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Drugs
Published in: Drugs 3/2015

01-02-2015 | R&D Insight Report

Secukinumab: First Global Approval

Authors: Mark Sanford, Kate McKeage

Published in: Drugs | Issue 3/2015

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Abstract

Secukinumab (Cosentyx™) is a fully human monoclonal antibody against interleukin-17A, formulated for intravenous and subcutaneous administration. It received its first global approval in Japan on 26 December 2014 for the treatment of psoriasis and psoriatic arthritis in adults who are not adequately responding to systemic therapies (except for biologic agents). In the USA and the EU, secukinumab was approved in early 2015 for the treatment of patients with moderate-to-severe plaque psoriasis. Secukinumab is also being investigated in patients with ankylosing spondylitis and rheumatoid arthritis. This article summarizes the milestones in the development of secukinumab leading to its first approval for the treatment of adult patients with psoriasis and psoriatic arthritis.
Literature
1.
2.
3.
4.
5.
6.
Gan EY, Chong WS, Tey HL. Therapeutic strategies in psoriasis patients with psoriatic arthritis: focus on new agents. BioDrugs. 2013;27(4):359–73.CrossRefPubMed
7.
Bruin G, Dragatin C, Aigner B, et al. The anti IL-17A IgG1 antibody distributes in dermal interstitial fluid as demonstrated by using dermal open flow microperfusion after a single 300 mg subcutaneous administration; assessment in healthy volunteers and patients with moderate-to-severe plaque psoriasis. J Invest Dermatol. 2014;134:S18.CrossRef
8.
Chioato A, Noseda E, Stevens M, et al. Treatment with the interleukin-17A-blocking antibody secukinumab does not interfere with the efficacy of influenza and meningococcal vaccinations in healthy subjects: results of an open-label, parallel-group, randomized single-center study. Clin Vaccine Immunol. 2012;19(10):1597–602.CrossRefPubMedCentralPubMed
9.
Rich P, Sigurgeirsson B, Thaci D, et al. Secukinumab induction and maintenance therapy in moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled, phase II regimen-finding study. Br J Dermatol. 2013;168:402–11.CrossRefPubMed
10.
Papp KA, Langley RG, Sigurgeirsson B, et al. Efficacy and safety of secukinumab in the treatment of moderate to severe plaque psoriasis: a randomised, double-blind, placebo-controlled phase II dose-ranging study. Br J Dermatol. 2012;168(2):412–21.CrossRef
11.
Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis: results of two phase 3 trials. N Engl J Med. 2014;371(4):326–38.CrossRefPubMed
12.
Blauvelt A, Prinz JC, Gottlieb AB, et al. Secukinumab administration by pre-filled syringe: efficacy, safety, and usability results from a randomized controlled trial in psoriasis (FEATURE). Br J Dermatol. 2014. doi:10.​1111/​bjd.​13348.
13.
Paul C, Lacour JP, Tedremets L, et al. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2014. doi:10.​1111/​jdv.​12751.
14.
Langley RGB, Feldman SR, Nyirady J, et al. The 5-point Investigator’s Global Assessment (IGA) scale: a modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatolog Treat. 2013. doi:10.​3109/​09546634.​2013.​865009.
15.
Langley RG, Reich K, Papavassilis C, et al. Multiple imputation methodology is reflective of secukinumab efficacy in real clinical practice: data from the FIXTURE and ERASUE studies in moderate to severe plaque psoriasis [abstract plus poster P99]. In: Psoriasis from Gene to Clinic 7th International Congress. 2014.
16.
Kingo K, Sofen H, Pathan R. Secukinumab prefilled syringes demonstrate patient satisfaction: analysis of the Self-Injection Assessment Questionnaire (SIAQ) in the FEATURE study [abstract no. P8137]. In: 72nd Annual Meeting of the American Academy of Dermatology. 2014.
17.
Kreutzer K, Lacour JP, You R. Secukinumab autoinjectors demonstrate patient satisfaction: an analysis of the Self-Injection Assessment Questionnaire (SIAQ) in the JUNCTURE Study [abstract no. P8417]. In: 72nd Annual Meeting of the American Academy of Dermatology. 2014.
