Rilzabrutinib effective and safe against chronic spontaneous urticaria, finds study

A recent study published in the Journal of Allergy and Clinical Immunology unveiled promising results from a Phase 2 study evaluating the efficacy and safety of rilzabrutinib (SAR444671) in addressing Chronic Spontaneous Urticaria (CSU). CSU is a distressing skin condition often resistant to conventional treatments, is characterized by recurring hives and intense itching, significantly impacting quality of life of the patients.

The RILECSU study encompassed a 52-week investigation involving adults with moderate-to-severe CSU that is inadequately managed by H1 antihistamine treatment alone. The study comprised a 12-week randomized, double-blind, placebo-controlled, dose-ranging phase that was succeeded by a 40-week open-label extension period.

The participants (N=160) were randomly assigned to receive rilzabrutinib at varying doses or a matching placebo. The individuals who were administered with rilzabrutinib at 400mg three times a day (TID) demonstrated significant improvements when compared to the placebo group. A marked reduction in weekly Itch Severity Score (ISS7) and Urticaria Activity Score (UAS7) was observed as early as Week 1, with sustained efficacy through Week 12.