Doses of 72 mg or 240 mg tied to complete control of symptoms after 12-week trial
THURSDAY, Oct. 3, 2019 (HealthDay News) — Ligelizumab appears to be a safe and effective treatment option for chronic spontaneous urticaria, according to a study published in the Oct. 3 issue of the New England Journal of Medicine.
In a phase 2b dose-finding study, Marcus Maurer, M.D., from Charité-Universitätsmedizin Berlin, and colleagues randomly assigned 382 patients to receive a single 120-mg dose of ligelizumab or ligelizumab at doses of 24 mg, 72 mg, or 240 mg, omalizumab (300 mg), or placebo administered subcutaneously every four weeks for 20 weeks. Disease symptoms were evaluated weekly.
The researchers found that at week 12, in the ligelizumab group, 30, 51, and 42 percent of the patients treated with 24 mg, 72 mg, and 240 mg, respectively, had a complete hives response versus 26 percent of the patients in the omalizumab group and no patients in the placebo group. The investigators observed a dose-response relationship. Among patients treated with 24 mg, 72 mg, and 240 mg, respectively, of ligelizumab, 30, 44, and 40 percent had complete control of symptoms versus 26 percent of the patients in the omalizumab group and no patients in the placebo group. No safety concerns were reported for ligelizumab or omalizumab.
“An anti-immunoglobulin E therapy that induces remission in more patients with a longer interval between administration of the drug is much appreciated and should gain clinical popularity,” writes the author of an accompanying editorial. “We all await better understanding about the causes of chronic spontaneous urticaria as we search for good predictive markers for responses to therapy.”
Several authors disclosed financial ties to pharmaceutical companies, including Novartis, which manufactures ligelizumab and funded the study.
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