Ustekinumab improves health-related quality of life in Korean and Taiwanese patients with moderate to severe psoriasis: Results from the PEARL trial

Journal of Drugs in Dermatology

Volumn 11, Issue 8, 2012, Pages 943-949

  Tsai, Tsen Fang ^a   Song, Michael ^b   Shen, Yaung Kaung ^b   Schenkel, Brad ^c   Choe, Yong Beom ^d   Kim, Nack In ^e   Lee, Joo Heung ^f   Lee, Ju Hee ^g   Song, Hae Jun ^h   Youn, Jai Il ⁱ  

^a NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^b JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^c Janssen Scientific Affairs LLC   (United States)

^d Konkuk University School of Medicine   (South Korea)

^e Kyung Hee University College of Medicine   (South Korea)

^f Sungkyunkwan University   (South Korea)

^g Yonsei University College of Medicine   (South Korea)

^h Korea University College of Medicine   (South Korea)

ⁱ Seoul National University   (South Korea)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; USTEKINUMAB;

ADULT; ARTICLE; ASIAN; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; ETHNIC DIFFERENCE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL; PSORIASIS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SELF REPORT; SOUTH KOREA; STATISTICAL SIGNIFICANCE; TREATMENT DURATION; TREATMENT OUTCOME;

ADULT; ANTIBODIES, MONOCLONAL; DERMATOLOGIC AGENTS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; PSORIASIS; QUALITY OF LIFE; REPUBLIC OF KOREA; SELF REPORT; SEVERITY OF ILLNESS INDEX; STATISTICS, NONPARAMETRIC; TAIWAN;

EID: 84864768280     PISSN: 15459616     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (47)

