What Are Biologics for Chronic Rhinosinusitis With Nasal Polyps?
Though there's no cure for chronic rhinosinusitis with nasal polyps (CRSwNP), treatments can relieve disruptive symptoms like congestion, losing your sense of smell, and breathing problems. Which treatments you use will depend on several things, including how serious your symptoms are and whether you also have other conditions like asthma or allergies. You'll probably need a combination of treatments for best results.
Finding the Right Chronic Rhinosinusitis With Nasal Polyps Treatment Can Take Time
Corticosteroid drugs are usually the first medical treatment for CRSwNP. They lessen swelling in your nasal passages by controlling inflammation. At the same time, they shrink polyps. Your doctor will most likely start you with a corticosteroid nasal spray. They may also recommend adding steroids to a nasal rinse (also called nasal irrigation). If your symptoms don't improve, your doctor will add an oral steroid, or they will add an oral steroid if there is a complete blockage of the nasal passage from the polyp. Another option is a breath-powered device that delivers corticosteroids more deeply into your nose. If these methods don't work well or your symptoms are serious, they may recommend that you take a corticosteroid by mouth for a short time.
If a bacterial infection or allergies are making your symptoms worse, your doctor might prescribe antibiotics or allergy medicines. If you have asthma along with CRSwNP, they may recommend a leukotriene modifier, which can block substances that lead to inflammation in your nasal passages and improve asthma symptoms.
Endoscopic sinus surgery to remove the polyps and open up your sinuses is another treatment approach. But it doesn't eliminate the need for corticosteroids. And nasal polyps often grow back after surgery. If this happens, you might need to get an implant in your sinuses that releases corticosteroid medication.
If you have serious CRSwNP that doesn't respond to these treatments, biologic drugs may be an option in CRSwNP with specific indications and not just standard treatments; after surgery; or when you're getting too much steroid medication. Instead of just relieving symptoms, biologics target the inflammation that causes them.
What Are Biologics?
Biologics are made in a lab using proteins or genetic material from living cells, like those from humans, animals, plants, or bacteria. Scientists use advanced biotechnology methods to remove these biological substances and reproduce them. They might clone genes that produce certain proteins, or combine DNA molecules from different sources.
Making these drugs is a complex and expensive process. They're often used to treat conditions that don't respond to more conventional medications, such as many autoimmune conditions. You usually take them as a shot or get them through an IV infusion.
Because these medicines target specific molecules of the inflammatory pathway , they can control inflammation without suppressing your entire immune system. They may work better than many traditional drugs.
Which Biologics Are Used to Treat Chronic Rhinosinusitis With Nasal Polyps?
The FDA has approved three biologics to treat CRSwNP. They include:
These drugs belong to a class of biologics called monoclonal antibodies. Monoclonal antibodies are lab-made versions (clones) of protective antibodies made by your immune system. Antibodies are proteins that attach to and block foreign substances in your body that could cause harm.
With CRSwNP, your immune system overreacts and causes inflammation in your sinuses. Monoclonal antibodies block certain substances or cells in your body that drive the inflammation. This can lessen swelling and improve symptoms like congestion and loss of smell.
What Are Interleukin Inhibitors?
Interleukin inhibitors are medicines that stop the action of immune system proteins called interleukins. These proteins help cells signal to each other in response to infections. Interleukins can become overactive and cause unnecessary inflammation responses, such as in chronic rhinosinusitis.
Two types of interleukin inhibitor drugs are used to treat chronic rhinosinusitis with nasal polyps. Each blocks a particular interleukin that’s involved in inflammation. They are:
Interleukin-4 (IL-4)/interleukin-13 (IL-13) inhibitors. This class includes dupilumab.
Interleukin-5 (IL-5) inhibitors. This class includes mepolizumab.
IL-4/IL-13 inhibitors
Dupilumab blocks interleukins IL-4 and IL-13 to help calm the overactive immune response in your body.
This medicine is FDA-approved to treat adults and children 12 and older who have chronic sinusitis with nasal polyps that's not well-controlled. It's meant to be used along with other medicines such as a steroid nasal spray or nasal irrigation.
Some people in the studies saw improvements in their sense of smell and nasal congestion within a week after they started taking dupilumab. Many noticed further improvements within a few weeks.
You take dupilumab as an injection under your skin once every two weeks. You can inject it yourself into your stomach or thigh. If someone else injects you, they can use the back of your upper arm. Your doctor will show you how to inject dupilumab so you can use it safely at home.
IL-5 inhibitors
Mepolizumab blocks the activity of interleukin-5 (IL-5). Specifically, it helps lower the number of eosinophils in your blood. Eosinophils are white blood cells made by IL-5. Having too many of them can cause inflammation.
