Ustekinumab for the treatment of psoriasis

References

• Griffiths CE, Barker JN. Pathogenesis and clinical features of psoriasis. Lancet370(9583), 263–271 (2007).
   PubMed Web of Science ®Google Scholar
• Rapp SR, Feldman SR, Exum ML, Fleischer AB Jr, Reboussin DM. Psoriasis causes as much disability as other major medical diseases. J. Am. Acad. Dermatol.41(3 Pt 1), 401–407 (1999).
   PubMed Web of Science ®Google Scholar
• Sommer DM, Jenisch S, Suchan M, Christophers E, Weichenthal M. Increased prevalence of the metabolic syndrome in patients with moderate to severe psoriasis. Arch. Dermatol. Res.298(7), 321–328 (2006).
   PubMed Web of Science ®Google Scholar
• Najarian DJ, Gottlieb AB. Connections between psoriasis and Crohn’s disease. J. Am. Acad. Dermatol.48(6), 805–821 (2003).
   PubMed Web of Science ®Google Scholar
• Brophy S, Taylor G, Blake D, Calin A. The interrelationship between sex, susceptibility factors, and outcome in ankylosing spondylitis and its associated disorders including inflammatory bowel disease, psoriasis, and iritis. J. Rheumatol.30(9), 2054–2058 (2003).
   PubMedGoogle Scholar
• Gelfand JM, Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB. Risk of myocardial infarction in patients with psoriasis. JAMA296(14), 1735–1741 (2006).
   PubMed Web of Science ®Google Scholar
• Nestle FO, Kaplan DH, Barker J. Psoriasis. N. Engl. J. Med.361(5), 496–509 (2009).
   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 a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet371(9625), 1665–1674 (2008).
   PubMed Web of Science ®Google Scholar
• 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). Lancet371(9625), 1675–1684 (2008).
   PubMed Web of Science ®Google Scholar
• Smith RL, Eyre S, Warren RB, Young HS, Griffiths CE, Worthington J. No association between polymorphisms in the interleukin-15 gene and early-onset psoriasis in a UK cohort suggests heterogeneity for this susceptibility locus identified in Chinese psoriasis patients. J. Invest. Dermatol.128(12), 2904–2905 (2008).
   PubMedGoogle Scholar
• Reddy M, Torres G, McCormick T et al. Positive treatment effects of ustekinumab in psoriasis: analysis of lesional and systemic parameters. J. Dermatol.37(5), 413–425 (2007).
   Google Scholar
• Parham C, Chirica M, Timans J et al. A receptor for the heterodimeric cytokine IL-23 is composed of IL-12Rβ1 and a novel cytokine receptor subunit, IL-23R. J. Immunol.168(11), 5699–5708 (2002).
   PubMed Web of Science ®Google Scholar
• Warren RB, Brown BC, Carmichael AJ, Griffiths CE. Long-term control of recalcitrant psoriasis with combination infliximab and methotrexate. Clin. Exp. Dermatol.34(3), 415–416 (2009).
   PubMed Web of Science ®Google Scholar
• Warren RB, Brown BC, Lavery D, Ashcroft DM, Griffiths CE. Biologic therapies for psoriasis: practical experience in a U.K. tertiary referral centre. Br. J. Dermatol.160(1), 162–169 (2009).
   PubMed Web of Science ®Google Scholar
• Ryan C, Thrash B, Warren RB, Menter A. The use of ustekinumab in autoimmune disease. Expert Opin. Biol. Ther.10(4), 587–604 (2010).
   PubMed Web of Science ®Google Scholar
• Gerdes S, Franke J, Domm S, Mrowietz U. Ustekinumab in the treatment of palmoplantar pustulosis. Br. J. Dermatol.163(5), 1116–1118 (2010).
   PubMed Web of Science ®Google Scholar
• Wohlrab J, Kreft B. Treatment of pityriasis rubra pilaris with ustekinumab. Br. J. Dermatol.163(3), 655–656 (2010).
