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


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov identifier NCT00237887.
Keck School of Medicine, University of Southern California, Keith Administration Building, Room 510, 1975 Zonal Avenue, Los Angeles, CA, 90089, USA. april.armstrong@med.usc.edu.
April W
AW
Armstrong
Instituto Dermatológico de Jalisco, Zapopan, Jalisco, Mexico.
Delfina Guadalupe
DG
Villanueva Quintero
Department of Dermatology, Hospital Eva Perón, San Martin, Buenos Aires, Argentina.
Cristina M
CM
Echeverría
AbbVie Inc., North Chicago, IL, USA.
Yihua
Y
Gu
AbbVie Inc., North Chicago, IL, USA.
Mahinda
M
Karunaratne
AbbVie Inc., North Chicago, IL, USA.
Ofelia
O
Reyes Servín
D000068879:Adalimumab / Q000627:therapeutic use*; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D000068879:Adalimumab