18.
Blauvelt A, Gottlieb A, Sigurgeirsson B. Secukinumab efficacy in subjects with moderate-to-severe plaque psoriasis and concomitant psoriatic arthritis: a subanalysis of the ERASURE study [abstract no. P8033]. In: 72nd Annual Meeting of the American Academy of Dermatology. 2014.
19.
Gottlieb A, Langley R, Philipp S, et al. Improvement in psoriasis symptoms and physical functioning with secukinumab compared with placebo and etanercept in subjects with moderate-to-severe plaque psoriasis and psoriatic arthritis: results of a subanalysis from the phase 3 fixture study [abstract no. L7]. Arthritis Rheum. 2013;65(12):3322.
20.
Papp K, Karpov A, Papavassilis C. Secukinumab efficacy in relationship with response to previous biologic psoriasis therapy: a subanalysis from the ERASURE Study [abstract no. P8011]. In: 72nd Annual Meeting of the American Academy of Dermatology. 2014.
21.
Rich P, Karpov A, Papavassilis C. Secukinumab efficacy stratified by body weight: a subanalysis from the ERASURE study [abstract no. P8013]. In: 72nd Annual Meeting of the American Academy of Dermatology. 2014.
22.
Warren R, Guettner A, Morita A, et al. Secukinumab efficacy in subjects with moderate to severe plaque psoriasis: pooled subgroup analyses by patient age of 4 phase 3 clinical studies [abstract no. P7563]. J Am Acad Dermatol. 2014;70(5 Suppl 1):AB186.
23.
Ohtsuki M, Morita A, Abe M, et al. Secukinumab efficacy and safety in Japanese patients with moderate-to-severe plaque psoriasis: subanalysis from ERASURE, a randomized, placebo-controlled, phase 3 study. J Dermatol. 2014;41(12):1039–46.CrossRefPubMed
24.
Thaci D, Humeniuk J, Frambach Y, et al. Secukinumab in moderate-to-severe plaque psoriasis: results from the Secukinumab Trial Analyzing the potential of intravenous administration To Upgrade the REsponse in psoriasis (STATURE) [abstract]. J German Soc Dermatol. 2014;12(Suppl):13.
25.
Mrowietz U, Leonardi C, Girolomoni G, et al. Secukinumab ‘fixed-interval’ versus ‘retreatment-as-needed’ regimen for moderate-to-severe plaque psoriasis: results from the Study Comparing secukinumab Use in Long-term Psoriasis maintenance therapy: fixed regimen versus re-Treatment Upon start of Relapse (SCULPTURE) [abstract]. Aust J Dermatol. 2014;55(Suppl 1):42.
26.
Mease P, McInnes IB, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, improves active psoriatic arthritis and inhibits radiographic progression: efficacy and safety data from a phase 3 randomized, multicenter, double-blind, placebo-controlled study [abstract no. 953]. Arthritis Rheum. 2014;66(Supp. 10):S423–S4.
27.
McInnes IB, Mease PJ, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, improves active psoriatic arthritis: 24-week efficacy and safety data from a phase 3 randomized, multicenter, double-blind, placebo-controlled study using subcutaneous dosing [abstract no. L1]. In: Annual Meeting of the American College of Rheumatology. 2014.
28.
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.CrossRefPubMed
29.
Baeten DL, Braun J, Baraliakos X, et al. Secukinumab, a monoclonal antibody to interleukin-17A, significantly improves signs and symptoms of active ankylosing spondylitis: results of a 52-week phase 3 randomized placebo-controlled trial with intravenous loading and subcutaneous maintenance dosing. [abstract no. 819]. Arthritis Rheum. 2014;66(Suppl 10):S360.
30.
Sieper J, Braun J, Baraliakos X, et al. Secukinumab, a monoclonal antibody to interleukin-17A, significantly improves signs and symptoms of active ankylosing spondylitis: results of a phase 3, randomized, placebo-controlled trial with subcutaneous loading and maintenance dosing. [abstract no. 536]. Arthritis Rheum. 2014;66(Supp. 10):S232.
31.
Genovese MC, Durez P, Richards HB, et al. Efficacy and safety of secukinumab in patients with rheumatoid arthritis: a phase II, dose-finding, double-blind, randomised, placebo controlled study. Ann Rheum Dis. 2012;72(6):863–9.CrossRefPubMed
