”
7.christophers e, griffiths cem, gaitanis g, et al. the unmet treatment need for moderate to severe psoriasis: results of a survey and chart review. j eur acad dermatol venereol. 2006;20:921-925.
针对银屑病关节炎和强直性脊柱炎的iii期研发计划正在进行中;预计2015年世界各国将陆续批准cosentyx用于治疗这些关节疾病
北京2015年1月5日电 /美通社/ -- 诺华公司日前宣布,日本厚生劳动省(mhlw)正式批准cosentyx? (secukin骨性关节炎治疗方法umab,曾用名ain457)用于对全身性治疗(除外生物制剂)应答不足的寻常型银屑病和银屑病关节炎(psa)成年患者这使得日本成为了全球第一个批准cosentyx的国家,也使得cosentyx成为了首个在日本获准用于上述两种适应症的白介素-17a (il-17a)抑制剂
6.stern rs, nijsten t, feldman s, et al. psoriasis is common, carries a substantial burden even when not extensive, and is associated with widespread treatment dissatisfaction. j i关节炎和风湿nvestig dermatol symp. 2004;9(2):136-9.nestle fo, kaplan dh, barker j. psoriasis. n engl j med. 2009; 361(5):496-509.
28.takahashi h,nakamura k, kaneko f, et, al. analysis of psoriasis patients registered with the japanese society for psoriasis research from 2002–2008. journal of dermatology. 2011;38: 1125–1129.
10.dougados m, baeten d. spondyloarthritis反应性关节炎症状. lancet. 2011; 377:2127-37.
3.paul c, lacour jp, tedremets l, et al. efficacy, safety, and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (juncture). j eur acad dermatol venereol. 2014; [published online ahead of print september 22, 2014].
关于cosentyx? (secukinumab)和白介素-17a踝关节炎症状 (il-17a)
12.gladman dd, antoni c, mease p, et al. psoriatic arthritis: epidemiology, clinical features, course, and outcome. ann rheum dis. 2005; 64:ii14-ii17.
cosentyx主要通过抑制 il-17a 发挥作用,il-17a 蛋白在银屑病受累皮肤中浓度较高,是银屑病、psa等炎性疾病发病的关键因素14-19全球大约30%的银屑病患者同时也患有psa12;如今该药获批意味着日本患者有了新的治疗选择,可以同时有效治疗这两种疾病
5.mcinnes ib. secukinumab, a human an骨性关节炎能治愈ti-interleukin-17a monoclonal antibody, improves active psoriatic arthritis: 24-week efficacy and safety data from a phase 3 randomized, multicenter, double-blind, placebo-controlled study using subcutaneous dosing. oral presentation at: acr/arhp annual meeting, boston, ma, usa, 2014. abstract number: l1.
--- 风湿和类风湿关节炎cosentyx (secukinumab)获批主要是因为iii期临床研究表明,该药在消除皮肤中重度斑块状银屑病以及改善银屑病关节炎的症状和体征方面具有显著且持久的疗效1-5--- 许多患者对现有银屑病或银屑病关节炎治疗无应答或不耐受,提示这类疾病的治疗需求尚未充分满足6-11--- 银屑病关节炎累及全球大约30%的银屑病患者,可能导致不可逆转的关节损害12,13;如今该药获准上市,患者便有了新的治疗选择,可以同时有效治疗这两种疾病--- iii期研究显示,在接受了cosentyx 300 mg治疗的患者中≥70%在开始治疗后16周内实现了皮损完全消除(pasi 100)或皮损接近完全消除 (pasi 90) 1
关于银屑病关节炎 (psa)
8.krueger j骨性膝关节炎g, koo j, lebwohl m, et al. the impact of psoriasis on quality of life: results for a 1998 national psoriasis foundation patient membership survey. arch derm. 2001;137:280-284.
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11.armstrong a, robertson a, wu j, et al. undertreatment, treatment trends, and treatment dissatisfaction a治类风湿关节炎的药mong patients with psoriasis and psoriatic arthritis in the united states: findings from the national psoriasis foundation surveys, 2003-2011.jama dermatol. 2013; 149(10):1180-1185.
