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Efficacy Analysis of Ligezizumab in the Treatment of Chronic Spontaneous Urticaria

In most patients with chronic spontaneous urticaria, most currently available therapies cannot completely control symptoms. Ligizumab is the next generation of high-affinity humanized monoclonal anti-IgE antibody. For patients with moderate to severe chronic spontaneous urticaria whose symptoms are not adequately controlled after treatment with approved doses or increased doses of H1-antihistamines, the dose-response relationship of ligerizumab and the relationship between The efficacy and safety data of omalizumab compared with placebo are very limited.

 

Recently, the top medical journal NEJM published a research article. In the phase 2b dose-finding trial, researchers randomly assigned patients to receive subcutaneous injections of 24 mg, 72 mg or 240 mg ligezizumab, 300 mg doses every 4 weeks Omalizumab or placebo, continued treatment for 20 weeks, or a single dose of 120 mg ligezizumab. Disease symptoms of urticaria, pruritus, and angioedema are monitored by weekly activity scores. The main purpose of the study is to determine the dose-response relationship for complete control of urticaria (using a weekly urticaria severity score, from 0 to 21, the higher the score indicates the higher the severity); the primary endpoint of this response is in the first Evaluation is carried out in 12 weeks. A weekly urticaria activity score of 0 indicates complete control of the symptoms (from 0 to 42, the higher the score, the higher the severity). The safety was analyzed throughout the test process.

 

A total of 382 patients in the study were randomized. In week 12, 30%, 51%, and 42% of patients treated with 24 mg, 72 mg, and 240 mg ligezizumab had complete control of urticaria. In contrast, omalizumab Only 26% of the patients in the resistant group had complete control of the urticaria in no patients in the placebo group. The researchers clarified the dose-response relationship. At week 12, 30%, 44%, and 40% of patients treated with 24 mg, 72 mg, and 240 mg ligezizumab had complete control of their symptoms. In contrast, omalizumab Only 26% of the patients in the placebo group had complete control of their symptoms. In this small and brief trial, there were no safety issues regarding ligezizumab or omalizumab.

 

It can be seen that compared with the use of omalizumab or placebo, patients with chronic spontaneous urticaria treated with 72 mg or 240 mg ligezizumab have a higher rate of complete symptom control.

 

Ligelizumab is a new generation of humanized anti-IgE recombinant antibody that can interrupt the IgE/FceR1 signaling pathway and has a higher IgE affinity than Xolair. It is currently in Phase III clinical stage. A randomized, double-blind, placebo and positive drug control, dose discovery trial was extended in 382 CSU-refractory CSU patients who are refractory to H1 antihistamines. The main goal is to determine the dose-response relationship to completely relieve acute Measles (complete remission of neutral measles is defined as a weekly neutral paralysis severity score of 0, with a score range of 0-21), and the effectiveness of the last monthly subcutaneous injection of ligezizumab as an add-on therapy to CSU was evaluated And security. Randomly assigned (see the figure below), using weekly activity scores to detect symptoms of measles, ulcerative pruritus, angioedema and other diseases, and assess the proportion of patients with acute measles who achieved complete remission at the 12th week.

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