Abstract
Secukinumab (Cosentyx®) is a fully human monoclonal antibody against the proinflammatory cytokine interleukin-17A. It is the first drug in its class to be approved for use in patients with active ankylosing spondylitis (AS). This article reviews the efficacy and tolerability of secukinumab in this indication and briefly summarizes its pharmacology. In ongoing phase III trials, 16 weeks’ treatment with subcutaneous secukinumab 150 mg was effective in terms of improving the clinical signs and symptoms of disease and health-related quality of life in patients with AS, with these improvements maintained during longer-term (up to 2 years) treatment. In subgroup analyses, secukinumab was effective both in tumour necrosis factor (TNF) inhibitor-naïve patients and in patients intolerant of or refractory to TNF inhibitors. Secukinumab was generally well tolerated, with a tolerability profile consistent with that seen previously in patients with plaque psoriasis. In the absence of head-to-head trials, the position of secukinumab with respect to TNF inhibitors remains to be fully determined. Nevertheless, secukinumab is an effective and generally well tolerated treatment option for patients with AS.
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References
Braun J, Sieper J. Ankylosing spondylitis. Lancet. 2007;369(9570):1379–90.
Ward MM, Deodhar A, Akl EA, et al. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2015;68(2):282–98.
Braun J, van den Berg R, Baraliakos X, et al. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2011;70(6):896–904.
Kiltz U, Heldmann F, Baraliakos X, et al. Treatment of ankylosing spondylitis in patients refractory to TNF-inhibition: are there alternatives? Curr Opin Rheumatol. 2012;24(3):252–60.
Patel DD, Lee DM, Kolbinger F, et al. Effect of IL-17A blockade with secukinumab in autoimmune diseases. Ann Rheum Dis. 2013;72(Suppl 2):ii116–23.
Toussirot E. The IL23/Th17 pathway as a therapeutic target in chronic inflammatory diseases. Inflamm Allergy Drug Targets. 2012;11(2):159–68.
Mei Y, Pan F, Gao J, et al. Increased serum IL-17 and IL-23 in the patient with ankylosing spondylitis. Clin Rheumatol. 2011;30(2):269–73.
Garnock-Jones KP. Secukinumab: a review in moderate to severe plaque psoriasis. Am J Clin Dermatol. 2015;16(4):323–30.
Shirley M. Secukinumab: a review in psoriatic arthritis. Drugs. 2016 (In press).
Novartis. COSENTYX® (secukinumab) injection, for subcutaneous use: prescribing information. 2016. http://www.accessdata.fda.gov. Accessed 25 May 2016.
Novartis Europharm Limited. Cosentyx: summary of product characteristics. 2016. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124. Accessed 25 May 2016.
Baeten D, Baraliakos X, Braun J, et al. Anti-interleukin-17A monoclonal antibody secukinumab in treatment of ankylosing spondylitis: a randomised, double-blind, placebo-controlled trial. Lancet. 2013;382(9906):1705–13.
Baraliakos X, Borah B, Braun J, et al. Long-term effects of secukinumab on MRI findings in relation to clinical efficacy in subjects with active ankylosing spondylitis: an observational study. Ann Rheum Dis. 2015;75(2):408–12.
European Medicines Agency. Assessment report EMA/CHMP/665405/2015: Cosentyx (secukinumab). 2015. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/003729/WC500199574.pdf. Accessed 25 May 2016.
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.
Kivitz A, Blanco R, Maradiaga M, et al. Secukinumab reduces signs and symptoms of active ankylosing spondylitis: results from a 16-week, randomised, placebo-controlled phase 3 trial [abstract no. 3287319]. J Clin Rheumatol. 2016;22(3):141.
US National Institutes of Health. ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov. Accessed 25 May 2016.
Baeten D, Blanco R, Geusens P, et al. Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis in anti-TNF-naive patients and those previously exposed to anti-TNF therapy: 52-week results from two randomized, double-blind, placebo-controlled phase 3 trials [abstract no. 2890]. Arthritis Rheumatol. 2015;67(Suppl 10):3482–4.
