Clinical and economic review of secukinumab for moderate-to-severe plaque psoriasis

References

• Boehncke W-H, Schön MP. Psoriasis. Lancet. 2015;386:983–994.
   PubMed Web of Science ®Google Scholar
• Christophers E. Psoriasis–epidemiology and clinical spectrum. Clin Exp Dermatol. 2001;26(4):314–320.
   PubMed Web of Science ®Google Scholar
• Rachakonda TD, Schupp CW, Armstrong AW. Psoriasis prevalence among adults in the United States. J Am Acad Dermatol. 2014;70(3):512–516.
   PubMed Web of Science ®Google Scholar
• Gelfand JM, Troxel AB, Lewis JD, et al. The risk of mortality in patients with psoriasis: Results from a population-based study. Arch Dermatol. 2007;143(12):1493–1499.
   PubMed Web of Science ®Google Scholar
• Hayes J, Koo J. Psoriasis: depression, anxiety, smoking, and drinking habits. Dermatol Ther. 2010;23(2):174–180.
   PubMed Web of Science ®Google Scholar
• Finlay AY, Coles EC. The effect of severe psoriasis on the quality of life of 369 patients. Br J Dermatol. 1995;132(2):236–244.
   PubMed Web of Science ®Google Scholar
• Gladman DD, Anhorn KA, Schachter RK, et al. HLA antigens in psoriatic arthritis. J Rheumatol. 1986;13(3):586–592.
   PubMed Web of Science ®Google Scholar
• Ahronowitz I, Fox L. Severe drug-induced dermatoses. Semin Cutan Med Surg. 2014;33(1):49–58.
   PubMed Web of Science ®Google Scholar
• Higgins E. Alcohol, smoking and psoriasis. Clin Exp Dermatol. 2000;25(2):107–110.
   PubMed Web of Science ®Google Scholar
• Qureshi AA, Dominguez PL, Choi HK, et al. Alcohol intake and risk of incident psoriasis in US women: a prospective study. Arch Dermatol. 2010;146(12):1364–1369.
   PubMedGoogle Scholar
• Armstrong AW, Harskamp CT, Dhillon JS, et al. Psoriasis and smoking: a systematic review and meta-analysis. Br J Dermatol. 2014;170(2):304–314.
   PubMed Web of Science ®Google Scholar
• Bremmer S, Van Voorhees AS, Hsu S, et al. Obesity and psoriasis: from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol. 2010;63(6):1058–1069.
   PubMed Web of Science ®Google Scholar
• Koebnick C, Black MH, Smith N, et al. The association of psoriasis and elevated blood lipids in overweight and obese children. J Pediatr. 2011;159(4):577–583.
   PubMed Web of Science ®Google Scholar
• Augustin M, Glaeske G, Radtke MA, et al. Epidemiology and comorbidity of psoriasis in children. Br J Dermatol. 2010;162(3):633–636.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Pathirana D, Ormerod AD, Saiag P, et al. European S3-guidelines on the systemic treatment of psoriasis vulgaris. J Eur Acad Dermatol Venereol JEADV. 2009;23(Suppl 2):1–70.
   PubMed Web of Science ®Google Scholar
• Steinman L. A brief history of TH17, the first major revision in the TH1/TH2 hypothesis of T cell–mediated tissue damage. Nat Med. 2007;13(2):139–145.
   PubMed Web of Science ®Google Scholar
• Lowes MA, Kikuchi T, Fuentes-Duculan J, et al. Psoriasis vulgaris lesions contain discrete populations of Th1 and Th17 T cells. J Invest Dermatol. 2008;128(5):1207–1211.
   PubMed Web of Science ®Google Scholar
• Büchau AS, Gallo RL. Innate immunity and antimicrobial defense systems in psoriasis. Clin Dermatol. 2007;25(6):616–624.
   PubMed Web of Science ®Google Scholar
• Nast A, Boehncke W-H, Mrowietz U, et al. S3 - Guidelines on the treatment of psoriasis vulgaris (English version). Update. J Dtsch Dermatol Ges J Ger Soc Dermatol JDDG. 2012;10(Suppl 2):S1–95.
