Ligelizumab achieves better control of symptoms of chronic spontaneous urticaria, finds study

It is a fact that most currently available therapies do not result in complete symptom control in the majority of patients with chronic spontaneous urticaria necessitating the need for finding new drugs. Ligelizumab is a next-generation high-affinity humanized monoclonal anti-IgE antibody that can be used in the disease.

Administration of ligelizumab therapy of 72 mg or 240 mg in patients with chronic spontaneous urticaria helped to achieve complete control of symptoms of chronic spontaneous urticaria. The new study has been published in The New England Journal of Medicine.

Dr Marcus Maurer, MD, of the Department of Dermatology and Allergy, Charité–Universitätsmedizin Berlin, Germany, and colleagues have conducted a small international trial and compared the efficacy and safety of omalizumab and ligelizumab relative to placebo in patients with Chronic spontaneous urticaria whose condition had not responded to standard-of-care therapy, including H1 antihistamines.

To compare the drugs, the researchers conducted a multicenter, double-blind, placebo-controlled, clinical trial (phase 2b) that involved 382 patients whose CSU was refractory to antihistamines and, in some cases, to leukotriene receptor antagonists. The patients were randomly assigned to receive either subcutaneous injections of omalizumab (300 mg), ligelizumab (24 mg, 72 mg, or 240 mg), or placebo every 4 weeks for 20 weeks. In addition, one group of patients received a single 120-mg dose of ligelizumab at week 0 followed by placebo every 4 weeks to test the duration of effec

Currently, multiple international guidelines recommend omalizumab as an add-on third-line therapy for patients whose condition does not respond to second-generation H1 antihistamines at locally approved doses, which is considered first-line treatment, or to escalation up to four times the approved dose, which is off-label second-line treatment, the authors note.Although add-on therapy with omalizumab has proven effective for many patients, not everyone's condition responds. Previous research has shown that ligelizumab binds to IgE with greater affinity than omalizumab and thus may have a stronger treatment effect, they explain.

The researchers concluded that a higher percentage of patients had complete control of symptoms of chronic spontaneous urticaria with ligelizumab therapy of 72 mg or 240 mg than with omalizumab or placebo. In addition to a higher response rate, ligelizumab appeared to work quickly. "[R]esponses according to changes from baseline in the weekly hives-severity score, itch-severity score, and urticaria activity score were observed as early as week 4 after receipt of the 72-mg, 120-mg, and 240-mg doses of ligelizumab, thus indicating an onset of action within this time frame for ligelizumab," the authors write.

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