Efficacy and safety of ustekinumab for the treatment of moderate-to-severe psoriasis: A phase III, randomized, placebo-controlled trial in Taiwanese and Korean patients (PEARL)

Journal of Dermatological Science - Tập 63 - Trang 154-163 - 2011
Tsen-Fang Tsai1, Ji-Chen Ho2, Michael Song3, Philippe Szapary3, Cynthia Guzzo3, Yuang-Kuang Shen3, Shu Li3, Kwang-Joong Kim4, Tae-Yoon Kim5, Jee-Ho Choi6, Jai-Il Youn7
1Department of Dermatology, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan
2Department of Dermatology, Chang-Gung Memorial Hospital, Kaohsiung Medical Center, Taiwan
3Centocor Research & Development, Inc., Malvern, PA, United States
4Hallyam University Sacred Heart Hospital, Gyeonggi-Do, Republic of Korea
5Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea
6Asan Medical Center, Seoul, Republic of Korea
7Seoul National University College of Medicine, Seoul, Republic of Korea

Tài liệu tham khảo

Menter, 2008, Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics, J Am Acad Dermatol, 58, 826, 10.1016/j.jaad.2008.02.039 Schön, 2005, Engl J Med, 352, 1899, 10.1056/NEJMra041320 Hong, 2008, The psychosocial and occupational impact of chronic skin disease, Dermatol Ther, 21, 54, 10.1111/j.1529-8019.2008.00170.x Kimball, 2005, The psychosocial burden of psoriasis, Am J Clin Dermatol, 6, 383, 10.2165/00128071-200506060-00005 Koo, 1996, Population-based epidemiologic study of psoriasis with emphasis on quality of life assessment, Dermatol Clin, 14, 485, 10.1016/S0733-8635(05)70376-4 Tsai, 2005, Current status and prospect for psoriasis treatment in Taiwan, Dermatol Sinica, 23, 69 Lew, 2004, Psoriasis vulgaris: cutaneous lymphoid tissue supports T-cell activation and “Type 1” inflammatory gene expression, Trends Immunol, 25, 295, 10.1016/j.it.2004.03.006 Bissonnette, 2009, Safety of conventional systemic agents and biologic agents in the treatment of psoriasis, J Cutan Med Surg, 13, S67, 10.2310/7750.2009.00023 Thaçi, 2008, Long-term data in the treatment of psoriasis, Br J Dermatol, 159, 18, 10.1111/j.1365-2133.2008.08781.x Tsai, 2009, The use of biologics for psoriasis in Asia-Pacific region, Curr Rheumatol Rev, 5, 149, 10.2174/157339709789208615 Asahina, 2010, Adalimumab in Japanese patients with moderate to severe chronic plaque psoriasis: efficacy and safety results from a Phase II/III randomized controlled study, J Dermatol, 37, 299, 10.1111/j.1346-8138.2009.00748.x Na, 2008, Low-dose etanercept therapy in moderate to severe psoriasis in Korean, J Dermatol, 35, 484, 10.1111/j.1346-8138.2008.00508.x Torii, 2010, Infliximab monotherapy in Japanese patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. A randomized, double-blind, placebo-controlled multicenter trial, J Dermatol Sci, 59, 40, 10.1016/j.jdermsci.2010.04.014 Huang, 2008, Clinical effectiveness and safety experience with alefacept in the treatment of patients with moderate-to-severe chronic plaque psoriasis in Taiwan: results of an open-label, single-arm, multicentre pilot study, J Eur Acad Dermatol Venereol, 22, 923, 10.1111/j.1468-3083.2007.02575.x Tsai, 2008, Clinical effectiveness and safety experience with efalizumab in the treatment of patients with moderate-to-severe plaque psoriasis in Taiwan: results of an open-label, single-arm pilot study, J Eur Acad Dermatol Venereol, 22, 345, 10.1111/j.1468-3083.2007.02430.x Oppmann, 2000, Novel p19 protein engages IL-12p40 to form a cytokine, IL-23, with biological activities similar as well as distinct from IL-12, Immunity, 13, 715, 10.1016/S1074-7613(00)00070-4 Yawalkar, 1998, Expression of interleukin-12 is increased in psoriatic skin, J Invest Dermatol, 111, 1053, 10.1046/j.1523-1747.1998.00446.x Lee, 2004, Increased expression of interleukin 23 p19 and p40 in lesional skin of patients with psoriasis vulgaris, J Exp Med, 199, 125, 10.1084/jem.20030451 Piskin, 2006, In vitro and in situ expression of IL-23 by keratinocytes in healthy skin and psoriasis lesions: enhanced expression in psoriatic skin, J Immunol, 176, 1908, 10.4049/jimmunol.176.3.1908 Hong, 1999, IL-12, independently of IFN-γ, plays a crucial role in the pathogenesis of a murine psoriasis-like skin