Biologics for CSU: When Is it Time to Try?

If you have chronic spontaneous urticaria (CSU), also called chronic hives, and treatments like antihistamines and steroids aren’t helping, you may be a good candidate for biologics.

What Are Biologics?

Biologics are medicines that target specific antibodies, molecules, and cell receptors that cause inflammation and may trigger an allergic reaction like CSU.

Omalizumab (Xolair) is the only FDA-approved biologic for CSU. It’s approved for adolescents and adults 12 years and older who have chronic hives. It’s a shot you get about once a month. It blocks IgE, the antibody that causes allergies.

When you first try a biologic, your doctor gives you the shot to make sure everything goes smoothly. “There’s about a 1 in 2,000 risk of having an allergic reaction to the medication, so the first several doses are administered in a physician’s office or [an] infusion clinic,” says Kara Wada, MD, an allergist and immunologist at the Ohio State University Wexner Medical Center in Columbus.

Your doctor may recommend that you keep taking your other CSU medicines at the same time.

Do Biologics Work Well?

Research suggests biologics are an effective treatment for CSU with a low risk of side effects. 

In one study, more than 70% of the participants felt better within 24 weeks of taking a biologic. If a biologic helps with your CSU symptoms, you may also see improvements in your sleep quality, stress levels, and quality of life.

Biologics are considered low–risk for side effects, compared with immunosuppressant and anti-inflammatory drugs for CSU.

When to Try a Biologic

Your doctor may recommend a biologic if traditional CSU treatments aren’t working for you.

“Typically, I start considering a biologic if a patient is having daily symptoms that aren’t responding well to antihistamine medications,” Wada says.

With CSU, it’s best to take a step-by-step approach. The first step may be over-the-counter antihistamines. Your doctor may recommend higher doses of antihistamines than you would take for other allergies.

Your doctor may also recommend steroids or other immunosuppressive medicines for a short time.

“It may take a few weeks to have improvement,” says Viktoryia Kazlouskaya, MD, PhD, a dermatologist and dermatopathologist at Khrom Dermatology & Aesthetics in Brooklyn, NY. “Patience is key.”

If your body is resistant to high doses of antihistamines, your doctor may recommend a biologic.

What Biologics Are Available Now

Although omalizumab is the only biologic approved for treating CSU right now, there are more on the horizon. “Other biologics are being studied, but aren’t yet FDA-approved,” Kazlouskaya says.

Some doctors may use biologics that are approved to treat other conditions. This is called off-label use. They may try biologics like benralizumab (Fasenra), dupilumab (Dupixent), mepolizumab (Nucala), reslizumab (Cinqair), and secukinumab (Cosentyx) to treat CSU.

Researchers are studying the following biologics to see how well they treat CSU:

Benralizumab (Fasenra), mepolizumab (Nucala), and reslizumab (Cinqair). These medicines are approved to treat asthma, but not CSU. Dupilumab (Dupixent). In a small study, this medicine helped people who didn’t respond to omalizumab. Ligelizumab (QGE031). Like omalizumab, this is an antibody that binds to IgE. Secukinumab (Cosentyx). This medicine may help people with chronic hives who don’t get relief from other treatment options.

Doctors hope to have more options as studies continue. With more biologics to choose from, doctors can use predictive biomarkers to choose which one is most likely to work for you.

What to Consider With Biologics

Though proven to have many benefits, biologics have also been shown to have several downsides.

Inconvenience. You may have to go to a doctor’s office every month to get your shot or IV. “If you’re low-risk, you may be able to do it at home,” Wada says, “but that’s less common.”

High costs. “Biologics also have a high price point,” Wada says. “Most people will need insurance coverage or will have to rely on the drug company’s copay assistance programs to help offset the costs.” On top of the biologic’s cost, you may also have to pay your doctor’s office or IV center for administrative costs if they charge any.

Long-term effect. Even though studies suggest biologics improve CSU symptoms, it’s unclear if they can change the long-term course of your CSU. If you take a biologic and decrease your dose or stop taking it altogether, it’s possible for your symptoms to come back. You might need to take a biologic for a long time to trigger remission. 

Health Insurance Considerations

“Unfortunately, it’s very challenging to get biologics for patients with CSU, especially if they don’t have private insurance coverage,” Kazlouskaya says.

You may have to wait a few months for approval. Your health insurance company may require you to try a less expensive medicine first, even if it’s not effective for CSU.

Even if your health insurance approves a biologic, you may still have high out-of-pocket costs, depending on the type of plan you have. “Some high-deductible health care plans require that patients meet their out-of-pocket costs before coverage kicks in,” Wada says.

If you have Medicare, you may not qualify for copay assistance programs.

Biologics may work well and give you relief from CSU symptoms. But they’re not for everyone. Talk to your allergist about what’s right for you and whether it’s time to try a biologic.