Impact of secukinumab on patient-reported outcomes in moderate to severe plaque psoriasis: a review of clinical studies

References

• Parisi R, Symmons DP, Griffiths CE, et al. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013;133:377–385.
   PubMed Web of Science ®Google Scholar
• Griffiths CE, Barker JN. Pathogenesis and clinical features of psoriasis. Lancet. 2007;370:263–271.
   PubMed Web of Science ®Google Scholar
• Lande R, Botti E, Jandus C, et al. The antimicrobial peptide LL37 is a T-cell autoantigen in psoriasis. Nat Commun. 2014;5:5621.
   PubMed Web of Science ®Google Scholar
• Campa M, Mansouri B, Warren R, et al. A review of biologic therapies targeting IL-23 and IL-17 for use in moderate-to-severe plaque psoriasis. Dermatol Ther (Heidelb). 2016;6:1–12.
   PubMed Web of Science ®Google Scholar
• Greb JE, Goldminz AM, Elder JT, et al. Psoriasis. Nat Rev Dis Primers. 2016;2:16082.
   PubMed Web of Science ®Google Scholar
• Krueger JG, Wharton KA Jr., Schlitt T, et al. IL-17A inhibition by secukinumab induces early clinical, histopathologic, and molecular resolution of psoriasis. J Allergy Clin Immunol. 2019;144:750–763.
   PubMed Web of Science ®Google Scholar
• Miossec P, Kolls JK. Targeting IL-17 and TH17 cells in chronic inflammation. Nat Rev Drug Discov. 2012;11:763–776.
   PubMed Web of Science ®Google Scholar
• Keijsers RR, Joosten I, van Erp PE, et al. Cellular sources of IL-17 in psoriasis: a paradigm shift? Exp Dermatol. 2014;23:799–803.
   PubMed Web of Science ®Google Scholar
• Lynde CW, Poulin Y, Vender R, et al. Interleukin 17A: toward a new understanding of psoriasis pathogenesis. J Am Acad Dermatol. 2014;71(1):141–150. .
   PubMed Web of Science ®Google Scholar
• Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009;361(5):496–509.
   PubMed Web of Science ®Google Scholar
• Garzorz-Stark N, Psoriasis Pathogenesis: EK. Keratinocytes are back in the spotlight. J Invest Dermatol. 2019;139:995–996.
   PubMed Web of Science ®Google Scholar
• Gaffen SL, Jain R, Garg AV, et al. The IL-23-IL-17 immune axis: from mechanisms to therapeutic testing. Nat Rev Immunol. 2014;14:585–600.
   PubMed Web of Science ®Google Scholar
• Hreggvidsdottir HS, Noordenbos T, Baeten DL. Inflammatory pathways in spondyloarthritis. Mol Immunol. 2014;57:28–37.
   PubMed Web of Science ®Google Scholar
• Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends Pharmacol Sci. 2009;30:95–103.
   PubMed Web of Science ®Google Scholar
• Finlay AY, Khan GK. Dermatology life quality index (DLQI)–a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19:210–216.
   PubMed Web of Science ®Google Scholar
• Puig L. PASI90 response: the new standard in therapeutic efficacy for psoriasis. J Eur Acad Dermatol Venereol. 2015;29:645–648.
   PubMed Web of Science ®Google Scholar
• 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;32:1507–1514.
   PubMed Web of Science ®Google Scholar
• Blauvelt A, Reich K, Tsai TF, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: results from the CLEAR study. J Am Acad Dermatol. 2017;76:60–9 e9.
   PubMed Web of Science ®Google Scholar
• Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis–results of two phase 3 trials. N Engl J Med. 2014;371:326–338.
   PubMed Web of Science ®Google Scholar
• 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;77:667–674.
   PubMed Web of Science ®Google Scholar
• 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;181:954–966.
   PubMed Web of Science ®Google Scholar
• 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;76:70–80.
   PubMed Web of Science ®Google Scholar
• Reich K, Sullivan J, Arenberger P, et al. Secukinumab shows high and sustained efficacy in nail psoriasis: 2.5-year results from the randomized placebo-controlled TRANSFIGURE study. Br J Dermatol. 2020. Accepted Author Manuscript. https://doi.org/https://doi.org/10.1111/bjd.19262
   Web of Science ®Google Scholar
• Huang YYM, Ruth JS, Hsu S. Loss of efficacy of secukinumab for psoriasis at 24 to 32 weeks. J Am Acad Dermatol. 2016;75:e169.
