Objective:Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin-17A and is approved for treating moderate-to-severe psoriasis.This phase 3,multicenter,randomized,double-blind,placebo-c...Objective:Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin-17A and is approved for treating moderate-to-severe psoriasis.This phase 3,multicenter,randomized,double-blind,placebo-controlled trial(NCT03364309;registered December 6,2017)evaluated the safety and efficacy of ixekizumab in Chinese patients with moderate-to-severe psoriasis.Methods:438 patients were randomized 2:2:1 to 80 mg ixekizumab every 2 weeks(IXE Q2W,n=176),80 mg ixekizumab every 4 weeks(IXE Q4W,n=174),or placebo(n=88).Efficacy was assessed by evaluating the static Physician’s Global Assessment score of 0 or 1(sPGA[0,1])and Psoriasis Area and Severity Index(PASI)75/90/100 responses,and nonresponder imputation was used for handling missing data.The safety profile was evaluated by assessing treatment emergent adverse events(AEs)and serious AEs.Results:At week 12,the sPGA(0,1)response rates were 3.4%,79.9%,and 86.4%in the placebo,IXE Q4W,and IXE Q2W groups,respectively.The PASI 75/90/100 response rates were 8.0%/2.3%/0.0%,87.4%/75.9%/29.3%,and 93.8%/82.4%/33.0%in the placebo,IXE Q4W,and IXE Q2W groups,respectively.Ixekizumab led to rapid PASI 50 responses,as early as week 1,whereas PASI 75 and sPGA(0,1)responses were observed from week 2.sPGA(0,1)and sPGA(0)responses were maintained through week 60 in a higher proportion of patients receiving IXE Q4W vs.placebo.The safety profile was consistent with previous studies of ixekizumab in psoriasis.Conclusion:Ixekizumab showed a rapid onset of action and high efficacy that was maintained through 60 weeks and was well tolerated with no unexpected AEs,in Chinese patients with moderate-to-severe plaque psoriasis.展开更多
BACKGROUND Interleukin-17(IL-17)inhibitors are known to cause exacerbation or new onset of inflammatory bowel disease upon administration.However,few reports have described characteristic endoscopic and histopathologi...BACKGROUND Interleukin-17(IL-17)inhibitors are known to cause exacerbation or new onset of inflammatory bowel disease upon administration.However,few reports have described characteristic endoscopic and histopathologic findings,and no small intestinal lesions have been reported so far.CASE SUMMARY A woman in her 60s with psoriasis was administered ixekizumab(IXE),an anti-IL-17A antibody,for the treatment of psoriasis.Twenty months after commencing treatment,the patient visited our hospital because of persistent diarrhea.Blood tests performed at the time of the visit revealed severe inflammation,and colonoscopy revealed multiple round ulcers throughout the colon.A tissue biopsy of the ulcer revealed infiltration of inflammatory cells and granuloma-like findings in the submucosal layer.Capsule endoscopy revealed multiple jejunal erosions.After the withdrawal of IXE,the symptoms gradually improved,and ulcer reduction and scarring of the colon were endoscopically confirmed.CONCLUSION To the best of our knowledge,17 reports have