Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis
Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis
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DOI：
10.1056/nejmoa1607017
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发表时间：
2017-04-20
影响因子：
158.5
通讯作者：
Padula, Steven J.
中科院分区：
文献类型：
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作者：
Papp, Kim A.;Blauvelt, Andrew;Padula, Steven J.
背景白介素-23被认为是银屑病发病的关键。我们比较了risankizumab (BI 655066)（一种人源化IgG1单克隆抗体，通过特异性靶向p19亚基抑制白介素-23信号传导，从而阻止白介素-23信号传导）和ustekinumab（白介素-12和白介素-23抑制剂）在中重度斑块型银屑病患者中的应用。方法：我们随机分配共166例患者接受皮下注射利桑单抗（在第0周注射18mg单剂量，或在第0、4和16周注射90mg或180mg单剂量）或ustekinumab（根据体重，在第0、4和16周注射45mg或90mg）。主要终点是第12周时银屑病面积和严重程度指数（PASI）评分较基线降低90%或更高。结果在第12周，利桑单抗组（90 mg和180 mg组，合并）PASI评分降低90%以上的患者比例为77%（83例患者中64例），而ustekinumab组（40例患者中16例）为40%（40例患者中16例）
BACKGROUNDInterleukin-23 is thought to be critical to the pathogenesis of psoriasis. We compared risankizumab (BI 655066), a humanized IgG1 monoclonal antibody that inhibits interleukin-23 by specifically targeting the p19 subunit and thus prevents interleukin-23 signaling, and ustekinumab, an interleukin-12 and interleukin-23 inhibitor, in patients with moderate-to-severe plaque psoriasis.METHODSWe randomly assigned a total of 166 patients to receive subcutaneous injections of risankizumab (a single 18-mg dose at week 0 or 90-mg or 180-mg doses at weeks 0, 4, and 16) or ustekinumab (45 or 90 mg, according to body weight, at weeks 0, 4, and 16). The primary end point was a 90% or greater reduction from baseline in the Psoriasis Area and Severity Index (PASI) score at week 12.RESULTSAt week 12, the percentage of patients with a 90% or greater reduction in the PASI score was 77% (64 of 83 patients) for risankizumab (90-mg and 180-mg groups, pooled), as compared with 40% (16 of 40 patients) for ustekinumab (P