   PubMed Web of Science ®Google Scholar
• Egeberg A, Bryld LE, Skov L. Drug survival of secukinumab and ixekizumab for moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2019;81:173–178.
   PubMed Web of Science ®Google Scholar
• D’Adamio S, Silvaggio D, Lombardo P, et al. The safety of anti-interleukins monoclonal antibodies for the treatment of psoriasis. Expert Opin Drug Saf. 2019;18:1031–1041.
   PubMed Web of Science ®Google Scholar
• Fobelo Lozano MJ, Serrano Gimenez R, Castro Fernandez M. Emergence of inflammatory bowel disease during treatment with secukinumab. J Crohns Colitis. 2018;12:1131–1133.
   PubMed Web of Science ®Google Scholar
• Secukinumab, summary of product characteristics. [cited 2020 Oct 24] Available from: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf.
   Google Scholar
• Patient-reported outcome measures: use in medical product development to support labeling claims. U.S. food and drug administration. [published 2019 Oct 17; cited 2020 Mar 16]. Available from: http://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims.
   Google Scholar
• Atherton PJ, Sloan JA. Rising importance of patient-reported outcomes. Lancet Oncol. 2006;7:883–884.
   PubMed Web of Science ®Google Scholar
• Snyder CF, Aaronson NK. Use of patient-reported outcomes in clinical practice. Lancet. 2009;374:369–370.
   PubMed Web of Science ®Google Scholar
• Kingsley C, Patel S. Patient-reported outcome measures and patient-reported experience measures. BJA Educ. 2017;17:137–144.
   Web of Science ®Google Scholar
• Franklin P, Chenok K, Lavalee D, et al. Framework to guide the collection and use of patient-reported outcome measures in the learning healthcare system. EGEMS (Wash DC). 2017;5:17.
   PubMedGoogle Scholar
• Field J, Holmes MM, Newell D. PROMs data: can it be used to make decisions for individual patients? A narrative review. Patient Relat Outcome Meas. 2019;10:233–241.
   PubMed Web of Science ®Google Scholar
• Ferreira BI, Abreu JL, Reis JP, et al. Psoriasis and associated psychiatric disorders: a systematic review on etiopathogenesis and clinical correlation. J Clin Aesthet Dermatol. 2016;9:36–43.
   PubMedGoogle Scholar
• Kimball AB, Jacobson C, Weiss S, et al. The psychosocial burden of psoriasis. Am J Clin Dermatol. 2005;6:383–392.
   PubMed Web of Science ®Google Scholar
• Taylor WJ, Mease PJ, Adebajo A, et al. Effect of psoriatic arthritis according to the affected categories of the international classification of functioning, disability and health. J Rheumatol. 2010;37:1885–1891.
   PubMed Web of Science ®Google Scholar
• Mrowietz U, Leonardi CL, Girolomoni G, et al. Secukinumab retreatment-as-needed versus fixed-interval maintenance regimen for moderate to severe plaque psoriasis: a randomized, double-blind, noninferiority trial (SCULPTURE). J Am Acad Dermatol. 2015;73:27–36 e1.
   PubMed Web of Science ®Google Scholar
• Strober B, Sigurgeirsson B, Popp G, et al. Secukinumab improves patient-reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo-controlled clinical trials. Int J Dermatol. 2016;55:401–407.
   PubMed Web of Science ®Google Scholar
• Lebwohl M, Swensen AR, Nyirady J, et al. The psoriasis symptom diary: development and content validity of a novel patient-reported outcome instrument. Int J Dermatol. 2014;53:714–722.
   PubMed Web of Science ®Google Scholar
• Mathias SD, Feldman SR, Crosby RD, et al. Measurement properties of a patient-reported outcome measure assessing psoriasis severity: the psoriasis symptoms and signs diary. J Dermatolog Treat. 2016;27:322–327.
