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

Journal of the American Academy of Dermatology - Tập 76 - Trang 405-417 - 2017
Andrew Blauvelt1, Kim A. Papp2, Christopher E.M. Griffiths3, Bruce Randazzo4,5, Yasmine Wasfi4, Yaung-Kaung Shen4, Shu Li4, Alexa B. Kimball6
1Oregon Medical Research Center, Portland, Oregon
2K. Papp Clinical Research and Probity Research Inc, Waterloo, Ontario, Canada
3Dermatology Center, Salford Royal Hospital, University of Manchester, Manchester Academic Health Science Center, Manchester, United Kingdom
4Janssen Research & Development, LLC, Spring House, Pennsylvania
5Department of Dermatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
6Department of Dermatology, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, Massachusetts

Tài liệu tham khảo

World Health Organization. Global report on psoriasis. Available from: http://apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf. Accessed May 31, 2016. Kragballe, 2013, Long-term management of scalp psoriasis: perspectives from the international psoriasis council, J Dermatol Treat, 24, 188, 10.3109/09546634.2012.681017 Tan, 2012, Nail psoriasis: a review, Am J Clin Dermatol, 13, 375, 10.2165/11597000-000000000-00000 Chung, 2014, Palmoplantar psoriasis is associated with greater impairment of health-related quality of life compared with moderate to severe plaque psoriasis, J Am Acad Dermatol, 71, 623, 10.1016/j.jaad.2014.04.063 Wozel, 2008, Psoriasis treatment in difficult locations: scalp, nails, and intertriginous areas, Clin Dermatol, 26, 448, 10.1016/j.clindermatol.2007.10.026 Nestle, 2009, Psoriasis, N Engl J Med, 361, 496, 10.1056/NEJMra0804595 Zheng, 2007, Interleukin-22, a THl7 cytokine, mediates IL-23-induced dermal inflammation and acanthosis, Nature, 445, 648, 10.1038/nature05505 Lyakh, 2008, Regulation of interleukin-12/interleukin-23 production and the T-helper 17 response in humans, Immunol Rev, 226, 112, 10.1111/j.1600-065X.2008.00700.x Reich, 2005, Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicenter, double-blind trial, Lancet, 366, 1367, 10.1016/S0140-6736(05)67566-6 Papp, 2005, A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction, Br J Dermatol, 152, 1304, 10.1111/j.1365-2133.2005.06688.x Menter, 2008, Adalimumab therapy for moderate to severe psoriasis: a randomized, controlled phase III trial, J Am Acad Dermatol, 58, 106, 10.1016/j.jaad.2007.09.010 Leonardi, 2008, Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomized, double-blind, placebo-controlled trial (PHOENIX 1), Lancet, 371, 1665, 10.1016/S0140-6736(08)60725-4 Papp, 2008, Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomized, double-blind, placebo-controlled trial (PHOENIX 2), Lancet, 371, 1675, 10.1016/S0140-6736(08)60726-6 Langley, 2014, Secukinumab in plaque psoriasis–results of two phase 3 trials, N Engl J Med, 371, 326, 10.1056/NEJMoa1314258 Griffiths, 2015, Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomized trials, Lancet, 386, 541, 10.1016/S0140-6736(15)60125-8 Lebwohl, 2015, Phase 3 studies comparing brodalumab with ustekinumab in psoriasis, N Engl J Med, 373, 1318, 10.1056/NEJMoa1503824 Kopp, 2015, Clinical improvement in psoriasis with specific targeting of interleukin-23, Nature, 521, 222, 10.1038/nature14175 Sofen, 2014, Guselkumab (an IL-23-specific mAb) demonstrates clinical and molecular response in patients with moderate-to-severe psoriasis, J Allergy Clin Immunol, 133, 1032, 10.1016/j.jaci.2014.01.025 Gordon, 2015, A phase 2 trial of guselkumab versus adalimumab for plaque psoriasis, N Engl J Med, 373, 136, 10.1056/NEJMoa1501646 Krueger, 2015, 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, 136, 