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NEJM:新型银屑病药物的治疗效率优于当前标准疗法

来源:生物谷 2015-07-10 09:16

2015年7月10日 讯 /生物谷BIOON/ --近日,一项发表于国际杂志New England Journal of Medicine上的研究论文中,来自美国西北大学的研究人员通过进行一项II期临床试验,结果表明,一种名为guselkumab的银屑病药物或可优于当前的标准疗法用于治疗慢性的皮肤疾病,文章中研究者对比了guselkumab和阿达木单抗的疗效,后者药物是一种常用于治疗银屑病的药物。

研究者Kenneth Gordon博士表示,我们的研究旨在寻找一系列新型药物来帮助患者抵御慢性皮肤疾病的发展;银屑病是一种免疫介导的疾病,其主要引发患者皮肤瘙痒、干燥以及出现红疹等,同时还会增加患者患抑郁症、心脏病及糖尿病等疾病的风险。目前银屑病在全球几乎影响着3%个体的健康,在所有病人中大约有一半银屑病患者都没有得到合适的治疗。

对于患者而言,该病将一直伴随他们存在,在本文进行的多中心联合研究中,研究人员对293名患中度至重度的银屑病患者进行研究,随机让患者接受两种药物中(药物guselkumab和阿达木单抗)的一种或安慰剂进行长达52周的治疗。在治疗16周和40周时,研究者对药物治疗的效率进行了级别的测量,即0-5,结果显示,相比阿达木单抗治疗组和安慰剂服用组患者而言,服用药物guselkumab的治疗组患者中大部分个体的得分都为0(银屑病完全清除)或1(轻度银屑病),在治疗40周时,81%的每天服用200mg剂量guselkumab的患者的得分为0或1,而服用阿达木单抗的患者中仅有49%的患者可以达到这样的得分。

研究者表示,这种新型药物是通过阻断参与银屑病发生的关键蛋白白介素23的功能来发挥作用的,Gordon表示,基于临床和前期基础研究,后期我们将改变对银屑病发病机制以及疗法的认识,本文研究或为我们提出了一种治疗银屑病的新见解,目前正在进行的III期临床试验中我们将会检测药物guselkumab的安全性以及有效性。(生物谷Bioon.com)

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A Phase 2 Trial of Guselkumab versus Adalimumab for Plaque Psoriasis

Kenneth B. Gordon, M.D., Kristina Callis Duffin, M.D., Robert Bissonnette, M.D., Jörg C. Prinz, M.D., Yasmine Wasfi, M.D., Ph.D., Shu Li, Ph.D., Yaung-Kaung Shen, Ph.D., Philippe Szapary, M.D., M.S.C.E., Bruce Randazzo, M.D., Ph.D., and Kristian Reich, M.D., Ph.D.

BACKGROUND Little is known about the effect of specific anti–interleukin-23 therapy, as compared with established anti–tumor necrosis factor therapies, for the treatment of moderate-to-severe plaque psoriasis. METHODS In a 52-week, phase 2, dose-ranging, randomized, double-blind, placebo-controlled, active-comparator trial, we compared guselkumab (CNTO 1959), an anti–interleukin-23 monoclonal antibody, with adalimumab in patients with moderate-to-severe plaque psoriasis. A total of 293 patients were randomly assigned to receive guselkumab (5 mg at weeks 0 and 4 and every 12 weeks thereafter, 15 mg every 8 weeks, 50 mg at weeks 0 and 4 and every 12 weeks thereafter, 100 mg every 8 weeks, or 200 mg at weeks 0 and 4 and every 12 weeks thereafter) through week 40, placebo, or adalimumab (standard dosage for psoriasis). At week 16, patients in the placebo group crossed over to receive guselkumab at a dose of 100 mg every 8 weeks. The primary end point was the proportion of patients with a Physician’s Global Assessment (PGA) score of 0 (indicating cleared psoriasis) or 1 (indicating minimal psoriasis) at week 16. RESULTS At week 16, the proportion of patients with a PGA score of 0 or 1 was significantly higher in each guselkumab group than in the placebo group: 34% in the 5-mg group, 61% in the 15-mg group, 79% in the 50-mg group, 86% in the 100-mg group, and 83% in the 200-mg group, as compared with 7% in the placebo group (P≤0.002 for all comparisons). Moreover, the proportion was significantly higher in the 50-mg, 100-mg, and 200-mg guselkumab groups than in the adalimumab group (58%) (P<0.05 for all comparisons). At week 16, the proportion of patients with at least a 75% improvement in Psoriasis Area and Severity Index scores was significantly higher in each guselkumab group than in the placebo group (P<0.001 for all comparisons). At week 40, the proportion of patients with a PGA score of 0 or 1 remained significantly higher in the 50-mg, 100-mg, and 200-mg guselkumab groups than in the adalimumab group (71%, 77%, and 81%, respectively, vs. 49%) (P<0.05 for all comparisons). Between week 0 and week 16, infections were observed in 20% of the patients in the guselkumab groups, 12% in the adalimumab group, and 14% in the placebo group. CONCLUSIONS The results of this phase 2 trial suggest that guselkumab may be an effective therapy for plaque psoriasis and that control of psoriasis can be achieved with specific anti–interleukin-23 therapy. (Funded by Janssen Research and Development; X-PLORE ClinicalTrials.gov number, NCT01483599.)

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