A Review of Biologic Therapies Targeting IL-23 and IL-17 for Use in Moderate-to-Severe Plaque Psoriasis

Dermatology and Therapy - Tập 6 Số 1 - Trang 1-12 - 2016
Molly Campa1, Bobbak Mansouri2, Debabrata Bandyopadhyay3, Alan Menter1
1Division of Dermatology, Baylor University Medical Center, Dallas, TX, USA
2Department of Dermatology, Baylor Scott and White Medical Center, Temple, TX, USA
3University of Manchester, Manchester, UK

Tóm tắt

Từ khóa


Tài liệu tham khảo

Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009;361(5):496–509.

Bos JD, De Rie MA. The pathogenesis of psoriasis: immunological facts and speculations. Immunol Today. 1999;20(1):40–6.

Christophers E. Psoriasis—epidemiology and clinical spectrum. Clin Exp Dermatol. 2001;26(4):314–20.

Kurd SK, Gelfand JM. The prevalence of previously diagnosed and undiagnosed psoriasis in US adults: results from NHANES 2003–2004. J Am Acad Dermatol. 2009;60(2):218–24.

Koo J. Population-based epidemiologic study of psoriasis with emphasis on quality of life assessment. Dermatol Clin. 1996;14(3):485–96.

Villasenor-Park J, Wheeler D, Grandinetti L. Psoriasis: evolving treatment for a complex disease. Cleve Clin J Med. 2012;79(6):413–23.

Mahil SK, Capon F, Barker JN. Genetics of psoriasis. Dermatol Clin. 2015;33(1):1–11.

Sharma J, Balakrishnan L, Datta KK, et al. A knowledgebase resource for interleukin-17 family mediated signaling. J Cell Commun Signal. 2015;9(3):291–6.

Lowes MA, Russell CB, Martin DA, Towne JE, Krueger JG. The IL-23/T17 pathogenic axis in psoriasis is amplified by keratinocyte responses. Trends Immunol. 2013;34(4):174–81.

Chandrakumar SF, Yeung J. Interleukin-17 antagonists in the treatment of psoriasis. J Cutan Med Surg. 2015;19(2):109–14.

Grine L, Dejager L, Libert C, Vandenbroucke RE. An inflammatory triangle in psoriasis: TNF, type I IFNs and IL-17. Cytokine Growth Factor Rev. 2015;26(1):25–33.

Teng MW, Bowman EP, McElwee JJ, et al. IL-12 and IL-23 cytokines: from discovery to targeted therapies for immune-mediated inflammatory diseases. Nat Med. 2015;21(7):719–29.

Malakouti M, Brown GE, Wang E, Koo J, Levin EC. The role of IL-17 in psoriasis. J Dermatol Treat. 2015;26(1):41–4.

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):650–7.

Isailovic N, Daigo K, Mantovani A, Selmi C. Interleukin-17 and innate immunity in infections and chronic inflammation. J Autoimmun. 2015;60:1–11.

Lin AM, Rubin CJ, Khandpur R, et al. Mast cells and neutrophils release IL-17 through extracellular trap formation in psoriasis. J Immunol (Baltimore, Md: 1950). 2011;187(1):490–500.

Ratner M. IL-17-targeting biologics aim to become standard of care in psoriasis. Nat Biotechnol. 2015;33(1):3–4.

Mansikka H RM, Hugunin M, Ivanov A, Brito A, Clabbers A, Cuff C, Hsieh CM, Okun M, Heuser R, Carter D, Hendrickson B, Pisal D, Goss S, Liu J, Locke C, Khan N, Padley R. Safety, tolerability, and functional activity of ABT-122, a dual TNF- and IL-17A-targeted DVD-Ig™, following single-dose administration in healthy subjects. Boston: American College of Rheumatology 2014 Annual Meeting; 2014.

Clincal Trial NCT02349451. http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02349451 . Accessed 1 June 2015.

Stelara® (ustekinumab) [prescribing information]. Beerse, Belgium: Janssen Biotech; 2009. http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261lbl.pdf . Accessed 12 Aug 2015.

European Public Assessments Reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&mid=WC0b01ac058001d124&searchTab=&alreadyLoaded=true&isNewQuery=true&status=Authorised&keyword=Enter+keywords&searchType=name&taxonomyPath=Diseases.Skin+and+Connective+Tissue+Diseases.Skin+Diseases.Skin+Diseases%2C+Papulosquamous&treeNumber=&currentCategory=Psoriasis&searchGenericType=generics . Accessed 8 Sept 2015.

Papp KA, Griffiths CE, Gordon K, et al. Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: final results from 5 years of follow-up. Br J Dermatol. 2013;168(4):844–54.

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(9625):1665–74.

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(9625):1675–84.

Griffiths CE, Strober BE, van de Kerkhof P, et al. Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. N Engl J Med. 2010;362(2):118–28.

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):706–14.

