Small molecules and antibodies for the treatment of psoriasis: a patent review (2010–2015)

References

• 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
• 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;206:249–258.
   PubMed Web of Science ®Google Scholar
• Ganguly D, Chamilos G, Lande R, et al. Self-RNA-antimicrobial peptide complexes activate human dendritic cells through TLR7 and TLR8. J Exp Med. 2009;206:1983–1994.
   PubMed Web of Science ®Google Scholar
• Lande R, Ganguly D, Facchinetti V, et al. Neutrophils activate plasmacytoid dendritic cells by releasing self-DNA-peptide complexes in systemic lupus erythematosus. Sci Transl Med. 2011;3:73ra19.
   PubMed Web of Science ®Google Scholar
• Nestle FO, Conrad C, Tun-Kyi A, et al. Plasmacytoid predendritic cells initiate psoriasis through interferon-alpha production. J Exp Med. 2005;202:135–143.
   PubMed Web of Science ®Google Scholar
• Lowes MA, Russell CB, Martin DA, et al. The IL-23/T17 pathogenic axis in psoriasis is amplified by keratinocyte responses. Trends Immunol. 2013;34:174–181.
   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;128:1207–1211.
   PubMed Web of Science ®Google Scholar
• Hijnen D, Knol EF, Gent YY, et al. CD8(+) T cells in the lesional skin of atopic dermatitis and psoriasis patients are an important source of IFN-g, IL-13, IL-17, and IL-22. J Invest Dermatol. 2013;133:973–979.
   PubMed Web of Science ®Google Scholar
• Cai Y, Shen X, Ding C, et al. Pivotal role of dermal IL-17-producing gammadelta T cells in skin inflammation. Immunity. 2011;35:596–610.
   PubMed Web of Science ®Google Scholar
• Chiricozzi A. Pathogenic role of IL-17 in psoriasis and psoriatic arthritis. Actas Dermosifiliogr. 2014;105:9–20.
   PubMedGoogle Scholar
• Mabuchi T, Takekoshi T, Hwang ST. Epidermal CCR6+ γδ T cells are major producers of IL-22 and IL-17 in a murine model of psoriasiform dermatitis. J Immunol. 2011;187:5026–5031.
   PubMed Web of Science ®Google Scholar
• Teunissen M, Munneke M, Bernink J, et al. Composition of innate lymphoid cell subsets in the human skin: enrichment of NCR. ILC3 in lesional skin and blood of psoriasis patients. J Invest Dermatol. 2014;134:2351–2360.
   PubMed Web of Science ®Google Scholar
• Lowes MA, Chamian F, Abello MV, et al. Increase in TNF-alpha and inducible nitric oxide synthase-expressing dendritic cells in psoriasis and reduction with efalizumab (anti-CD11a). Proc Natl Acad Sci USA. 2005;102:19057–19062.
   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;185:5688–5691.
   PubMed Web of Science ®Google Scholar
• Chiricozzi A, Guttman-Yassky E, Suárez-Fariñas M, et al. Integrative responses to IL-17 and TNF-a in human keratinocytes account for key inflammatory pathogenic circuits in psoriasis. J Invest Dermatol. 2011;131:677–87.35.
   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
• Leonard WJ, O’Shea JJ. Jaks and STATs: biological implications. Annu Rev Immunol. 1998;16:293–322.
   PubMed Web of Science ®Google Scholar
• Igaz P, Toth S, Falus A. Biological and clinical significance of the JAK-STAT pathway; lessons from knockout mice. Inflamm Res. 2001;50:435–441.
   PubMed Web of Science ®Google Scholar
• Shuai K, Liu B. Regulation of JAK-STAT signalling in the immune system. Nat Rev Immunol. 2003;3(11):900–911.
   PubMed Web of Science ®Google Scholar
• Chiricozzi A, Faleri S, Saraceno R, et al. Tofacitinib for the treatment of moderate-to-severe psoriasis. Expert Rev Clin Immunol. 2015;11:443–455.
   PubMed Web of Science ®Google Scholar
• Schafer P. Apremilast mechanism of action and application to psoriasis and psoriatic arthritis. Biochem Pharmacol. 2012;83:1583–1590.
   PubMed Web of Science ®Google Scholar
• Cyster JG. Chemokines, sphingosine-1-phosphate, and cell migration in secondary lymphoid organs. Annu Rev Immunol. 2005;23:127–159.
   PubMed Web of Science ®Google Scholar
• Kaminska B, Swiatek-Machado K. Targeting signaling pathways with small molecules to treat autoimmune disorders. Expert Rev Clin Immunol. 2008;4:93–112.
