Journal
ARCHIVES OF DERMATOLOGY
Volume 147, Issue 4, Pages 429-436Publisher
AMER MEDICAL ASSOC
DOI: 10.1001/archdermatol.2010.384
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Funding
- Abbott Laboratories
- Abbott
- Amgen
- Centocor
- Pfizer
- Galderma
- Merck
- GlaxoSmithKline
- Novartis
- Graceway
- Inhibitex
- LEO Pharma
- AICuris
- Janssen-Ortho
- Schering
- Wyeth
- Celgene
- Inc LEO Pharma
- Inc LEO Pharma, Schering
- Wyeth/Pfizer
- Neostrata
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Objective: To determine the efficacy, safety, and sustainability of response to adalimumab therapy for moderate to severe chronic plaque psoriasis involving hands and/or feet. Design: Sixteen-week, randomized, double-blind, placebo-controlled evaluation of adalimumab therapy for moderate to severe chronic plaque psoriasis involving the hands and/or feet with a 12-week open-label extension (Randomized Controlled Evaluation of Adalimumab in Treatment of Chronic Plaque Psoriasis of the Hands and Feet [REACH]). Setting: Multicenter outpatient study in the United States and Canada. Participants: Patients with chronic plaque psoriasis on the hands and/or feet with a Physician's Global Assessment of hands and/or feet (hfPGA) score of moderate or above. Intervention: Patients were randomized 2: 1 to adalimumab (80 mg at week 0, then 40 mg every other week starting at week 1) or to matching placebo. Main Outcome Measure: Percentage of patients achieving an hfPGA score of clear or almost clear at week 16. Results: Seventy-two patients (adalimumab [n=49]; placebo [n=23]) were evaluated. Baseline percentages of patients with moderate and severe hfPGA scores were 76% and 24%, respectively, for the adalimumab group and 74% and 26%, respectively, for the placebo group. At week 16, 31% and 4% of patients randomized to adalimumab and placebo, respectively, achieved an hfPGA score of clear or almost clear (P=.01). At week 28, 80% of the hfPGA clear or almost clear response was maintained from week 16 (25% for patients randomized to adalimumab). Adverse events in both groups were generally mild to moderate. In both periods combined, nasopharyngitis (27% and 13% for adalimumab-and placebo-treated patients, respectively) was most frequently reported. Conclusion: Adalimumab is efficacious and well tolerated for treatment of chronic plaque psoriasis of hands and/or feet, with efficacy largely maintained to 28 weeks. Trial Registration: clinicaltrials.gov Identifier: NCT00735787 Arch Dermatol. 2011;147(4):429-436. Published online December 20, 2010. doi:10.1001/archdermatol.2010.384
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