documented IL-17 inhibitorinduced entero-colitis with endoscopic images,endoscopic findings,and pathological characteristics,including the present case.Nine of these cases showed diffuse loss of vascular pattern,coarse mucosa/ulcer formation in the left colon,and endoscopic findings similar to those of ulcerative colitis.In the remaining eight cases,discontinuous erosions and ulcerations from the terminal ileum to the rectum were seen,with endoscopic findings similar to those of Crohn’s disease.In this case,the findings were confirmed by capsule endoscopy,which has not been previously reported.展开更多
目的分析白细胞介素(IL)抑制剂类生物制剂在斑块状银屑病治疗中的研究现状及热点。方法检索2011年1月1日至2022年4月30日在Web of Science核心合集数据库发表的IL抑制剂类生物制剂在斑块状银屑病治疗方面的相关研究,利用CiteSpace5.8.R...目的分析白细胞介素(IL)抑制剂类生物制剂在斑块状银屑病治疗中的研究现状及热点。方法检索2011年1月1日至2022年4月30日在Web of Science核心合集数据库发表的IL抑制剂类生物制剂在斑块状银屑病治疗方面的相关研究,利用CiteSpace5.8.R3软件进行文献的可视化分析,从发文量、国家/地区、机构、作者、期刊等文献关键特征分析该领域的研究现状,通过文献共被引、关键词共现、聚类及突现分析该领域的知识基础、研究热点及前沿。结果共纳入文献2056篇,近10年发文量呈逐年递增趋势,共计104个国家/地区的545个机构参与了IL抑制剂类药物治疗斑块状银屑病的研究,其中美国发文量805篇,占总发文量的39.15%居首位,且与德国、英国、瑞士、加拿大等有密切合作,发文最多的机构是瑞士诺华制药,发文最多的作者是德国汉堡艾本多夫医学中心的Reich K,被引频次第一的作者是加拿大Prob Med公司的Papp KA,被引频次最高的期刊为British Journal of Dermatology;该领域的研究热点主要为生物制剂治疗斑块状银屑病的作用机制、疗效及安全性研究,研究前沿为长期疗效及安全性研究、特殊人群研究、新型双特异性抗体的研究、自我给药研究及在其他疾病的应用研究等。结论近10年来,IL抑制剂类生物制剂治疗斑块状银屑病发展迅速,研究主要集中在治疗的有效性和安全性上,未来更应该关注对特殊人群及真实世界的研究。展开更多
基金This study was sponsored by Eli Lilly, the manufacturer/licensee of ixekizumab.
文摘Objective:Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin-17A and is approved for treating moderate-to-severe psoriasis.This phase 3,multicenter,randomized,double-blind,placebo-controlled trial(NCT03364309;registered December 6,2017)evaluated the safety and efficacy of ixekizumab in Chinese patients with moderate-to-severe psoriasis.Methods:438 patients were randomized 2:2:1 to 80 mg ixekizumab every 2 weeks(IXE Q2W,n=176),80 mg ixekizumab every 4 weeks(IXE Q4W,n=174),or placebo(n=88).Efficacy was assessed by evaluating the static Physician’s Global Assessment score of 0 or 1(sPGA[0,1])and Psoriasis Area and Severity Index(PASI)75/90/100 responses,and nonresponder imputation was used for handling missing data.The safety profile was evaluated by assessing treatment emergent adverse events(AEs)and serious AEs.Results:At week 12,the sPGA(0,1)response rates were 3.4%,79.9%,and 86.4%in the placebo,IXE Q4W,and IXE Q2W groups,respectively.The PASI 75/90/100 response rates were 8.0%/2.3%/0.0%,87.4%/75.9%/29.3%,and 93.8%/82.4%/33.0%in the placebo,IXE Q4W,and IXE Q2W groups,respectively.Ixekizumab led to rapid PASI 50 responses,as early as week 1,whereas PASI 75 and sPGA(0,1)responses were observed from week 2.sPGA(0,1)and sPGA(0)responses were maintained through week 60 in a higher proportion of patients receiving IXE Q4W vs.placebo.The safety profile was consistent with previous studies of ixekizumab in psoriasis.Conclusion:Ixekizumab showed a rapid onset of action and high efficacy that was maintained through 60 weeks and was well tolerated with no unexpected AEs,in Chinese patients with moderate-to-severe plaque psoriasis.
