Barzolvolimab, a novel anti-KIT monoclonal antibody, has shown promising results in reducing the severity of hives in adults suffering from chronic spontaneous urticaria (CSU) who have not found relief with antihistamines. According to a randomized phase II trial, patients treated with different doses of barzolvolimab experienced a significant improvement in the 7-day Urticaria Activity Score (UAS7) compared to those on a placebo. The higher the dose of barzolvolimab, the greater the reduction in UAS7, indicating a dose-dependent response.
In addition to improvements in UAS7, barzolvolimab also demonstrated clinically and statistically significant benefits in the 7-day Hives Severity Score (HSS7) and the Itch Severity Score (ISS7) during the trial. Patients, whether naive or refractory to omalizumab, saw comparable improvements in UAS7 with barzolvolimab treatment, highlighting its potential as an effective therapy for CSU. The percentage of patients achieving well-controlled disease status was notably higher in the barzolvolimab groups compared to the placebo group, with complete responses observed in a significant proportion of patients receiving the highest dose of the drug.
While the efficacy of barzolvolimab is promising, it is essential to consider the adverse events associated with treatment. Patients receiving barzolvolimab reported higher rates of adverse events, such as skin and subcutaneous tissue disorders, infections, and infestations, compared to those on placebo. Some patients also experienced neurological issues, changes in hair color, and neutropenia, underscoring the importance of monitoring and managing potential side effects.
To be eligible for the phase II study of barzolvolimab, adult patients with CSU had to meet specific criteria, including a confirmed diagnosis of CSU for at least 6 months, persistent itching and hives despite antihistamine treatment, and refractoriness to second-generation antihistamines. Patients needed to have elevated UAS7 and ISS7 scores to qualify for the trial, with exclusion criteria aimed at ensuring the study population was representative of individuals with CSU.
The phase II trial enrolled 207 participants who were randomized to receive different doses of barzolvolimab or placebo subcutaneously. The study population consisted predominantly of women, with various racial backgrounds represented. Patients’ baseline UAS7 and Urticaria Control Test scores were similar across groups, indicating a well-balanced study population. The average duration of CSU in the participants was over 5 years, emphasizing the chronic nature of the condition and the need for effective treatment options.
After 16 weeks, patients initially on the 75-mg dose of barzolvolimab or placebo will be re-randomized to receive higher doses of the drug for an additional 20 weeks. The results of the ongoing trial will provide further insights into the long-term efficacy and safety of barzolvolimab in patients with CSU. Moreover, plans for phase III studies of barzolvolimab indicate a continued focus on evaluating its therapeutic potential and expanding its clinical utility.
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