disorder, J Immunol, 162, 7480, 10.4049/jimmunol.162.12.7480 Aggarwall, 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 Trinchieri, 2003, Interleukin-12 and the regulation of innate resistance and adaptive immunity, Nat Rev Immunol, 3, 133, 10.1038/nri1001 Tada, 2006, Interleukin-12 production by monocytes from patients with psoriasis and its inhibition by ciclosporin A, Br J Dermatol, 154, 1180, 10.1111/j.1365-2133.2006.07180.x Liu, 2008, A genome-wide association study of psoriasis and psoriatic arthritis identifies new disease loci, PLoS Genet, 4, e1000041, 10.1371/journal.pgen.1000041 Nair, 2010, Genetic evidence for involvement of the IL23 pathway in Thai psoriatics, Arch Dermatol Res, 302, 139, 10.1007/s00403-009-0986-y Krueger, 2007, A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis, N Engl J Med, 356, 580, 10.1056/NEJMoa062382 Leonardi, 2008, 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, 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 randomised, double-blind, placebo-controlled trial (PHOENIX 2), Lancet, 371, 1675, 10.1016/S0140-6736(08)60726-6 Griffiths, 2010, Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis, N Engl J Med, 362, 118, 10.1056/NEJMoa0810652 Data on file. Centocor Research & Development. Fredriksson, 1978, Severe psoriasis: oral therapy with a new retinoid, Dermatologica, 157, 238, 10.1159/000250839 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 Lebwohl, 2010, Ustekinumab improves health-related quality of life in patients with moderate-to-severe psoriasis: results from the PHOENIX 1 trial, Br J Dermatol, 162, 137, 10.1111/j.1365-2133.2009.09491.x Langley, 2010, 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, 457, 10.1016/j.jaad.2009.09.014 Chang, 2009, Epidemiological study of psoriasis in the national health insurance database in Taiwan, Acta Derm Venereol, 89, 262, 10.2340/00015555-0642 Tsai, 2011, Epidemiology and comorbidities of psoriasis patients in a National Database in Taiwan, J Dermatol Sci, 63, 40, 10.1016/j.jdermsci.2011.03.002 Nolan, 1999, Hepatotoxicity associated with isoniazid preventive therapy: a 7-year survey from a public health tuberculosis clinic, JAMA, 281, 1014, 10.1001/jama.281.11.1014 Chiu HY, Hsueh PR, Tsai TF. Clinical experience of QuantiFERON®-TB Gold testing in psoriasis patients treated with tumour necrosis factor blockers in Taiwan. Br J Dermatol; 2011;164:553-9. Kimball, 2008, National Psoriasis Foundation clinical consensus on psoriasis comorbidities and recommendations for screening, J Am Acad Dermatol, 58, 1031, 10.1016/j.jaad.2008.01.006 Gelfand, 2006, Risk of myocardial infarction in patients with psoriasis, JAMA, 296, 1735, 10.1001/jama.296.14.1735 Neimann, 2006, Prevalence of cardiovascular risk factors in patients with psoriasis, J Am Acad Dermatol, 55, 829, 10.1016/j.jaad.2006.08.040 Lin, 2011, Increased risk of acute myocardial infarction in patients with psoriasis: a 5-year population-based study in Taiwan, J Am Acad Dermatol, 64, 495, 10.1016/j.jaad.2010.01.050 Lebwohl M, Leonardi C, Griffiths CE, Prinz JC, Szapary PO, Yeilding N, et al. Long-term safety experience of ustekinumab in patients with moderate-to-severe psoriasis (Part I of II): results from analyses of general safety parameters from pooled Phase 2 and 3 clinical trials. J Am Acad Dermatol; in press. Gordon KB, Papp KA, Langley RG, Ho V, Kimball AB, Guzzo C, et al. Long-term safety experience of ustekinumab in patients with moderate-to-severe psoriasis (Part II of II): results from analyses of infections and malignancy from pooled Phase 2 and 3 clinical trials. J Am Acad Dermatol; in press. Reich, 2011, Cardiovascular safety of ustekinumab in patients with moderate-to-severe psoriasis: results of integrated analyses of data from phase II and III clinical studies, Br J Dermatol, 164, 862, 10.1111/j.1365-2133.2011.10257.x Lebwohl, 2010, 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, 571, 10.1016/j.jaad.2009.11.012 Lin, 2003, Prevalence of overweight and obesity and its associated factors: findings from National Nutrition and Health Survey in Taiwan, 1993–1996, Prev Med, 37, 233, 10.1016/S0091-7435(03)00119-1