Risankizumab for the treatment of moderate to severe psoriasis

References

• Megna M, Balato A, Napolitano M, et al. Psoriatic disease treatment nowadays: unmet needs among the “jungle of biologic drugs and small molecules”. Clin Rheumatol. 2018;37(7):1739–1741.
   PubMed Web of Science ®Google Scholar
• O’Shea JJ, Steward-Tharp SM, Laurence A, et al. Signal transduction and Th17 cell differentiation. Microbes Infect. 2009;11(5):599–611.
   PubMed Web of Science ®Google Scholar
• Hawkes JE, Chan TC, Krueger JG. Psoriasis pathogenesis and the development of novel targeted immune therapies. J Allergy Clin Immunol. 2017;140:645–653.
   PubMed Web of Science ®Google Scholar
• Chiricozzi A, Romanelli P, Volpe E, et al. Scanning the immunopathogenesis of psoriasis. Int J Mol Sci. 2018;19(1):E179.
   PubMed Web of Science ®Google Scholar
• Gilliet M, Conrad C, Geiges M, et al. Psoriasis triggered by toll-like receptor 7 agonist imiquimod in the presence of dermal plasmacytoid dendritic cell precursors. Arch Dermatol. 2004;140:1490–1495.
   PubMed Web of Science ®Google Scholar
• Albanesi C, Scarponi C, Pallotta S, et al. Chemerin expression marks early psoriatic skin lesions and correlates with plasmacytoid dendritic cell recruitment. J Exp Med. 2009;206(1):249–258.
   PubMed Web of Science ®Google Scholar
• Blauvelt A, Chiricozzi A. The immunologic role of IL-17 in psoriasis and psoriatic arthritis pathogenesis. Clin Rev Allergy Immunol. 2018. Epub ahead of print. DOI:10.1007/s12016-018-8702-3
   PubMed Web of Science ®Google Scholar
• Chiricozzi A, Nograles KE, Johnson-Huang LM, et al. IL-17 induces an expanded range of downstream genes in reconstituted human epidermis model. PLoS ONE. 2014;9:e90284.
   PubMed Web of Science ®Google Scholar
• Martin DA, Towne JE, Kricorian G, et al. The emerging role of IL-17 in the pathogenesis of psoriasis: preclinical and clinical findings. J Invest Dermatol. 2013;133:17–26.
   PubMed Web of Science ®Google Scholar
• Capon F. The Genetic Basis of Psoriasis. Int J Mol Sci. 2017;18(12):E2526.
   PubMed Web of Science ®Google Scholar
• Hasegawa H, Mizoguchi I, Chiba Y, et al. Expanding diversity in molecular structures and functions of the IL-6/IL-12 heterodimeric cytokine family. Front Immunol. 2016;7:479.
   PubMed Web of Science ®Google Scholar
• Oppmann B, Lesley R, Blom B, et al. Novel p19 protein engages IL-12p40 to form a cytokine, IL-23, with biological activities similar as well as distinct from IL-12. Immunity. 2000;13:715–725.
   PubMed Web of Science ®Google Scholar
• Tonini A, Gualtieri B, Panduri S, et al. A new class of biologic agents facing the therapeutic paradigm in psoriasis: anti-IL-23 agents. Expert Opin Biol Ther. 2018;18(2):135–148.
   PubMed Web of Science ®Google Scholar
• Liu W, Ouyang X, Yang J, et al. AP-1 activated by toll-like receptors regulates expression of IL-23 p19. J Biol Chem. 2009;284(36):24006–24016.
   PubMed Web of Science ®Google Scholar
• Parham C, Chirica M, Timans J, et al. A receptor for the heterodimeric cytokine IL-23 is composed of IL-12Rbeta1 and a novel cytokine receptor subunit, IL-23R. J Immunol. 2002;168(11):5699–5708.
   PubMed Web of Science ®Google Scholar
• Cho ML, Kang JW, Moon YM, et al. STAT3 and NF-kappaB signal pathway is required for IL-23-mediated IL-17 production in spontaneous arthritis animal model IL-1 receptor antagonist-deficient mice. J Immunol. 2006;176(9):5652–5661.