116, 10.1016/j.jaci.2015.01.018 Papp, 2015, Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial, Br J Dermatol, 173, 930, 10.1111/bjd.13932 Teng, 2015, IL-12 and IL-23 cytokines: from discovery to targeted therapies for immune-mediated inflammatory diseases, Nature Med, 21, 719, 10.1038/nm.3895 Reich, 2017, J Am Acad Dermatol, 76, 418, 10.1016/j.jaad.2016.11.042 Fredriksson, 1978, Severe psoriasis – oral therapy with a new retinoid, Dermatologica, 157, 238, 10.1159/000250839 Rich, 2003, Nail Psoriasis Severity Index: a useful tool for evaluation of nail psoriasis, J Am Acad Dermatol, 49, 206, 10.1067/S0190-9622(03)00910-1 Finlay, 1994, Dermatology Life Quality Index (DLQI)–a simple practical measure for routine clinical use, Clin Exp Dermatol, 19, 210, 10.1111/j.1365-2230.1994.tb01167.x Mathias, 2016, Measurement properties of a patient reported outcome measure assessing psoriasis severity: the Psoriasis Symptoms and Signs Diary, J Dermatol Treat, 27, 322, 10.3109/09546634.2015.1114567 Feldman, 2016, Development of a patient-reported outcome questionnaire for use in adults with moderate-to-severe plaque psoriasis: the Psoriasis Symptoms and Signs Diary, J Dermatol Surg, 20, 19, 10.1016/j.jdds.2015.07.004 Revicki, 2008, Relationship between clinical response to therapy and health-related quality of life outcomes in patients with moderate to severe plaque psoriasis, Dermatology, 216, 260, 10.1159/000113150 Viswanathan, 2015, Total skin clearance results in improvements in health-related quality of life and reduced symptom severity among patients with moderate to severe psoriasis, J Dermatol Treat, 26, 235, 10.3109/09546634.2014.943687 Blauvelt, 2015, IL-23/IL-17A dysfunction phenotypes Inform possible clinical effects from anti-IL-17A therapies, J Investig Dermatol, 135, 1946, 10.1038/jid.2015.144 Aggarwal, 2003, Interleukin-23 promotes a distinct CD4 T cell activation state characterized by the production of Interleukin-17, J Biol Chem, 278, 1910, 10.1074/jbc.M207577200 Wilson, 2007, Development, cytokine profile and function of human interleukin 17–producing helper T cells, Nature Immunol, 8, 950, 10.1038/ni1497 Ness-Schwickerath, 2010, Cytokine requirements for the differentiation and expansion of IL-17A- and IL-22-producing human Vgamma2Vdelta2 T cells, J Immunol, 184, 7268, 10.4049/jimmunol.1000600 Villanova, 2014, Characterization of innate lymphoid cells in human skin and blood demonstrates increase of NKp44+ ILC3 in psoriasis, J Investig Dermatol, 134, 984, 10.1038/jid.2013.477 Ward, 2014, A new player on the psoriasis block: IL-17A- and IL-22-producing innate lymphoid cells, J Investig Dermatol, 134, 2305, 10.1038/jid.2014.216 Teunissen, 2014, Composition of innate lymphoid cell subsets in the human skin: enrichment of NCR+ ILC3 in lesional skin and blood of psoriasis patients, J Investig Dermatol, 134, 2351, 10.1038/jid.2014.146 Blauvelt, 2007, New concepts in the pathogenesis and treatment of psoriasis: key roles for IL-23, IL-17A, and TGF-β1, Expert Rev Dermatol, 2, 69, 10.1586/17469872.2.1.69 2002 1998 1998 2015 2016 Papp, 2015, Safety surveillance for ustekinumab and other psoriasis treatments from the Psoriasis Longitudinal Assessment and Registry (PSOLAR), J Drugs Dermatol, 14, 706 Kimball, 2013, Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis treated for up to 5 years in the PHOENIX 1 study, J Eur Acad Dermatol Venereol, 27, 1535, 10.1111/jdv.12046 Langley, 2015, Long-term efficacy and safety of ustekinumab, with and without dosing adjustment, in patients with moderate-to-severe psoriasis: results from the PHOENIX 2 study through 5 years of follow-up, Br J Dermatol, 172, 1371, 10.1111/bjd.13469