   PubMedGoogle Scholar
• Kleinpenning MM, Langewouters AM, Van De Kerkhof PC, Greebe RJ. Severe pyoderma gangrenosum unresponsive to etanercept and adalimumab. J. Dermatolog. Treat. DOI:10.3109/09546631003797106 (2010) (Epub ahead of print).
   Google Scholar
• Asumalahti K, Ameen M, Suomela S et al. Genetic analysis of PSORS1 distinguishes guttate psoriasis and palmoplantar pustulosis. J. Invest. Dermatol.120(4), 627–632 (2003).
   PubMed Web of Science ®Google Scholar
• 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.123(6), 1037–1044 (2004).
   PubMed Web of Science ®Google Scholar
• Gottlieb AB, Cooper KD, McCormick TS et al. A Phase 1, double-blind, placebo-controlled study evaluating single subcutaneous administrations of a human interleukin-12/23 monoclonal antibody in subjects with plaque psoriasis. Curr. Med. Res. Opin.23(5), 1081–1092 (2007).
   PubMed Web of Science ®Google Scholar
• Zhu Y, Hu C, Lu M et al. Population pharmacokinetic modeling of ustekinumab, a human monoclonal antibody targeting IL-12/23p40, in patients with moderate to severe plaque psoriasis. J. Clin. Pharmacol.49(2), 162–175 (2009).
   PubMed Web of Science ®Google Scholar
• Fredriksson T, Pettersson U. Severe psoriasis – oral therapy with a new retinoid. Dermatologica157(4), 238–244 (1978).
   PubMedGoogle Scholar
• Feldman SR, Koo JY, Menter A, Bagel J. Decision points for the initiation of systemic treatment for psoriasis. J. Am. Acad. Dermatol.53(1), 101–107 (2005).
   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.19(3), 210–216 (1994).
   PubMed Web of Science ®Google Scholar
• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr. Scand.67(6), 361–370 (1983).
   PubMed Web of Science ®Google Scholar
• Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med. Care30(6), 473–483 (1992).
   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.356(6), 580–592 (2007).
   PubMed Web of Science ®Google Scholar
• Griffiths CE, Strober BE, van de Kerkhof P et al. Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. N. Engl. J. Med.362(2), 118–128 (2010).
   PubMed Web of Science ®Google Scholar
• Lebwohl M, Papp K, Han C et al. Ustekinumab improves health-related quality of life in patients with moderate-to-severe psoriasis: results from the PHOENIX 1 trial. Br. J. Dermatol.162(1), 137–146 (2010).
   PubMed Web of Science ®Google Scholar
• Langley RG, Feldman SR, Han C et al. Ustekinumab significantly improves symptoms of anxiety, depression, and skin-related quality of life in patients with moderate-to-severe psoriasis: results from a randomized, double-blind, placebo-controlled Phase III trial. J. Am. Acad. Dermatol.63(3), 457–465 (2010).
   PubMed Web of Science ®Google Scholar
• Kim YK, Suh IB, Kim H et al. The plasma levels of interleukin-12 in schizophrenia, major depression, and bipolar mania: effects of psychotropic drugs. Mol. Psychiatry7(10), 1107–1114 (2002).
   PubMed Web of Science ®Google Scholar
• Gladmann D, Harris ED, Budd RC et al. Psoriatic arthritis. In: Kelley’s Textbook of Rheumatology. WB Saunders, PA, USA, 1155–1164 (2004).
   Google Scholar
• Gottlieb A, Menter A, Mendelsohn A et al. Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial. Lancet373(9664), 633–640 (2009).
   PubMed Web of Science ®Google Scholar
• Gladman DD, Helliwell P, Mease PJ, Nash P, Ritchlin C, Taylor W. Assessment of patients with psoriatic arthritis: a review of currently available measures. Arthritis Rheum.50(1), 24–35 (2004).
   PubMed Web of Science ®Google Scholar
• Kavanaugh A, Menter A, Mendelsohn A, Shen YK, Lee S, Gottlieb AB. Effect of ustekinumab on physical function and health-related quality of life in patients with psoriatic arthritis: a randomized, placebo-controlled, Phase II trial. Curr. Med. Res. Opin.26(10), 2385–2392 (2010).
