Reporting of Quality of Life in Clinical Trials of Biologics for Plaque Psoriasis: A Systematic Review
Main Article Content
Keywords
plaque psoriasis, quality of life, Dermatology Life Quality Index, Systematic Review, biologic therapy
Abstract
Background: Psoriasis is a chronic remitting and relapsing skin disease. For many patients, improved quality of life (QoL) is as important as clinical improvement of lesions.
Objective: To review reporting of Dermatology Life Quality Index (DLQI) in randomized controlled trials (RCTs) of biologics for adult patients with plaque psoriasis.
Methods: A systematic review was conducted in 4 databases for RCTs that measured DLQI at baseline and endpoint. A data collection form was created for collecting study variables. Risk of bias was assessed using the Cochrane risk of bias tool.
Results: Thirty-four RCTs enrolling 16,784 patients were included. Complete baseline and final mean DLQI data was retrieved for 24 studies (70.6%). The mean DLQI at baseline was reported in 79.4% of RCTs. The median at baseline was reported in 14.7% of RCTs. The mean DLQI at endpoint was reported in 23.5% of RCTs and the median DLQI at endpoint was reported in 5.9% of RCTs. The mean change in DLQI was reported in 64.7% of RCTs.
Conclusions: DLQI was measured in most clinical trials assessing the efficacy of biologics for psoriasis. Studies did not adhere to uniform standards in publishing results, making analysis of the impact on DLQI challenging.
Key Words: plaque psoriasis, quality of life, Dermatology Life Quality Index, Systematic Review, biologic therapy
References
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2. De arruda LH, De moraes AP. The impact of psoriasis on quality of life. Br J Dermatol. 2001;144 Suppl 58:33-6.
3. Rapp SR, Feldman SR, Exum ML, Fleischer AB, Reboussin DM. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999;41(3 Pt 1):401-7.
4. Langley RG, Krueger GG, Griffiths CE. Psoriasis: epidemiology, clinical features, and quality of life. Ann Rheum Dis. 2005;64 Suppl 2:ii18-23.
5. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210-6.
6. Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 2008 Nov;159(5):997-1035. Epub 2008 Sep 15.
7. Ali FM, Cueva AC, Vyas J, et al. A systematic review of the use of quality-of-life instruments in randomized controlled trials for psoriasis. Br J Dermatol. 2016;
8. Loo WJ, Diba V, Chawla M et al. Dermatology Life Quality Index: influence of an illustrated version. Br J Dermatol 2003; 148:279–84.
9. Smith CH, Anstey AV, Barker JNWN et al. British Association of Dermatologists’ guidelines for biologic interventions for psoriasis. 2009. Br J Dermatol 2009; 161:987–1019.
10. Finlay AY, Basra MKA, Piguet V et al. Dermatology Life Quality Index (DLQI): a paradigm shift to patient-centered outcomes. J Invest Dermatol 2012; 132:2464–5.
11. Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AY. Translating the science of quality of life into practice: What do dermatology life quality index scores mean?. J Invest Dermatol. 2005;125(4):659-64.
12. Mattei PL, Corey KC, Kimball AB. Psoriasis Area Severity Index (PASI) and the Dermatology Life Quality Index (DLQI): the correlation between disease severity and psychological burden in patients treated with biological therapies. J Eur Acad Dermatol Venereol 2014; 28:333–7.
13. Katugampola RP, Lewis VJ, Finlay AY. The Dermatology Life Quality Index: assessing the efficacy of biological therapies for psoriasis. Br J Dermatol. 2007;156(5):945-50.
14. Reich K, Sinclair R, Roberts G, Griffiths CE, Tabberer M, Barker J. Comparative effects of biological therapies on the severity of skin symptoms and health-related quality of life in patients with plaque-type psoriasis: a meta-analysis. Curr Med Res Opin. 2008;24(5):1237-54.
15. Korman NJ, Zhao Y, Roberts J, et al. Impact of psoriasis flare and remission on quality of life and work productivity: a real-world study in the USA. Dermatol Online J. 2016;22(7)
16. Shah K, Mellars L, Changolkar A, Feldman SR. Real-world burden of comorbidities in US patients with psoriasis. J Am Acad Dermatol. 2017;77(2):287-292.e4.
17. Darjani A, Heidarzadeh A, Golchai J, et al. Quality of life in psoriatic patients: a study using the short form-36. Int J Prev Med. 2014;5(9):1146-52.
18. Korman NJ, Zhao Y, Pike J, Roberts J. Relationship between psoriasis severity, clinical symptoms, quality of life and work productivity among patients in the USA. Clin Exp Dermatol. 2016;41(5):514-21.