   PubMed Web of Science ®Google Scholar
• Seavey MM, Dobrzanski P. The many faces of Janus kinase. Biochem Pharmacol. 2012;83(9):1136–1145.
   PubMed Web of Science ®Google Scholar
• Pesu M, Candotti F, Husa M, et al. Jak3, severe combined immunodeficiency, and a new class of immunosuppressive drugs. Immunological Reviews. 2005;203:127–142.
   PubMed Web of Science ®Google Scholar
• Pfizer.Crystalline and non- crystalline forms of tofacitinib, and a pharmaceutical composition comprising tofacitinib and a penetration enhancer. WO2012137111A1. 2012.
   Google Scholar
• Sandborn WJ, Ghosh S, Panes J, et al. Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis. N Engl J Med. 2012;367(7):616–624.
   PubMed Web of Science ®Google Scholar
• Fleischmann R, Kremer J, Cush J, et al. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med. 2012;367(6):495–507.
   PubMed Web of Science ®Google Scholar
• van Vollenhoven RF, Fleischmann R, Cohen S, et al. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med. 2012;367(6):508–519.
   PubMed Web of Science ®Google Scholar
• Papp KA, Menter A, Strober B, et al. Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: a Phase 2b randomized placebo-controlled dose-ranging study. Br J Dermatol. 2012;167:668–677.
   PubMed Web of Science ®Google Scholar
• Bachelez H, van de Kerkhof PC, Strohal R, et al. Tofacitinib versus etanercept or placebo in moderate-to-severe chronic plaque psoriasis: a phase 3 randomised non-inferiority trial. Lancet. 2015;386(9993):552–561.
   PubMed Web of Science ®Google Scholar
• Ports WC, Khan S, Lan S, et al. A randomized phase 2a efficacy and safety trial of the topical Janus kinase inhibitor tofacitinib in the treatment of chronic plaque psoriasis. Br J Dermatol. 2013;169(1):137–145.
   PubMed Web of Science ®Google Scholar
• Concert pharmaceuticals Inc. Deuterated derivatives of ruxolitinib WO2013188783A1. 2013.
   Google Scholar
• Punwani N, Scherle P, Flores R, et al. Preliminary clinical activity of a topical JAK1/2 inhibitor in the treatment of psoriasis. J Am Acad Dermatol. 2012;67(4):658–664.
   PubMed Web of Science ®Google Scholar
• Ortiz-Ibanez K, Alsina MM, Munoz-Santos C. Tofacitinib and other kinase inhibitors in the treatment of psoriasis. Actas Dermosifiliogr. 2013;104(4):304–310.
   PubMedGoogle Scholar
• Abbvie Inc.Jak1 selective inhibitor and uses thereof. US20150118229A1. 2015.
   Google Scholar
• Celgene corp.Methods and compositions using pde4 inhibitors for the treatment and management of autoimmune and inflammatory diseases. WO2012149251A1. 2012.
   Google Scholar
• Schafer PH, Parton A, Gandhi AK, et al. Apremilast, a cAMP phosphodiesterase-4 inhibitor, demonstrates anti-inflammatory activity in vitro and in a model of psoriasis. Br J Pharmacol. 2010;159:842–855.
   PubMed Web of Science ®Google Scholar
• Papp K, Cather JC, Rosoph L, et al. Efficacy of apremilast in the treatment of moderate to severe psoriasis: a randomised controlled trial. Lancet. 2012;380:738–746.
   PubMed Web of Science ®Google Scholar
• Papp K, Reich K, Leonardi CL, et al. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1). Am Acad Dermatol. 2015;73(1):37–49.
   PubMed Web of Science ®Google Scholar
• Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. Treatment of psoriatic arthritis in a phase 3 randomized, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor. Ann Rheum Dis. 2014;73:1020–1026.
   PubMed Web of Science ®Google Scholar
• http://www.otezla.com/otezla-prescribing-information.pdf
   Google Scholar
• Busa S, Kavanaugh A. Drug safety evaluation of apremilast for treating psoriatic arthritis. Expert Opin Drug Saf. 2015;14(6):979–985.
   PubMed Web of Science ®Google Scholar
• Can-Fite Biopharma Ltd.Pharmaceutical composition comprising a3 adenosine receptor agonist (ib-meca/cf-101) for treatment of psoriasis. WO2011027348A1. 2011.
   Google Scholar
• Fishman P, Bar-Yehuda S, Liang BT, et al. Pharmacological and therapeutic effects of A3 adenosine receptor agonists. Drug Discov Today. 2012;17:359–366.