   PubMed Web of Science ®Google Scholar
• Volpe E, Servant N, Zollinger R, et al. A critical function for transforming growth factor-beta, interleukin 23 and proinflammatory cytokines in driving and modulating human T(H)-17 responses. Nat Immunol. 2008;9(6):650–657.
   PubMed Web of Science ®Google Scholar
• Langrish CL, Chen Y, Blumenschein WM, et al. IL-23 drives a pathogenic T cell population that induces autoimmune inflammation. J Exp Med. 2005;201(2):233–240.
   PubMed Web of Science ®Google Scholar
• Kagami S, Rizzo HL, Kurtz SE, et al. IL-23 and IL-17A, but not IL-12 and IL-22, are required for optimal skin host defense against Candida albicans. J Immunol. 2010;185(9):5453–5462.
   PubMed Web of Science ®Google Scholar
• Chiricozzi A, Saraceno R, Chimenti MS, et al. Role of IL-23 in the pathogenesis of psoriasis: a novel potential therapeutic target? Expert Opin Ther Targets. 2014;18(5):513–525.
   PubMed Web of Science ®Google Scholar
• Lee E, Trepicchio WL, Oestreicher JL, et al. Increased expression of interleukin 23 p19 and p40 in lesional skin of patients with psoriasis vulgaris. J Exp Med. 2004;199(1):125–130.
   PubMed Web of Science ®Google Scholar
• Piskin G, Sylva-Steenland RM, Bos JD, et al. In vitro and in situ expression of IL-23 by keratinocytes in healthy skin and psoriasis lesions: enhanced expression in psoriatic skin. J Immunol. 2006;176:1908–1915.
   PubMed Web of Science ®Google Scholar
• Zaba LC, Krueger JG, Lowes MA. Resident and “inflammatory” dendritic cells in human skin. J Invest Dermatol. 2009;129:302–308.
   PubMed Web of Science ®Google Scholar
• Fotiadou C, Lazaridou E, Sotiriou E, et al. IL-17A, IL-22, and IL-23 as markers of psoriasis activity: a cross-sectional, hospital-based study. J Cutan Med Surg. 2015;19(6):555–560.
   PubMed Web of Science ®Google Scholar
• Tonel G, Conrad C, Laggner U, et al. Cutting edge: a critical functional role for IL-23 in psoriasis. J Immunol. 2010;185(10):5688–5691.
   PubMed Web of Science ®Google Scholar
• van der Fits L, Mourits S, Voerman JS, et al. Imiquimod-induced psoriasis-like skin inflammation in mice is mediated via the IL-23/IL-17 axis. J Immunol. 2009;182(9):5836–5845.
   PubMed Web of Science ®Google Scholar
• Nakajima K, Kanda T, Takaishi M, et al. Distinct roles of IL-23 and IL-17 in the development of psoriasis-like lesions in a mouse model. J Immunol. 2011;186(7):4481–4489.
   PubMed Web of Science ®Google Scholar
• Chan JR, Blumenschein W, Murphy E, et al. IL-23 stimulates epidermal hyperplasia via TNF and IL-20R2-dependent mechanisms with implications for psoriasis pathogenesis. J Exp Med. 2006;203(12):2577–2587.
   PubMed Web of Science ®Google Scholar
• Singh S, Kroe-Barrett RR, Canada KA, et al. Selective targeting of the IL23 pathway: generation and characterization of a novel high-affinity humanized anti-IL23A antibody. MAbs. 2015;7(4):778–791.
   PubMed Web of Science ®Google Scholar
• Krueger JG, Ferris LK, Menter A, et al. Anti-IL-23A mAb BI 655066 for treatment of moderate-to-severe psoriasis: safety, efficacy, pharmacokinetics, and biomarker results of a single-rising-dose, randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2015;136(1):116–124.e7.