19. Warren RB, Kleyn CE, Gulliver WP. Cumulative life course impairment in psoriasis: patient perception of disease-related impairment throughout the life course. Br J Dermatol. 2011;164 Suppl 1:1-14.
20. Jungo P, Maul JT, Djamei V, et al. Superiority in Quality of Life Improvement of Biologics over Conventional Systemic Drugs in a Swiss Real-Life Psoriasis Registry. Dermatology (Basel). 2017;
21. Jaeschke R, Singer J, Guyatt GH: Ascertaining the minimal clinically important difference. Control Clin Trials 1989; 10: 407–415.
22. Basra MK, Salek MS, Camilleri L, Sturkey R, Finlay AY. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology (Basel). 2015;230(1):27-33.
23. Feldman SR, Goffe B, Rice G, et al. The Challenge of Managing Psoriasis: Unmet Medical Needs and Stakeholder Perspectives. Am Health Drug Benefits. 2016;9(9):504-513.
24. Yiu ZZ, Exton LS, Jabbar-lopez Z, et al. Risk of Serious Infections in Patients with Psoriasis on Biologic Therapies: A Systematic Review and Meta-Analysis. J Invest Dermatol. 2016;136(8):1584-91.
25. Le cleach L, Chassany O, Levy A, Wolkenstein P, Chosidow O. Poor reporting of quality of life outcomes in dermatology randomized controlled clinical trials. Dermatology (Basel). 2008;216(1):46-55.
26. Asahina A, Nakagawa H, Etoh T, Ohtsuki M. 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(4):299-310.
27. 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.
28. Shikiar R, Heffernan M, Langley RG, Willian MK, Okun MM, Revicki DA. Adalimumab treatment is associated with improvement in health-related quality of life in psoriasis: patient-reported outcomes from a phase II randomized controlled trial. J Dermatolog Treat. 2007;18(1):25-31.
29. Wallace K, Gordon K, Langley R, Chen D. Dermatologic quality of life in patients with moderate to severe plaque psoriasis receiving 48 weeks of adalimumab therapy. J Am Acad Dermatol 2005; 52 (Suppl 1): 180.
30. Revicki D, Willian MK, Saurat JH, et al. Impact of adalimumab treatment on health-related quality of life and other patient-reported outcomes: results from a 16-week randomized controlled trial in patients with moderate to severe plaque psoriasis. Br J Dermatol. 2008;158(3):549-57.
31. Revicki DA, Willian MK, Menter A, et al. Impact of adalimumab treatment on patient-reported outcomes: results from a Phase III clinical trial in patients with moderate to severe plaque psoriasis. J Dermatolog Treat. 2007;18(6):341-50.
32. Bachelez H, Van de kerkhof PC, Strohal R, et al. Tofacitinib versus etanercept or placebo in moderate-to-severe chronic plaque psoriasis: a phase 3 randomised non-inferiority trial. Lancet. 2015;386(9993):552-61.
33. Valenzuela F, Paul C, Mallbris L, et al. Tofacitinib versus etanercept or placebo in patients with moderate to severe chronic plaque psoriasis: patient-reported outcomes from a Phase 3 study. J Eur Acad Dermatol Venereol. 2016;30(10):1753-1759.
34. 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.
35. Leonardi CL, Powers JL, Matheson RT, et al. Etanercept as monotherapy in patients with psoriasis. N Engl J Med. 2003;349(21):2014-22.
36. Gottlieb AB, Matheson RT, Lowe N, et al. A randomized trial of etanercept as monotherapy for psoriasis. Arch Dermatol. 2003;139(12):1627-32.
37. Lowe N, Lebsack M Wande L. Psoriasis patients show improved quality of life when treated with Etanercept. Ann Dermatol Venereol 2002; 129: 1S762.
38. Krueger GG, Langley RG, Finlay AY, et al. Patient-reported outcomes of psoriasis improvement with etanercept therapy: results of a randomized phase III trial. Br J Dermatol. 2005;153(6):1192-9.
39. Tyring S, Gottlieb A, Papp K, et al. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial. Lancet. 2006;367(9504):29-35.
40. Reich K, Segaert S, Van de kerkhof P, et al. Once-weekly administration of etanercept 50 mg improves patient-reported outcomes in patients with moderate-to-severe plaque psoriasis. Dermatology (Basel). 2009;219(3):239-49.
41. Gottlieb AB, Leonardi C, Kerdel F, Mehlis S, Olds M, Williams DA. 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.