The FDA has approved mepolizumab for adults who have CRSwNP and haven't responded well enough to nasal corticosteroids. It's considered an "add-on" maintenance treatment, which means you still need to take other medicines while you use it.
People in the studies who used mepolizumab saw significantly smaller polyps and improvement in nasal blockages by 52 weeks.
At first, you'll get mepolizumab as an injection at your doctor's office. Later, you can give it to yourself at home, once every four weeks. You can inject it into your thigh or belly. If a caregiver injects it, they can use your upper arm.
What Are Immune Globulin Antagonists?
Immune globulin antagonists are medicines that block a type of antibody that’s involved in creating immune responses in your body.
Omalizumab is an immune globulin antagonist originally approved to treat asthma. It stops the action of a substance called immunoglobulin E (IgE). When your body makes too much IgE, this promotes chronic inflammation.
The FDA has approved omalizumab to treat adults with CRSwNP who have tried nasal corticosteroids but haven’t found enough relief.
Clinical trials showed that people with CRSwNP who took omalizumab had:
Smaller nasal polyps
Less congestion
People in the studies saw these benefits in as little as four weeks.
A health care professional will inject omalizumab at your doctor's office for the initial treatments. After three doses, you can inject it yourself at home. You should take it every two to four weeks. You can inject omalizumab in the front of your thigh or stomach. If someone else gives you the injection, they can use your upper arm.
How Effective Are Biologics?
Studies show that biologics work well for about 60%-70% of people with CRSwNP who use them. Most people have less congestion, smaller nasal polyps, and an improved sense of smell. But biologics don't work well for everyone.
It's not clear how long people need to take these drugs or whether they can taper off their usage once they get long-term symptom relief. Experts recommend that doctors evaluate how well the treatment is working at least every six months.
At this point, there are no head-to-head clinical trials to compare how well dupilumab, mepolizumab, and omalizumab work. But scientists have looked at different data on the medicines, and some reports have suggested that dupilumab may improve symptoms the most.
What Are Common Side Effects of Biologics?
Like any medicine, biologics can cause side effects. What kind of problems you might notice may depend in part on which drug you take.
Common side effects of dupilumab include:
Skin reactions from the shot
Swelling, redness, or itching in the eye or eyelid
Blurry vision
Eosinophilia (a high count of certain white blood cells)
Gastritis (inflammation of your stomach lining)
Joint pain
Trouble sleeping
Tooth pain
If you take mepolizumab, you may notice these common side effects:
Headache
Reactions where the needle went in
Back pain
Tiredness
Mouth/throat pain
Joint pain
The most common side effects of omalizumab are:
Headache
Reactions where the needle went in
Joint pain
Upper belly pain
Dizziness
Are Biologics Safe?
Biologics are generally considered safe, but like most drugs, they can sometimes cause serious side effects.
For example, dupilumab may cause:
Severe allergic reactions
Eye problems like pain, blurry vision, or other vision changes
Inflammation of your blood vessels (in people who have asthma)
Severe joint aches and pain
People who use dupilumab should get regular eye exams since the drug sometimes causes eye complications. They should also avoid using live vaccines (those made with weak forms of a living virus or bacteria, such as the chickenpox and rotavirus vaccines). That's because using biologics makes you slightly more likely to get infections.
Mepolizumab has been known to cause:
Severe allergic reactions
Low blood pressure
Rash
Hives
Herpes zoster infections (which can cause shingles)
Your doctor may recommend that you get a shingles vaccine before you start using mepolizumab, since it could raise your risk of getting the infection that causes shingles.
Omalizumab contains a boxed warning because it may cause a life-threatening allergic reaction. Some other serious side effects of this medicine can include:
Cancer
Inflammation of your blood vessels (in people who have asthma)
Fever, muscle aches, and rash
Parasite infections
Heart and circulation issues
Who Shouldn’t Take Biologics?
You don't need biologics if you can manage your symptoms with other treatments like corticosteroids and surgery.
People who are allergic to any of the ingredients in biologics should avoid them.
And if you're pregnant, plan to become pregnant, or nurse a baby, you may not be able to take a biologic. Talk to your doctor about the risks.
How Much Do Biologics Cost?
Biologics can be pricey. But most people don’t pay the list price. Your out-of-pocket costs will depend on which treatment you use and your insurance coverage. Every policy is different, so talk to your provider about your specific plan. Some policies may require you to try less expensive treatments before using biologics.
Here are some examples of out-of-pocket costs:
The list price of dupilumab is $3,803.20 per carton.
The list price for a single dose of mepolizumab is around $3,689.
The list price of omalizumab runs about $30,000-$60,000 a year.
Drug companies offer various assistance programs, coupons, and copay cards to make these medicines more affordable:
These plans can often be used with or without insurance. You can check the drug companies' websites for more information.
Some nonprofit organizations also provide financial assistance.
Show Sources
SOURCES:
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