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Drug Evaluation

Guselkumab for the treatment of psoriasis

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Pages 459-468 | Received 01 Dec 2017, Accepted 21 Feb 2018, Published online: 03 Mar 2018

References

  • Huerta C, Rivero E, Rodriguez LA. Incidence and risk factors for psoriasis in the general population. Arch Dermatol. 2007;143:1559–1565.
  • Megna M, Napolitano M, Balato A, et al. Psoriasis in children: a review. Curr Pediatr Rev. 2015;11:10–26.
  • Springate DA, Parisi R, Kontopantelis E, et al. Incidence, prevalence and mortality of patients with psoriasis: a U.K population-based cohort study. Br J Dermatol. 2017;176:650–658.
  • Egeberg A, Skov L, Gislason GH, et al. Incidence and prevalence of psoriasis in Denmark. Acta Derm Venereol. 2017;97:808–812.
  • Parisi R, Symmons DP, Griffiths CE, et al. Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. Invest Dermatol. 2013;133:377–385.
  • Takeshita J, Grewal S, Langan SM, et al. Psoriasis and comorbid diseases: epidemiology. J Am Acad Dermatol. 2017;76:377–390.
  • Napolitano M, Caso F, Scarpa R, et al. Psoriatic arthritis and psoriasis: differential diagnosis. Clin Rheumatol. 2016;35:1893–1901.
  • Tonel G, Conrad C. Interplay between keratinocytes and immune cells –recent insights into psoriasis pathogenesis. Int J Biochem Cell Biol. 2009;41:963–968.
  • Kim J, Krueger JG. The immunopathogenesis of psoriasis. Dermatol Clin. 2015;33:13–23.
  • Meller S, Di Domizio J, Voo KS, et al. T(H)17 cells promote microbial killing and innate immune sensing of DNA via interleukin 26. Nat Immunol. 2015;16:970–979.
  • Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009;361:496–509.
  • Puig L. The role of IL 23 in the treatment of psoriasis. Expert Rev Clin Immunol. 2017;13:525–534.
  • Girolomoni G, Strohal R, Puig L, et al. The role of IL-23 and the IL-23/T(H) 17 immune axis in the pathogenesis and treatment of psoriasis. J Eur Acad Dermatol Venereol. 2017;31:1616–1626.
  • Eberle FC, Brück J, Holstein J, et al. Recent advances in understanding psoriasis. F1000Res. 2016;5:F1000.
  • Boehncke WH, Katsambas A, Ortonne JP, et al. EADV preceptorship: advances in dermatology. J Eur Acad Dermatol Venereol. 2010;24:2–24.
  • Feldman SR, Zhao Y, Navaratnam P, et al. Patterns of medication utilization and costs associated with the use of etanercept, adalimumab, and ustekinumab in the management of moderate-to-severe psoriasis. J Manag Care Spec Pharm. 2015(21):201–209.
  • Cline A, Hill D, Lewallen R, et al. Current status and future prospects for biologic treatments of psoriasis. Expert Rev Clin Immunol. 2016;12:1273–1287.
  • Chen Z, Gong Y, Shi Y. Novel biologic agents targeting interleukin-23 and interleukin-17 for moderate-to-severe psoriasis. Clin Drug Investig. 2017;37:891-899.
  • Jeon C, Sekhon S, Yan D, et al. Monoclonal antibodies inhibiting IL-12, −23, and −17 for the treatment of psoriasis. Hum Vaccin Immunother. 2017;13:2247–2259.
  • Galluzzo M, D’adamio S, Bianchi L, et al. Tildrakizumab for treating psoriasis. Expert Opin Biol Ther. 2017;17:645–657.
  • Papp KA, Blauvelt A, Bukhalo M, et al. Risankizumab versus ustekinumab for moderate-to-severe plaque psoriasis. N Engl J Med. 2017;376:1551–1560.
  • TREMFYA (guselkumab), Chemistry Review. FDA Drug Approvals and Databases. Application No.: 761061, Approval Date: 07/ 13/2017. [cited 2017 Nov 20]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761061Orig1s000ChemR.pdf
  • TREMFYA (guselkumab), Multi-Discipline Review/ Summary,Clinical, Non-Clinical. FDA Drug Approvals and Databases. Application No.: 761061, Approval Date: 07/ 13/2017. [cited 2017 Nov 20]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761061Orig1s000MultidisciplineR.pdf
  • Zhuang Y, Calderon C, Marciniak SJ Jr, et al. First-in-human study to assess guselkumab (anti-IL-23 mAb) pharmacokinetics/safety in healthy subjects and patients with moderate-to-severe psoriasis. Eur J Clin Pharmacol. 2016;72:1303–1310.
