Dr. Dawn Sammons discusses the benefits and risks associated with biologic treatment for chronic spontaneous urticaria.
“The biggest one is… not a new development. It’s an old development that I think that we have all as dermatologists been missing,” said Dawn Sammons, DO, who presented “New Developments in Chronic Urticaria” at the 2022 Winter Clinical Dermatology Conference.
“[Omalizumab] is an injectable biologic that is fantastic for treating chronic spontaneous urticaria, or CSU, but it’s not getting utilized,” said Dr. Sammons.
Omalizumab (Xolair, Genentech and Novartis) was FDA approved in 2014, but it’s a treatment option dermatologists are missing, she said.
“When we look at total prescriptions written, only 3% are written by dermatologists. And if we look at it the other way, only 6% of dermatologists are actually using it.”
In clinical trials of omalizumab conducted prior to the 2014 approval, about 50% to 60% of CSU patients experienced improvement and 33% to 50% achieved 100% resolution, said Dr. Sammons. Today, postmarketing and independent study data show that about 80% of patients are true drug responders.
“My favorite question is, why are dermatologists not using this?”
While most dermatologists are more comfortable having patients use antihistamines to manage CSU, they aren’t always that effective, said Dr. Sammons.
“We’ll go up to four times the over-the-counter dosing… but there’s always going to be a subset of patients who that doesn’t work for. I think unfortunately, as dermatologists, we’re falling short because when that happens, either we’re referring out to allergy or putting patients on oral immunosuppressants that are fraught with all sorts of side effects and drug interactions.”
Even worse, if patients don’t receive appropriate treatment, they may become frustrated and give up, said Dr. Sammons.
“We’re all seeing these patients with chronic urticaria, and they’re miserable, miserable patients. They’re so itchy and uncomfortable.”
To better understand the seeming resistance to prescribing omalizumab, Dr. Sammons decided to conduct an informal study and asked several colleagues if they were using omalizumab for their CSU patients and, if not, the reason why.
“What I overwhelmingly heard is that physicians were afraid of it. And that’s because the drug, unfortunately, has a Blackbox warning for anaphylaxis. It’s this anaphylaxis fear that I think is keeping my peers from utilizing the drug and appropriately treating their patients when new generation antihistamines aren’t effective.”
According to omalizumab clinical trials, the risk for anaphylaxis is 0.2%, said Dr. Sammons.
“When you translate that, what does that mean for real-life data?”
The general population has a 0.05% to 2% overall lifetime risk of experiencing anaphylaxis, whether it’s from being stung by a bee, consuming shellfish, or reacting to a drug, said Dr. Sammons.
“So, we know that comparatively the risk is much lower with omalizumab.”
Looking more closely, researchers in Europe examined anaphylaxis risk.1
“[Researchers] compared the risk for anaphylaxis based on real-life experience of how many [incidents] have been reported. And what we find is, many of the biologics that my colleagues and I are writing every single day, for psoriasis or atopic dermatitis, have actually a higher risk for anaphylaxis than this drug.”
Dr. Sammons believes the fear of this risk, which may be unfounded, may be what is preventing dermatologists from using the biologic.
“There are some new things in the pipeline that are coming but …we have something awesome right now that we should be using, not waiting around for another year or two or three for the new drugs to come out.”
Reference
- Gülsen A, Wedi B, Jappe U. Hypersensitivity reactions to biologics (part I): allergy as an important differential diagnosis in complex immune-derived adverse events. Allergo J Int. 2020;29:97-125.
