A research group at Kyoto University announced that it has conducted a phase III clinical trial (comparative study) of nemolizumab, a new treatment for atopic dermatitis, and confirmed the improvement and safety of itching in moderate to severe patients. bottom.

 Atopic dermatitis, whose main lesion is pruritic eczema, causes a decrease in concentration at work and school due to itching and sleep disorders, and significantly reduces the quality of life of patients.Itching associated with atopic dermatitis is thought to be induced by the binding of IL-31 (interleukin 31), a protein, to nerve cells, and nemolizumab has a medicinal effect by inhibiting the binding. Demonstrate.

 This research group conducted a clinical trial in 13 patients with atopic dermatitis aged 215 years or older in Japan who had moderate to severe pruritus.This study was conducted in combination with anti-inflammatory external drugs such as steroids, and 143 patients received nemolizumab and 72 patients received a placebo containing no active ingredient subcutaneously every 16 weeks for 4 weeks. The safety was compared.

 As a result, the degree of pruritus decreased by an average of 16% in the group treated with placebo 21.4 weeks after administration, whereas it decreased by an average of 42.8% in the group treated with nemolizumab, showing a statistically significant improvement. Was done.In addition, the evaluation index based on the severity of skin findings such as eczema and redness and the extent of lesions also showed a significant improvement in the nemolizumab-administered group compared with the placebo-administered group.
 On the other hand, the incidence of adverse events was similar in both groups, most of which were mild or moderate, and no significant side effects of nemolizumab were confirmed.

 The results of this study, which confirmed the effectiveness of nemolizumab, are important results that lead to the identification of the mechanism of action of pruritus in atopic dermatitis. It may also reduce the social loss caused by.

Paper information:[The New England Journal of Medicine] Trial of Nemolizumab and Topical Agents for Atopic Dermatitis with Pruritus

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