A recent publication at the American Academy of Allergy, Asthma & Immunology revealed that patients suffering from chronic spontaneous urticaria (CSU) experienced an improvement in urticaria activity symptom scores with the use of barzolvolimab. CSU is a debilitating disease characterized by the presence of hives and itching, with or without angioedema, lasting for more than six weeks. This condition poses significant emotional and economic challenges for the patient.
The study conducted by Maurer and colleagues’ sheds light on the pivotal role mast cells (MCs) in CSU. The phase 2 trial enrolled 208 refractory CSU patients, divided into various treatment groups receiving diverse barzolvolimab doses or a placebo. All treatment arms exhibited significant enhancements in Urticaria Activity Scores (UAS7) with the 300 mg group showcasing the most substantial improvements. The efficacy of barzolvolimab manifested rapidly within the initial weeks of treatment. Barzolvolimab’s effectiveness extended to addressing both hives and itching, the common symptoms of CSU. Weekly Hives Severity Score and Weekly Itch Severity Score improvements were observed across all treatment groups compared to the placebo. Patients in all treatment groups reported improved scores compared to those on placebo, indicating a positive impact on their symptoms. The drug also helped many patients achieve treatment goals, with a notable percentage experiencing complete relief or better symptom management.
The study highlighted barzolvolimab’s predictability and low-grade drug-related toxicities in contrast to other treatments like omalizumab. The safety profile revealed no severe adverse events linked to the drug, with only minor side effects such as changes in hair color and neutropenia. Maurer et al., underscored the positive influence of barzolvolimab on patients’ well-being and anticipated its potential applications in various mast cell-related disorders beyond CSU. The study hinted at the broader implications of mast cell depletion, suggesting potential benefits in conditions with mast cell signatures, such as type 1 allergies.
Maurer and colleagues emphasized that barzolvolimab, particularly at 150 mg Q4W and 300mg Q8W, demonstrated clinically meaningful and statistically significant improvements in UAS7 compared to the placebo at the 12-week mark in patients with antihistamine-refractory CSU. The treatment exhibited favorable tolerability and safety profiles, warranting further exploration and development of barzolvolimab as a potential therapeutic avenue for CSU.
Reference
Maurer M, Kobielusz-Gembala I, Mitha E, Leflein J, Gotua M, Kwiek B, et al. Barzolvolimab Significantly Decreases Chronic Spontaneous Urticaria Disease Activity and is Well Tolerated: Top Line Results from a Phase 2 Trial. Journal of Allergy and Clinical Immunology. 2024 Feb 1;153(2):AB366.