文摘BACKGROUND Interleukin-17(IL-17)inhibitors are known to cause exacerbation or new onset of inflammatory bowel disease upon administration.However,few reports have described characteristic endoscopic and histopathologic findings,and no small intestinal lesions have been reported so far.CASE SUMMARY A woman in her 60s with psoriasis was administered ixekizumab(IXE),an anti-IL-17A antibody,for the treatment of psoriasis.Twenty months after commencing treatment,the patient visited our hospital because of persistent diarrhea.Blood tests performed at the time of the visit revealed severe inflammation,and colonoscopy revealed multiple round ulcers throughout the colon.A tissue biopsy of the ulcer revealed infiltration of inflammatory cells and granuloma-like findings in the submucosal layer.Capsule endoscopy revealed multiple jejunal erosions.After the withdrawal of IXE,the symptoms gradually improved,and ulcer reduction and scarring of the colon were endoscopically confirmed.CONCLUSION To the best of our knowledge,17 reports have documented IL-17 inhibitorinduced entero-colitis with endoscopic images,endoscopic findings,and pathological characteristics,including the present case.Nine of these cases showed diffuse loss of vascular pattern,coarse mucosa/ulcer formation in the left colon,and endoscopic findings similar to those of ulcerative colitis.In the remaining eight cases,discontinuous erosions and ulcerations from the terminal ileum to the rectum were seen,with endoscopic findings similar to those of Crohn’s disease.In this case,the findings were confirmed by capsule endoscopy,which has not been previously reported.
文摘目的分析白细胞介素(IL)抑制剂类生物制剂在斑块状银屑病治疗中的研究现状及热点。方法检索2011年1月1日至2022年4月30日在Web of Science核心合集数据库发表的IL抑制剂类生物制剂在斑块状银屑病治疗方面的相关研究,利用CiteSpace5.8.R3软件进行文献的可视化分析,从发文量、国家/地区、机构、作者、期刊等文献关键特征分析该领域的研究现状,通过文献共被引、关键词共现、聚类及突现分析该领域的知识基础、研究热点及前沿。结果共纳入文献2056篇,近10年发文量呈逐年递增趋势,共计104个国家/地区的545个机构参与了IL抑制剂类药物治疗斑块状银屑病的研究,其中美国发文量805篇,占总发文量的39.15%居首位,且与德国、英国、瑞士、加拿大等有密切合作,发文最多的机构是瑞士诺华制药,发文最多的作者是德国汉堡艾本多夫医学中心的Reich K,被引频次第一的作者是加拿大Prob Med公司的Papp KA,被引频次最高的期刊为British Journal of Dermatology;该领域的研究热点主要为生物制剂治疗斑块状银屑病的作用机制、疗效及安全性研究,研究前沿为长期疗效及安全性研究、特殊人群研究、新型双特异性抗体的研究、自我给药研究及在其他疾病的应用研究等。结论近10年来,IL抑制剂类生物制剂治疗斑块状银屑病发展迅速,研究主要集中在治疗的有效性和安全性上,未来更应该关注对特殊人群及真实世界的研究。
文摘目的:回顾性分析依奇珠单抗治疗中重度银屑病的疗效及安全性。方法:收集2021年8月至2023年7月在我院接受使用依奇珠单抗治疗的76例中重度银屑病患者临床资料。依奇珠单抗的初始剂量为160 mg皮下注射,分2次注射,注射后剂量调整为80 mg,于2、4、6、8、10、12周皮下注射,最后改为80 mg维持剂量,每4周一次。分析患者治疗前后的病情改善情况和患者治疗过程中不良反应发生情况。结果:76例银屑病患者中T-spot试验阳性8例,轻度肝功能异常5例,轻度肾功能异常2例。经依奇珠单抗治疗后,银屑病面积及严重程度指数(psoriasis area and severity index,PASI)75改善的患者占100%(76/76),PASI 90改善的患者占89.5%(68/76),PASI 100改善的患者占59.2%(45/76)。依奇珠单抗对银屑病关节炎及银屑病甲的疗效显著。治疗中发生的不良反应有注射部位红肿8例,风团样瘙痒性皮疹2例,急性咽喉炎1例,口腔溃疡1例,局限性湿疹3例,面颈部瘙痒性红斑1例,上呼吸道感染5例。结论:依奇珠单抗治疗中重度银屑病具有良好的疗效及安全性。