Sieper J, Braun J, Baraliakos X, et al. Secukinumab efficacy in anti-TNF-naive patients and patients previously exposed to anti-TNF therapy: results of a randomized, double-blind, placebo-controlled phase 3 study (MEASURE 2) in active ankylosing spondylitis [abstract no. THU0210]. Ann Rheum Dis. 2015;74(Suppl 2):272.
Wei J, Baeten D, Sieper J, et al. Secukinumab improves signs and symptoms of active ankylosing spondylitis in Asian patients: pooled results from two phase 3 trials [abstract no. APL15-0425]. Int J Rheum Dis. 2015;18(Suppl 1):25.
Baeten D, Braun J, Sieper J, et al. Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis: 2-year efficacy and safety results from a phase 3, randomized, double-blind, placebo-controlled trial [abstract no. 2896]. Arthritis Rheumatol. 2015;67(Suppl 10):3490–2.
Baraliakos X, Braun J, Sieper J, et al. Secukinumab reduces sacroiliac joint and spinal inflammation in patients with ankylosing spondylitis: MRI data from a phase 3 randomized, double-blind, placebo-controlled study (MEASURE 1) [abstract no. THU0233]. Ann Rheum Dis. 2015;74(Suppl 2):281.
Baraliakos X, Deodhar AA, Braun J, et al. Effect of interleukin-17A inhibition on spinal radiographic changes through 2 years in patients with active ankylosing spondylitis: results of a phase 3 study with secukinumab [abstract no. 6L]. Arthritis Rheumatol. 2015;67(Suppl 10):3939–41.
Deodhar A, Sieper J, Emery P, et al. Secukinumab significantly improves physical function, quality of life, and work productivity through 52 weeks in subjects with active ankylosing spondylitis in the phase 3 MEASURE 2 study [abstract no. AB0736]. Ann Rheum Dis. 2015;74(Suppl 2):1144.
Deodhar AA, Baeten DL, Braun J, et al. Secukinumab, a monoclonal antibody to interleukin-17A, significantly improves physical function and quality of life in subjects with active ankylosing spondylitis: results of a phase 3 randomized, placebo-controlled trial with intravenous loading and subcutaneous maintenance dosing [abstract no. 538]. Arthritis Rheumatol. 2014;66(Suppl 10):S233–4.
Deodhar AA, Baeten D, Sieper J, et al. Safety and tolerability of secukinumab in patients with active ankylosing spondylitis: pooled safety analysis of two phase 3, randomized, controlled trials [abstract no. 2887]. Arthritis Rheumatol. 2015;67(Suppl 10):3478–9.
Harding FA, Stickler MM, Razo J, et al. The immunogenicity of humanized and fully human antibodies: residual immunogenicity resides in the CDR regions. mAbs. 2010;2(3):256–65.
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During the peer review process, the manufacturer of secukinumab was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
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The preparation of this review was not supported by any external funding.
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Hannah Blair and Sohita Dhillon are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.
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The manuscript was reviewed by: R. Alten, Department of Internal Medicine II, Rheumatology, Clinical Immunology & Osteology, Schlosspark-Klinik Teaching Hospital Charité University Medicine Berlin, Berlin, Germany; S. Appenzeller, Department of Medicine, State University of Campinas, Sao Paulo, Brazil; M. Bergman, Department of Medicine, Drexel University College of Medicine, Philadelphia, PA, USA; M. J. Puszczewicz, Department of Rheumatology and Internal Medicine, Poznan University of Medical Sciences, Poznan, Poland; D. Wendling, Department of Rheumatology, University Teaching Hospital, CHRU de Besancon, Besancon, France.
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Blair, H.A., Dhillon, S. Secukinumab: A Review in Ankylosing Spondylitis. Drugs 76, 1023–1030 (2016). https://doi.org/10.1007/s40265-016-0598-8
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DOI: https://doi.org/10.1007/s40265-016-0598-8