Patient-reported outcomes of adalimumab, phototherapy, and placebo in the Vascular Inflammation in Psoriasis Trial: A randomized controlled study

Megan H. Noe, Marilyn T. Wan, Daniel B. Shin, April W. Armstrong, Kristina Callis Duffin, Zelma C. Chiesa Fuxench, Robert E. Kalb, Alan Menter, Eric Simpson, Junko Takeshita, Stephen K. Tyring, Abby S. Van Voorhees, Nehal N. Mehta, Joel M. Gelfand

Research output: Contribution to journalArticle

Abstract

Background: There are limited data about the impact of narrowband ultraviolet B phototherapy on patient-reported measures of health-related quality of life. Objective: To evaluate the impact of adalimumab and phototherapy on health-related quality of life. Methods: We examined patient-reported outcomes from a multicenter, randomized, placebo-controlled trial (ClinicalTrials.gov no. NCT01553058). The Dermatology Life Quality Index and EQ-5D-3L were evaluated every 4 weeks. Results: We enrolled 97 patients: 30.9% were female, mean age was 43.5 years (standard deviation, 14.0), and median Psoriasis Area and Severity Index score was 16.7 (interquartile range, 13.9-21.6). At week 12, patients being treated with adalimumab (odds ratio [OR], 2.88; 95% confidence interval [CI], 1.02-8.17) and phototherapy (OR, 8.83; 95% CI, 2.47-31.57) were more likely to achieve the minimal clinically important difference in the Dermatology Life Quality Index compared with those receiving placebo. There were higher odds of achieving the minimal clinically important difference for the EQ-5D-3L Index score when comparing phototherapy versus placebo (OR, 9.78; 95% CI, 2.99-31.95) and phototherapy versus adalimumab (OR, 4.07; 95% CI, 1.42-11.70). Limitations: Small sample size, secondary analysis, generalizability. Conclusion: Phototherapy and adalimumab both improve skin-related quality of life and overall health-related quality of life compared with placebo in patients with psoriasis; however, patients treated with phototherapy achieved more improvement in overall health-related quality of life compared with patients treated with adalimumab.

Original languageEnglish (US)
JournalJournal of the American Academy of Dermatology
DOIs
StateAccepted/In press - Jan 1 2019

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Phototherapy
Psoriasis
Blood Vessels
Randomized Controlled Trials
Placebos
Quality of Life
Inflammation
Odds Ratio
Confidence Intervals
Dermatology
Adalimumab
Patient Reported Outcome Measures
Sample Size
Skin

Keywords

  • adalimumab
  • DLQI
  • EQ5D
  • patient-reported outcomes
  • phototherapy
  • psoriasis
  • randomized controlled trials

ASJC Scopus subject areas

  • Dermatology

Cite this

Patient-reported outcomes of adalimumab, phototherapy, and placebo in the Vascular Inflammation in Psoriasis Trial : A randomized controlled study. / Noe, Megan H.; Wan, Marilyn T.; Shin, Daniel B.; Armstrong, April W.; Duffin, Kristina Callis; Chiesa Fuxench, Zelma C.; Kalb, Robert E.; Menter, Alan; Simpson, Eric; Takeshita, Junko; Tyring, Stephen K.; Van Voorhees, Abby S.; Mehta, Nehal N.; Gelfand, Joel M.

In: Journal of the American Academy of Dermatology, 01.01.2019.

Research output: Contribution to journalArticle

Noe, MH, Wan, MT, Shin, DB, Armstrong, AW, Duffin, KC, Chiesa Fuxench, ZC, Kalb, RE, Menter, A, Simpson, E, Takeshita, J, Tyring, SK, Van Voorhees, AS, Mehta, NN & Gelfand, JM 2019, 'Patient-reported outcomes of adalimumab, phototherapy, and placebo in the Vascular Inflammation in Psoriasis Trial: A randomized controlled study', Journal of the American Academy of Dermatology. https://doi.org/10.1016/j.jaad.2019.05.080
Noe, Megan H. ; Wan, Marilyn T. ; Shin, Daniel B. ; Armstrong, April W. ; Duffin, Kristina Callis ; Chiesa Fuxench, Zelma C. ; Kalb, Robert E. ; Menter, Alan ; Simpson, Eric ; Takeshita, Junko ; Tyring, Stephen K. ; Van Voorhees, Abby S. ; Mehta, Nehal N. ; Gelfand, Joel M. / Patient-reported outcomes of adalimumab, phototherapy, and placebo in the Vascular Inflammation in Psoriasis Trial : A randomized controlled study. In: Journal of the American Academy of Dermatology. 2019.
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abstract = "Background: There are limited data about the impact of narrowband ultraviolet B phototherapy on patient-reported measures of health-related quality of life. Objective: To evaluate the impact of adalimumab and phototherapy on health-related quality of life. Methods: We examined patient-reported outcomes from a multicenter, randomized, placebo-controlled trial (ClinicalTrials.gov no. NCT01553058). The Dermatology Life Quality Index and EQ-5D-3L were evaluated every 4 weeks. Results: We enrolled 97 patients: 30.9{\%} were female, mean age was 43.5 years (standard deviation, 14.0), and median Psoriasis Area and Severity Index score was 16.7 (interquartile range, 13.9-21.6). At week 12, patients being treated with adalimumab (odds ratio [OR], 2.88; 95{\%} confidence interval [CI], 1.02-8.17) and phototherapy (OR, 8.83; 95{\%} CI, 2.47-31.57) were more likely to achieve the minimal clinically important difference in the Dermatology Life Quality Index compared with those receiving placebo. There were higher odds of achieving the minimal clinically important difference for the EQ-5D-3L Index score when comparing phototherapy versus placebo (OR, 9.78; 95{\%} CI, 2.99-31.95) and phototherapy versus adalimumab (OR, 4.07; 95{\%} CI, 1.42-11.70). Limitations: Small sample size, secondary analysis, generalizability. Conclusion: Phototherapy and adalimumab both improve skin-related quality of life and overall health-related quality of life compared with placebo in patients with psoriasis; however, patients treated with phototherapy achieved more improvement in overall health-related quality of life compared with patients treated with adalimumab.",
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T2 - A randomized controlled study

