Impact of adalimumab treatment on health-related quality of life and other patient-reported outcomes: results from a 16-week randomized controlled trial in patients with moderate to severe plaque psoriasis.
BACKGROUND
Health-related quality of life (HRQOL) and other patient-reported outcomes (PROs) are important in evaluating the impact of psoriasis and its treatment.


OBJECTIVE
To assess the impact of adalimumab treatment on HRQOL and other PROs in patients with moderate to severe psoriasis.


METHODS
A 16-week, double-blind, double-dummy, randomized controlled trial evaluated the efficacy and safety of adalimumab in 271 adults with moderate to severe chronic plaque psoriasis. Patients were randomized in a 2:2:1 ratio to adalimumab, methotrexate (MTX) or placebo. PROs were evaluated throughout the study and included the Dermatology Life Quality Index (DLQI), Patient's Global Assessment of disease severity, plaque psoriasis and psoriatic arthritis pain visual analogue scale (VAS), Psoriasis-Related Pruritus Assessment and EuroQOL 5D (EQ-5D).


RESULTS
Statistically significant differences were observed between the adalimumab- and placebo-treated and the MTX-treated groups on mean DLQI total scores during the 16-week double-blind study (both P<0.001). Significant differences, favouring adalimumab compared with placebo, were also observed on the Patient's Global Assessment of disease severity (P<0.001), VAS for pain (P<0.001), Psoriasis-Related Pruritus Assessment (P<0.001), EQ-5D VAS (P<0.001) and EQ-5D index score (P<0.01). Compared with MTX, adalimumab resulted in statistically significantly greater improvements in the Patient's Global Assessment of disease severity (P<0.001), the VAS for pain (P<0.01) and the Psoriasis-Related Pruritus Assessment (P<0.001).


CONCLUSIONS
Adalimumab was efficacious in improving dermatology-specific HRQOL, disease control and symptom outcomes in patients with moderate to severe psoriasis.
Revicki
D
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Center for Health Outcomes Research, United BioSource Corporation, Bethesda, MD 20814, USA. dennis.revicki@unitedbiosource.com
Willian
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Saurat
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Papp
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Ortonne
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Sexton
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Camez
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D000068879:Adalimumab; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004812:Epidemiologic Methods; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage* / Q000009:adverse effects; D011565:Psoriasis / Q000188:drug therapy* / Q000276:immunology; D011788:Quality of Life / Q000523:psychology; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D000068879:Adalimumab; D008727:Methotrexate