1. Schmitt J, Ford DE. Understanding the relationship between objective disease severity, psoriatic symptoms, illness-related stress, health-related quality of life and depressive symptoms in patients with psoriasis - a structural equations modeling approach. Gen Hosp Psychiatry. 2007;29:134-140.
2. Gelfand JM, Gladman DD, Mease PJ, et al. Epidemiology of psoriatic arthritis in the population of the United States. J Am Acad Dermatol. 2005;53:573-577.
3. Neimann AL, Shin DB, Wang X, et al. Prevalence of cardiovascular risk factors in patients with psoriasis. J Am Acad Dermatol. 2006;55:829-835.
4. Kimball AB, Gladman D, Gelfand JM, et al. National Psoriasis Foundation clinical consensus on psoriasis comorbidities and recommendations for screening. J Am Acad Dermatol. 2008;58:1031-1042.
5. Youn JI. Psoriasis in Koreans. In:Eun H-C, Kim S-C, Lee W-S, eds. Asian Skin and Skin Diseases. Special book of the 22nd World Congress of Dermatology, Seoul, Korea:2011:27-37.
6. Hong J, Koo B, Koo J. The psychosocial and occupational impact of chronic skin disease. Dermatol Ther. 2008;21:54-59.
7. Choi J, Koo JYM. Quality of life issues in psoriasis. J Am Acad Dermatol 2003;49:S57-S61.
8. Krueger G, Koo J, Lebwohl M, et al. The impact of psoriasis on quality of life. Arch Dermatol. 2001;137:280-284.
9. Kimball AB, Jacobson C, Weiss S, et al. The psychosocial burden of psoriasis. Am J Clin Dermatol. 2005;6:383-392.
10. De Arruda LHF, De Moraes APF. The impact of psoriasis on quality of life. Br J Dermatol. 2001;144(Suppl 58):33-36.
11. Weiss SC, Kimball AB, Liewehr DJ, et al. Quantifying the harmful effect of psoriasis on health-related quality of life. J Am Acad Dermatol. 2002;47:512-518.
12. Griffiths CEM, Barker JNWN. Pathogenesis and clinical features of psoriasis. Lancet. 2007;370:263-271.
13. Chandran V, Raychaudhuri SP. Geoepidemiology and environmental factors of psoriasis and psoriatic arthritis. J Autoimmun. 2010;34:J314-J321.
14. Gudjonsson JE, Elder JT. Psoriasis:epidemiology. Clin Dermatol 2007;25:535-546.
15. Yip SY. The prevalence of psoriasis in the Mongoloid race. J Am Acad Dermatol. 1984;10:965-968.
16. Kawada A, Tezuka T, Nakamizo Y, et al. A survey of psoriasis in Japan from 1982 to 2001. J Dermatol Sci. 2003;31:59-64.
17. Tsai TF, Wang TS, Hung ST, et al. Epidemiology and comorbidities of psoriasis patients in a national database in Taiwan. J Dermatol Sci. 2011;63:40-46.
18. Tsai T-F, Yeh T-Y. The use of biologics for psoriasis in Asia-Pacific region. Curr Rheumatol Rev. 2009;5:149-152.
19. Lew W, Lee E, Krueger JG. Psoriasis genomics: analysis of proinflammatory (type 1) gene expression in large plaque (Western) and small plaque (Asian) psoriasis vulgaris. Br J Dermatol. 2004;150:668-676.
20. Hamamoto Y, Tateno H, Ishida T, Muto M. Lack of association between promoter polymorphism of the tumour necrosis factor-α gene and psoriatic arthritis in Japanese patients. J Invest Dermatol. 2000;115:1162-1163.
21. Jee S-H, Tsai T-F, Tsai W-L, et al. HLA-DRB1*0701 and DRB1*1401 are associated with genetic susceptibility to psoriasis vulgaris in a Taiwanese population. Br J Dermatol. 1998;139:978-983.
22. Tsai T-F, Hu C-Y, Tsai W-L, et al. HLA-Cw6 specificity and polymorphic residues are associated with susceptibility among Chinese psoriatics in Taiwan. Arch Dermatol Res. 2002;294:214-220.
23. Lin T-Y, See L-C, Shen Y-M, Liang C-Y, Chang H-N, Lin Y-K. Quality of life in patients with psoriasis in Northern Taiwan. Chang Gung Med J. 2011:34:186-196.
24. Yang Y, Koh D, Khoo L, Nyuant SZ, Ng V, Goh CL. The psoriasis disability index in Chinese patients:contribution of clinical and psychological variables. Int J Dermatol. 2005;44:925-929.
25. Torii H, Nakagawa H; the Japanese infliximab study investigators. 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. 2010;59:40-49.
26. Huang PH, Liao YH, Wei CC, et al. 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. 2008;22:923-930.
27. Asahina A, Nakagawa H, Etoh T, Ohtsuki M; the adalimumab M04-688 study group. 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. 2010;37:299-310.
28. Tsai TF, Liu MT, Liao YH, Licu D. 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. 2008;22:345-352.
29. Torii H, Sato N, Yoshinari T, et al. Dramatic impact of a Psoriasis Area and Severity Index 90 response on the quality of life in patients with psoriasis: An analysis of Japanese clinical trials of infliximab. J Dermatology. 2011;39:1-7.
30. Tsai T-F, Ho J-C, Song, M, et al; the PEARL investigators. Efficacy and safety of ustekinumb for the treatment of moderate-to-severe psoriasis: a phase III, randomized, placebo-controlled trial in Taiwanese and Korean patients (PEARL). J Dermatol Sci. 2011;63:154-163.
31. Leonardi CL, Kimball AB, Papp K, et al;PHOENIX 1 study investigators. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in psoriasis patients:76-week results from a randomised, doubleblind, placebo-controlled trial (PHOENIX 1). Lancet. 2008;371:1665-1674.
32. Papp KA, Langley RG, Lebwohl M, et al; PHOENIX 2 study investigators. Effi- cacy 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;371:1675-1684.
33. 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. 2010;162:137-146.
34. 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. 2010;63:457-465.
35. Fredriksson T, Pettersson U. Severe psoriasis - oral therapy with a new retinoid. Dermatologica. 1978;157:238-244.
36. Finlay AY, Khan GK. Dermatology life quality index (DLQI) - a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19:210-216.
37. Wang X-L, Zhao T-E, Zhang X-Q. Assessment on the reliability and validity of the Dermatology Life Quality Index in Chinese version. Chin J Epidemiol. 2004;25:791-793.
38. He Z, Lu C, Basra MK, Ou A, Yan Y, Li L. Psychometric properties of the Chinese version of dermatology life quality index (DLQI) in 851 Chinese patients with psoriasis. J Eur Acad Dermatol Venereol. (2011) doi:10.1111/j.1468-3083. 2011.04371.x
39. Hongbo Y, Thomas CL, Harrison MA, et al. Translating the science of quality of life into practice: What do Dermatology Life Quality Index scores mean? J Invest Dermatol. 2005;125:659-664.
40. Basra MKA, Fenech R, Gatt RM, et al. The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 2008;159:997-1035.
41. Finlay AY, Khan GK. Dermatology Life Quality Index: information & conditions concerning use. http://www.dermatology.org.uk/quality/dlqi/ qualitydlqi-info.html. Published December 6, 1993. Accessed October 3, 2011.
42. Shikiar R, Willian MK, Okun MM, et al. The validity and responsiveness of three quality of life measures in the assessment of psoriasis patients: results of a phase II study. Health Qual Life Outcomes. 2006;4:71.
43. Katugampola RP, Lewis VJ, Finlay AY. The Dermatology Life Quality Index: assessing the efficacy of biological therapies for psoriasis. Br J Dermatol. 2007;156:945-950.
44. Igarashi A, Kato T, Kato M, et al; the Japanese ustekinumab study group. Efficacy and safety of ustekinumab in Japanese patients with moderate-to-severe plaque-type psoriasis: long-term results from a phase 2/3 clinical trial. J Dermatol. (2011) doi:10.1111/j.1346-8138.2011.01347.x.
45. Nakagawa H, Schenkel B, Kato M, et al. Impact of ustekinumab on health-related quality of life in Japanese patients with moderate to severe plaque psoriasis:results from a randomized, double-blind, placebo-controlled Phase 2/3 trial. J Dermatol. (2012) doi: 10.1111/j.1346-8138.2012.01521.x.
46. Kimball AB, Krueger G, Woolley JM. The Dermatology Life Quality Index (DLQI) provides qualitatively different information from the PASI. J Amer Acad Dermatol. 2004;50(Suppl):P156.
47. Shah SK, Arthur A, Yang Y-C, Stevens S, Alexis AF. A retrospective study to investigate racial and ethnic variations in the treatment of psoriasis with etanercept. J Drugs Dermatol. 2011;10:866-872.