Chronic spontaneous urticaria (CSU) causes itchy hives that last for weeks, months, or even years. Standard medicines, like antihistamines and steroids, don’t always help. But a class of drugs called biologics may work when others don’t. Biologics target your immune system. Biologics and biosimilars are a new frontier in CSU treatment that may help you feel better.
How Do Biologics Work?
Biologics are a little different from standard medicines, including ones you may have already tried for CSU.
Which Biologics Are Used to Treat CSU?
The FDA has approved two types of biologics to treat CSU:
When Are Biologics Prescribed for CSU?
The biologics dupilumab (Dupixent) and omalizumab (Xolair) are used for CSU when standard treatments don’t work well for you. Both of these medicines are made for adults and children 12 or older.
As you consider biologic treatments for CSU, there are some terms that will help you better understand these medications and how they work:
How Do You Take Biologics for CSU?
You get both dupilumab and omalizumab as an injection under your skin.
You or a caregiver can inject dupilumab shots at home. It comes as a prefilled syringe or pen. After a first-time “loading” dose, you usually inject dupilumab every two weeks.
With omalizumab, your health care provider will give you injections at a clinic to start. If things go well after your first few treatments, you or a caregiver can give shots of omalizumab at home. It comes as a prefilled syringe or autoinjector device that you use every four weeks. The dosage comes as 150 milligrams or 300 milligrams.
How Effective Are Biologics for CSU?
In clinical trials, biologics helped people with CSU feel better:
- In two phase III studies of people with CSU, dupilumab significantly lessened itching and hives compared to a placebo (a fake treatment with no medicine). The patients who took dupilumab were also more likely to have their disease under control.
- In a clinical study, people with CSU who took 300 milligrams of omalizumab reported less itching and 67% fewer hives after 12 weeks. About 36% of patients were totally relieved of their hives and itching.
Are Biologics Safe?
Biologics are generally thought to be safe. But there are some risks to know about.
Dupilumab can cause serious issues like:
- Severe allergic reactions, such as skin reactions
- Severe joint pain
Omalizumab’s label contains a special warning because it can cause life-threatening allergic reactions. This medicine may also raise your risk for serious problems, like:
- Cancer
- Parasite infections
- Fever, muscle aches, or rash
- Heart and circulation problems
To take biologics safely, it helps to:
- Learn about the possible side effects and symptoms you might have.
- Keep track of your medication schedule carefully. Know what to do if you miss a dose.
- Stick to a healthy diet and daily exercise habits.
- To lower the risk of food poisoning, you may want to avoid soft cheeses and unpasteurized or raw foods.
- Make sure to get vaccines to prevent infections, like the flu, pneumonia, and COVID-19.
- Don’t get any “live” vaccines while you’re taking biologics or biosimilars. Ask your doctor which ones are unsafe.
What Are Common Side Effects of Biologics for CSU?
Like most medicines, biologics can cause side effects. Some may go away on their own, but let your doctor know if they don’t or if they make you very uncomfortable or get in the way of your daily life.
Let your care team know right away if you have any of the following:
- Rash
- Fever
- Swollen lymph nodes
- Swelling of the face, lips, or tongue
- Trouble breathing
- Eye pain, redness, or discharge
- Blurry vision
- Numbness or tingling
- Serious weakness or fatigue
Who Should Not Take Biologics for CSU?
You shouldn’t take biologics for other types of hives.
These medicines are designed for adults and children ages 12 and older. It’s not known if they are safe or effective for younger children.
Biologics are not an option for people who are allergic to the ingredients in them. Biologics might not be a good choice if you’ve had severe allergic reactions in the past. Also, don’t take omalizumab if you have a latex allergy or other type of allergy. The needle cap on the medicine’s prefilled syringe contains latex.
Doctors don’t know if biologics could harm a fetus. Talk to your doctor if you’re pregnant or plan to become pregnant before you use these medicines. The same goes for if you’re breastfeeding.
Don’t take omalizumab to treat other types of hives.
In a phase III clinical trial, researchers compared Omlyclo to Xolair. They found the medicines were equally effective. When patients switched from Xolair to Omlyclo, they saw the same results.
How Much Do Biologics for CSU Cost?
Biologics are expensive medicines. Generally, retail prices run hundreds of thousands of dollars per year. The amount you pay will depend on your insurance coverage, the pharmacy you use, and other factors.
Generally, biosimilars, like omalizumab (Omlyclo), are much less expensive than biologics. Some studies suggest prices for biosimilars are between 15% and 35% lower than the brand-name biologics. What you pay will depend a lot on your insurance coverage.
Drugmakers often offer patient assistance programs to help you afford these medicines, such as:
Some charitable organizations and patient advocacy programs also provide financial support for these medicines. These programs include:
Clinical Trials of Biologics for CSU
Clinical trials are research studies that help doctors figure out if certain treatments, like biologics and biosimilars, are safe and work well. If you take part in a clinical trial, you may get to try a new therapy before it’s widely available.
To find a clinical trial, you can talk to your doctor or search online:
Are Biologics Right for My CSU Treatment?
If you have CSU symptoms that affect your daily life, a biologic might be beneficial for you.