Body Region Involvement and Quality of Life in Psoriasis: Analysis of a Randomized Controlled Trial of Adalimumab

• Published in: American journal of clinical dermatology Vol. 17; no. 6; pp. 691 - 699
• Main Authors: Armstrong, April W., Villanueva Quintero, Delfina Guadalupe, Echeverría, Cristina M., Gu, Yihua, Karunaratne, Mahinda, Reyes Servín, Ofelia
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.12.2016; Springer Nature B.V
• Subjects: Adalimumab - therapeutic use; Adult; Anti-Inflammatory Agents - therapeutic use; Dermatology; Double-Blind Method; Female; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; Original; Original Research Article; Pharmacology/Toxicology; Pharmacotherapy; Psoriasis - drug therapy; Quality of Life; Randomized Controlled Trials as Topic; Severity of Illness Index; Treatment Outcome; Psoriasis; Adalimumab; Dermatology Life Quality Index; Dermatology Life Quality Index Score; Body Region
• ISSN: 1175-0561; 1179-1888
• DOI: 10.1007/s40257-016-0229-x

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.