   PubMed Web of Science ®Google Scholar
• David M, Akerman L, Ziv M, et al. Treatment of plaque-type psoriasis with oral CF101: data from an exploratory randomized phase 2 clinical trial. J Eur Acad Dermatol Venereol. 2012;26:361–367.
   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
• Yeilding N, Szapary P, Brodmerkel C, et al. Development of the IL-12/23 antagonist ustekinumab in psoriasis: past, present, and future perspectives–an update. Ann N Y Acad Sci. 2011;1222:30–39.
   PubMed Web of Science ®Google Scholar
• Bartlett BL, Tyring SK. Ustekinumab for chronic plaque psoriasis. Lancet. 2008;371(9625):1639–1640.
   PubMed Web of Science ®Google Scholar
• Sorenson E, Koo J. Evidence-based adverse effects of biologic agents in the treatment of moderate-to-severe psoriasis: providing clarity to an opaque topic. J Dermatolog Treat. 2015;26(6):493–501.
   PubMed Web of Science ®Google Scholar
• 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 arandomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008;371(9625):1665–1674.
   PubMed Web of Science ®Google Scholar
• Krueger GG, Langley RG, Leonardi C, et al. A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. N Engl J Med. 2007;356(6):580–592.
   PubMed Web of Science ®Google Scholar
• AbbVie Inc.Methods for treating psoriasis by administering an antibody which binds an epitope of the p40 subunit of IL-12 and/or IL-23. US9051368B2. 2015.
   Google Scholar
• Langley RG, Papp K, Gottlieb AB, et al. Safety results from a pooled analysis of randomized controlled phase II and III clinical trials and interim data from an open-label extension trial of the interleukin-12/23 monoclonal antibody, briakinumab, in moderate to severe psoriasis. J Eur Acad Dermatol Venereol. 2013;27:1252–1261.
   PubMed Web of Science ®Google Scholar
• Papp KA, Sundaram M, Bao Y, et al. Effects of briakinumab treatment for moderate to severe psoriasis on health-related quality of life and work productivity and activity impairment: results from a randomized phase III study. J Eur Acad Dermatol Venereol. 2014;28(6):790–798.
   PubMed Web of Science ®Google Scholar
• Merck Sharp & Dohme.Crystalline anti-human IL-23 antibodies. WO2014004436A2. 2014.
   Google Scholar
• 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(4):1032–1040.
   PubMed Web of Science ®Google Scholar
• Merck Sharp & Dohme Corp. IL-23 antagonists for treatment or prevention of skin rash associated with treatment with p13k/akt pathway inhibitors. WO2013009535A1. 2013.
   Google Scholar
• Papp K, Thaçi D, Reich K, et al. Tildrakizumab (MK-3222), an Anti- IL-23p19 monoclonal antibody, improves psoriasis in a phase 2b randomized placebo-controlled trial. Br J Dermatol. 2015;173(4):930–939.
   PubMed Web of Science ®Google Scholar
• Barrett Rabinow JO Werling; Baxter international inc., Baxter healthcare Sa. Methods and compositions for reducing pain, inflammation, and/or immunological reactions associated with parenterally administering a primary therapeutic Agent. US20150024031 A1. 2015.
   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.
   PubMed Web of Science ®Google Scholar
• Kirkham BW, Kavanaugh A, Reich K. Interleukin-17A: a unique pathway in immune-mediated diseases: psoriasis, psoriatic arthritis and rheumatoid arthritis. Immunology. 2014;141:133–142.
   PubMed Web of Science ®Google Scholar
• Chiricozzi A, Krueger JG. IL-17 targeted therapies for psoriasis. Expert Opin Investig Drugs. 2013;22(8):993–1005.
   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;71:141–150.
   PubMed Web of Science ®Google Scholar
• Reich K, Papp KA, Matheson RT, et al. Evidence that a neutrophil-keratinocyte crosstalk is an early target of IL-17A inhibition in psoriasis. Exp Dermatol. 2015;24:529–535.
   PubMed Web of Science ®Google Scholar
• Novartis AG.Methods of treating psoriasis using IL-17 antagonists. WO2012045848A1. 2012.
   Google Scholar
• Novelli L, Chimenti MS, Chiricozzi A, et al. The new era for the treatment of psoriasis and psoriatic arthritis: perspectives and validated strategies. Autoimmun Rev. 2014;13(1):64–69.
   PubMed Web of Science ®Google Scholar
• Hueber W, Sands BE, Lewitzky S, et al. Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn’s disease: unexpected results of a randomised, double-blind placebo-controlled trial. Gut. 2012;61(12):1693–1700.
   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
• 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;73:400–409.
   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.
   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;41:1039–1046.
