3,155
Views
5
CrossRef citations to date
0
Altmetric
Articles

Clinical efficacy and safety of secukinumab in patients with psoriasis and comorbidities: pooled analysis of 4 phase 3 clinical trials

, , , , , , & show all
Pages 1482-1490 | Received 27 Aug 2020, Accepted 23 Sep 2020, Published online: 21 Oct 2020

References

  • Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029–1072.
  • Carvalho AV, Romiti R, Souza CD, et al. Psoriasis comorbidities: complications and benefits of immunobiological treatment. An Bras Dermatol. 2016;91(6):781–789.
  • Kirby B, Lynch M. Adipokines and psoriasis: the obesity link. Br J Dermatol. 2018;179(2):239.
  • Armstrong AW, Harskamp CT, Armstrong EJ. The association between psoriasis and obesity: a systematic review and meta-analysis of observational studies. Nutr Diabetes. 2012;2:e54.
  • Fleming P, Kraft J, Gulliver WP, et al. The relationship of obesity with the severity of psoriasis: a systematic review. J Cutan Med Surg. 2015;19(5):450–456.
  • Armstrong AW, Harskamp CT, Armstrong EJ. Psoriasis and the risk of diabetes mellitus: a systematic review and meta-analysis. JAMA Dermatol. 2013;149(1):84–91.
  • Brauchli YB, Jick SS, Meier CR. Psoriasis and the risk of incident diabetes mellitus: a population-based study. Br J Dermatol. 2008;159(6):1331–1337.
  • Mehta NN, Azfar RS, Shin DB, et al. Patients with severe psoriasis are at increased risk of cardiovascular mortality: cohort study using the General Practice Research Database. Eur Heart J. 2010;31(8):1000–1006.
  • Gelfand JM, Neimann AL, Shin DB, et al. Risk of myocardial infarction in patients with psoriasis. JAMA. 2006;296(14):1735–1741.
  • Gelfand JM, Dommasch ED, Shin DB, et al. The risk of stroke in patients with psoriasis. J Invest Dermatol. 2009;129(10):2411–2418.
  • Alinaghi F, Calov M, Kristensen LE, et al. Prevalence of psoriatic arthritis in patients with psoriasis: a systematic review and meta-analysis of observational and clinical studies. J Am Acad Dermatol. 2019;80(1):251–265.e19.
  • Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005;64(Suppl. 2):ii14–ii17.
  • Griffiths CE, Reich K, Lebwohl M, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015;386(9993):541–551.
  • 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):326–338.
  • Thaci D, Blauvelt A, Reich K, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol. 2015;73(3):400–409.
  • Gottlieb A, Sullivan J, van Doorn M, et al. Secukinumab shows significant efficacy in palmoplantar psoriasis: results from GESTURE, a randomized controlled trial. J Am Acad Dermatol. 2017;76(1):70–80.
  • Reich K, Sullivan J, Arenberger P, et al. Effect of secukinumab on the clinical activity and disease burden of nail psoriasis: 32-week results from the randomized placebo-controlled TRANSFIGURE trial. Br J Dermatol. 2019;181(5):954–966.
  • Bagel J, Duffin KC, Moore A, et al. The effect of secukinumab on moderate-to-severe scalp psoriasis: results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study. J Am Acad Dermatol. 2017;77(4):667–674.
  • Orbai AM, McInnes IB, Coates LC, et al. Effect of secukinumab on the different GRAPPA-OMERACT core domains in psoriatic arthritis: a pooled analysis of 2049 patients. J Rheumatol. 2020;47(6):854–864.
  • Kivitz AJ, Nash P, Tahir H, et al. Efficacy and safety of subcutaneous secukinumab 150 mg with or without loading regimen in psoriatic arthritis: results from the FUTURE 4 study. Rheumatol Ther. 2019;6(3):393–407.
  • McInnes IB, Mease PJ, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015;386(9999):1137–1146.
  • Mease PJ, McInnes IB, Kirkham B, et al. Secukinumab inhibition of interleukin-17A in patients with psoriatic arthritis. N Engl J Med. 2015;373(14):1329–1339.
  • Nash P, Mease PJ, McInnes IB, et al. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.
  • Marzo-Ortega H, Sieper J, Kivitz A, et al. Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 3-year results from the phase III trial, MEASURE 2. RMD Open. 2017;3(2):e000592.
  • Baeten D, Sieper J, Braun J, et al. Secukinumab, an interleukin-17A inhibitor, in ankylosing spondylitis. N Engl J Med. 2015;373(26):2534–2548.
  • Papp K, Alavi A, Brassard D, et al. Secukinumab treatment results in improvement of disease characteristics in patients with moderate to severe psoriasis: 24 month follow-up data from the PURE registry. J Am Acad Dermatol. 2019;81(4(Suppl. 1)):AB274.
  • Augustin M, Jullien D, Martin A, et al. Real-world evidence of secukinumab in psoriasis treatment – a meta-analysis of 43 studies. J Eur Acad Dermatol Venereol. 2020;34(6):1174–1185.
