FDA Approves Remibrutinib for Symptomatic Dermographism Not Controlled by Antihistamines
The oral BTK inhibitor, already approved for chronic spontaneous urticaria, now covers adults whose friction-triggered hives are not controlled by H1 antihistamines.
Patients with symptomatic dermographism, whose skin breaks out in itchy wheals from everyday skin friction, scratching or rubbing, have had few options beyond antihistamines. On Oct. 7, Novartis announced that the Food and Drug Administration had approved remibrutinib (Rhapsido) as the first treatment for adults with symptomatic dermographism inadequately controlled by H1 antihistamines.
Remibrutinib is an oral, highly selective Bruton's tyrosine kinase inhibitor. Its first FDA approval, for chronic spontaneous urticaria, came just over a year ago. Novartis says it is now the only prescription treatment with approved uses in both conditions when antihistamines alone do not control symptoms, and that more than 90 percent of adults with chronic hives have one of the two.
The trial behind the approval
The approval is based on the symptomatic dermographism cohort of the phase 3 RemIND trial, which enrolled patients who remained symptomatic on second-generation H1 antihistamines. Novartis reported complete response from hives, measured with the Total Fric Score. At week 12, 29.3 percent of patients on remibrutinib had a complete response, compared with 14.0 percent on placebo (P = .0229), according to Novartis. The company said responses were seen as early as week 2.
Fewer than a third of treated patients reached complete response at 12 weeks, about double the placebo rate.
"Remibrutinib offers, for the first time, an approach to treatment specifically for SD patients who remain inadequately controlled with H1 antihistamines alone, representing a meaningful step forward for this population," said Giselle Mosnaim, MD, MS, an allergist and immunologist at Endeavor Health and the lead RemIND investigator, in the company's announcement.
Safety
Through week 24 of clinical trials, the safety profile in symptomatic dermographism was consistent with that seen in chronic spontaneous urticaria, Novartis said. The most common adverse events, at an incidence of 3 percent or more, were nasopharyngitis, bleeding, headache, nausea and abdominal pain. The company said no routine laboratory monitoring is required.
Why it matters
Symptomatic dermographism is the most prevalent type of chronic inducible urticaria, and Novartis says more than half of patients remain symptomatic despite H1 antihistamines. Dermatology Times editor in chief Christopher Bunick, MD, PhD, said in the publication's coverage of the approval: "Now, with a new FDA approved indication for symptomatic dermatographism, it will continue to elevate care for patients with another type of urticarial rash whose treatment has previously been limited to ineffective topical corticosteroids or oral antihistamines."
The approval is relevant to the allergists, dermatologists and primary care physicians who see patients with chronic hives. RemIND also evaluated remibrutinib in cold urticaria and cholinergic urticaria, and Novartis said it plans to submit the full RemIND dataset to health authorities globally, where appropriate.
Marcus Bell covers health policy, reimbursement, and regulation for The Script Pad.
This article is for professional education and does not replace clinical judgment. Treatment decisions should be based on the individual patient and current guidelines.