42. Feldman SR, Gordon KB, Bala M, et al. Infliximab treatment results in significant improvement in the quality of life of patients with severe psoriasis: a double-blind placebo-controlled trial. Br J Dermatol. 2005;152(5):954-60.
43. Gottlieb AB, Evans R, Li S, et al. Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2004;51(4):534-42.
44. Feldman SR, Gottlieb AB, Bala M, et al. Infliximab improves health-related quality of life in the presence of comorbidities among patients with moderate-to-severe psoriasis. Br J Dermatol. 2008;159(3):704-10.
45. Menter A, Feldman SR, Weinstein GD, et al. 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. 2007;56(1):31.e1-15.
46. Yang HZ, Wang K, Jin HZ, et al. Infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis: a randomized, double-blind, placebo-controlled multicenter trial. Chin Med J. 2012;125(11):1845-51.
47. Torii H, Nakagawa H. 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(1):40-9.
48. Reich K, Nestle FO, Papp K, et al. Improvement in quality of life with infliximab induction and maintenance therapy in patients with moderate-to-severe psoriasis: a randomized controlled trial. Br J Dermatol. 2006;154(6):1161-8.
49. 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.
50. Leonardi C, Matheson R, Zachariae C, et al. Anti-interleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis. N Engl J Med. 2012;366(13):1190-9.
51. Gordon K, Blauvelt A, Langley R. Ixekizumab for treatment of moderate-to-severe plaque psoriasis: 60-week results from a double-blind phase 3 induction and randomized withdrawal study (UNCOVER-1). 73rd Annual Meeting of the American Academy of Dermatology 2015: 20-24.
52. Augustin M, Abeysinghe S, Mallya U, et al. Secukinumab treatment of plaque psoriasis shows early improvement in DLQI response - results of a phase II regimen-finding trial. J Eur Acad Dermatol Venereol. 2016;30(4):645-9.
53. Thaçi 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.
54. Blauvelt A, Korman N, Mollon P, et al. Secukinumab treatment provides faster and more effective relief from patient-reported quality-of-life impact than ustekinumab in subjects with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2016;74(5):AB273.
55. 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.
56. Paul C, Lacour JP, Tedremets L, et al. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2015;29(6):1082-90.
57. 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.
58. 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.
59. Igarashi A, Kato T, Kato M, Song M, Nakagawa H. 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. 2012;39(3):242-52.
60. Krueger GG, Langley RG, Leonardi C, et al. A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. N Engl J Med. 2007;356(6):580-92.
61. Zhu X, Zheng M, Song M, et al. Efficacy and safety of ustekinumab in Chinese patients with moderate to severe plaque-type psoriasis: results from a phase 3 clinical trial (LOTUS). J Drugs Dermatol. 2013;12(2):166-74.
62. Tsai TF, Ho JC, Song M, et al. 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). J Dermatol Sci. 2011;63(3):154-63.
63. Papp KA, Blauvelt A, Bukhalo M, et al. Selective blockade of Il-23p19 with Bi 655066 is associated with significant improvement in Qol outcomes compared with ustekinumab in patients with moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2016;74(5):AB275
2. De arruda LH, De moraes AP. The impact of psoriasis on quality of life. Br J Dermatol. 2001;144 Suppl 58:33-6.
3. Rapp SR, Feldman SR, Exum ML, Fleischer AB, Reboussin DM. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999;41(3 Pt 1):401-7.
4. Langley RG, Krueger GG, Griffiths CE. Psoriasis: epidemiology, clinical features, and quality of life. Ann Rheum Dis. 2005;64 Suppl 2:ii18-23.
5. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210-6.
6. Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 2008 Nov;159(5):997-1035. Epub 2008 Sep 15.
7. Ali FM, Cueva AC, Vyas J, et al. A systematic review of the use of quality-of-life instruments in randomized controlled trials for psoriasis. Br J Dermatol. 2016;
8. Loo WJ, Diba V, Chawla M et al. Dermatology Life Quality Index: influence of an illustrated version. Br J Dermatol 2003; 148:279–84.
9. Smith CH, Anstey AV, Barker JNWN et al. British Association of Dermatologists’ guidelines for biologic interventions for psoriasis. 2009. Br J Dermatol 2009; 161:987–1019.
10. Finlay AY, Basra MKA, Piguet V et al. Dermatology Life Quality Index (DLQI): a paradigm shift to patient-centered outcomes. J Invest Dermatol 2012; 132:2464–5.
11. Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AY. Translating the science of quality of life into practice: What do dermatology life quality index scores mean?. J Invest Dermatol. 2005;125(4):659-64.
