How Biologics Treat Severe Asthma and What is Available
For many people who live with asthma, their symptoms are managed by identifying and avoiding triggers, taking daily oral medications, and using a quick relief inhaler. However, for some people, these measures aren’t enough to manage their day-to-day asthma symptoms, and they need stronger medications. This is the case for 5% to 10% of the people living with asthma.
In recent years, new drugs called biologics have been approved for treating moderate-to-severe asthma. Biologic therapies offer new ways of treatment because they target specific antibodies (blood proteins) responsible for causing asthma.
Biologics are powerful medicines made of tiny components, including sugars, proteins, DNA, whole tissues, or cells. They come from all sorts of living sources—mammals, insects, plants, bacteria, and more.
Biologic drugs are the latest and most advanced treatments available today for the treatment of numerous diseases and conditions. Many of these are making it possible to treat illnesses that previously were considered untreatable.
They treat inflammatory conditions by addressing the issue at the immune system level, which is the root cause of many diseases. But because these drugs come from a variety of sources, they are more complicated.
In fact, they take a lot more work to produce, and once they are formulated, they are more susceptible to light and temperature and should be managed safely and kept correctly.
Doctors will prescribe biologics for people with severe asthma whose symptoms aren’t being controlled by inhaled corticosteroids, short-acting beta agonists, and other standard asthma medications.
A biologic drug can help to manage shortness of breath and coughing. It may also reduce and prevent asthma attacks and lessen the intensity of attacks that do happen.
When given for people with asthma, these drugs work by targeting different molecules and proteins in the body that contribute to symptoms.
According to a 2016 report in the journal Current Opinion in Allergy and Clinical Immunology, the primary benefit of biologics is to significantly decrease the frequency of “asthma exacerbation, emergency room visits, hospitalization, and need for oral steroids.” Further, biologics can improve life quality for people with the condition, and some biologics have even improved lung function in people with severe asthma.
There are currently five approved biologics for the treatment of severe asthma. Xolair targets allergy antibodies known as immunoglobulin E (IgE), and the other four biologics (Dupixent, Nucala, Fasenra and Cinqair) target pathways that affect eosinophils, a cell involved in allergic inflammation.
IgE is a substance that occurs naturally in the body. IgE is naturally produced by B cell lymphocytes—a type of white blood cell—when fighting off infection. IgE also increases when someone is exposed to an allergen, such as cat, dust-mite or pollen and triggers an allergic reaction, which may include increased symptoms that results in an asthma attack.
Eosinophilic asthma (EA) is a severe kind of asthma, marked by high white blood cell levels. These cells—called eosinophils—usually fight infections and bacteria. However, in people with EA, they cause inflammation and swelling in the airways and respiratory system.
The more eosinophilic cells there are, the more severe asthma symptoms will be. But EA is rare, only affecting about 5% of adults with asthma. Unfortunately, EA is also difficult to treat and can significantly alter a person’s quality of life.
Recognizing the symptoms of EA—which many include obstructed airflow, shortness of breath, chronic sinus infections, and nasal polyps—can help your doctor find effective treatments to help reduce complications.
There are many new biologic therapy options available to treat severe asthma. They work by disrupting the pathways that lead to inflammation in the body that causes asthma symptoms. Xolair and Nucala are approved for patients as young as six years old, while Dupixent and Fasenra are approved for patients as young as 12 years old. Cinqair is approved for adults 18 years and over.
Xolair (omalizumab): Xolair was approved in 2016 by the U.S. Food and Drug and Administration (FDA) for adults and children ages 6 and up, who have poorly controlled asthma and allergies to year-round allergens dust mites, pet dander, or cockroach debris.
It works by blocking IgE proteins on immune cells and prevents them from releasing their chemicals. The medication is available as a subcutaneous (shots given under the skin) injection taken once or twice a month, depending on the dose prescribed.
Studies show it can reduce the number of asthma attacks, prevent hospitalizations, and reduce the need for other asthma treatments, especially steroids.
Dupixent (dupilumab): Doctors prescribe Dupixent for people with eosinophilic asthma that is poorly controlled. It works by blocking inflammatory cells responsible for asthma symptoms. The medication is given once every other week.
You will receive the first three doses of Dupixent at the doctor's office so that you will learn how to inject it. You will be monitored for one hour after the first dose to make sure you do not have an adverse reaction to the medication. With the next two doses, you will be monitored for 30 minutes.