Paul C, Puig L, Kragballe K, et al. Transition to ustekinumab in patients with moderate-to-severe psoriasis and inadequate response to methotrexate: a randomized clinical trial (TRANSIT). Br J Dermatol. 2014;170(2):425–34.

Wilder EG, Patel M, Hebeler K, Menter A. Ustekinumab treatment for psoriasis in 119 patients maintained on therapy for a minimum of one year: a review. J Drugs Dermatol. 2014;13(8):905–10.

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 Dermatol Treat. 2015;26(6):493–501.

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(11):2632–40.

Gniadecki R, Bang B, Bryld LE, et al. Comparison of long-term drug survival and safety of biologic agents in patients with psoriasis vulgaris. Br J Dermatol. 2015;172(1):244–52.

Ryan C, Leonardi CL, Krueger JG, et al. Association between biologic therapies for chronic plaque psoriasis and cardiovascular events: a meta-analysis of randomized controlled trials. JAMA. 2011;306(8):864–71.

Gordon KB, Langley RG, Gottlieb AB, et al. A phase III, randomized, controlled trial of the fully human IL-12/23 mAb briakinumab in moderate-to-severe psoriasis. J Invest Dermatol. 2012;132(2):304–14.

Strober BE, Crowley JJ, Yamauchi PS, Olds M, Williams DA. Efficacy and safety results from a phase III, randomized controlled trial comparing the safety and efficacy of briakinumab with etanercept and placebo in patients with moderate to severe chronic plaque psoriasis. Br J Dermatol. 2011;165(3):661–8.

Gottlieb AB, Leonardi C, Kerdel F, et al. Efficacy and safety of briakinumab vs. etanercept and placebo in patients with moderate to severe chronic plaque psoriasis. Br J Dermatol. 2011;165(3):652–60.

Reich K, Langley RG, Papp KA, et al. A 52-week trial comparing briakinumab with methotrexate in patients with psoriasis. N Engl J Med. 2011;365(17):1586–96.

Papp K, Thaci 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):930–9.

Clinical Trial NCT01729754. https://www.clinicaltrials.gov/ct2/show/NCT01729754 . Accessed 11 Sept 2015.

Clinical Trial NCT01722331. https://www.clinicaltrials.gov/ct2/show/NCT01722331 . Accessed 11 Sept 2015.

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):116–24 e7.

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):778–91.

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(2):136–44.

A study of guselkumab in the treatment of participants with moderate to severe plaque-type psoriasis with randomized withdrawal and retreatment (VOYAGE 2), NCT02207244. https://www.clinicaltrials.gov/ct2/show/NCT02207244 . Accessed 22 Aug 2015.

A study of guselkumab in the treatment of participants with moderate to severe plaque-type psoraisis (VOYAGE 1), NCT02207231. https://www.clinicaltrials.gov/ct2/show/NCT02207231 . Accessed 22 Aug 2015.

A study of guselkumab in participants with moderate to severe plaque-type psoriasis and an inadequate response to ustekinumab (NAVIGATE), NCT02203032. https://www.clinicaltrials.gov/ct2/show/NCT02203032 . Accessed 22 Aug 2015.

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):326–38.

Cosentyx™ (secukinumab) [prescribing information]. Basel SN. http://www.pharma.us.novartis.com/product/pi/pdf/cosentyx.pdf . Accessed 2 Sept 2015.

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):1693–700.

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):484–93.

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.

Thaci 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):400–9.

Griffiths CE, Reich K, Lebwohl M, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015;386(9993):541–51.

Papp KA, Leonardi C, Menter A, et al. Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis. N Engl J Med. 2012;366(13):1181–9.

Amgen to terminate participation in co-development and commercialization of brodalumab [press release]. Thousand Oaks, California: PRNewswire; 22 May 2015.

AstraZeneca and Valeant Pharmaceuticals to partner on brodalumab [press release]; 1 September 2015.

Papp K, Leonardi C, Menter A, et al. Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment. J Am Acad Dermatol. 2014;71(6):1183–90 e3.

Papp K, Menter A, Strober B, et al. Efficacy and safety of brodalumab in subpopulations of patients with difficult-to-treat moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2015;72(3):436–9 e1.

Papp K RK, Leonardi C, Paul C, Blauvelt A, Baran W, Bolduc C, Toth D, Langley RG, Cather J, Gottlieb A, Thaci D, Milmont CE, Li J, Klekotka P, Kricorian G, Nirula A. Efficacy and safety of brodalumab in patients with moderate to severe plaque psoriasis: Results of AMAGINE-1, a phase 3, randomized, double-blind, placebo-controlled study through week 12. San Francisco, CA: American Academy of Dermatology Annual Meeting; 20–24 March; 2015.

Amgen and AstraZeneca announce positive results from Phase III study of brodalumab (AMG 827) in patients with moderate-to-severe plaque psoriasis [press release]. AstraZenca Global; 9 May 2014.

Lebwohl M, Strober B, Menter A, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med. 2015;373(14):1318–28.