Earlier this month, the FDA approved Rhapsido (remibrutinib) for symptomatic dermographism (SD), a type of chronic hives that flares with friction or pressure on the skin. That made the Novartis pill the first treatment for SD in the United States. A new clinician FAQ, as reported by Dermatology Times, breaks down the details patients are most likely to ask about, from how the drug works to what the side effects look like.
Who is Rhapsido approved for?
Rhapsido is approved for adults with SD and for adults with chronic spontaneous urticaria (CSU), in both cases when H1 antihistamines aren’t controlling symptoms. It’s the only prescription treatment approved for both.
That covers a lot of people. According to Novartis, more than 90 percent of adults with chronic hives have either CSU or SD, and more than half of people with SD stay symptomatic on antihistamines. Before this approval, SD treatment was largely limited to topical corticosteroids or oral antihistamines.
How does it work, and do you need regular blood work?
Rhapsido is a highly selective Bruton’s tyrosine kinase inhibitor (BTKi). It blocks the BTK pathway involved in histamine release, a key driver of hives and swelling. Its activity in mast cells is why it’s being used across different types of hives.
It’s a pill taken by mouth, and Novartis says no routine lab monitoring is required.
How well did it work in trials?
In the SD group of the phase 3 RemIND trial, which enrolled people still symptomatic on second-generation H1 antihistamines, 29.3 percent of patients on Rhapsido had a complete response from hives at week 12, compared with 14 percent on placebo. Novartis reported responses as early as week two.
The earlier CSU approval was based on two phase 3 trials, REMIX-1 and REMIX-2, where Rhapsido lowered weekly urticaria activity scores more than placebo at week 12.
What are the side effects?
Through week 24 of clinical trials, the safety profile was consistent across SD and CSU. The most common side effects, seen in at least 3 percent of patients, were nasal congestion, sore throat and runny nose (nasopharyngitis); bleeding; headache; nausea and abdominal pain.
On liver safety, Novartis reported no signals in two phase 3 trials of the drug in relapsing multiple sclerosis, in line with what it has seen in CSU.
What’s next for Rhapsido?
Outside the United States, Rhapsido is approved for CSU in the EU, the U.K. and China. RemIND also tested the drug in cold urticaria and cholinergic urticaria, and Novartis plans to submit the full data set, including those groups, to health authorities worldwide. Rhapsido is also being studied in hidradenitis suppurativa and food allergy.
If antihistamines haven’t gotten your hives under control, ask your dermatologist whether Rhapsido makes sense for you. In the meantime, these dermatologist-approved ways to treat hives at home may help between appointments.
