Long-term effects of secukinumab on MRI findings in relation to clinical efficacy in subjects with active ankylosing spondylitis: an observational study

被引:70
作者
Baraliakos, Xenofon [1 ]
Borah, Babul [2 ]
Braun, Juergen [1 ]
Baeten, Dominique [3 ]
Laurent, Didier [4 ]
Sieper, Joachim [5 ]
Emery, Paul [6 ,7 ]
McInnes, Iain B. [8 ]
van Laar, Jacob M. [9 ]
Wordsworth, Paul [10 ]
Wollenhaupt, Juergen [11 ]
Kellner, Herbert [12 ]
Colin, Laurence [4 ]
Vandenhende, Francois [13 ]
Radford, Kath [4 ]
Hueber, Wolfgang [4 ]
机构
[1] Rheumazentrum Ruhrgebiet, Claudiusstr 45, D-44649 Herne, Germany
[2] Novartis Inst BioMed Res, Cambridge, MA USA
[3] Univ Amsterdam, Amsterdam, Netherlands
[4] Novartis Inst BioMed Res, Basel, Switzerland
[5] Charite Campus Benjamin Franklin, Berlin, Germany
[6] Univ Leeds, Leeds Inst Rheumat & Musculoskeletal Med, Leeds, W Yorkshire, England
[7] Leeds Teaching Hosp NHS Trust, NIHR Leeds Musculoskeletal Biomed Res Unit, Leeds, W Yorkshire, England
[8] Univ Glasgow, Glasgow, Lanark, Scotland
[9] Newcastle Univ, Newcastle Upon Tyne NE1 7RU, Tyne & Wear, England
[10] Nuffield Orthopaed Ctr, NIHR Oxford Comprehens Biomed Res Ctr, Oxford OX3 7LD, England
[11] Schoen Klin Hamburg, Hamburg, Germany
[12] Ctr Inflammatory Joint Dis, Munich, Germany
[13] ClinBAY, Genappe, Belgium
关键词
RESONANCE-IMAGING EXAMINATIONS; NECROSIS FACTOR AGENTS; SPINAL INFLAMMATION; DOUBLE-BLIND; SPONDYLARTHRITIS; MULTICENTER; INFLIXIMAB; CRITERIA; THERAPY;
D O I
10.1136/annrheumdis-2015-207544
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
Introduction A 28-week study suggested efficacy of the anti-interleukin-17A monoclonal antibody secukinumab in active ankylosing spondylitis (AS). MRI-assessed inflammation was reduced at weeks 6, 28. Objective To analyse the longer-term effects of secukinumab on MRI inflammatory and non inflammatory spinal lesions in relation to its clinical efficacy in subjects with active AS. Methods Spinal MRI results (baseline, week 94) for 13 subjects with AS initially treated with secukinumab 2x10 mg/kg intravenously (n=10) or placebo (n=3) and receiving a secukinumab maintenance dose of 3 mg/kg IV every 4 weeks up to week 94 were evaluated by the Berlin score; inflammatory/non-inflammatory (fatty) changes were assessed at vertebral edges (VEs). Results were compared with clinical outcomes. Results Most of the 13 subjects assessed at week 94 had sustained clinical responses: 8 (62%) achieved Assessment of SpondyloArthritis international Society 20% (ASAS20), including 6 (46%) achieving ASAS40 responses, corresponding to 75% and 83% reductions in the Berlin score, respectively. In the 10 subjects treated with secukinumab throughout the study period, 79/91 (87%) inflammatory VEs at baseline resolved by week 94; new fatty lesions occurred in 39/796 (4.9%) of VEs; 87/124 (70%) VEs with fatty lesions at baseline remained unchanged; 30% were no longer visible. Conclusions In this pilot study, secukinumab treatment up to 2 years yielded sustained clinical improvement accompanied by regression of spinal inflammation. The impact of secukinumab on the development of fatty changes and bone formation in AS will be assessed in larger trials.
引用
收藏
页码:408 / 412
页数:5
相关论文
共 17 条
[1]
Anti-interleukin-17A monoclonal antibody secukinumab in treatment of ankylosing spondylitis: a randomised, double-blind, placebo-controlled trial [J].
