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ARD:评估Taltz(ixekizumab)与阿达木单抗治疗银屑病关节炎患者的疗效和安全性

2021-09-07 医路坦克 MedSci原创

IXe较Ada至Wk52同时改善PSA患者的关节和皮肤效果显著。IXe对银屑病有更好的疗效,在肌肉骨骼表现上至少与Ada相当。无论同时使用csDMaRD,IXe疗效都是一致的。

     Ixekizumab(IXE)是一种免疫球蛋白G4单克隆抗体,可选择性抑制IL-17A,其在多个PsA结构域的功效已经建立。尽管许多bDMARDs被批准用于治疗PsA,但没有直接的比较可用于证据为基础的治疗决定。

     该为期52周的试验,比较ixekizumab(IXe)和adalimumab(Ada)对566例银屑病关节炎(PSA)患者(两组平均分布)的美国风湿病学会(ACR)50和银屑病面积和严重程度指数(PASI)100的反应。在Wk24这一主要终点,IXe优于Ada。通过WK52来确定最终的疗效和安全性结果,包括对伴随使用的常规人工合成抗风湿药(CsDMaRD)进行预先指定的亚组分析。

     SPIRIT-H2H是一项WK52多中心、开放标签、盲法评估的研究,将IXe和Ada与PSA进行比较。患者被随机分成1:1的IXe或Ada,根据同时使用csDMaRD和存在中到重度斑块型牛皮癣进行分层。WK24和WK52的预先指定终点包括肌肉骨骼、牛皮癣、生活质量结果、亚组分析和安全性。

  结果:服用IXE和ADA的患者在WK52同时达到ACR50和PASI100(39%vs26%,p<0.001)和PASI100(64%vs41%,p<0.001)的比例明显高于服用ADA的患者。IXE和Ada在WK52的ACR50(49.8%比49.8%,p=0.924)、治疗目标结果、末端炎和指炎消退方面的疗效相似。无论同时使用csDMaRD,对IXe的反应都是一致的。在WK52时,服用IXe单一疗法的患者明显多于接受Ada单一疗法的患者(38%比19%,p=0.007),同时有更多的PASI100反应(66%比35%,p<0.001),而单用IXe的患者比单用Ada的患者同时出现更多的ACR50和PASI100(P=0.007)。IXe或Ada没有新的安全性发现。

结论:IXe较Ada至Wk52同时改善PSA患者的关节和皮肤效果显著。IXe对银屑病有更好的疗效,在肌肉骨骼表现上至少与Ada相当。无论同时使用csDMaRD,IXe疗效都是一致的。

文献来源:  

Smolen JS,  Mease P,  Tahir H,Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52,Ann Rheum Dis 2020 10;79(10)

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    2021-11-06 hjwang88
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    2021-10-29 shizhenshan
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    2022-03-26 snf701207
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    2021-09-09 lmm397
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    2021-09-08 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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