2.blauvelt a, prinz j, gottlieb ab, et al. secukinumab administration by pre-filled syringe: efficacy, safety, and usability results from a randomi类风湿关节炎的起因zed controlled trial in psoriasis (feature). br j dermatol. 2014; [published online ahead of print august 16, 2014].
cosentyx是一种选择性中和il-17a的人单克隆抗体14,15il-17a在银屑病受累皮肤中浓度较高,是试验性治疗药物的首选靶点14,19研究还表明,在银屑病关节炎、强直性脊柱炎等其他炎性关节疾病中,il-17a在促进机体免疫应答方面也起着重要的作用26
cosentyx获批主要是基于相关研究的安全性和疗效结果,包括10多项总共纳入了将近4,000例中重度斑块状银屑病患者的ii期和iii期试验1-3,13 以及2项纳入了1,000多例 psa患者肩关节炎的关键性iii期试验 future 1和future 24,5在所有试验中,cosentyx均表现出了良好的安全性特征,两个cosentyx 治疗组(300 mg和150 mg)的不良事件 (aes)发生率和严重程度相似 1-5,23
银屑病是一种慢性免疫介导性疾病,其特征是皮损厚而广泛,称为斑块,已知会引起瘙痒、脱屑和疼痛;银屑病可能明显影响患者生理和心理方面的生活质量6,20,21psa与银屑病密切相关,可能引起关节疼痛和僵硬、皮肤和指甲银屑病、手指脚趾肿胀、持续性疼痛性肌腱炎以及不可逆转的关节损害13多达40%的患者可能发生关节破坏和永久性身体畸形22
2014年11月,cosentyx 获得了欧洲药品管理局人用药品委员会(chmp)的积极意见,推荐欧洲各国将cos右膝关节骨性关节炎entyx作为中重度银屑病患者的一线治疗并于2014年10月获得了fda皮肤与眼科药物顾问委员会(dodac)对该适应症的全票支持
26.mease pj, armstrong aw. managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. drugs. 2014;74:423-41.
1.langley rg, elewski be, lebwohl m, et al. secukinumab in plaque psorias关节炎症状及治疗is: results of two phase three trials. n engl j med. 2014. jul 9;371(4):326-38.
诺华制药全球负责人david epstein表示:“我们很高兴日本在全球率先批准cosentyx用于治疗银屑病和银屑病关节炎,为日本超过400,000名银屑病和银屑病关节炎患者提供新的治疗选择”“将近一半的银屑病和psa患者对现有治疗不满意如今该药获准上市,我们应该能够解决这一重要的尚未满足的治疗需求,切实提高这些患者的生活质量
关于银屑病
4.mease pj, mcinnes ib, kirkham b, et al. secukinumab, a human anti–interl颞颌关节炎能自愈eukin-17a monoclonal antibody, improves active psoriatic arthritis and inhibits radiographic progression: efficacy and safety data from a phase 3 randomized, multicenter, double-blind, placebo-controlled study. oral presentation at: acr/arhp annual meeting, boston, ma, usa, 2014. presentation number 948.
27.kubo关节炎的治疗方法ta k, sato m, ohaba n, et al. national reciept database no katsuyo kanosei wo saguru – kansen no ekigaku kenkyu kara- (potential usage of national receipt database – epidemiology study of psoriasis -). japanese society of pharmacoepidemiology, november 16-17, 2013, tokyo, 2013:39
这种令人痛苦的常见病并非单纯的美观问题,即使患者症状很轻,其日常生活也会类风湿关节炎的危害受到影响6而且,多达50%的患者对包括生物制剂在内的现有治疗并不满意,因此急需新的银屑病治疗药物6-9
在银屑病临床试验中,70%的患者在开始cosentyx 300 mg治疗后16周内实现了皮损完全消除或皮损接近完全消除 (p
13.american college of rheumatology (acr) website. "spondylarthritis (spondylarthropathy)."http://x?refid=114. accessed february 2014.
references
银屑病关节炎(psa)是一种使人日渐衰弱的长期炎性疾病,可能引起明显残疾、生活质量下降以及寿命缩短12psa累及大约0.3%~1%的总人口,多达四分之一的银屑病骨性关节炎能治愈患者可能都合并有psa,只是有的未被诊断 12,24在日本,psa累及超过3%的银屑病患者28
银屑病大约累及全球3%的人口,全球患者总人数超过1.25亿25据估计,日本大约有430,000名银屑病患者27
9.sterry w, barker j, boehncke wh, et al. biological therapies in the systemic management of psoriasis: international consensus conference. br j dermatol. 2004;151 suppl 69:3-17
白癜风治疗的有效医院重庆白癜风医院