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勃林格殷格翰first in class单抗对罕见银屑病显奇效

医药魔方 医药魔方 来源:医药魔方
2019-03-12
银屑病
原文

3月7日,《新英格兰医学杂志》发表了BI 655139治疗泛发性脓疱型银屑病(generalised pustular psoriasis,GPP) 的I期研究结果。


脓疱型银屑病是银屑病中较少见的一种类型,占比不超过1%,临床上通常分为泛发性脓疱型银屑病和掌跖型银屑病。泛发性脓疱型银屑病,以四肢屈侧及皱襞处较多,也可累及全身,皮损初发为在急性炎症红斑的基础上,出现多数密集针头至粟粒大小无菌性表浅脓胞,附有少量菲薄鳞屑。


泛发性脓疱型银屑病罕见,有时伴有发热和身体萎靡不振,一些严重病例会导致器官衰竭和严重感染,进而威胁生命。这种情况下,患者需要住院接受局部和系统药物治疗,包括控制炎症的免疫抑制剂、抗TNF药物以及预防感染的抗生素等。尚无快速缓解症状的靶向疗法可用。BI 655139是勃林格殷格翰开发的first in class的抗IL-36单抗药物。


在这项I期研究中,7例患者静脉注射1次BI 655139之后,3例患者在注射后的48h实现脓疱完全清除,有5例患者在1周后实现了皮损改善,4周之后7例患者的平均皮损面积改善接近80%,而且这个疗效能够维持到第20周。


该研究作者是勃林格殷格翰的CNS及免疫疾病药物研发负责人Jan Poth,他指出:“我们是最早专注研发IL-36靶向疗法在皮肤科中应用的公司之一,尚需要进一步的研究来探索BI 655139的疗效及持续时间、不良反应。基于I期研究的结果,我们会尽快启动BI 655139在更多泛发性脓疱型银屑病患者中的II期研究。”


BI 655139在泛发性脓疱型银屑病试验中的初步成功也提示了这个药物在其他免疫疾病的潜力,比如更常见的炎症性肠病。目前,BI 655139在掌跖脓疱病、溃疡性肠炎、克罗恩病、特应性皮炎中的研究也正在进行中。


开发IL-36项目的公司并不多,另外一家是美国的AnaptysBio公司,其产品ANB019处于II期阶段,预计今年底公布在泛发性脓疱型银屑病和掌跖脓疱病中的II期结果。

机器翻译

On March 7, the New England Journal of Medicine published the results of a phase I study of BI 655139 in generalized pustular psoriasis (GPP).

Pustular psoriasis is a less common form of psoriasis, accounting for no more than 1% of psoriasis, and is usually divided clinically into generalized pustular psoriasis and palmoplantar psoriasis.Generalized pustular psoriasis, with more flexures and folds of the limbs, may also affect the whole body, the initial onset of skin lesions is on the basis of acute inflammatory erythema, the emergence of most dense needles to miliary size aseptic superficial pus cells, with a small amount of thin scales.

Generalized pustular psoriasis is rare, sometimes associated with fever and malaise, and some severe cases can lead to organ failure and serious infections that can be life-threatening.In this case, the patient needs to be hospitalized for treatment with topical and systemic medications, including immunosuppressants to control inflammation.Anti-TNF drugs and antibiotics to prevent infection.No targeted therapy for rapid symptom relief is available.BI 655139 is a first in class anti-IL-36 monoclonal antibody developed by Boehringer Ingelheim.

In this phase I study, after a single intravenous injection of BI 655139 in 7 patients, 3 patients achieved complete pustular clearance at 48 hours after injection, 5 patients achieved improvement in skin lesions after 1 week, and after 4 weeks, 7 patients achieved nearly 80% improvement in mean lesion area, and this effect was maintained through week 20.

"We are one of the first companies to focus on developing IL-36-targeted therapies in dermatology," said Jan Poth, director of drug development for CNS and immune diseases at Boehringer Ingelheim. "Further studies are needed to explore the efficacy and duration of BI 655139."Adverse reactions.Based on the results of the phase I study, we will initiate the phase II study of BI 655139 in more patients with generalized pustular psoriasis as soon as possible.

The initial success of BI 655139 in the generalized pustular psoriasis trial also suggests the potential of this drug in other immune disorders, such as the more common inflammatory bowel disease.Currently, BI 655139 in palmoplantar pustulosis.Ulcerative enteritis.Crohn's disease.Studies in atopic dermatitis are also ongoing.

There are not many companies developing the IL-36 program. The other is AnaptysBio in the United States, whose product ANB019 is in phase II and is expected to announce phase II results in generalized pustular psoriasis and palmoplantar pustulosis by the end of this year.

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