Chronic spontaneous urticaria improvement seen with remibrutinib

Remibrutinib provided significant improvement in chronic spontaneous urticaria in a phase 2b dose affirming trial presented at the EADV virtual congress.

A highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor, remibrutinib (LOU064, Novartis) is being developed for the potential treatment of multiple immune-mediated diseases.

The double-blind, randomized, placebo-controlled study included 311 adult patients with CSU who were randomly assigned to one of seven groups: 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), 100 mg twice daily (n = 45) and placebo (n = 43). Of these, 281 completed the 12-week treatment period.

After 4 and 12 weeks of treatment, Urticaria Activity Score 7 (UAS7) improvements from baseline were achieved in all doses at a significantly greater rate than placebo.

Mean improvement at week 4 was –19.1 for the 10 mg once daily group, –19.1 for 35 mg once daily group, –14.7 for 100 mg once daily group, –16 for 10 mg twice daily group, –20 for 25 mg twice daily group, –18.1 for 100 mg twice daily group and –5.4 for the placebo group (P < 0.0001).

In addition, more patients in the treatment groups achieved a complete absence of hives and itch.

A rapid improvement was also recorded within the first week for many patients.

“There is a dose response, which is nice and guides us in the further development of this novel treatment, and more importantly, there is a marked benefit that patients have from this treatment early on,” Marcus Maurer, MD, professor of dermatology and allergy and associate director of the Allergie-Centrum-Charité in Berlin, Germany, said in his presentation.

Safety profiles were also similar among all dose ranges with no dose-dependent adverse events reported.