Baeten, Dominique ;
Baraliakos, Xenofon ;
Braun, Juergen ;
Sieper, Joachim ;
Emery, Paul ;
van der Heijde, Desiree ;
McInnes, Iain ;
van Laar, Jacob M. ;
Landewe, Robert ;
Wordsworth, Paul ;
Wollenhaupt, Juergen ;
Kellner, Herbert ;
Paramarta, Jacqueline ;
Wei, Jiawei ;
Brachat, Arndt ;
Bek, Stephan ;
Laurent, Didier ;
Li, Yali ;
Wang, Ying A. ;
Bertolino, Arthur P. ;
Gsteiger, Sandro ;
Wright, Andrew M. ;
Hueber, Wolfgang .
LANCET, 2013, 382 (9906) :1705-1713
[2]
Magnetic resonance imaging examinations of the spine in patients with Ankylosing spondylitis before and after therapy with the tumor necrosis factor α receptor fusion protein etanercept [J].
Baraliakos, X ;
Davis, J ;
Tsuji, W ;
Braun, J .
ARTHRITIS AND RHEUMATISM, 2005, 52 (04) :1216-1223
[3]
Which spinal lesions are associated with new bone formation in patients with ankylosing spondylitis treated with anti-TNF agents? A long-term observational study using MRI and conventional radiography [J].
Baraliakos, X. ;
Heldmann, F. ;
Callhoff, J. ;
Listing, J. ;
Appelboom, T. ;
Brandt, J. ;
Van den Bosch, F. ;
Breban, M. ;
Burmester, G. R. ;
Dougados, M. ;
Emery, P. ;
Gaston, H. ;
Grunke, M. ;
Van Der Horst-Bruinsma, I. E. ;
Landewe, R. ;
Leirisalo-Repo, M. ;
Sieper, J. ;
De Vlam, K. ;
Pappas, D. ;
Kiltz, U. ;
Van Der Heijde, D. ;
Braun, J. .
ANNALS OF THE RHEUMATIC DISEASES, 2014, 73 (10) :1819-1825
[4]
Baraliakos X, 2013, ARTHRITIS RHEUM-US, V65, pS768
[5]
The relationship between inflammation and new bone formation in patients with ankylosing spondylitis [J].
Baraliakos, Xenofon ;
Listing, Joachim ;
Rudwaleit, Martin ;
Sieper, Joachim ;
Braun, Juergen .
ARTHRITIS RESEARCH & THERAPY, 2008, 10 (05)
[6]
The fatty Romanus lesion: a non-inflammatory spinal MRI lesion specific for axial spondyloarthropathy [J].
Bennett, A. N. ;
Rehman, A. ;
Hensor, E. M. A. ;
Marzo-Ortega, H. ;
Emery, P. ;
McGonagle, D. .
ANNALS OF THE RHEUMATIC DISEASES, 2010, 69 (05) :891-894
[7]
Major reduction in spinal inflammation in patients with ankylosing spondylitis after treatment with infliximab -: Results of a multicenter, randomized, double-blind, placebo-controlled magnetic resonance imaging study [J].
Braun, J ;
Landewé, R ;
Hermann, KGA ;
Han, J ;
Yan, S ;
Williamson, P ;
van der Heijde, D .
ARTHRITIS AND RHEUMATISM, 2006, 54 (05) :1646-1652
[8]
International ASAS consensus statement for the use of anti-tumour necrosis factor agents in patients with ankylosing spondylitis [J].
Braun, J ;
Pham, T ;
Sieper, J ;
Davis, J ;
van der Linden, S ;
Dougados, M ;
van der Heijde, D .
ANNALS OF THE RHEUMATIC DISEASES, 2003, 62 (09) :817-824
[9]
Magnetic resonance imaging examinations of the spine in patients with ankylosing spondylitis, before and after successful therapy with infliximab - Evaluation of a new scoring system [J].
Braun, J ;
Baraliakos, X ;
Golder, W ;
Brandt, J ;
Rudwaleit, M ;
Listing, J ;
Bolow, M ;
Sieper, J ;
van der Heijde, D .
ARTHRITIS AND RHEUMATISM, 2003, 48 (04) :1126-1136
[10]
Golimumab reduces spinal inflammation in ankylosing spondylitis: MRI results of the randomised, placebo- controlled GO-RAISE study [J].
Braun, Juergen ;
Baraliakos, Xenofon ;
Hermann, Kay-Geert A. ;
van der Heijde, Desiree ;
Inman, Robert D. ;
Deodhar, Atul A. ;
Baratelle, Anna ;
Xu, Stephen ;
Xu, Weichun ;
Hsu, Benjamin .
ANNALS OF THE RHEUMATIC DISEASES, 2012, 71 (06) :878-884