Adalimumab treatment is associated with improvement in health-related quality of life in psoriasis: patient-reported outcomes from a phase II randomized controlled trial.
BACKGROUND
Psoriasis substantially impairs the health-related quality of life (HRQOL) of patients, and a comprehensive evaluation of treatment includes HRQOL measures.


OBJECTIVE
To assess the impact of adalimumab on patient-reported outcomes (PROs) of patients with moderate to severe psoriasis.


METHODS
In a Phase II, randomized, controlled trial, the efficacy and safety of two dosages of adalimumab (40 mg weekly or every other week) versus placebo were assessed for 12 weeks in the treatment of moderate to severe plaque psoriasis. Patients completed the Dermatology Life Quality Index (DLQI), Short-Form 36 (SF-36) Health Survey, and EuroQOL-5D (EQ-5D) at baseline and 12 weeks. The primary endpoint was the percentage of patients achieving a > or =75% reduction in the Psoriasis Area and Severity Index score (PASI 75). Investigators assessed PASI and Physician's Global Assessment (PGA) scores.


RESULTS
Adalimumab patients (either dosage) displayed significantly greater improvements versus placebo patients in DLQI, EQ-5D, and SF-36 Mental Component Summary scores, as well as in Bodily Pain, Vitality, Social Functioning, Role-Emotional, and Mental Health domains. The adalimumab 40-mg weekly group also reported significantly greater improvements in SF-36 Physical Component Summary scores versus the placebo group.


CONCLUSIONS
Both adalimumab dosages were efficacious in improving dermatology-specific and general PROs in patients with moderate to severe psoriasis.
Shikiar
Richard
R
Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Heffernan
Michael
M
Langley
Richard G
RG
Willian
Mary K
MK
Okun
Martin M
MM
Revicki
Dennis A
DA
D000068879:Adalimumab; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D002170:Canada; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006304:Health Status; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; D000068879:Adalimumab