32.
Durez P, Genovese MC, Richards HB, et al. Secukinumab treatment provides sustained response over one year in patients with rheumatoid arthritis [abstract no. O17]. Rheumatology. 2012;51(Suppl 3):329.
33.
Strand V, Kosinski M, Gnanasakthy A, et al. Secukinumab treatment in rheumatoid arthritis is associated with incremental benefit in the clinical outcomes and HRQoL improvements that exceed minimally important thresholds. Health Qual Life Outcomes. 2014. doi:10.​1186/​1477-7.
34.
Adami S, Beaulieu A, Rahman P, et al. A randomized placebo-controlled phase 2 study to evaluate efficacy, safety and tolerability of two secukinumab loading dose regimens in subjects with active rheumatoid arthritis despite treatment with methotrexate [abstract]. Arthritis Rheum. 2013;65(Suppl 10):S220.
35.
Burmester GR, Durez P, Shestakova G, et al. Association of HLA-DRB1 alleles with clinical responses to the anti-interleukin-17A monoclonal antibody secukinumab in a cohort of patients with active rheumatoid arthritis: an exploratory phase 2 biomarker study [abstract no. 1737]. Arthritis Rheum. 2013;65(Suppl 10):1737.
36.
Dick AD, Tugal-Tutkun I, Foster S, et al. Secukinumab in the treatment of noninfectious uveitis: results of three randomized, controlled clinical trials. Ophthalmology. 2013;120(4):777–87.CrossRefPubMed
37.
Havrdova E, Belova A, Goloborodko A, et al. Sensitivity analysis of a phase IIa study of secukinumab in relapsing remitting multiple sclerosis. Mult Scler. 2013;1:210–1.
38.
Hueber W, Sands BE, Lewitzky S, et al. Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn’s disease: unexpected results of a randomised, double-blind placebo-controlled trial. Gut. 2012;61(12):1693–700.CrossRefPubMed
39.
Matteson EL, Dasgupta B, Schmidt WA, et al. A 2-week single-blind, randomized, 3-arm proof of concept study of the effects of secukinumab (anti-IL17 mAb), canakinumab (anti-IL-1b mAb), or corticosteroids on initial disease activity scores in patients with PMR, followed by an open-label extension to assess safety and effect duration [abstract no. 885]. Arthritis Rheum. 2014;66(Supp. 10):S391–S2.
40.
41.
Philipp S, Escrig C, Papavassilis C, et al. Secukinumab treatment shows a neutral impact on the lipid profile of patients with moderate to severe plaque psoriasis in a dose-ranging study [abstract no. P6508]. In: 71st Annual Meeting of the American Academy of Dermatology. 2013.
42.
Tsai T, Blauvelt A, Karpov A, et al. Evaluation of infections with secukinumab in a pooled analysis of 10 clinical studies of moderate-to-severe plaque psoriasis [abstract no. 193]. J Invest Dermatol. 2014;134:S33.CrossRef
43.
Reich K, Blauvelt A, Armstrong A, et al. Secukinumab, a novel anti-IL-17A antibody, exhibits low immunogenicity during long-term treatment in subjects with psoriasis [abstract plus poster P103]. In: Psoriasis from Gene to Clinic 7th International Congress. 2014.
44.
Novartis. Head-to-head psoriasis study demonstrates superiority of Novartis Cosentyx™ to Stelara® in clearing skin [media release]. 12 Dec 2014. http://​www.​novartis.​com. Accessed 6 Jan 2015.
45.
Griffiths C, Guettner A, Prinz J, et al. Secukinumab safety in subjects with moderate to severe plaque psoriasis: a pooled analysis of neutropenia from 10 clinical studies [abstract no. P8266]. J Am Acad Dermatol. 2014;70(5 Suppl 1):AB188.
46.
Ward N, Guettner A, Sands B, et al. Secukinumab safety and tolerability in subjects with moderate to severe plaque psoriasis: a pooled subgroup analysis of 10 clinical studies evaluating exacerbation of Crohn’s disease [abstract no. P8233]. J Am Acad Dermatol. 2014;70(5 Suppl 1):AB188.
Metadata
Title
Secukinumab: First Global Approval
Authors
Mark Sanford
Kate McKeage
Publication date
01-02-2015
Publisher
Springer International Publishing
Published in
Drugs / Issue 3/2015
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-015-0359-0

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