   Web of Science ®Google Scholar
• Mrowietz U, Kragballe K, Reich K, et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011;303(1):1–10.
   PubMed Web of Science ®Google Scholar
• Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012;148(1):95–102.
   PubMedGoogle Scholar
• Papp K, Gulliver W, Lynde C, et al. Canadian Psoriasis Guidelines Committee. Canadian guidelines for the management of plaque psoriasis: overview. J Cutan Med Surg. 2011;15(4):210–219.
   PubMed Web of Science ®Google Scholar
• Steinke SIB, Peitsch WK, Ludwig A, et al. Cost-of-Illness in Psoriasis: Comparing Inpatient and Outpatient Therapy. PLoS ONE [Internet]. 2013 Oct 23 [cited 2015 Aug 5]; 8(10):e78152. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3806808/.
   PubMed Web of Science ®Google Scholar
• Beyer V, Wolverton SE. Recent trends in systemic psoriasis treatment costs. Arch Dermatol. 2010;146(1):46–54.
   PubMedGoogle Scholar
• Staidle JP, Dabade TS, Feldman SR. A pharmacoeconomic analysis of severe psoriasis therapy: a review of treatment choices and cost efficiency. Expert Opin Pharmacother. 2011;12(13):2041–2054.
   PubMed Web of Science ®Google Scholar
• Cheng J, Feldman SR. The cost of biologics for psoriasis is increasing. Drugs Context [Internet]. 2014 Dec 17;3:1–10. [cited 2015 Aug 5]. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4295913/.
   Google Scholar
• Lee A, Gregory V, Gu Q, et al. Cost-effectiveness of Secukinumab compared to current treatments for the treatment of moderate to severe plaque Psoriasis in Canada. Value Health. 2015;18(3):A182.
   Web of Science ®Google Scholar
• Schmitt JM, Ford DE. Work limitations and productivity loss are associated with health-related quality of life but not with clinical severity in patients with psoriasis. Dermatol Basel Switz. 2006;213(2):102–110.
   PubMed Web of Science ®Google Scholar
• Brezinski EA, Dhillon JS, Armstrong AW. Economic Burden of Psoriasis in the United States: A Systematic Review. JAMA Dermatol. 2015;151(6):651–658.
   PubMed Web of Science ®Google Scholar
• Lønnberg AS, Zachariae C, Skov L. Targeting of interleukin-17 in the treatment of psoriasis. Clin Cosmet Investig Dermatol. 2014;7:251–259.
   PubMedGoogle Scholar
• Sanford M, McKeage K. Secukinumab: first global approval. Drugs. 2015;75(3):329–338.
   PubMed Web of Science ®Google Scholar
• Xiong H-Z, Gu J-Y, He Z-G, et al. Efficacy and safety of secukinumab in the treatment of moderate to severe plaque psoriasis: a meta-analysis of randomized controlled trials. Int J Clin Exp Med. 2015;8(3):3156–3172.
   PubMed Web of Science ®Google Scholar
• Hueber W, Patel DD, Dryja T, et al. Effects of AIN457, a fully human antibody to interleukin-17A, on psoriasis, rheumatoid arthritis, and uveitis. Sci Transl Med. 2010;2(52):52ra72.
   PubMed Web of Science ®Google Scholar
• Papp KA, Langley RG, Sigurgeirsson B, et al. Efficacy and safety of secukinumab in the treatment of moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled phase II dose-ranging study. Br J Dermatol. 2013;168(2):412–421.
   PubMed Web of Science ®Google Scholar
• 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(2):402–411.
   PubMed Web of Science ®Google Scholar
• Paul C, Lacour J-P, 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 JEADV. 2015;29(6):1082–1090.
   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(2):484–493.
   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(4):326–338.
   PubMed Web of Science ®Google Scholar
• 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):1039–1046.
   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(1):27–36.e1.
   PubMed Web of Science ®Google Scholar
• Thaçi D, Humeniuk J, Frambach Y, et al. Secukinumab in psoriasis: randomized, controlled phase 3 trial results assessing the potential to improve treatment response in partial responders (STATURE). Br J Dermatol. 2015;173:777–787.
