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  • Title: Body Region Involvement and Quality of Life in Psoriasis: Analysis of a Randomized Controlled Trial of Adalimumab.
    Author: Armstrong AW, Villanueva Quintero DG, Echeverría CM, Gu Y, Karunaratne M, Reyes Servín O.
    Journal: Am J Clin Dermatol; 2016 Dec; 17(6):691-699. PubMed ID: 27815915.
    Abstract:
    BACKGROUND: Psoriasis severity and treatment responsiveness vary by body region, which differentially impacts quality of life (QoL). OBJECTIVE: The objective of the study was to examine adalimumab efficacy by body region and regional response and QoL relationship. METHODS: Patients (n = 1212) with moderate-to-severe psoriasis were randomized 2:1 to 80 mg at week 0, followed by adalimumab 40 mg or placebo every other week for 16 weeks in the double-blind REVEAL study. Psoriasis Area and Severity Index (PASI) responses and Dermatology Life Quality Index outcomes were analyzed. RESULTS: Week 16 regional mean PASI improvements were significantly greater with adalimumab (83.1 ± 1.57, 81.3 ± 1.58, 75.7 ± 1.34, and 73.9 ± 1.26% in the trunk, head, upper extremities, and lower extremities, respectively; all p < 0.001 vs. placebo). Likewise, percentages of patients with regional PASI ≥75/≥90/100% reduction from baseline were significantly higher with adalimumab (all p < 0.001); adalimumab responses were greater for the trunk (77.9/65.0/59.1%) and head (74.6/66.1/62.8%; all p ≤ 0.0001 vs. lower) than upper (67.7/45.1/39.6%; p = 0.4, p = 0.04, p = 0.0005, respectively, vs. lower) and lower extremities (65.7/40.0/31.3%). Adalimumab significantly improved Dermatology Life Quality Index scores vs. placebo (8.2- vs 1.7-point decrease from baseline; p < 0.001). LIMITATIONS: The study was a post hoc analysis. CONCLUSIONS: Adalimumab treatment resulted in statistically significant and clinically meaningful improvements in disease severity and QoL. QoL improvements were associated with PASI responses in all body regions. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00237887.
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