Patient-Reported Outcomes of Adalimumab, Phototherapy, and Placebo in the Vascular Inflammation in Psoriasis Trial: A Randomized Controlled Study.

Alan M. Menter M.D.
Noe, M. H., M. T. Wan, D. B. Shin, A. W. Armstrong, K. C. Duffin, Z. C. Chiesa Fuxench, R. E. Kalb, A. Menter, E. L. Simpson, J. Takeshita, S. K. Tyring, A. S. Van Voorhees, N. N. Mehta and J. M. Gelfand (2019). “Patient-Reported Outcomes of Adalimumab, Phototherapy, and Placebo in the Vascular Inflammation in Psoriasis Trial: A Randomized Controlled Study.” J Am Acad Dermatol Jun 1. [Epub ahead of print].
BACKGROUND: There is limited data about the impact of narrowband ultraviolet B phototherapy on patient-reported measures of health-related quality of life (HRQoL). OBJECTIVE: To evaluate the impact of adalimumab and phototherapy on HRQoL. METHODS: We examined patient-reported outcomes (PROs) from a multicenter, randomized placebo-controlled trial (NCT01553058). Dermatology Life Quality Index (DLQI) and EQ-5D-3L were evaluated every 4 weeks. RESULTS: We enrolled 97 patients: 30.9% female, mean (SD) age 43.5(14.0) years, median (interquartile range) PASI 16.7(13.9-21.6). At week 12, patients being treated with adalimumab (OR: 2.88, 95% 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 (MCID) in DLQI compared to placebo. There were higher odds of achieving the MCID 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 to placebo in patients with psoriasis, however, phototherapy treated patients achieved more improvement in overall health quality of life compared to patients treated with adalimumab.