   PubMed Web of Science ®Google Scholar
• Lebwohl M, Yeilding N, Szapary P et al. Impact of weight on the efficacy and safety of ustekinumab in patients with moderate to severe psoriasis: rationale for dosing recommendations. J. Am. Acad. Dermatol.63(4), 571–579 (2010).
   PubMed Web of Science ®Google Scholar
• Marodi L, Casanova JL. Can primary immunodeficiencies help to provide insights into infectious risks of therapeutic antibodies? Nat. Rev. Immunol.10(5), 299–300 (2010).
   PubMedGoogle Scholar
• Bustamante J, Boisson-Dupuis S, Jouanguy E et al. Novel primary immunodeficiencies revealed by the investigation of paediatric infectious diseases. Curr. Opin. Immunol.20(1), 39–48 (2008).
   PubMed Web of Science ®Google Scholar
• Zhang SY, Boisson-Dupuis S, Chapgier A et al. Inborn errors of interferon (IFN)-mediated immunity in humans: insights into the respective roles of IFN-α/β, IFN-γ, and IFN-λ in host defense. Immunol. Rev.226, 29–40 (2008).
   PubMed Web of Science ®Google Scholar
• Fortin A, Abel L, Casanova JL, Gros P. Host genetics of mycobacterial diseases in mice and men: forward genetic studies of BCG-osis and tuberculosis. Ann. Rev. Genomics Hum. Genet.8, 163–192 (2007).
   PubMedGoogle Scholar
• Gordon K, Leonardi C, Lebwohl M et al.. The ustekinumab safety experience in patients with moderate-to-severe psoriasis: results from pooled analyses of Phase 2 and 3 clinical trial data. Poster P 1170. Presented at: EADV Annual Congress. Berlin, Germany, 7–11 October 2009.
   Google Scholar
• Warren RB, Brown BC, Lavery D, Griffiths CE. Adalimumab for psoriasis: practical experience in a U.K. tertiary referral centre. Br. J. Dermatol.163(4), 859–862 (2010).
   PubMed Web of Science ®Google Scholar
• Smith CH, Anstey AV, Barker JN et al. British Association of Dermatologists’ guidelines for biologic interventions for psoriasis 2009. Br. J. Dermatol.161(5), 987–1019 (2009).
   PubMed Web of Science ®Google Scholar
• Lebwohl M, Bagel J, Gelfand JM et al. From the Medical Board of the National Psoriasis Foundation: monitoring and vaccinations in patients treated with biologics for psoriasis. J. Am. Acad. Dermatol.58(1), 94–105 (2008).
   PubMed Web of Science ®Google Scholar
• Doherty SD, Van Voorhees A, Lebwohl MG et al. National Psoriasis Foundation consensus statement on screening for latent tuberculosis infection in patients with psoriasis treated with systemic and biologic agents. J. Am. Acad. Dermatol.59(2), 209–217 (2008).
   PubMed Web of Science ®Google Scholar
• Koutruba N, Emer J, Lebwohl M. Review of ustekinumab, an interleukin-12 and interleukin-23 inhibitor used for the treatment of plaque psoriasis. Ther. Clin. Risk Manag.6, 123–141 (2010).
   PubMed Web of Science ®Google Scholar
• Weiss JM, Subleski JJ, Wigginton JM, Wiltrout RH. Immunotherapy of cancer by IL-12-based cytokine combinations. Expert Opin. Biol. Ther.7(11), 1705–1721 (2007).
   PubMed Web of Science ®Google Scholar
• Chien AL, Elder JT, Ellis CN. Ustekinumab: a new option in psoriasis therapy. Drugs69(9), 1141–1152 (2009).
   PubMed Web of Science ®Google Scholar
• Cardenes M, Angel-Moreno A, Fieschi C et al. Oesophageal squamous cell carcinoma in a young adult with IL-12R β 1 deficiency. J. Med. Genet.47(9), 635–637 (2010).
