File photo: A Novartis building in Cambridge, Massachusetts, in November 2019. Photo: Thsmi002 / Wikimedia Commons / CC BY-SA 4.0. Cropped.
Novartis has reported 52-week results for its hives medicine Rhapsido in adults whose symptoms remained troublesome despite antihistamine treatment.
The company said Nov. 12 that the Phase 3 RemIND study found responses lasting through a year of treatment in three types of chronic inducible urticaria, a condition in which specific triggers bring on itchy hives or swelling.
Those triggers can be as ordinary as light scratching, cold air or the rise in body temperature that comes with exercise or a hot bath.
The study enrolled 362 adults whose symptoms were not adequately controlled by second-generation H1 antihistamines. Researchers tested Rhapsido, also called remibrutinib, at 25 milligrams twice a day.
Results differed by the trigger
At week 52, complete or partial responses on tests designed for each type of hives were reported in 46.8% of patients who started Rhapsido for symptomatic dermographism, in which skin friction or scratching causes hives. The corresponding figures were 83.3% for cold-triggered hives and 58.2% for cholinergic urticaria, which can follow body heating.
These figures combine full and partial responses. They do not mean that everyone counted was free of symptoms.
The long-term results also need a qualification: patients who initially received placebo switched to Rhapsido at week 24. By week 52, both groups were taking the medicine. The year-end figures are therefore not a comparison between the drug and an untreated placebo group.
Patients who switched from placebo had week-52 response rates of 47.7%, 88.9% and 69.8% in the same three groups, respectively, Novartis said.
More detail still matters
Earlier in the study, the drug and placebo groups could be compared directly. At week one, complete or partial response rates were 41.8% versus 19.2% for scratching-triggered hives and 67.4% versus 28.9% for cold-triggered hives. For body-heating-triggered hives, the week-two figures were 65.2% versus 45.6%.
Novartis said the safety findings through week 52 were consistent with earlier experience. Its announcement did not provide detailed side-effect rates, discontinuation figures or the number of patients in each hives subgroup.
The company said the results will be presented at the American College of Allergy, Asthma & Immunology meeting and will support additional regulatory submissions. The announcement reports follow-up study results, not a new regulatory approval.
Novartis said Rhapsido is already approved in the United States for chronic spontaneous urticaria and symptomatic dermographism; these follow-up data will support additional submissions.
JBizNews Desk | East Hanover, New Jersey
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