  • Yiu ZZN, Mason KJ, Hampton PJ, et al. Drug survival of adalimumab, ustekinumab and secukinumab in patients with psoriasis: a prospective cohort study from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR). Br J Dermatol. 2020;183(2):294–302.
  • 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. 2015;172(2):484–493.
  • 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. 2015;29(6):1082–1090.
  • Bissonnette R, Luger T, Thaci D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018;32(9):1507–1514.
  • Baraliakos X, Braun J, Deodhar A, et al. Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study. RMD Open. 2019;5(2):e001005.
  • Deodhar A, Mease PJ, McInnes IB, et al. Long-term safety of secukinumab in patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis: integrated pooled clinical trial and post-marketing surveillance data. Arthritis Res Ther. 2019;21(1):111.
  • Mease PJ, Kavanaugh A, Reimold A, et al. Secukinumab provides sustained improvements in the signs and symptoms in psoriatic arthritis: final 5 year efficacy and safety results from a phase 3 trial. Ann Rheum Dis. 2019;78(Suppl. 2):917. Abstract FRI0451.
  • Al-Mutairi N, Nour T. The effect of weight reduction on treatment outcomes in obese patients with psoriasis on biologic therapy: a randomized controlled prospective trial. Expert Opin Biol Ther. 2014;14(6):749–756.
  • Kaushik SB, Lebwohl MG. CME part I psoriasis: which therapy for which patient: psoriasis comorbidities and preferred systemic agents. J Am Acad Dermatol. 2019;80(1):27–40.
  • Menter A, Gordon KB, Leonardi CL, et al. Efficacy and safety of adalimumab across subgroups of patients with moderate to severe psoriasis. J Am Acad Dermatol. 2010;63(3):448–456.
  • Singh S, Facciorusso A, Singh AG, et al. Obesity and response to anti-tumor necrosis factor-α agents in patients with select immune-mediated inflammatory diseases: a systematic review and meta-analysis. PLoS One. 2018;13(5):e0195123.
  • Papp KA, Langley RG, Lebwohl M, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008;371(9625):1675–1684.
  • Thibodaux RJ, Triche MW, Espinoza LR. Ustekinumab for the treatment of psoriasis and psoriatic arthritis: a drug evaluation and literature review. Expert Opin Biol Ther. 2018;18(7):821–827.
  • Zhu Y, Hu C, Lu M, et al. Population pharmacokinetic modeling of ustekinumab, a human monoclonal antibody targeting IL-12/23p40, in patients with moderate to severe plaque psoriasis. J Clin Pharmacol. 2009;49(2):162–175.
  • Naldi L, Addis A, Chimenti S, et al. Impact of body mass index and obesity on clinical response to systemic treatment for psoriasis. Evidence from the Psocare project. Dermatology (Basel). 2008;217(4):365–373.
  • Puig L. Obesity and psoriasis: body weight and body mass index influence the response to biological treatment. J Eur Acad Dermatol Venereol. 2011;25(9):1007–1011.
  • Szepietowski J, Rich P, Loeffler J, et al. Secukinumab 300 mg shows superior efficacy across subject body weight groups: pooled analysis of phase 3 ERASURE and FIXTURE trials. J Am Acad Dermatol. 2015;72(5):AB248.
  • Reich K, Puig L, Szepietowski JC, et al. Secukinumab dosing optimization in patients with moderate-to-severe plaque psoriasis: results from the randomized, open-label OPTIMISE study. Br J Dermatol. 2020;182(2):304–315.
  • Lynch M, Ahern T, Sweeney CM, et al. Adipokines, psoriasis, systemic inflammation, and endothelial dysfunction. Int J Dermatol. 2017;56(11):1103–1118.
  • Paller AS, Mercy K, Kwasny MJ, et al. Association of pediatric psoriasis severity with excess and central adiposity: an international cross-sectional study. JAMA Dermatol. 2013;149(2):166–176.
  • Becker L, Tom WL, Eshagh K, et al. Excess adiposity preceding pediatric psoriasis. JAMA Dermatol. 2014;150(5):573–574.
  • Yang YW, Keller JJ, Lin HC. Medical comorbidity associated with psoriasis in adults: a population-based study. Br J Dermatol. 2011;165(5):1037–1043.
  • Yeung H, Takeshita J, Mehta NN, et al. Psoriasis severity and the prevalence of major medical comorbidity: a population-based study. JAMA Dermatol. 2013;149(10):1173–1179.
  • Strober B, Karki C, Mason M, et al. Characterization of disease burden, comorbidities, and treatment use in a large, US-based cohort: results from the Corrona Psoriasis Registry. J Am Acad Dermatol. 2018;78(2):323–332.
  • Strober BE, Germino R, Guana A, et al. US real-world effectiveness of secukinumab for the treatment of psoriasis: 6-month analysis from the Corrona Psoriasis Registry. J Dermatolog Treat. 2020;31(4):333–341.
  • Kaushik SB, Lebwohl MG. CME part II psoriasis: which therapy for which patient: focus on special populations and chronic infections. J Am Acad Dermatol. 2019;80(1):43–53.