   PubMed Web of Science ®Google Scholar
• Thaçi 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.
   PubMed Web of Science ®Google Scholar
• Nast A, Jacobs A, Rosumeck S, et al. Efficacy and Safety of Systemic Long-Term Treatments for Moderate-to-Severe Psoriasis: A Systematic Review and Meta-Analysis. J Invest Dermatol. 2015;135:2641–2648.
   PubMed Web of Science ®Google Scholar
• US FDA. Drug Approval Package: Cosentyx (secukinumab) 2015. [Internet]. [cited 2015 Aug 19]. Available from: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails.
   Google Scholar
• European Medicines Agency. Cosentyx: authorization details [Internet]. [ cited 2015 Aug 19]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124.
   Google Scholar
• Health Canada. COSENTYX: summary basis of decision [Internet]. [cited 2015 Aug 18]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2015_cosentyx_170732-eng.php.
   Google Scholar
• Drummond M, Schulpher M, Torrance G, et al. Methods for the economic evaluation of health care programmes. 3rd ed. New York (NY): Oxford University Press; 2005.
   Google Scholar
• Pan F, Brazier NC, Shear NH, et al. Cost utility analysis based on a head-to-head Phase 3 trial comparing ustekinumab and etanercept in patients with moderate-to-severe plaque psoriasis: a Canadian perspective. Value Health J Int Soc Pharmacoeconomics Outcomes Res. 2011;14(5):652–656.
   PubMed Web of Science ®Google Scholar
• Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005;64(suppl 2):ii14–7.
   PubMed Web of Science ®Google Scholar
• Gladman DD. Psoriatic arthritis. Dermatol Ther. 2009;22(1):40–55.
   PubMed Web of Science ®Google Scholar
• Ritchlin CT, Kavanaugh A, Gladman DD, et al. Treatment recommendations for psoriatic arthritis. Ann Rheum Dis. 2009;68(9):1387–1394.
   PubMed Web of Science ®Google Scholar
• Husted JA, Gladman DD, Farewell VT, et al. Health-related quality of life of patients with psoriatic arthritis: A comparison with patients with rheumatoid arthritis. Arthritis Care Res. 2001;45(2):151–158.
   Web of Science ®Google Scholar
• 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):S423–4. 27.
   Google Scholar
• 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 Lond Engl. 2015;386:1137–1146.
   PubMed Web of Science ®Google Scholar
• Zachariae H, Kragballe K, Hansen HE, et al. Renal biopsy findings in long-term cyclosporin treatment of psoriasis. Br J Dermatol. 1997;136(4):531–535. Available from: http://www.ncbi.nlm.nih.gov/pubmed/9155953
   Google Scholar
• Rosenberg P, Urwitz H, Johannesson A, et al. Psoriasis patients with diabetes type 2 are at high risk of developing liver fibrosis during methotrexate treatment. J Hepatol. 2007;46(6):1111–1118.
   PubMed Web of Science ®Google Scholar
• Nijsten TE, Stern RS. The increased risk of skin cancer is persistent after discontinuation of psoralen+ultraviolet A: a cohort study. J Invest Dermatol. 2003;121(2):252–258.
   PubMed Web of Science ®Google Scholar
• Levin EC, Gupta R, Brown G, et al. Biologic fatigue in psoriasis. J Dermatol Treat. 2014;25(1):78–82.
   PubMed Web of Science ®Google Scholar
• Papp K, Gottlieb AB, Naldi L, et al. Safety Surveillance for Ustekinumab and Other Psoriasis Treatments From the Psoriasis Longitudinal Assessment and Registry (PSOLAR). J Drugs Dermatol JDD. 2015;14(7):706–714.
   PubMed Web of Science ®Google Scholar
• Tsao NW, Bansback NJ, Shojania K, et al. The issue of comparators in economic evaluations of biologic response modifiers in rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2012;26(5):659–676.
   PubMed Web of Science ®Google Scholar