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比美珠单抗治疗中重度斑块型银屑病优于阿达木单抗
作者:小柯机器人 发布时间:2021/4/29 23:51:30

英国曼彻斯特大学Richard B. Warren团队比较了比美珠单抗和阿达木单抗治疗斑块型银屑病的效果。2021年4月23日,该研究发表在《新英格兰医学杂志》上。

比美珠单抗是一种选择性抑制白细胞介素-17A和白细胞介素-17F的单克隆IgG1抗体。比美珠单抗与肿瘤坏死因子抑制剂阿达木单抗治疗中重度斑块型银屑病的疗效和安全性尚未得到广泛的研究。

研究组招募了478名中重度斑块型银屑病患者,将其按1:1:1的比例随机分组,其中158名每4周接受一次皮下注射比美珠单抗治疗,共56周;161名每4周接受一次比美珠单抗治疗,持续16周,之后每8周接受一次,至第56周;159名每2周接受一次皮下注射阿达木单抗治疗,持续24周,之后每4周接受一次比美珠单抗治疗,持续56周。主要结局是第16周时,银屑病面积和严重程度指数(PASI)评分比基线下降90%及以上(PASI 90缓解),以及研究者的整体评估(IGA)得分为0或1,表示皮肤病变清除或几乎清除。

参与者的平均年龄为44.9岁;基线检查时的平均PASI评分为19.8分。在第16周,比美珠单抗合并组319名患者中有275名(86.2%)出现PASI 90缓解,阿达木单抗组159名患者中有75名(47.2%),组间差异显著。比美珠单抗合并组中有272名患者(85.3%)IGA得分为0或1,阿达木单抗组中有91名(57.2%),组间差异亦显著。比美珠单抗组中最常见的不良反应为上呼吸道感染、口腔念珠菌病(主要为轻中度)、高血压和腹泻。

研究结果表明,比美珠单抗在减轻斑块型银屑病的症状和体征方面,16周内的疗效优于阿达木单抗,但与口腔念珠菌病和腹泻的发生率较高相关。

附:英文原文

Title: Bimekizumab versus Adalimumab in Plaque Psoriasis | NEJM

Author: Richard B. Warren, M.D., Ph.D.,, Andrew Blauvelt, M.D.,, Jerry Bagel, M.D.,, Kim A. Papp, M.D., Ph.D.,, Paul Yamauchi, M.D., Ph.D.,, April Armstrong, M.D., M.P.H.,, Richard G. Langley, M.D.,, Veerle Vanvoorden, M.Sc.,, Dirk De Cuyper, M.D.,, Christopher Cioffi, Ph.D.,, Luke Peterson, M.S.,, Nancy Cross, M.D.,, and Kristian Reich, M.D., Ph.D.

Issue&Volume: 2021-04-23

Abstract:

Background

Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin-17A and interleukin-17F. The efficacy and safety of bimekizumab as compared with the tumor necrosis factor inhibitor adalimumab in patients with moderate-to-severe plaque psoriasis have not been extensively examined.

Methods

We randomly assigned patients with moderate-to-severe plaque psoriasis in a 1:1:1 ratio to receive subcutaneous bimekizumab at a dose of 320 mg every 4 weeks for 56 weeks; bimekizumab at a dose of 320 mg every 4 weeks for 16 weeks, then every 8 weeks for weeks 16 to 56; or subcutaneous adalimumab at a dose of 40 mg every 2 weeks for 24 weeks, followed by bimekizumab at a dose of 320 mg every 4 weeks to week 56. The primary end points were a 90% or greater reduction from baseline in the Psoriasis Area and Severity Index (PASI) score (PASI 90 response; PASI scores range from 0 to 72, with higher scores indicating worse disease) and an Investigator’s Global Assessment (IGA) score of 0 or 1, signifying clear or almost clear skin (scores range from 0 [clear skin] to 4 [severe disease]), at week 16. The analysis of the primary end points tested noninferiority at a margin of 10 percentage points and then tested for superiority.

Results

A total of 614 patients were screened, and 478 were enrolled; 158 patients were assigned to receive bimekizumab every 4 weeks, 161 to receive bimekizumab every 4 weeks and then every 8 weeks, and 159 to receive adalimumab. The mean age of the patients was 44.9 years; the mean PASI score at baseline was 19.8. At week 16, a total of 275 of 319 patients (86.2%) who received bimekizumab (both dose groups combined) and 75 of 159 (47.2%) who received adalimumab had a PASI 90 response (adjusted risk difference, 39.3 percentage points; 95% confidence interval [CI], 30.9 to 47.7; P<0.001 for noninferiority and superiority). A total of 272 of 319 patients (85.3%) who received bimekizumab and 91 of 159 (57.2%) who received adalimumab had an IGA score of 0 or 1 (adjusted risk difference, 28.2 percentage points; 95% CI, 19.7 to 36.7; P<0.001 for noninferiority and superiority). The most common adverse events with bimekizumab were upper respiratory tract infections, oral candidiasis (predominantly mild or moderate as recorded by the investigator), hypertension, and diarrhea.

Conclusions

In this 56-week trial, bimekizumab was noninferior and superior to adalimumab through 16 weeks in reducing symptoms and signs of plaque psoriasis but was associated with a higher frequency of oral candidiasis and diarrhea. Longer and larger trials are required to determine the efficacy and safety of bimekizumab as compared with other agents in the treatment of plaque psoriasis.

DOI: 10.1056/NEJMoa2102388

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2102388

 

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home