AU - Noe, Megan H.

AU - Wan, Marilyn T.

AU - Shin, Daniel B.

AU - Armstrong, April W.

AU - Duffin, Kristina Callis

AU - Chiesa Fuxench, Zelma C.

AU - Kalb, Robert E.

AU - Menter, Alan

AU - Simpson, Eric

AU - Takeshita, Junko

AU - Tyring, Stephen K.

AU - Van Voorhees, Abby S.

AU - Mehta, Nehal N.

AU - Gelfand, Joel M.

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N2 - Background: There are limited data about the impact of narrowband ultraviolet B phototherapy on patient-reported measures of health-related quality of life. Objective: To evaluate the impact of adalimumab and phototherapy on health-related quality of life. Methods: We examined patient-reported outcomes from a multicenter, randomized, placebo-controlled trial (ClinicalTrials.gov no. NCT01553058). The Dermatology Life Quality Index and EQ-5D-3L were evaluated every 4 weeks. Results: We enrolled 97 patients: 30.9% were female, mean age was 43.5 years (standard deviation, 14.0), and median Psoriasis Area and Severity Index score was 16.7 (interquartile range, 13.9-21.6). At week 12, patients being treated with adalimumab (odds ratio [OR], 2.88; 95% confidence interval [CI], 1.02-8.17) and phototherapy (OR, 8.83; 95% CI, 2.47-31.57) were more likely to achieve the minimal clinically important difference in the Dermatology Life Quality Index compared with those receiving placebo. There were higher odds of achieving the minimal clinically important difference for the EQ-5D-3L Index score when comparing phototherapy versus placebo (OR, 9.78; 95% CI, 2.99-31.95) and phototherapy versus adalimumab (OR, 4.07; 95% CI, 1.42-11.70). Limitations: Small sample size, secondary analysis, generalizability. Conclusion: Phototherapy and adalimumab both improve skin-related quality of life and overall health-related quality of life compared with placebo in patients with psoriasis; however, patients treated with phototherapy achieved more improvement in overall health-related quality of life compared with patients treated with adalimumab.

AB - Background: There are limited data about the impact of narrowband ultraviolet B phototherapy on patient-reported measures of health-related quality of life. Objective: To evaluate the impact of adalimumab and phototherapy on health-related quality of life. Methods: We examined patient-reported outcomes from a multicenter, randomized, placebo-controlled trial (ClinicalTrials.gov no. NCT01553058). The Dermatology Life Quality Index and EQ-5D-3L were evaluated every 4 weeks. Results: We enrolled 97 patients: 30.9% were female, mean age was 43.5 years (standard deviation, 14.0), and median Psoriasis Area and Severity Index score was 16.7 (interquartile range, 13.9-21.6). At week 12, patients being treated with adalimumab (odds ratio [OR], 2.88; 95% confidence interval [CI], 1.02-8.17) and phototherapy (OR, 8.83; 95% CI, 2.47-31.57) were more likely to achieve the minimal clinically important difference in the Dermatology Life Quality Index compared with those receiving placebo. There were higher odds of achieving the minimal clinically important difference for the EQ-5D-3L Index score when comparing phototherapy versus placebo (OR, 9.78; 95% CI, 2.99-31.95) and phototherapy versus adalimumab (OR, 4.07; 95% CI, 1.42-11.70). Limitations: Small sample size, secondary analysis, generalizability. Conclusion: Phototherapy and adalimumab both improve skin-related quality of life and overall health-related quality of life compared with placebo in patients with psoriasis; however, patients treated with phototherapy achieved more improvement in overall health-related quality of life compared with patients treated with adalimumab.

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KW - DLQI

KW - EQ5D

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KW - phototherapy

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KW - randomized controlled trials

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