OBJECTIVE: The primary outcome was to evaluate the effect of 300 mg secukinumab in achieving MDA in patients with psoriasis and identify the most useful criteria to define MDA in such patients. The secondary outcome was to identify clinical factors influencing MDA.
METHODS: In this post hoc analysis of the SUPREME study, in which 433 patients were enrolled, MDA was assessed using established criteria: ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) and Dermatology Life Quality Index 0/1 (MDA-1), PASI score ≤1 or body surface area (BSA) <3% (MDA-2), or Investigator Global Assessment x BSA (MDA-1a and MDA-2a), for which cut-off values were obtained in patients achieving MDA-1 and MDA-2, respectively.
RESULTS: After 16 weeks of secukinumab, 65% and 76% of the evaluable population achieved MDA-1 and MDA-2, respectively; at Week 24, this was 70% and 83%. Factors that positively influenced MDA at Week 16 were younger age, lower weight and body mass index, absence of depression and anxiety, and lower serum levels of complement C3 and high-sensitivity C-reactive protein. MDA-1a and MDA-2a were achieved by 64% and 74% of patients at Week 16 and by 70% and 81% at Week 24, respectively.
CONCLUSIONS: Patients treated with secukinumab achieved high levels of MDA at Weeks 16 and 24, regardless of the method used to calculate MDA.
目的:主要结果是评估300mg苏金单抗在银屑病患者中实现MDA的作用,并确定在此类患者中定义MDA的最有用标准。次要结果是确定影响MDA的临床因素。
方法:在对SUPREME研究的事后分析中,其中433名患者入组,使用既定标准评估MDA:银屑病面积和严重程度指数(PASI90)和皮肤病生活质量指数0/1(MDA-1)改善≥90%,PASI评分≤1或体表面积(BSA)<3%(MDA-2),或研究者全球评估xBSA(MDA-1a和MDA-2a),分别在获得MDA-1和MDA-2的患者中获得了临界值。
结果:苏金单抗16周后,65%和76%的可评价群体分别获得MDA-1和MDA-2;在第24周,这是70%和83%。在第16周时对MDA有积极影响的因素是年龄较小,较低的体重和体重指数,没有抑郁和焦虑,并降低血清补体C3和高敏C反应蛋白水平。MDA-1a和MDA-2a在第16周分别有64%和74%的患者和在第24周分别有70%和81%的患者。
结论:无论用于计算MDA的方法如何,接受苏金单抗治疗的患者在第16周和第24周都达到了高水平的MDA。