   PubMedGoogle Scholar
• Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH. Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a Phase II, double-blind, placebo-controlled, randomised, dose-ranging study. Lancet Neurol.7(9), 796–804 (2008).
   PubMed Web of Science ®Google Scholar
• Li J, Gran B, Zhang GX et al. Differential expression and regulation of IL-23 and IL-12 subunits and receptors in adult mouse microglia. J. Neurol. Sci.215(1–2), 95–103 (2003).
   PubMed Web of Science ®Google Scholar
• Segal BM, Shevach EM. IL-12 unmasks latent autoimmune disease in resistant mice. J. Exp. Med.184(2), 771–775 (1996).
   PubMed Web of Science ®Google Scholar
• Lee TS, Yen HC, Pan CC, Chau LY. The role of interleukin 12 in the development of atherosclerosis in ApoE-deficient mice. Arterioscler. Thromb. Vasc. Biol.19(3), 734–742 (1999).
   PubMed Web of Science ®Google Scholar
• Hauer AD, Uyttenhove C, de Vos P et al. Blockade of interleukin-12 function by protein vaccination attenuates atherosclerosis. Circulation112(7), 1054–1062 (2005).
   PubMed Web of Science ®Google Scholar
• Gordon K, Leonardi C, Griffiths CE et al. P-560 – ustekinumab safety update: cumulative experience from longer term follow-up of patients treated in the ustekinumab psoriasis clinical development program. Presented at: European Academy of Dermatology and Venereology. Gothenberg, Sweden, 6–10 October 2010.
   Google Scholar
• Ghislain PD, Poulin Y, Wasel N et al. P589 – maintanence of long-term efficacy of ustekinumab through year 3 for patients with moderate-to-severe psoriasis. Presented at: European Academy of Dermatology and Venereology. Gothenberg, Sweden, 6–10 October 2010.
   Google Scholar
• Downs AM. Observational case series on a group of patients with severe psoriasis who failed to respond to antitumour necrosis factor α biologics and switched to ustekinumab. Br. J. Dermatol.163(2), 433–434 (2010).
   PubMedGoogle Scholar
• Clemmensen A, Spon M, Skov L, Zachariae C, Gniadecki R. Responses to ustekinumab in the anti-TNF agent-naive vs. anti-TNF agent-exposed patients with psoriasis vulgaris. J. Eur. Acad. Dermatol. Venereol. DOI: 10.1111/j.1468-3083.2010.03914.x (2010) (Epub ahead of print).
   PubMedGoogle Scholar
• Smith RL, Warren RB, Griffiths CE, Worthington J. Genetic susceptibility to psoriasis: an emerging picture. Genome Med.1(7), 72 (2009).
   PubMedGoogle Scholar
• Warren RB, Smith RL, Campalani E et al. Outcomes of methotrexate therapy for psoriasis and relationship to genetic polymorphisms. Br. J. Dermatol.160(2), 438–441 (2009).
   PubMed Web of Science ®Google Scholar
• Ryan C, Menter A, Warren RB. The latest advances in pharmacogenetics and pharmacogenomics in the treatment of psoriasis. Mol. Diagn. Ther.14(2), 81–93 (2010).
   PubMed Web of Science ®Google Scholar
• Warren RB, Smith RL, Campalani E et al. Genetic variation in efflux transporters influences outcome to methotrexate therapy in patients with psoriasis. J. Invest. Dermatol.128(8), 1925–1929 (2008).
   PubMed Web of Science ®Google Scholar
• Zaba LC, Suarez-Farinas M, Fuentes-Duculan J et al. Effective treatment of psoriasis with etanercept is linked to suppression of IL-17 signaling, not immediate response TNF genes. J. Allergy Clin. Immunol.124(5), 1022–1010; e1–e395 (2009).
   PubMed Web of Science ®Google Scholar
• Boy MG, Wang C, Wilkinson BE et al. Double-blind, placebo-controlled, dose-escalation study to evaluate the pharmacologic effect of CP-690,550 in patients with psoriasis. J. Invest. Dermatol.129(9), 2299–2302 (2009).
   PubMed Web of Science ®Google Scholar