Advertisement

Drugs

, Volume 76, Issue 10, pp 1023–1030 | Cite as

Secukinumab: A Review in Ankylosing Spondylitis

  • Hannah A. BlairEmail author
  • Sohita Dhillon
Adis Drug Evaluation

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.

Keywords

Ankylose Spondylitis Minimum Clinically Important Difference Tumour Necrosis Factor Inhibitor Plaque Psoriasis Bath Ankylose Spondylitis Disease Activity Index 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

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.

Compliance with Ethical Standards

Funding

The preparation of this review was not supported by any external funding.

Conflict of interest

Hannah Blair and Sohita Dhillon are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.

References

  1. 1.
    Braun J, Sieper J. Ankylosing spondylitis. Lancet. 2007;369(9570):1379–90.CrossRefPubMedGoogle Scholar
  2. 2.
    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.CrossRefPubMedGoogle Scholar
  3. 3.
    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.CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    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.CrossRefPubMedGoogle Scholar
  5. 5.
    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.Google Scholar
  6. 6.
    Toussirot E. The IL23/Th17 pathway as a therapeutic target in chronic inflammatory diseases. Inflamm Allergy Drug Targets. 2012;11(2):159–68.CrossRefPubMedGoogle Scholar
  7. 7.
    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.CrossRefPubMedGoogle Scholar
  8. 8.
    Garnock-Jones KP. Secukinumab: a review in moderate to severe plaque psoriasis. Am J Clin Dermatol. 2015;16(4):323–30.CrossRefPubMedGoogle Scholar
  9. 9.
    Shirley M. Secukinumab: a review in psoriatic arthritis. Drugs. 2016 (In press).Google Scholar
  10. 10.
    Novartis. COSENTYX® (secukinumab) injection, for subcutaneous use: prescribing information. 2016. http://www.accessdata.fda.gov. Accessed 25 May 2016.
  11. 11.
    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.
  12. 12.
    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.CrossRefPubMedGoogle Scholar
  13. 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.CrossRefPubMedGoogle Scholar
  14. 14.
    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.
  15. 15.
    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.CrossRefPubMedGoogle Scholar
  16. 16.
    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.Google Scholar
  17. 17.
    US National Institutes of Health. ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov. Accessed 25 May 2016.
  18. 18.
    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.Google Scholar
  19. 19.
    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.CrossRefGoogle Scholar
  20. 20.
    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.Google Scholar
  21. 21.
    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.Google Scholar
  22. 22.
    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.CrossRefGoogle Scholar
  23. 23.
    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.Google Scholar
  24. 24.
    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.Google Scholar
  25. 25.
    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.Google Scholar
  26. 26.
    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.Google Scholar
  27. 27.
    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.Google Scholar

Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  1. 1.SpringerAucklandNew Zealand

Personalised recommendations