option for patients and families in its potential to reduce the risk of allergic reactions from accidental exposures they may face in day-to-day life." One hundred eighty patients ages 1 to 55 years old entered Stage 1 of the OUtMATCH study unable to tolerate up to 100 mg of peanut protein (equivalent to about one third of a peanut), and up to 300 mg of at least two other food proteins among milk, egg, cashew, walnut, hazelnut and wheat. After 16 to 20 weeks of treatment with Xolair or placebo, each participant completed four separate blinded food challenges (including a placebo ingredient) to assess patients' ability to consume a single dose of at least 600 mg of peanut protein (primary endpoint), and a single dose of at least 1,000 mg of milk, egg, wheat, cashew, hazelnut or walnut protein (secondary endpoints) without experiencing moderate to severe allergic reactions. Results showed that, compared to placebo, a statistically significant (pPercentage of Patients Successfully Consuming Predefined Threshold Dose of Seven Foods
Additionally, out of three adult OUtMATCH participants, two completed Stage 1 of the study; the adult who received Xolair met the primary endpoint compared to the placebo-enrolled adult patient. Adverse event rates in the study were similar between Xolair and placebo. The most common adverse event in Xolair-treated children and adolescents was injection site reaction (9%). "These pivotal results show promise for children, families and adults living with the constant risk of potentially life-threatening allergic reactions to common food allergens following an accidental exposure," said Angelika Jahreis, M.D., Ph.D., Development Unit Head, Immunology, Novartis. "We are proud to partner with the National Institutes of Health and leading research institutions on this study and are thrilled that Xolair is an important new treatment option for people with food allergies." While efficacy cannot be established from uncontrolled, open-label studies, for 38 children who continued Xolair for 24-28 weeks in an open-label extension, the percentage of patients who were able to consume 600 mg or more of peanut protein and 1,000 mg or more of egg, milk and/or cashew protein without moderate to severe dose-limiting symptoms was maintained. About 3.4 million children and 13.6 million adults in the US will have been diagnosed with IgE-mediated food allergies, based on estimates for 20241,2. Food allergy prevalence has been on the rise for the past 20 years6. There are 160 different foods that cause IgE-mediated food allergy7. Allergic reactions can range from mild to moderate, including hives and swelling, to severe and life-threatening, such as anaphylaxis3. More than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once, and it is estimated that food-related anaphylaxis results in 30,000 medical events treated in emergency rooms in the US each year1,2,3. The Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food Allergic Children and Adults (OUtMATCH; NCT03881696) study is an NIH-sponsored, three-stage, multicenter, randomized, double-blind, placebo-controlled study evaluating Xolair safety and efficacy in patients aged 1 to 55 years who are allergic to peanuts and at least two other common foods. Stage 1 included 180 patients (177 children and adolescents; 3 adults) who were randomly assigned to receive placebo or Xolair injections either every two weeks or every four weeks for 16 to 20 weeks. The Xolair dose and dosing interval were determined by total serum IgE level and body weight at baseline. After 16 to 20 weeks of treatment with Xolair or placebo, each participant completed four separate blinded food challenges where they were given gradually increasing amounts of peanut protein, two other food proteins they were allergic to, and a placebo ingredient. The food challenges were conducted in a carefully controlled setting with investigators looking for signs and symptoms of allergic reaction to assess patients' ability to consume a single dose of at least 600 mg of peanut protein (primary endpoint), and a single dose of at least 1,000 mg of milk, egg, wheat, cashew, hazelnut or walnut protein (secondary endpoints) without experiencing dose-limiting symptoms, which were defined as moderate to severe allergic reactions, including skin, respiratory or gastrointestinal symptoms. In the US, Xolair is the only approved antibody designed to target and block immunoglobulin E (IgE). By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade. Indications and Important Safety Information
XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat: moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens. It is not known if XOLAIR is safe and effective in people with asthma under 6 years of age. food allergy in people 1 year of age and older to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic. While taking XOLAIR you should continue to avoid all foods to which you are allergic. It is not known if XOLAIR is safe and effective in people with food allergy under 1 year of age. IMPORTANT SAFETY INFORMATION
What is the most important information I should know about XOLAIR? Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction: low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of "impending doom" swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing
Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction. Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions,
are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive and use XOLAIR. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I receive and use XOLAIR? When starting treatment XOLAIR should be given by your healthcare provider in a healthcare setting. If your healthcare provider decides that you or a caregiver may be able to give your own XOLAIR prefilled syringe or autoinjector injections, you should receive training on the right way to prepare and inject XOLAIR. Do not try to inject XOLAIR until you have been shown the right way to give XOLAIR prefilled syringe or autoinjector injections by a healthcare provider. Use XOLAIR exactly as prescribed by your healthcare provider. The XOLAIR autoinjector (all doses) is intended for use only in adults and adolescents aged 12 years and older. For children 12 years of age and older, XOLAIR prefilled syringe or autoinjector may be self-injected under adult supervision. For children 1 to 11 years of age, XOLAIR prefilled syringe should be injected by a caregiver. See the detailed Instructions for Use that comes with XOLAIR for information on the right way to prepare and inject XOLAIR. XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks. In people with asthma, CRSwNP and food allergy, a blood test for a substance called IgE must be performed before starting XOLAIR to determine the appropriate dose and dosing frequency. In people with chronic hives, a blood test is not necessary to determine the dose or dosing frequency. Do not decrease or stop taking any of your other asthma, CRSwNP, hive medicine, food allergy medicine or allergen immunotherapy, unless your healthcare providers tell you to. You may not see improvement in your symptoms right away after XOLAIR treatment. If your symptoms do not improve or get worse, call your healthcare provider. If you inject more XOLAIR than prescribed, call your healthcare provider right away. What are the possible side effects of XOLAIR? XOLAIR may cause serious side effects, including: Cancer. Cases of cancer were observed in some people who received XOLAIR. Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive XOLAIR. This usually, but not always, happens 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 XOLAIR. Tell your healthcare provider right away if you have rash; chest pain; shortness of breath; or a feeling of pins and needles or numbness of your arms or legs. Fever, muscle aches, and rash. Some people get these symptoms 1 to 5 days after receiving a XOLAIR injection. If you have any of these symptoms, tell your healthcare provider. The most common side effects of XOLAIR: These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects. Please see full Prescribing Information, including Medication Guide for additional Important Safety Information and Instructions for Use.
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