After the initial doses, you can administer the injections at home on your own.
Nucala (mepolizumab): Nucula is prescribed for people with eosinophilic asthma, which is a type of severe asthma.
Eosinophils are a type of white blood cells that can cause inflammation and swelling in the airways and respiratory system.
The more eosinophils in the blood, the more severe the symptoms of asthma can be. Nucala works by reducing the number of eosinophils in your blood.
Fasenra (benralizumab): Fasenra is prescribed for treating eosinophilic asthma and works by reducing the number of eosinophils in the blood. It is an injection treatment, taken once every four weeks for the first three doses, and then taken once every eight weeks.
Cinqair (reslizumab): Cinqair is also a medication for people with eosinophilic asthma. Similarly to other biologics for asthma, it works to reduce the number of eosinophils blood cells.
It is given as an intravenous (IV, or through the vein) infusion once every four weeks. Infusion treatments are usually done at an infusion center.
After you receive a dose of medication, the staff at the infusion center will monitor you for a period of time to make sure you don’t have any adverse reactions to the medications.
Your doctor will work with you to recommend what biologic therapies can help manage your asthma your symptoms, medications you currently take, and blood test results. You will still need to take other asthma medications and use your rescue inhalers, although it is possible your doctor may reduce medication doses once asthma is under control.
Biologic drugs are generally safe, but side effects are possible. Side effects of biologic drugs depend on the specific drug and the way in which it is administrated.
While rare, some biologic drugs can cause allergic reactions called anaphylaxis, which may include:
- Hives or a rash
- Swelling in the face, mouth, or tongue
- Shortness of breath
- Low blood pressure
- Problems with swallowing
- Dizziness and/or fainting
Other biologics can increase a person’s risk for infections. Biologics given by injection can cause injection site irritation or swelling, while biologics given by IV can cause infusion reactions.
Injection site reactions may include redness, swelling, pain, and itching. Infusion reactions include pain, swelling, redness at the IV site, headache, flushing, nausea, and rash.
Other common side effects of biologics include:
- Cold- symptoms
- Sinus infection
Biologic therapy may not work for everyone and it may require the use of other treatments as well. It is ly your doctor will initially introduce a biologic to treat your asthma as part of your treatment plan to see if it helps manage symptoms.
If you are able to find a biologic that works for you, this may cut down the number of asthma attacks you experience.
It is also possible that you may eventually be able to cut back on the number of other treatments you take, including corticosteroids.
Biologic drugs are expensive and may cost thousands of dollars per year.
Because of the high cost, your doctor and other healthcare providers (pharmacist or nurse) will work with your insurance company to make sure a biologic is covered prior to your starting the treatment.
And it may take a few months to see if the biologic is helping. Your doctor will give you a timeframe for how long you will be on a biologic if your asthma is under control.
One of the newest developments for treatment of moderate to Severe Asthma is a group of medications called “biologics.” Each of these treatments is designed to target and block a particular part of your immune system involved in allergic reactions and asthma symptoms.
Your doctor might consider using one of these medications if you still have Severe Asthma symptoms in spite of using your controller medications as directed.
Biologics are an add-on option and do not replace your existing controller and reliever medications, although some people may eventually be able to reduce the dose of their inhaled or oral corticosteroid.
What is a biologic treatment?
The term “biologic” is used for medications and other healthcare products that are made from living animals, plants, or cells, instead of through a chemical process. Biologics include a wide range of products, such as vaccines and blood products, as well as medications used to treat certain medical conditions (e.g., insulin for diabetes).
All of the biologic medications currently used for asthma are antibodies, a kind of protein that occurs naturally in our bodies. By designing and producing a biologic antibody, we can tailor it to help control disease; for instance, by shutting down lung inflammation or other processes that lead to asthma attacks.
How are biologics used to treat asthma?
Biologics fall into the category of “controller” medications – that is, they are used to help the body gain long-term control of everyday asthma symptoms and to reduce the overall risk of an asthma attack. other controllers, biologics are not used for rapid relief of an asthma attack – that is a job for short-acting reliever medications.
For more information on how controller and reliever medications work together, and details on the available options, please see Asthma Canada’s booklet Breathe Easy™: Medications.
If your doctor is considering using a biologic to treat your asthma, the biologic would be added to the reliever and controller medications you are currently taking.
