德国汉堡-埃彭多夫大学医学中心Kristian Reich团队比较了比美珠单抗与苏金单抗治疗斑块型银屑病的疗效。2021年4月23日，《新英格兰医学杂志》发表了该成果。

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。比美珠单抗与单独选择性抑制白细胞介素-17A的苏金单抗相比，治疗中重度斑块型银屑病患者的疗效和安全性尚未得到广泛研究。

在这项临床3b期试验中，研究组招募了743名中重度斑块型银屑病患者，将其按1：1随机分组，其中373名每4周接受一次比美珠单抗治疗，370名每4周接受一次苏金单抗治疗，持续至48周。在第16周，将接受比美珠单抗治疗的患者按1：2的比例再随机分组，每4周或每8周接受一次维持剂量治疗，持续至第48周。主要终点为在第16周时银屑病面积和严重程度指数（PASI）评分比基线下降100%。

第16周时，比美珠单抗组中有230名患者（61.7%）的PASI评分（PASI 100）较基线水平下降了100%，显著高于苏金单抗组（181名，48.9%）。第48周时，比美珠单抗组中有250名患者（67.0%）出现PASI 100缓解，显著高于苏金单抗组（171名，46.2%）。在第4周的时间点，比美珠单抗组有265名患者（71.0%）的PASI评分较基线水平下降75%或更大，显著高于苏金单抗组的175名患者（47.3%）。但比美珠单抗组有72例（19.3%）患者发生口腔念珠菌病，显著高于苏金单抗组（11例，3.0%）。

研究结果表明，对于中重度银屑病患者，使用比美珠单抗治疗与苏金单抗相比显著提高了第16和48周时的皮肤清除率，但与口腔念珠菌病有关（主要为轻中度）。

附：英文原文

Title: Bimekizumab versus Secukinumab in Plaque Psoriasis | NEJM

Author: Kristian Reich, M.D., Ph.D.,, Richard B. Warren, M.D., Ph.D.,, Mark Lebwohl, M.D.,, Melinda Gooderham, M.D.,, Bruce Strober, M.D., Ph.D.,, Richard G. Langley, M.D.,, Carle Paul, M.D., Ph.D.,, Dirk De Cuyper, M.D.,, Veerle Vanvoorden, M.Sc.,, Cynthia Madden, M.D.,, Christopher Cioffi, Ph.D.,, Luke Peterson, M.S.,, and Andrew Blauvelt, M.D.

Issue&Volume: 2021-04-23

Abstract:

Background

Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits both interleukin-17A and interleukin-17F. The efficacy and safety of bimekizumab as compared with secukinumab, which selectively inhibits interleukin-17A alone, in patients with moderate-to-severe plaque psoriasis have not been extensively examined.

Methods

In this phase 3b trial, we randomly assigned patients with moderate-to-severe plaque psoriasis, in a 1:1 ratio, to receive bimekizumab at a dose of 320 mg every 4 weeks or secukinumab at a dose of 300 mg weekly to week 4, followed by every 4 weeks to week 48. At week 16, patients receiving bimekizumab underwent rerandomization, in a 1:2 ratio, to receive maintenance dosing every 4 weeks or every 8 weeks to week 48. The primary end point was 100% reduction from baseline in the Psoriasis Area and Severity Index (PASI) score at week 16. The primary analysis was first tested for the noninferiority of bimekizumab to secukinumab at a margin of 10 percentage points and then tested for superiority.

Results

A total of 1005 patients were screened and 743 were enrolled; 373 patients were assigned to receive bimekizumab and 370 to receive secukinumab. At week 16, a total of 230 patients (61.7%) in the bimekizumab group and 181 (48.9%) in the secukinumab group had a 100% reduction from baseline in the PASI score (PASI 100) (adjusted risk difference, 12.7 percentage points; 95% confidence interval [CI], 5.8 to 19.6); bimekizumab was shown to be noninferior and superior to secukinumab (P<0.001 for noninferiority and superiority). At week 48, a total of 250 patients (67.0%) treated with bimekizumab had a PASI 100 response, as compared with 171 patients (46.2%) treated with secukinumab (adjusted risk difference, 20.9 percentage points; 95% CI, 14.1 to 27.7; P<0.001). At the week 4 time point, 265 patients (71.0%) in the bimekizumab group had 75% or greater reduction from baseline in the PASI score, as compared with 175 patients (47.3%) in the secukinumab group (adjusted risk difference, 23.7; 95% CI, 17.0 to 30.4; P<0.001). Oral candidiasis occurred more often with bimekizumab (72 patients, 19.3%) than with secukinumab (11 patients, 3.0%).

Conclusions

In patients with moderate-to-severe psoriasis, treatment with bimekizumab resulted in greater skin clearance than treatment with secukinumab over 16 and 48 weeks but was associated with oral candidiasis (predominantly mild or moderate as recorded by the investigator). Longer and larger trials are required to determine the comparative effect and risks of interleukin-17 inhibitors in psoriasis.

DOI: 10.1056/NEJMoa2102383

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2102383