In the pathological changes of psoriasis vulgaris,excessive proliferation of keratinocytes,proliferation of microvessels,infiltration of a large number of inflammatory cells,and great shortening of epidermal replaceme...In the pathological changes of psoriasis vulgaris,excessive proliferation of keratinocytes,proliferation of microvessels,infiltration of a large number of inflammatory cells,and great shortening of epidermal replacement time,are the manifestations of Qi and Yin depletion,and they all correspond with pathological changes of nutrient Qi and blood deficiency caused by excessive loss.The treatment of psoriasis should focus on cold straight fire,convergence and fixation.Therefore,it is feasible to treat psoriasis with hoop in theory,and it is found that"cold hoop confining medicine"may be more suitable for the treatment of psoriasis vulgaris in the gradual progress of the experiment.The research could provide theoretical basis for the application of cold hoop confining medicine represented by brusatol in psoriasis vulgaris and related diseases.展开更多
Background:Atopic dermatitis(AD)affects approximately 10%of adults worldwide.CM310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 signaling.This ...Background:Atopic dermatitis(AD)affects approximately 10%of adults worldwide.CM310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 signaling.This trial aimed to evaluate the efficacy and safety of CM310 in Chinese adults with moderate-to-severe AD.Methods:This multicenter,randomized,double-blind,placebo-controlled,phase 2b trial was conducted in 21 medical institutions in China from February to November 2021.Totally 120 eligible patients were enrolled and randomized(1:1:1)to receive subcutaneous injections of 300 mg CM310,150 mg CM310,or placebo every 2 weeks for 16 weeks,followed by an 8-week follow-up period.The primary endpoint was the proportion of patients achieving≥75%improvement in the Eczema Area and Severity Index(EASI-75)score from baseline at week 16.Safety and pharmacodynamics were also studied.Results:At week 16,the proportion of EASI-75 responders from baseline was significantly higher in the CM310 groups(70%[28/40]for high-dose and 65%[26/40]for low-dose)than that in the placebo group(20%[8/40]).The differences in EASI-75 response rate were 50%(high vs.placebo,95%CI 31%-69%)and 45%(low vs.placebo,95%CI 26%-64%),with both P values<0.0001.CM310 at both doses also significantly improved the EASI score,Investigator’s Global Assessment score,daily peak pruritus Numerical Rating Scale,AD-affected body surface area,and Dermatology Life Quality Index compared with placebo.CM310 treatment reduced levels of thymus and activation-regulated chemokine,total immunoglobulin E,lactate dehydrogenase,and blood eosinophils.The incidence of treatment-emergent adverse events(TEAEs)was similar among all three groups,with the most common TEAEs reported being upper respiratory tract infection,atopic dermatitis,hyperlipidemia,and hyperuricemia.No severe adverse events were deemed to be attributed to CM310.Conclusion:CM310 at 150 mg and 300 mg every 2 weeks demonstrated significant efficacy and was well-tolerated in adults with moderate-to-severe AD.Trial Registration:ClinicalTrials.gov,NCT04805411.展开更多
基金Supported by National Science Foundation for Young Scholars(81704090)Key Projects of Chongqing Municipal Science and Technology Commission(cstc2017jcyjbx0044).
文摘In the pathological changes of psoriasis vulgaris,excessive proliferation of keratinocytes,proliferation of microvessels,infiltration of a large number of inflammatory cells,and great shortening of epidermal replacement time,are the manifestations of Qi and Yin depletion,and they all correspond with pathological changes of nutrient Qi and blood deficiency caused by excessive loss.The treatment of psoriasis should focus on cold straight fire,convergence and fixation.Therefore,it is feasible to treat psoriasis with hoop in theory,and it is found that"cold hoop confining medicine"may be more suitable for the treatment of psoriasis vulgaris in the gradual progress of the experiment.The research could provide theoretical basis for the application of cold hoop confining medicine represented by brusatol in psoriasis vulgaris and related diseases.
基金funded by the National 13th Five-Year Plan for Major New Drug Development of China(No.2017ZX09302010)
文摘Background:Atopic dermatitis(AD)affects approximately 10%of adults worldwide.CM310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 signaling.This trial aimed to evaluate the efficacy and safety of CM310 in Chinese adults with moderate-to-severe AD.Methods:This multicenter,randomized,double-blind,placebo-controlled,phase 2b trial was conducted in 21 medical institutions in China from February to November 2021.Totally 120 eligible patients were enrolled and randomized(1:1:1)to receive subcutaneous injections of 300 mg CM310,150 mg CM310,or placebo every 2 weeks for 16 weeks,followed by an 8-week follow-up period.The primary endpoint was the proportion of patients achieving≥75%improvement in the Eczema Area and Severity Index(EASI-75)score from baseline at week 16.Safety and pharmacodynamics were also studied.Results:At week 16,the proportion of EASI-75 responders from baseline was significantly higher in the CM310 groups(70%[28/40]for high-dose and 65%[26/40]for low-dose)than that in the placebo group(20%[8/40]).The differences in EASI-75 response rate were 50%(high vs.placebo,95%CI 31%-69%)and 45%(low vs.placebo,95%CI 26%-64%),with both P values<0.0001.CM310 at both doses also significantly improved the EASI score,Investigator’s Global Assessment score,daily peak pruritus Numerical Rating Scale,AD-affected body surface area,and Dermatology Life Quality Index compared with placebo.CM310 treatment reduced levels of thymus and activation-regulated chemokine,total immunoglobulin E,lactate dehydrogenase,and blood eosinophils.The incidence of treatment-emergent adverse events(TEAEs)was similar among all three groups,with the most common TEAEs reported being upper respiratory tract infection,atopic dermatitis,hyperlipidemia,and hyperuricemia.No severe adverse events were deemed to be attributed to CM310.Conclusion:CM310 at 150 mg and 300 mg every 2 weeks demonstrated significant efficacy and was well-tolerated in adults with moderate-to-severe AD.Trial Registration:ClinicalTrials.gov,NCT04805411.