Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis: results of a randomised, double-blind, placebo-controlled, proof-of-concept, dose-finding phase 2 study.
Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis: results of a randomised, double-blind, placebo-controlled, proof-of-concept, dose-finding phase 2 study.
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DOI：
10.1136/annrheumdis-2018-213328
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发表时间：
2018-09
影响因子：
27.4
通讯作者：
Padula SJ
中科院分区：
文献类型：
--
作者：
Baeten D;Østergaard M;Wei JC;Sieper J;Järvinen P;Tam LS;Salvarani C;Kim TH;Solinger A;Datsenko Y;Pamulapati C;Visvanathan S;Hall DB;Aslanyan S;Scholl P;Padula SJ
目的：评价人源化单抗risankizumab治疗活动期强直性脊柱炎(AS)的疗效和安全性。有活动期疾病(巴斯强直性脊柱炎疾病活动指数评分为≥4)的159名生物幼稚AS患者被随机(1：1：1：1)服用Risankizumab(单剂18 mg，第1天、第8、16和24周90 mg或180 mg)或安慰剂，为期24周。主要结果是在12周时，国际脊柱性关节炎协会(ASAS40)的评估改善了40%。对接受至少一剂研究药物的患者进行了安全性评估。12周时，18 mg组、90 mg组和180 mg组的ASAS40有效率分别为25.5%、20.5%和15.0%，而安慰剂组为17.5%。180 mg risankizumab组和安慰剂组(主要终点)之间的估计比例差异为-2.5%(95%可信区间-21.8%至17.0%；p=0.42.所有治疗组的不良事件发生率相似。使用risankizumab的治疗没有达到研究的主要终点，也没有证据表明与安慰剂相比，在活动期AS患者中有临床意义的改善，这表明IL-23可能不是AS疾病发病机制和症状的相关驱动因素。NCT02047110；预告。
To evaluate the efficacy and safety of risankizumab, a humanised monoclonal antibody targeting the p19 subunit of interleukin-23 (IL-23), in patients with active ankylosing spondylitis (AS). A total of 159 patients with biological-naïve AS, with active disease (Bath Ankylosing Spondylitis Disease Activity Index score of ≥4), were randomised (1:1:1:1) to risankizumab (18 mg single dose, 90 mg or 180 mg at day 1 and weeks 8, 16 and 24) or placebo over a 24-week blinded period. The primary outcome was a 40% improvement in Assessment in Spondylo Arthritis International Society (ASAS40) at week 12. Safety was assessed in patients who received at least one dose of study drug. At week 12, ASAS40 response rates were 25.5%, 20.5% and 15.0% in the 18 mg, 90 mg and 180 mg risankizumab groups, respectively, compared with 17.5% in the placebo group. The estimated difference in proportion between the 180 mg risankizumab and placebo groups (primary endpoint) was –2.5% (95% CI –21.8 to 17.0; p=0.42). Rates of adverse events were similar in all treatment groups. Treatment with risankizumab did not meet the study primary endpoint and showed no evidence of clinically meaningful improvements compared with placebo in patients with active AS, suggesting that IL-23 may not be a relevant driver of disease pathogenesis and symptoms in AS. NCT02047110; Pre-results.
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影响因子：
158.5
作者：
Baeten, Dominique;Sieper, Joachim;Richards, Hanno B.
通讯作者：
Richards, Hanno B.
DOI：
10.1002/art.21337
发表时间：
2005-08-15
期刊：
ARTHRITIS & RHEUMATISM-ARTHRITIS CARE & RESEARCH
影响因子：
--
作者：
Maksymowych, WP;Inman, RD;Lambert, RGW
通讯作者：
Lambert, RGW
影响因子：
158.5
作者：
Papp, Kim A.;Blauvelt, Andrew;Padula, Steven J.
通讯作者：
Padula, Steven J.
影响因子：
168.9
作者：
Baeten, Dominique;Baraliakos, Xenofon;Hueber, Wolfgang
通讯作者：
Hueber, Wolfgang
DOI：
10.1124/jpet.115.224246
发表时间：
2015-08-01
影响因子：
3.5
作者：
Mangan, Paul R.;Su, Linhui Julie;Salter-Cid, Luisa M.
通讯作者：
Salter-Cid, Luisa M.