Remibrutinib shows potential in chronic spontaneous urticaria
21 Sep 2022
Cold urticaria is a condition where one is allergic to the cold weather; it is estimated to affect 1% to 3% of all sufferers of urticaria.Treatment with remibrutinib, a novel oral inhibitor of Bruton’s tyrosine kinase, appears to be both safe and effective for the treatment of chronic spontaneous urticaria, a new study has found.
Researchers performed a randomized, double-blinded, placebo-controlled phase IIb dose-finding study, enrolling 311 patients. All had at least moderately active chronic spontaneous urticaria which had inadequately been controlled with second-generation antihistamines.
Remibrutinib was given at 10-mg once-daily (n=44), 35-mg once-daily (n=44), 100-mg once-daily (n=47), 10-mg twice-daily (n=44), 25-mg twice-daily (n=44), and 100-mg twice-daily (n=44) doses; 43 were assigned to placebo. The main study outcomes were the 4-week change in the Urticaria Activity Score (UAS7) and safety.
All remibrutinib doses induced symptom improvements across 12 weeks of treatment. UAS7 scores through week 4 showed a 19.1-point drop in the 10-mg once-daily and 35-mg once-daily dose groups. Similar effects were reported for the other remibrutinib doses, with score reductions ranging from 14.7 to 20.0 points.
Placebo patients, meanwhile, only saw a 5.4-point decrease in UAS7 scores from baseline (p<0.0001 vs all remibrutinib doses).
In terms of safety, most adverse events were of mild or moderate severity and showed no dose-dependent pattern in incidences.
“Remibrutinib demonstrated robust clinical efficacy across a range of doses with a rapid onset of action and a favourable safety profile in the treatment of chronic spontaneous urticaria,” the researchers said.