Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo- and active comparator–controlled VOYAGE 2 trial

Journal of the American Academy of Dermatology - Tập 76 - Trang 418-431 - 2017
Kristian Reich1, April W. Armstrong2, Peter Foley3,4, Michael Song5, Yasmine Wasfi5, Bruce Randazzo5, Shu Li5, Y.-K. Shen5, Kenneth B. Gordon6
1Dermatologikum Hamburg and SCIderm Research Institute, Hamburg, Germany
2University of Southern California, Los Angeles, California
3University of Melbourne, St Vincent’s Hospital, Melbourne, Australia
4Skin and Cancer Foundation Inc, Carlton, Australia
5Janssen Research & Development, LLC, Spring House, Pennsylvania
6Northwestern University Feinberg School of Medicine, Chicago, Illinois

Tài liệu tham khảo

Lebwohl, 2016, US perspectives in the management of psoriasis and psoriatic arthritis: patient and physician results from the population-based multinational assessment of psoriasis and psoriatic arthritis (MAPP) survey, Am J Clin Dermatol, 17, 87, 10.1007/s40257-015-0169-x Kragballe, 2014, Unmet needs in the treatment of psoriasis, Eur J Dermatol, 24, 523, 10.1684/ejd.2014.2403 Blome, 2016, Patient-relevant treatment goals in psoriasis, Arch Dermatol Res, 308, 69, 10.1007/s00403-015-1613-8 Strober, 2016, Clinical meaningfulness of complete skin clearance in psoriasis, J Am Acad Dermatol, 75, 77, 10.1016/j.jaad.2016.03.026 Bartos, 2016, Review of maintenance of response to psoriasis treatments, J Dermatolog Treat, 27, 293, 10.1080/09546634.2016.1177158 Gniadecki, 2015, Comparison of long-term drug survival and safety of biologic agents in patients with psoriasis vulgaris, Br J Dermatol, 172, 244, 10.1111/bjd.13343 Gordon, 2015, A phase 2 trial of guselkumab versus adalimumab for plaque psoriasis, N Engl J Med, 373, 136, 10.1056/NEJMoa1501646 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 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 Lebwohl, 2015, Phase 3 studies comparing brodalumab with ustekinumab in psoriasis, N Engl J Med, 373, 1318, 10.1056/NEJMoa1503824 Leonardi, 2012, Anti-interleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis, N Engl J Med, 366, 1190, 10.1056/NEJMoa1109997 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 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 Langley, 2014, Secukinumab in plaque psoriasis–results of two phase 3 trials, N Engl J Med, 371, 326, 10.1056/NEJMoa1314258 Blauvelt, 2017, Efficacy and safety of guselkumab, an anti-IL-23 monoclonal antibody, compared with adalimumab for the continuous treatment of moderate-to-severe psoriasis: results from the phase III VOYAGE 1 trial, J Am Acad Dermatol, 76, 405, 10.1016/j.jaad.2016.11.041 Brezinski, 2012, Off-label biologic regimens in psoriasis: a systematic review of efficacy and safety of dose escalation, reduction, and interrupted biologic therapy, PLoS One, 7, e33486, 10.1371/journal.pone.0033486 Doshi, 2016, Biologic therapy adherence, discontinuation, switching, and restarting among patients with psoriasis in the US Medicare population, J Am Acad Dermatol, 74, 1057, 10.1016/j.jaad.2016.01.048 Bonafede, 2013, Treatment patterns with etanercept and adalimumab for psoriatic diseases in a real-world setting, J Dermatolog Treat, 24, 369, 10.3109/09546634.2012.755255 Svedbom, 2015, Treatment patterns with topicals, traditional systemics and biologics in psoriasis - a Swedish database analysis, J Eur Acad Dermatol Venereol, 29, 215, 10.1111/jdv.12494 Ware, 1992, The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection, Med Care, 30, 473, 10.1097/00005650-199206000-00002 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 Dermatolog 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 Dermatol Surg, 20, 19, 10.1016/j.jdds.2015.07.004 Gordon, 2006, Clinical response in psoriasis patients discontinued from and then reinitiated on etanercept therapy, J Dermatolog Treat, 17, 9, 10.1080/09546630500472838 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 Menter, 2007, A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis, J Am Acad Dermatol, 56, 31.e1, 10.1016/j.jaad.2006.07.017 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 Brunner, 2013, Infliximab induces downregulation of the IL-12/IL-23 axis in 6-sulfo-LacNac (slan)+ dendritic cells and macrophages, J Allergy Clin Immunol, 132, 1184, 10.1016/j.jaci.2013.05.036 Reich, 2015, Evidence that a neutrophil-keratinocyte crosstalk is an early target of IL-17A inhibition in psoriasis, Exp Dermatol, 24, 529, 10.1111/exd.12710 Miossec, 2009, Interleukin-17 and type 17 helper T cells, N Engl J Med, 361, 888, 10.1056/NEJMra0707449 Zheng, 2007, Interleukin-22, a T(H)17 cytokine, mediates IL-23-induced dermal inflammation and acanthosis, Nature, 445, 648, 10.1038/nature05505