Translating Improvements with Ixekizumab in Clinical Trial Outcomes into Clinical Practice: ASAS40, Pain, Fatigue, and Sleep in Ankylosing Spondylitis

Rheumatology and Therapy - Tập 6 Số 3 - Trang 435-450 - 2019
Philip J. Mease1, Jessica A. Walsh2, Xenofon Baraliakos3, Robert D. Inman4, Kurt de Vlam5, James Cheng‐Chung Wei6, Theresa Hunter7, Gaia Gallo7, David Sandoval7, Fangyi Zhao7, Yan Dong7, Rebecca Bolce7, Helena Marzo‐Ortega8
1Division of Rheumatology Clinical Research, University of Washington and Swedish Medical Center, Seattle, WA, USA
2University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, UT, USA
3Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Germany
4Departments of Immunology and Medicine, University Health Network, University of Toronto, Toronto, ON, Canada
5Division of Rheumatology, University Hospitals Leuven, Leuven, Belgium
6Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan
7Eli Lilly and Company, Indianapolis, IN, USA
8NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK

Tóm tắt

Từ khóa


Tài liệu tham khảo

Reveille JD. Epidemiology of spondyloarthritis in North America. Am J Med Sci. 2011;341(4):284–6.

Gran JT, Husby G, Hordvik M. Prevalence of ankylosing spondylitis in males and females in a young middle-aged population of Tromso, Northern Norway. Ann Rheum Dis. 1985;44(6):359–67.

Rudwaleit M, van der Heijde D, Landewe R, et al. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009;68(6):777–83.

Strand V, Singh JA. Patient burden of axial spondyloarthritis. J Clin Rheumatol. 2017;23(7):383–91.

van der Heijde D, Ramiro S, Landewe R, et al. 2016 Update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017;76(6):978–91.

Glintborg B, Ostergaard M, Krogh NS, Dreyer L, Kristensen HL, Hetland ML. Predictors of treatment response and drug continuation in 842 patients with ankylosing spondylitis treated with anti-tumour necrosis factor: results from 8 years’ surveillance in the Danish nationwide DANBIO registry. Ann Rheum Dis. 2010;69(11):2002–8.

Heiberg MS, Koldingsnes W, Mikkelsen K, et al. The comparative one-year performance of anti–tumor necrosis factor alpha drugs in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: results from a longitudinal, observational, multicenter study. Arthritis Rheum. 2008;59(2):234–40.

Inman RD, Davis JC Jr, Heijde D, et al. Efficacy and safety of golimumab in patients with ankylosing spondylitis: results of a randomized, double-blind, placebo-controlled, phase III trial. Arthritis Rheum. 2008;58(11):3402–12.

van der Heijde D, Kivitz A, Schiff MH, et al. Efficacy and safety of adalimumab in patients with ankylosing spondylitis: results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2006;54(7):2136–46.

Dougados M, Baeten D. Spondyloarthritis. Lancet. 2011;377(9783):2127–37.

Yeremenko N, Paramarta JE, Baeten D. The interleukin-23/interleukin-17 immune axis as a promising new target in the treatment of spondyloarthritis. Curr Opin Rheumatol. 2014;26(4):361–70.

Liu L, Lu J, Allan BW, et al. Generation and characterization of ixekizumab, a humanized monoclonal antibody that neutralizes interleukin-17A. J Inflamm Res. 2016;9:39–50.

Deodhar A, Poddubnyy D, Pacheco-Tena C, et al. Efficacy and safety of ixekizumab in the treatment of radiographic axial spondyloarthritis: sixteen-week results of a phase III randomized, double-blind, placebo-controlled trial in patients with prior inadequate response or intolerance to tumor necrosis factor inhibitors. Arthritis Rheumatol. 2019;71(4):599–611.

van der Heijde D, Cheng-Chung Wei J, Dougados M, et al. Ixekizumab, an interleukin-17A antagonist in the treatment of ankylosing spondylitis or radiographic axial spondyloarthritis in patients previously untreated with biological disease-modifying anti-rheumatic drugs (COAST-V): 16 week results of a phase 3 randomised, double-blind, active-controlled and placebo-controlled trial. Lancet. 2018;392(10163):2441–51.

Sieper J, Rudwaleit M, Baraliakos X, et al. The Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis. 2009;68(Suppl 2):ii1–44.v.

Baeten D, Sieper J, Braun J, et al. Secukinumab, an interleukin-17A inhibitor, in ankylosing spondylitis. N Engl J Med. 2015;373(26):2534–48.

Davis JC, van der Heijde DM, Braun J, et al. Sustained durability and tolerability of etanercept in ankylosing spondylitis for 96 weeks. Ann Rheum Dis. 2005;64(11):1557–62.

Lambert RG, Salonen D, Rahman P, et al. Adalimumab significantly reduces both spinal and sacroiliac joint inflammation in patients with ankylosing spondylitis: a multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2007;56(12):4005–14.

van der Heijde D, Dougados M, Landewe R, et al. Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpA. Rheumatology (Oxford). 2017;56(9):1498–509.

van der Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum. 1984;27(4):361–8.

Machado PM, Landewé R, van der Heijde D. Ankylosing Spondylitis Disease Activity Score (ASDAS): 2018 update of the nomenclature for disease activity states. Ann Rheum Dis. 2018;77:1539–40.

Naegeli AN, Flood E, Tucker J, Devlen J, Edson-Heredia E. The patient experience with fatigue and content validity of a measure to assess fatigue severity: qualitative research in patients with ankylosing spondylitis (AS). Health Qual Life Outcomes. 2013;11:192.

Deodhar A, Braun J, Inman RD, et al. Golimumab reduces sleep disturbance in patients with active ankylosing spondylitis: results from a randomized, placebo-controlled trial. Arthritis Care Res (Hoboken). 2010;62(9):1266–71.

Helman CG. Disease versus illness in general practice. J R Coll Gen Pract. 1981;31(230):548–52.