   PubMed Web of Science ®Google Scholar
• Paul C, Reich K, Gottlieb AB, et al. Secukinumab improves hand, foot and nail lesions in moderate-to-severe plaque psoriasis: subanalysis of a randomized, double-blind, placebo-controlled, regimen-finding phase 2 trial. J Eur Acad Dermatol Venereol. 2014;28:1670–1675.
   PubMed Web of Science ®Google Scholar
• 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;29:1082–1090.
   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;172:484–493.
   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
• Amgen Inc. Use of il-17 receptor a antigen binding proteins. WO2011046958A1. 2011.
   Google Scholar
• Mease PJ, Genovese MC, Mutebi A, et al. Improvement in psoriasis signs and symptoms assessed by the psoriasis symptom inventory with brodalumab treatment in patients with psoriatic arthritis. J Rheumatol. 2016;43(2):343–349.
   PubMedGoogle Scholar
• Barbe RJ. Amgen, Astra Zeneca’s brodalumab meets primary endpoints of third Phase III trial in moderate-to severe-plaque psoriasis. First Word Pharma Web. 2014. Available from: http://www.firstwordpharma.com/node/1248329?tsid=17#axzz4AtSuEQbH
   Google Scholar
• Bauer E, Lucier J, Furst DE. Brodalumab -an IL-17RA monoclonal antibody for psoriasis and psoriatic arthritis. Expert Opin Biol Ther. 2015;15(6):883–893.
   PubMed Web of Science ®Google Scholar
• Corning Inc.Delamination resistance pharmaceutical glass containers containing active pharmaceutical ingredients. US2014341888A1. 2014.
   Google Scholar
• Leonardi C, Matheson R, Zachariae C, et al. Anti-interleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis. N Engl J Med. 2012;366(13):1190–1199.
   PubMed Web of Science ®Google Scholar
• Kanakaraj P, Puffer BA, Yao XT, et al. Simultaneous targeting of TNF and Ang2 with a novel bispecific antibody enhances efficacy in an in vivo model of arthritis. MAbs. 2012;4(5):600–613.
   PubMed Web of Science ®Google Scholar
• Binz HK, Amstutz P, Plückthun A. Engineering novel binding proteins from nonimmunoglobulin domains. Nat Biotechnol. 2005;23(10):1257–1268.
   PubMed Web of Science ®Google Scholar
• Gebauer M, Skerra A. Engineered protein scaffolds as next generation antibody therapeutics. Curr Opin Chem Biol. 2009;13(3):245–255.
   PubMed Web of Science ®Google Scholar
• Covagen A Il-17 binding compounds and medical uses thereof - US20130005659A1. 2013.
   Google Scholar
• Silacci M, Baenziger-Tobler N, Lembke W, et al. Linker length matters, fynomer-Fc fusion with an optimized linker displaying picomolar IL-17A inhibition potency. J Biol Chem. 2014;289(20):14392–14398.
   PubMed Web of Science ®Google Scholar
• JUNG KEEHOON.Fusion protein capable of binding vegf-a and tnf-alpha. US8927232B2. 2015.
   Google Scholar
• Jung K, Lee D, Lim HS, et al. Double anti-angiogenic and anti-inflammatory protein Valpha targeting VEGF-A and TNF-alpha in retinopathy and psoriasis. J Bilo Chem. 2011;286(16):14410–14418.
   PubMed Web of Science ®Google Scholar
• Covagen AGA novel fusion protein comprising an antibody light chain and a polypeptide binding to IL-17. EP2597102A1. 2013.
   Google Scholar
• Biocon LTD. Use of a CD6 binding partner and method based thereon. WO2015011658A1. 2015.
   Google Scholar
• Nair P, Melarkode R, Rajkumar D, et al. CD6 synergistic co-stimulation promoting proinflammatory response is modulated without interfering with the activated leucocyte cell adhesion molecule interaction. Clin Exp Immunol. 2010;162:116–130.
   PubMed Web of Science ®Google Scholar
• Krupashankar DS, Dogra S, Kura M, et al. Efficacy and safety of itolizumab, a novel anti-CD6 monoclonal antibody, in patients with moderate to severe chronic plaque psoriasis: results of a double-blind, randomized, placebo-controlled, phase-III study. J Am Acad Dermatol. 2014;71(3):484–492.
   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(4):645–648.
   PubMed Web of Science ®Google Scholar
• K Papp et al. 2015. Efficacy and safety of different dose regimens of a novel selective IL-23p19 inhibitor (BI 655066) compared with ustekinumab in patients with moderate-to-severe plaque psoriasis. 73rd Annual Meeting of the American Academy of Dermatology, San Francisco, California, 2015 Mar 20–24 [Presentation].
   Google Scholar