Tufts Medical Center, 800 Washington Street, Boston, MA 02111, USA.
Br J Dermatol. 2011 Sep;165(3):652-60. doi: 10.1111/j.1365-2133.2011.10418.x. Epub 2011 Aug 4.
The anti-interleukin-12/23p40 monoclonal antibody briakinumab has been shown in a phase II study to be effective psoriasis treatment.
The aim of the current study was to assess the efficacy, safety and tolerability of briakinumab compared with etanercept and placebo in patients with moderate to severe chronic plaque psoriasis.
In this phase III, 12-week study (M10-114, NCT00691964), 347 patients were randomized in a 2 : 2 : 1 ratio to receive 200 mg briakinumab at weeks 0 and 4 followed by 100 mg briakinumab at week 8 (n = 138); 50 mg of etanercept twice weekly 3-4 days apart at weeks 0-11 (n = 141); or placebo injections matching active treatment (n = 68). The co-primary efficacy endpoints were the proportion of patients achieving a Physician's Global Assessment (PGA) of 0/1 at week 12, and the proportion of patients achieving a Psoriasis Area and Severity Index (PASI) 75 response at week 12.
Of the briakinumab-treated patients, 71·0% achieved a PGA of 0/1 at week 12 as compared with 39·7% of etanercept-treated patients and 2·9% of placebo-treated patients, (P < 0·001, for both comparisons). Of the briakinumab-treated patients 81·9% achieved a PASI 75 response at week 12 as compared with 56·0% of etanercept-treated and 7·4% of placebo-treated patients (P < 0·001, for both comparisons). Serious adverse event rates were reported in four (2·9%) patients receiving briakinumab, one (0·7%) patient receiving etanercept and one (1·5%) placebo-treated patient.
In patients with moderate to severe psoriasis, briakinumab had superior efficacy to both placebo and etanercept at 12 weeks as administered in this study.
抗白细胞介素-12/23p40 单克隆抗体 briakinumab 在一项 II 期研究中已被证明是有效的银屑病治疗药物。
本研究旨在评估 briakinumab 与依那西普和安慰剂相比，在中度至重度慢性斑块型银屑病患者中的疗效、安全性和耐受性。
在这项为期 12 周的 III 期研究（M10-114，NCT00691964）中，347 名患者以 2:2:1 的比例随机分组，分别接受 200 mg briakinumab 治疗，第 0 周和第 4 周，第 8 周给予 100 mg briakinumab（n=138）；每周 0-11 天给予 50 mg 依那西普，每 3-4 天给药一次（n=141）；或匹配活性治疗的安慰剂注射（n=68）。主要疗效终点为第 12 周时达到医生总体评估（PGA）0/1 的患者比例，以及第 12 周时达到银屑病面积和严重程度指数（PASI）75 反应的患者比例。
接受 briakinumab 治疗的患者中，71.0%在第 12 周时达到 PGA 0/1，而接受依那西普治疗的患者中为 39.7%，接受安慰剂治疗的患者中为 2.9%（均 P<0.001）。在接受 briakinumab 治疗的患者中，81.9%在第 12 周时达到 PASI 75 反应，而接受依那西普治疗的患者中为 56.0%，接受安慰剂治疗的患者中为 7.4%（均 P<0.001）。在接受 briakinumab 治疗的患者中，有 4 例（2.9%）出现严重不良事件，接受依那西普治疗的患者中有 1 例（0.7%），接受安慰剂治疗的患者中有 1 例（1.5%）。
在中度至重度银屑病患者中，与安慰剂和依那西普相比，本研究中使用的 briakinumab 在 12 周时具有更好的疗效。
