Anti-interleukin-17A monoclonal antibody secukinumab in treatment of ankylosing spondylitis: a randomised, double-blind, placebo-controlled trial

塞库金单抗 医学 强直性脊柱炎 安慰剂 临床终点 内科学 不利影响 临床试验 关节炎 银屑病性关节炎 病理 替代医学
作者
Dominique Baeten,Xenofon Baraliakos,Jürgen Braun,Joachim Sieper,Paul Emery,Désirée van der Heijde,Iain B. McInnes,Jacob M van Laar,Robert Landewé,P Wordsworth,J. Wollenhaupt,Herbert Kellner,Jacqueline E Paramarta,Jiawei Wei,Arndt Brachat,Stephan Bek,Didier Laurent,Yali Li,Ying A. Wang,Arthur P. Bertolino,Sandro Gsteiger,A. Wright,Wolfgang Hueber
出处
期刊:The Lancet [Elsevier]
卷期号:382 (9906): 1705-1713 被引量:511
标识
DOI:10.1016/s0140-6736(13)61134-4
摘要

Background Ankylosing spondylitis is a chronic immune-mediated inflammatory disease characterised by spinal inflammation, progressive spinal rigidity, and peripheral arthritis. Interleukin 17 (IL-17) is thought to be a key inflammatory cytokine in the development of ankylosing spondylitis, the prototypical form of spondyloarthritis. We assessed the efficacy and safety of the anti-IL-17A monoclonal antibody secukinumab in treating patients with active ankylosing spondylitis. Methods We did a randomised double-blind proof-of-concept study at eight centres in Europe (four in Germany, two in the Netherlands, and two in the UK). Patients aged 18–65 years were randomly assigned (in a 4:1 ratio) to either intravenous secukinumab (2×10 mg/kg) or placebo, given 3 weeks apart. Randomisation was done with a computer-generated block randomisation list without a stratification process. The primary efficacy endpoint was the percentage of patients with a 20% response according to the Assessment of SpondyloArthritis international Society criteria for improvement (ASAS20) at week 6 (Bayesian analysis). Safety was assessed up to week 28. This study is registered with ClinicalTrials.gov, number NCT00809159. Findings 37 patients with moderate-to-severe ankylosing spondylitis were screened, and 30 were randomly assigned to receive either intravenous secukinumab (n=24) or placebo (n=6). The final efficacy analysis included 23 patients receiving secukinumab and six patients receiving placebo, and the safety analysis included all 30 patients. At week 6, ASAS20 response estimates were 59% on secukinumab versus 24% on placebo (99·8% probability that secukinumab is superior to placebo). One serious adverse event (subcutaneous abscess caused by Staphylococcus aureus) occurred in the secukinumab-treated group. Interpretation Secukinumab rapidly reduced clinical or biological signs of active ankylosing spondylitis and was well tolerated. It is the first targeted therapy that we know of that is an alternative to tumour necrosis factor inhibition to reach its primary endpoint in a phase 2 trial. Funding Novartis.
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