   PubMed Web of Science ®Google Scholar
• Strober B, Gottlieb AB, Sherif B, et al. Secukinumab sustains early patient-reported outcome benefits through 1 year: results from 2 phase III randomized placebo-controlled clinical trials comparing secukinumab with etanercept. J Am Acad Dermatol. 2017;76:655–661.
   PubMed Web of Science ®Google Scholar
• 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;73:400–409.
   PubMed Web of Science ®Google Scholar
• Pickard AS, Gooderham M, Hartz S, et al. EQ-5D health utilities: exploring ways to improve upon responsiveness in psoriasis. J Med Econ. 2017;20:19–27.
   PubMed Web of Science ®Google Scholar
• Yang Y, Brazier J, Longworth L. EQ-5D in skin conditions: an assessment of validity and responsiveness. Eur J Health Econ. 2015;16:927–939.
   PubMed Web of Science ®Google Scholar
• Reilly Associates. [cited 2020 Oct 13]. Available from: http://www.reillyassociates.net/.
   Google Scholar
• Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993;4:353–365.
   PubMed Web of Science ®Google Scholar
• Puig L, Augustin M, Blauvelt A, et al. Effect of secukinumab on quality of life and psoriasis-related symptoms: a comparative analysis versus ustekinumab from the CLEAR 52-week study. J Am Acad Dermatol. 2018;78:741–748.
   PubMed Web of Science ®Google Scholar
• Bagel J, Nia J, Hashim PW, et al. Secukinumab is superior to ustekinumab in clearing skin in patients with moderate to severe plaque psoriasis (16-week CLARITY results). Dermatol Ther (Heidelb). 2018;8:571–579.
   PubMed Web of Science ®Google Scholar
• 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;172:484–493.
   PubMed Web of Science ®Google Scholar
• Keininger D, Coteur G. Assessment of self-injection experience in patients with rheumatoid arthritis: psychometric validation of the self-injection assessment questionnaire (SIAQ). Health Qual Life Outcomes. 2011;9:2.
   PubMed Web of Science ®Google Scholar
• Augustin M, Dauden E, Mrowietz U, et al. Secukinumab treatment leads to normalization of quality of life and disease symptoms in psoriasis patients with or without prior systemic psoriasis therapy: the PROSE study results. J Eur Acad Dermatol Venereol. 2020. https://doi.org/https://doi.org/10.1111/jdv.16632.
   Google Scholar
• 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;31:333–341.
   PubMed Web of Science ®Google Scholar
• Elkinton JR. Medicine and the quality of life. Ann Intern Med. 1966;64:711–714.
   PubMed Web of Science ®Google Scholar
• Felce D, Perry J. Quality of life: its definition and measurement. Res Dev Disabil. 1995;16:51–74.
   PubMed Web of Science ®Google Scholar
• Liu BC. Quality of life: concept, measure and results. Am J Econ Sociology. 1975;34:4–13.
   Web of Science ®Google Scholar
• Ferrans CE. Quality of life: conceptual issues. Semin Oncol Nurs. 1990;6:248–254.
   PubMedGoogle Scholar
• Pais-Ribeiro JL. Quality of life is a primary end-point in clinical settings. Clin Nutr. 2004;23:121–130.
   PubMed Web of Science ®Google Scholar
• Estoque RC, Togawa T, Ooba M, et al. A review of quality of life (QOL) assessments and indicators: towards a “QOL-Climate” assessment framework. Ambio. 2019;48:619–638.
   PubMed Web of Science ®Google Scholar
• Krueger GG, Feldman SR, Camisa C, et al. Two considerations for patients with psoriasis and their clinicians: what defines mild, moderate, and severe psoriasis? What constitutes a clinically significant improvement when treating psoriasis? J Am Acad Dermatol. 2000;43:281–285.
   PubMed Web of Science ®Google Scholar
• Choi J, Koo JY. Quality of life issues in psoriasis. J Am Acad Dermatol. 2003;49:S57–61.
   PubMed Web of Science ®Google Scholar
• Larsen MH, Krogstad AL, Wahl AK. Alexithymia, illness perception and self-management competency in psoriasis. Acta Derm Venereol. 2017;97:934–940.
   PubMed Web of Science ®Google Scholar