Biologics – Xolair, Nucala, Fasenra, Tezspire and Dupixent
For many years, treatment for allergic conditions and asthma included avoidance, implementation of environmental controls, use of antihistamines, anti-inflammatory medications and subcutaneous or sublingual immunotherapy. However, in the last 20+ years, several biologic therapies (Xolair, Nucala, Fasenra, Tezpire and Dupixent) have been developed, targeting specific pathways within the immune system that contribute to chronic allergic and respiratory diseases such as asthma, atopic dermatitis, urticaria (hives), chronic sinusitis with nasal polyps, and recently (2024), severe food allergies. These medications target specific proteins and other molecules that cause the allergic and inflammatory reaction and thus help to prevent or block the reaction in the first place. In addition, biologics take an “inside out” approach to treating these conditions by addressing the issue at the immune system level, the root cause of many allergic diseases. Studies have shown that these medications can help to prevent severe asthma attacks often leading to emergency room visits, reduce the use of oral steroids, increase one’s level of activity and most importantly, improve one’s quality of life. They are often very effective at reducing the need for repeat sinus surgery, helping to control hives when standard medications do not work and can drastically reduce the risk of a severe allergic reaction in patients with food allergies. In most cases, a blood test is used to determine which biologic is best for a particular patient and with Xolair, what dose would be most appropriate for treatment.
XOLAIR (omalizumab)
Xolair is a prescription medication that was initially designed to treat moderate to severe asthma. IgE is a substance that occurs naturally in the body. When people with allergic asthma breathe in allergens, such as cat, dust-mite or pollen, their bodies make more IgE. This increase in IgE can then lead to increased symptoms, including an asthma attack. Xolair works by helping to block IgE from triggering an allergic reaction.
Our office has been administering Xolair since it was initially approved to treat allergic asthma in 2003. The moderate to severe asthma patient should have a positive skin test to a significant allergen such as pollen, cat or dust. Xolair was approved to treat Chronic Urticaria (hives) in 2014, making it the first and only drug targeting this condition. It was later approved to treat chronic sinusitis with nasal polyps and then, in 2024, to help prevent life threatening food allergies. In one study, the majority of patients who had severe allergic reactions to peanuts with exposure to less than 1 peanut were able to eat multiple peanuts before experiencing a severe reaction. Of note, treatment is not specific to a particular food, but will treat all food allergies.
Xolair is a prescription medication typically given in a medical facility either every 2 or 4 weeks, with dosing based on the patient’s weight and IgE level.
NUCALA (mepolizumab) and Fasenra (benralizumab)
Fasenra (benralizumab) is a prescription medication used to treat severe eosinophilic asthma. It works by targeting and reducing eosinophils, a type of white blood cell involved in inflammation. For severe eosinophilic asthma, Fasenra is used as an add-on maintenance treatment for patients aged 6 years and older. It helps reduce asthma attacks, improve lung function, and decrease the need for oral steroids. After 3 monthly injections, Fasenra is administered every 8 weeks.
Nucala (mepolizumab) is a prescription medication used to treat several conditions related to high levels of eosinophils, a type of white blood cell involved in inflammation. Nucala works by targeting and inhibiting interleukin-5 (IL-5), a protein that plays a key role in the growth and survival of eosinophils. Treatment with Nucala reduces the number of eosinophils, leading to better control of symptoms.
In our office, Nucala is used to treat Severe Eosinophilic Asthma: Nucala is used as an add-on maintenance treatment for patients aged 6 years and older. It helps reduce asthma attacks and the need for oral steroids, and is administered once a month. Nucala has also been approved to treat Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): By inhibiting interleukin-5, Nucala helps reduce symptoms such as nasal congestion and the size of nasal polyps in adults, improving sense of smell and taste. For both conditions, Nucala is administered in our office once a month subcutaneously.
DUPIXENT (dupilumab)
Dupixent is approved for the treatment of a number of medical conditions, including Atopic Dermatitis, Chronic Rhinosinusitis with Nasal Polyps, and Asthma. Dupixent works by blocking a type of protein called an interleukin (IL) from binding to their cell receptors. Interleukins contribute to a functioning immune system by helping to fight off viruses or bacteria in our bodies. When the immune system goes haywire, it can trigger certain ILs to mistakenly attack the body, resulting in chronic inflammatory conditions such as Atopic Dermatitis. Dupixent curbs the immune system’s over-reaction that results in atopic dermatitis. In clinical trials, nearly half of the patients in the study experienced significant improvement in their skin after only 16 weeks of treatment with Dupixent. Patients who may be candidates for treatment with Dupixent include those that have tried a variety of topical prescription therapies and are still uncontrolled, those that suffer from inadequate control of itching and those with ≥10% of their body covered with lesions and/or may involve problem areas such as the face, hands, and feet. Skin conditions are not only physically uncomfortable, but can cause patients to be self-conscious about their appearance.
In moderate to severe asthma, Dupixent’s mechanism of action is to inhibit the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13). These are two key proteins that contribute to Type 2 inflammation, which is linked to moderate-to-severe asthma. Inhibiting the signaling was associated with decreases of inflammatory biomarkers, leading to a reduction in asthma symptoms.
Dupixent (dupilumab) is used as an add-on maintenance treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in adults and children aged 12 years and older whose disease is not controlled. It reduces nasal polyps: Dupixent targets and inhibits IL-4 and IL-13 signaling, which are key drivers of type 2 inflammation. This helps reduce the size and number of nasal polyps. Dupixent improves nasal congestion: By reducing inflammation, Dupixent helps alleviate nasal congestion and obstruction, making it easier to breathe, and this medication also decreases the need for surgery. Clinical studies have shown that patients taking Dupixent required fewer surgeries and systemic steroids compared to those on placebo. Additionally, Dupixent enhances quality of life with patients often experiencing improved sense of smell and overall quality of life due to reduced symptoms. Dupixent is administered via subcutaneous injection every two weeks
TEZSPIRE (tezepelumab-ekko)
Tezspire is approved for the treatment of severe asthma in patients 12 and older whose symptoms are not well controlled with high doses of combination lung inhalers. Tezspire is a monoclonal antibody (a type of protein) and also a thymic stromal lymphopoietin (TSLP) blocker. TSLP causes airway irritation and swelling (inflammation). By blocking TSLP, Tezspire helps to decrease airway irritation and swelling, therefore helping to decrease asthma symptoms. Unlike most other biological medications approved to treat asthma, qualification for Tezpire is not dependent on specific blood test results. For patients with severe bronchial asthma whose breathing symptoms are not adequately controlled by their current treatment regimen, it is important to meet with an experienced allergist or pulmonologist to determine if Tezpire is the right choice for you. Tezspire is administered subcutaneously once a month.
What are possible side effects of Biologicals?
The most common side effects associated with these medications is an injection-site reaction. Severe allergic or hypersensitivity reactions are rare, but can occur. Patients receiving Xolair and other biologicals (with the exception of Dupixent, which can be self- administered at home) are kept in the office for at least thirty minutes after their injection, and are observed closely for any adverse reactions.
Treatment with biologics can be very effective, but as with all treatments, there are multiple factors to consider, including cost, potential side effects and time commitment. We are here to help guide you so that you can make the most informed decision about the best treatment for your asthma, chronic hives, chronic sinusitis, food allergy or atopic dermatitis.
