By Mark G. Lebwohl, as told to Kendall Morgan
Mark G. Lebwohl, MD, is a dermatologist at Mount Sinai in New York City. The information here represents his knowledge and experience as a medical professional. He treats people with chronic spontaneous urticaria (CSU) and has been involved with clinical trials testing the safety and efficacy of remibrutinib as a potential new treatment option for CSU.
Chronic spontaneous urticaria (CSU) is an inflammatory disorder of the skin. Another name for it is chronic hives. You may have it if you've got unpredictable itchy red welts for more than six weeks. CSU involves chemicals, including histamine, in your body that send signals involved in allergic reactions, but it isn't an allergy. It's a condition that involves various types of immune cells, including inflammatory cells and antibody-producing B cells.
While treatments for CSU are available, they don't always work to fully control the hives. There's hope that medicines targeting an important player in immune signals may soon offer a new way to treat CSU. The target is a protein called Bruton tyrosine kinase (BTK). BTK inhibitors that block this protein are now used to treat some other conditions, including certain B-cell cancers. Clinical trials have shown that a BTK inhibitor called remibrutinib works to treat CSU in adults who don't get control of their CSU by taking antihistamines. In a phase III trial, the treatment led to significant improvement in itching and hives after 12 weeks. To explore how the medication works and who might benefit from it, we spoke with Mark G. Lebwohl, MD, a dermatologist at Mount Sinai in New York City.
Who may benefit from treatment with remibrutinib?
I think remibrutinib will be welcome for patients with chronic urticaria. There are other treatments out there now. Dupilumab is now used a lot by dermatologists, and they're used to using that. Allergists and dermatologists use omalizumab (Xolair). I happen to use a lot of omalizumab for chronic urticaria. But there are patients who are not adequately served by those drugs. One reason is that they're not perfect. They don't make everyone better. They're also injectable.
What's different about this new drug?
Patients with CSU will come in, and they have a big event. They've got hives all over, and they want to be clear right away. This new drug is very fast. You also take it orally. There's no need for an injection. It's a BTK inhibitor, so it works by an entirely different mechanism than any drugs we've used for CSU before.
How effective is this treatment?
In the clinical trials, it was highly effective. The results are certainly as good as what we see with all of the other agents available, but it's very fast. And, it's a pill. So, it has two big advantages: It's a pill – no more need for injections – and it's very fast. Within days, patients see a dramatic response.
Is there evidence this drug will work for people who don't respond to other medicines now in use?
That remains to be seen. That will be studied [in the future], no doubt, and it remains to be seen.
How do you take remibrutinib?
In clinical trials, people with CSU took 25 milligrams of remibrutinib twice a day as an add-on treatment. Throughout the trials, participants took their regular doses of H1 antihistamines.
Are there any side effects or safety concerns?
The number of adverse events in the trial were similar between people taking remibrutinib and those taking the placebo. The one side effect that we see is called petechiae. They're little red spots on the lower legs. They have not been associated with any coagulation (blood clotting) abnormalities. So, nobody has had a bleeding problem or anything like that. But it's kind of striking that there's this completely unexpected side effect that did occur.
Are there people who shouldn't take this treatment, or who may not benefit from it?
We do know that the clinical trial excluded people who have a clearly defined trigger for their chronic urticaria, such as cold, heat, or pressure. You may want to avoid this medicine if you have certain other health conditions, including cardiovascular, neurological, pulmonary, bleeding, or other disorders, or a history of gastrointestinal bleeding. The trial excluded people who take medications to prevent blood clotting or who have liver diseases, such as acute or chronic hepatitis, cirrhosis, or liver failure. It's always a good idea to let your doctor know about any health conditions you have before taking any new medicine.
Should people already be asking their doctors about whether this treatment might be an option for them?
Yes. I certainly think the drug will be distributed widely to dermatologists and to allergists. People who have chronic hives will now have something that works for the vast majority of patients and works quickly. So, yes, go to your dermatologist or your allergist and ask about it.
Will insurance cover it?
Insurance coverage varies. It's always a good idea to check with your insurance company to see what they'll cover. You can also check their website for a list of covered prescriptions. Sometimes you'll need prior authorization to get a medicine covered. If your insurance doesn't cover it, you may be able to ask for an exception. If you have questions about your treatment options or what's covered, ask your doctor for help.
