IFN-α kinoid in systemic lupus erythematosus: results from a phase IIb, randomised, placebo-controlled study
IFN-α kinoid in systemic lupus erythematosus: results from a phase IIb, randomised, placebo-controlled study
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DOI：
10.1136/annrheumdis-2019-216379
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发表时间：
2020-03-01
影响因子：
27.4
通讯作者：
Lucas Tee, Michael
中科院分区：
文献类型：
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作者：
Houssiau, Frederic A.;Thanou, Aikaterini;Lucas Tee, Michael
目的评价干扰素-α激动素(干扰素-K)免疫治疗疫苗在为期36周的IIb期随机、双盲、安慰剂(PBO)对照试验中的疗效和安全性。W36的主要终点是干扰素基因签名的中和和基于BILAG的综合狼疮评估(BICLA)，经强制皮质类固醇(CS)逐渐减少。结果干扰素-K诱导91%的治疗患者中和抗干扰素-α2b血清抗体，降低干扰素基因签名(P
Objective To evaluate the efficacy and safety of the immunotherapeutic vaccine interferon-alpha kinoid (IFN-K) in a 36-week (W) phase IIb, randomised, double-blind, placebo (PBO)-controlled trial in adults with active systemic lupus erythematosus (SLE) despite standard of care.Methods Patients with SLE (185) with moderate to severe disease activity and positive interferon (IFN) gene signature were randomised to receive IFN-K or PBO intramuscular injections (days 0, 7 and 28 and W12 and W24). Coprimary endpoints at W36 were neutralisation of IFN gene signature and the BILAG-Based Composite Lupus Assessment (BICLA) modified by mandatory corticosteroid (CS) tapering.Results IFN-K induced neutralising anti-IFN-alpha 2b serum antibodies in 91% of treated patients and reduced the IFN gene signature (p