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Many patients do not see meaningful improvement with the current standard treatment. New data suggest this monoclonal antibody might be a better choice.
New data suggest benralizumab (Fasenra) could be an important new option in the treatment of patients with chronic spontaneous urticaria (CSU).
The data showed that the anti-interleukin-5-receptor (IL5R) alpha monoclonal antibody led to a sustained improvement in CSU symptoms in a small investigation of 12 patients who were unresponsive to the standard treatment of second-generation H1 antihistamines.
The investigators, including corresponding author Jonathan A. Bernstein, MD, of the University of Cincinnati College of Medicine, said the data warranted further study of the therapy.
The patients in the study (9 women and 3 men with average ages of 47.3 years) had had CSU symptoms for a mean duration of 7.0 years at the start of the study, and their baseline 7-day urticaria activity scores (UAS7) ranged from 16 to 42. Forty-two is the highest possible score, indicating the greatest severity.
The study had a run-in period of 14 days, after which patients were given a single dose of placebo and then 3 monthly subcutaneous injections of 30 mg of benralizumab. Two more monthly visits were conducted in the 2 months following treatment. The primary endpoint was change in UAS7 scores from baseline to week 20.
Three patients did not complete the study; one was lost to follow up, one withdrew due to nonresponse, and the last withdrew for personal reasons. Still, 2 of the 3 had shown improvement in UAS7 scores at the time of their withdrawal, Bernstein and colleagues said.
The data showed that benralizumab had consistent results that improved from the third check-in to the final check-in. By the third visit, UAS7 scores had declined by an average of 10.9 points. The fourth check-in saw a similar benefit (10.8-point decline), but by the fifth visit, the average decline was 15.7 points, with 5 patients reporting a complete response (UAS score of 0), and 2 patients reporting UAS7 scores of 6 or lower at 20 or 24 weeks. Scores of 6 or lower were considered partial responses. No drug-related adverse events were reported.
The authors said the use of benralizumab makes sense because urticarial lesions are characterized by increased lymphocytes and perivascular eosinophilic infiltrates, which they said implies that interleukin-5 plays a role in the disease.
Bernstein told HCPLive that the response, which included improvement in both components of UAS7 scores (pruritus severity and wheal size) was impressive.
“It was not immediately obvious the effect of an IL5R in hives, but the response was significant and long-lasting as we followed patients 2 months after discontinuation, which showed persistent response,” he said.
Bernstein and colleagues noted that their responses were similar to those found in a study of the anti-immunoglobulin E antibody omalizumab (Xolair).
The investigators theorized that the persistent impact of benralizumab might be due to a modification of biologic pathways involved in persistent cutaneous inflammation.
“These observations support the use of benralizumab in the treatment of chronic spontaneous urticaria that is unresponsive to second-generation H1 antihistamines and provide evidence of a pathogenic role for infiltrating eosinophils,” they wrote.
Bernstein said his group will report additional results in a subsequent publication, which will shed some light on the drug’s mechanism of action.
The investigators a double-blind, placebo-controlled trial ought to be undertaken in order to verify these results in a larger patient population.
The correspondence, "Benralizumab for Chronic Spontaneous Urticaria," was published online in The New England Journal of Medicine.