  • Kauffman CL, Aria N, Toichi E, et al. A phase I study evaluating the safety, pharmacokinetics, and clinical response of a human IL-12 p40 antibody in subjects with plaque psoriasis. J Invest Dermatol. 2004;123:1037–1044.
  • Balato N, Napolitano M, Ayala F, et al. Nonalcoholic fatty liver disease, spleen and psoriasis: new aspects of low-grade chronic inflammation. World J Gastroenterol. 2015;21:6892–6897.
  • Sofen H, Smith S, Matheson RT, et al. Guselkumab (an IL-23-specific mAb) demonstrates clinical and molecular response in patients with moderate-to-severe psoriasis. J Allergy Clin Immunol. 2014;133:1032–1040.
  • Gordon KB, Duffin KC, Bissonnette R, et al. A phase 2 trial of guselkumab versus adalimumab for plaque psoriasis. N Engl J Med. 2015;373:136–144.
  • Blauvelt A, Papp KA, Griffiths CE, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76:405–417.
  • Reich K, Armstrong AW, Foley P, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017;76:418–431.
  • Langley RG, Tsai TF, Flavin S, et al. Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase III NAVIGATE trial. Br J Dermatol. 2018;178:114-123.
  • Carey W, Glazer S, Gottlieb AB, et al. Relapse, rebound, and psoriasis adverse events: an advisory group report. J Am Acad Dermatol. 2006;54:171–181.
  • Krueger JG, Fretzin S, Suarez-Farinas M, et al. IL-17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis. J Allergy Clin Immunol. 2012;130:145–154.
  • Langowski JL, Zhang X, Wu L, et al. IL-23 promotes tumour incidence and growth. Nature. 2006;442:461–465.
  • Schulz SM, Kohler G, Schutze N, et al. Protective immunity to systemic infection with attenuated Salmonella enterica serovar enteritidis in the absence of IL-12 is associated with IL-23-dependent IL-22, but not IL-17. J Immunol. 2008;181:7891–7901.
  • Chackerian AA, Chen SJ, Brodie SJ, et al. Neutralization or absence of the interleukin-23 pathway does not compromise immunity to mycobacterial infection. Infect Immun. 2006;74:6092–6099.
  • Teng MW, Vesely MD, Duret H, et al. Opposing roles for IL-23 and IL-12 in maintaining occult cancer in an equilibrium state. Cancer Res. 2012;72:3987–3996.
  • Jantschitsch C, Weichenthal M, Proksch E, et al. IL-12 and IL-23 affect photocarcinogenesis differently. J Invest Dermatol. 2012;132:1479–1486.
  • Balato N, Megna M, Di Costanzo L, et al. Educational and motivational support service: a pilot study for mobile-phone-based interventions in patients with psoriasis. Br J Dermatol. 2013;168:201–205.
  • Warren RB, Smith CH, Yiu ZZ, et al. Differential drug survival of biologic therapies for the treatment of psoriasis: a prospective observational cohort study from the British Association of Dermatologists Biologic Interventions Register (BADBIR). J Invest, Dermatol. 2015;135:2632–2640.
  • Menter A, Tyring SK, Gordon K, et al. Adalimumab therapy for moderate to severe psoriasis: a randomized, controlled phase III trial. J Am Acad Dermatol. 2008;58:106–115.
  • Papp KA, Tyring S, Lahfa M, et al. A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol. 2005;152:1304–1312.
  • Reich K, Nestle FO, Papp K, et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet. 2005;366:1367–1374.
  • Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab in moderate-to severe plaque psoriasis. N Engl J Med. 2016;375:345–356.
  • 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.
  • Leonardi CL, Kimball AB, Papp KA, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008;371:1665–1674.
  • 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;371:1675–1684.
  • Papp KA, Reich K, Paul C, et al. A prospective phase 3, randomized, double-blind, placebo controlled study of brodalumab in patients with moderate-to severe plaque psoriasis. Br J Dermatol. 2016;175:273–286.
  • Lebwohl M, Strober B, Menter A, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med. 2015;373:1318–1328.
  • Ovejero-Benito MC, Muñoz-Aceituno E, Reolid A, et al. Pharmacogenetics and pharmacogenomics in moderate-to-severe psoriasis. Am J Clin Dermatol. 2017 Sep 18. [Epub ahead of print]. DOI:10.1007/s40257-017-0322-9

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