12. Mattei PL, Corey KC, Kimball AB. Psoriasis Area Severity Index (PASI) and the Dermatology Life Quality Index (DLQI): the correlation between disease severity and psychological burden in patients treated with biological therapies. J Eur Acad Dermatol Venereol 2014; 28:333–7.
13. Katugampola RP, Lewis VJ, Finlay AY. The Dermatology Life Quality Index: assessing the efficacy of biological therapies for psoriasis. Br J Dermatol. 2007;156(5):945-50.
14. Reich K, Sinclair R, Roberts G, Griffiths CE, Tabberer M, Barker J. Comparative effects of biological therapies on the severity of skin symptoms and health-related quality of life in patients with plaque-type psoriasis: a meta-analysis. Curr Med Res Opin. 2008;24(5):1237-54.
15. Korman NJ, Zhao Y, Roberts J, et al. Impact of psoriasis flare and remission on quality of life and work productivity: a real-world study in the USA. Dermatol Online J. 2016;22(7)
16. Shah K, Mellars L, Changolkar A, Feldman SR. Real-world burden of comorbidities in US patients with psoriasis. J Am Acad Dermatol. 2017;77(2):287-292.e4.
17. Darjani A, Heidarzadeh A, Golchai J, et al. Quality of life in psoriatic patients: a study using the short form-36. Int J Prev Med. 2014;5(9):1146-52.
18. Korman NJ, Zhao Y, Pike J, Roberts J. Relationship between psoriasis severity, clinical symptoms, quality of life and work productivity among patients in the USA. Clin Exp Dermatol. 2016;41(5):514-21.
19. Warren RB, Kleyn CE, Gulliver WP. Cumulative life course impairment in psoriasis: patient perception of disease-related impairment throughout the life course. Br J Dermatol. 2011;164 Suppl 1:1-14.
20. Jungo P, Maul JT, Djamei V, et al. Superiority in Quality of Life Improvement of Biologics over Conventional Systemic Drugs in a Swiss Real-Life Psoriasis Registry. Dermatology (Basel). 2017;
21. Jaeschke R, Singer J, Guyatt GH: Ascertaining the minimal clinically important difference. Control Clin Trials 1989; 10: 407–415.
22. Basra MK, Salek MS, Camilleri L, Sturkey R, Finlay AY. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology (Basel). 2015;230(1):27-33.
23. Feldman SR, Goffe B, Rice G, et al. The Challenge of Managing Psoriasis: Unmet Medical Needs and Stakeholder Perspectives. Am Health Drug Benefits. 2016;9(9):504-513.
24. Yiu ZZ, Exton LS, Jabbar-lopez Z, et al. Risk of Serious Infections in Patients with Psoriasis on Biologic Therapies: A Systematic Review and Meta-Analysis. J Invest Dermatol. 2016;136(8):1584-91.
25. Le cleach L, Chassany O, Levy A, Wolkenstein P, Chosidow O. Poor reporting of quality of life outcomes in dermatology randomized controlled clinical trials. Dermatology (Basel). 2008;216(1):46-55.
26. Asahina A, Nakagawa H, Etoh T, Ohtsuki M. 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(4):299-310.
27. 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.
28. Shikiar R, Heffernan M, Langley RG, Willian MK, Okun MM, Revicki DA. Adalimumab treatment is associated with improvement in health-related quality of life in psoriasis: patient-reported outcomes from a phase II randomized controlled trial. J Dermatolog Treat. 2007;18(1):25-31.
29. Wallace K, Gordon K, Langley R, Chen D. Dermatologic quality of life in patients with moderate to severe plaque psoriasis receiving 48 weeks of adalimumab therapy. J Am Acad Dermatol 2005; 52 (Suppl 1): 180.
30. Revicki D, Willian MK, Saurat JH, et al. Impact of adalimumab treatment on health-related quality of life and other patient-reported outcomes: results from a 16-week randomized controlled trial in patients with moderate to severe plaque psoriasis. Br J Dermatol. 2008;158(3):549-57.
31. Revicki DA, Willian MK, Menter A, et al. Impact of adalimumab treatment on patient-reported outcomes: results from a Phase III clinical trial in patients with moderate to severe plaque psoriasis. J Dermatolog Treat. 2007;18(6):341-50.
32. Bachelez H, Van de kerkhof PC, Strohal R, et al. Tofacitinib versus etanercept or placebo in moderate-to-severe chronic plaque psoriasis: a phase 3 randomised non-inferiority trial. Lancet. 2015;386(9993):552-61.
33. Valenzuela F, Paul C, Mallbris L, et al. Tofacitinib versus etanercept or placebo in patients with moderate to severe chronic plaque psoriasis: patient-reported outcomes from a Phase 3 study. J Eur Acad Dermatol Venereol. 2016;30(10):1753-1759.