   PubMed Web of Science ®Google Scholar
• Suleiman AA, Khatri A, Minocha M, et al. Population pharmacokinetics of the interleukin-23 inhibitor risankizumab in subjects with psoriasis and Crohn’s Disease: analyses of phase I and II trials. Clin Pharmacokinet. 2018. Epub ahead of print. DOI:10.1007/s40262-018-0704-z
   PubMed Web of Science ®Google Scholar
• Papp KA, Blauvelt A, Bukhalo M, et al. Risankizumab versus Ustekinumab for moderate-to-severe plaque psoriasis. N Engl J Med. 2017;376(16):1551–1560.
   PubMed Web of Science ®Google Scholar
• Blauvelt A, Papp KA, Gooderham M, et al., Thompson EHZ Efficacy and safety of risankizumab, an interleukin-23 inhibitor, in patients with moderate-to-severe chronic plaque psoriasis: 16-week results from the phase III IMMhance trial. FC – 29 Poster presented at Psoriasis from gene to clinic, 30th November – 2nd December 2017
   Google Scholar
• Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis(UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650–661.
   PubMed Web of Science ®Google Scholar
• https://clinicaltrials.gov/ct2/show/NCT03478787
   Google Scholar
• EUCTR2015‐003623‐65. BI 655066 (risankizumab) versus adalimumab in a randomised, double blind, parallel group trial in moderate to severe plaque psoriasis to assess safety and efficacy after 16 weeks of treatment and after inadequate adalimumab treatment response (IMMvent) ‐ BI 655066 (risankizumab) versus adalimumab. 2016 May 17 Available from: www.clinicaltrialsregister.eu/ctr‐search/search?query=eudract–number%3A2015‐003623‐65/EUCTR2015‐003623‐65.
   Google Scholar
• Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005;64(2):ii14–7.
   PubMed Web of Science ®Google Scholar
• Cohen AD, Dreiher J, Birkenfeld S. Psoriasis associated with ulcerative colitis and Crohn’s disease. J Eur Acad Dermatol Venereol. 2009;23:561–565.
   PubMed Web of Science ®Google Scholar
• https://news.abbvie.com/news/abbvie-receives-orphan-drug-designation-for-investigational-il-23-inhibitor-risankizumab-from-us-food-and-drug-administration-for-treatment-pediatric-patients-with-crohns-disease.htm
   Google Scholar
• Feagan BG, Sandborn WJ, D’Haens G, et al. Induction therapy with the selective interleukin-23 inhibitor risankizumab in patients with moderate-to-severe Crohn’s disease: a randomised, double-blind, placebo-controlled phase 2 study. Lancet. 2017;389(10080):1699–1709.
   PubMed Web of Science ®Google Scholar
• Mease PJ, Kellner H, Morita A, et al. Efficacy and safety results from a phase 2 trial of risankizumab, a selective IL-23p19 inhibitor, in patients with active psoriatic arthritis [abstract]. Arthritis Rheumatol. 2017;69(10).
   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. 2015;14(7):706–714.
   PubMed Web of Science ®Google Scholar
• Dávila-Seijo P, Dauden E, Carretero G, et al. Survival of classic and biological systemic drugs in psoriasis: results of the BIOBADADERM registry and critical analysis. J Eur Acad Dermatol Venereol. 2016;30(11):1942–1950.
   PubMed Web of Science ®Google Scholar
• Medina C, Carretero G, Ferrandiz C, et al. Safety of classic and biologic systemic therapies for the treatment of psoriasis in elderly: an observational study from national BIOBADADERM registry. J Eur Acad Dermatol Venereol. 2015;29(5):858–864.
   PubMed Web of Science ®Google Scholar
• Egeberg A, Ottosen MB, Gniadecki R, et al. Safety, efficacy and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis. Br J Dermatol. 2018;178(2):509–519.
   PubMed Web of Science ®Google Scholar
• Blauvelt A, Lebwohl MG, Bissonnette R. IL-23/IL-17A dysfunction phenotypes inform possible clinical effects from anti-IL-17A therapies. J Invest Dermatol. 2015;135:1946–1953.
   PubMed Web of Science ®Google Scholar