Biologics do not replace these medications, although some people may find that they are able to reduce the dose of their controller medication after several doses of a biologic.
Please note that you should only reduce the dose of your controller if your doctor tells you to do so.
Who should consider taking a biologic for asthma?
Biologics are not for everyone. They are intended to be used by people with Severe Asthma that is difficult to control with standard reliever and controller medications. This is why your doctor will probably try a variety of reliever and controller medications before suggesting a biologic.
How can my doctor decide which biologic is right for me?
We sometimes think of asthma as a single medical condition.
However, when scientists looked closely at the way inflammation happens in the airways, they found that there are actually different types of asthma, involving different parts of the immune system.
Because biologics are designed to work very specifically, your doctor will need to figure out what type of asthma you have in order to choose a biologic that will work well for you.
Right now, biologics are available in Canada that target two types of Severe Asthma: allergic (IgE-mediated) asthma and eosinophilic asthma.
What is allergic asthma and how do biologics treat it?
Allergic asthma is a common condition where triggers (allergens) in the environment pollen, house dust mites, or pet dander can provoke asthma attacks and symptoms.
If you have this kind of asthma, your body produces large amounts of a protein called IgE (immunoglobulin E).
When you encounter one of your allergic triggers, this IgE causes the release of immune mediators such as histamine, which are responsible for the airway inflammation and constriction (tightening) that are present during an asthma attack.
If you have allergic asthma, and it is severe enough that you cannot manage it using standard controllers and relievers, your doctor might consider a biologic medication that blocks the action of IgE. Before starting treatment, you will need to have a blood test to confirm that you have a particular level of IgE in your bloodstream.
What is eosinophilic asthma and how do biologics treat it?
Some people with asthma produce a higher than normal number of a particular kind of inflammatory cell called an eosinophil. These cells play an important role in causing airway inflammation and increasing the risk of an asthma attack.
If your doctor suspects you have this form of asthma, you will ly be asked to give a sample of blood, and possibly also a sample of sputum (the material you cough up from your lungs), in order to test whether you have a high level of eosinophils.
For people with eosinophilic asthma who are unable to manage their symptoms with standard relievers and controllers, there are biologic medications available that reduce the body’s production of eosinophils. This lowers the number of eosinophils and the level of inflammation in the lungs, which can reduce the risk of asthma attacks.
How do these two types of asthma relate to each other?
Each of these two conditions can occur on its own, but they can also overlap.
In particular, it is common for people with allergic (IgE-mediated) asthma to also have high levels of eosinophils, so they could possibly be treated with a biologic that targets either side of the immune reaction.
In overlapping cases, your doctor might choose which biologic to try whether the allergic or the eosinophilic side of the asthma is causing more concern.
If you only have one of the conditions – that is, allergic asthma without eosinophils, or eosinophilic asthma without an allergic side – your doctor will prescribe the biologic that is most appropriate for that type.
How are biologic treatments given?
Biologic treatments are injected by a doctor or nurse. Depending which particular biologic you are taking, this may happen at a hospital or clinic or in your own home, and the injection will be given either just under the skin (subcutaneously) or into a vein (intravenously).
The schedule for injections of a biologic will depend on the particular treatment being used, but in general these medications are given every two to four weeks.
For some biologics, you may need a higher dose than can be delivered in one injection, your blood tests and your body weight. If more than one shot is needed, each will be given in a different area of your body.
What are the possible side effects of biologics?
The most serious side effect that can happen with biologic treatments is the development of an allergic or allergic- reaction. These reactions are rare, but in some cases they can be serious.
Symptoms can include breathing difficulties, faintness/dizziness, rash, swelling, and itching.
Allergic reactions most often occur right after the injection, but sometimes symptoms can start several days later.
If your doctor is considering a biologic to treat your asthma, be sure to ask about the risks of an allergic reaction, the most severe of which is called anaphylaxis, and find out what symptoms to watch for and what to do if they occur.
People taking biologics have also reported some less serious but more common side effects, which can include:
- Pain, redness, itching, and/or a burning sensation where the injection was given
- Increased risk of infections such as colds, flu, and urinary tract infections
This is not a complete list of the side effects that may happen with biologics; if your doctor is considering a biologic for you, please make sure to ask about the possible side effects that could happen with the specific medication you will be using.