34. 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.
35. Leonardi CL, Powers JL, Matheson RT, et al. Etanercept as monotherapy in patients with psoriasis. N Engl J Med. 2003;349(21):2014-22.
36. Gottlieb AB, Matheson RT, Lowe N, et al. A randomized trial of etanercept as monotherapy for psoriasis. Arch Dermatol. 2003;139(12):1627-32.
37. Lowe N, Lebsack M Wande L. Psoriasis patients show improved quality of life when treated with Etanercept. Ann Dermatol Venereol 2002; 129: 1S762.
38. Krueger GG, Langley RG, Finlay AY, et al. Patient-reported outcomes of psoriasis improvement with etanercept therapy: results of a randomized phase III trial. Br J Dermatol. 2005;153(6):1192-9.
39. Tyring S, Gottlieb A, Papp K, et al. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial. Lancet. 2006;367(9504):29-35.
40. Reich K, Segaert S, Van de kerkhof P, et al. Once-weekly administration of etanercept 50 mg improves patient-reported outcomes in patients with moderate-to-severe plaque psoriasis. Dermatology (Basel). 2009;219(3):239-49.
41. Gottlieb AB, Leonardi C, Kerdel F, Mehlis S, Olds M, Williams DA. 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.
42. Feldman SR, Gordon KB, Bala M, et al. Infliximab treatment results in significant improvement in the quality of life of patients with severe psoriasis: a double-blind placebo-controlled trial. Br J Dermatol. 2005;152(5):954-60.
43. Gottlieb AB, Evans R, Li S, et al. Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2004;51(4):534-42.
44. Feldman SR, Gottlieb AB, Bala M, et al. Infliximab improves health-related quality of life in the presence of comorbidities among patients with moderate-to-severe psoriasis. Br J Dermatol. 2008;159(3):704-10.
45. Menter A, Feldman SR, Weinstein GD, et al. 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. 2007;56(1):31.e1-15.
46. Yang HZ, Wang K, Jin HZ, et al. Infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis: a randomized, double-blind, placebo-controlled multicenter trial. Chin Med J. 2012;125(11):1845-51.
47. Torii H, Nakagawa H. 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(1):40-9.
48. Reich K, Nestle FO, Papp K, et al. Improvement in quality of life with infliximab induction and maintenance therapy in patients with moderate-to-severe psoriasis: a randomized controlled trial. Br J Dermatol. 2006;154(6):1161-8.
49. 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.
50. Leonardi C, Matheson R, Zachariae C, et al. Anti-interleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis. N Engl J Med. 2012;366(13):1190-9.
51. Gordon K, Blauvelt A, Langley R. Ixekizumab for treatment of moderate-to-severe plaque psoriasis: 60-week results from a double-blind phase 3 induction and randomized withdrawal study (UNCOVER-1). 73rd Annual Meeting of the American Academy of Dermatology 2015: 20-24.
52. Augustin M, Abeysinghe S, Mallya U, et al. Secukinumab treatment of plaque psoriasis shows early improvement in DLQI response - results of a phase II regimen-finding trial. J Eur Acad Dermatol Venereol. 2016;30(4):645-9.
53. Thaçi 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.
54. Blauvelt A, Korman N, Mollon P, et al. Secukinumab treatment provides faster and more effective relief from patient-reported quality-of-life impact than ustekinumab in subjects with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2016;74(5):AB273.
55. 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.
56. Paul C, Lacour JP, Tedremets L, et al. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2015;29(6):1082-90.
57. 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.
58. 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.
59. Igarashi A, Kato T, Kato M, Song M, Nakagawa H. 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. 2012;39(3):242-52.
60. Krueger GG, Langley RG, Leonardi C, et al. A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. N Engl J Med. 2007;356(6):580-92.
61. Zhu X, Zheng M, Song M, et al. Efficacy and safety of ustekinumab in Chinese patients with moderate to severe plaque-type psoriasis: results from a phase 3 clinical trial (LOTUS). J Drugs Dermatol. 2013;12(2):166-74.
62. Tsai TF, Ho JC, Song M, et al. 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). J Dermatol Sci. 2011;63(3):154-63.
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Sep 7, 2018
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Prado, G., Nichols, A. J., Florez-White, M., & Kerdel, F. (2018). Reporting of Quality of Life in Clinical Trials of Biologics for Plaque Psoriasis: A Systematic Review. SKIN The Journal of Cutaneous Medicine, 2(5). https://doi.org/10.25251/2.5.2
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