Adalimumab for Treatment of Moderate to Severe Chronic Plaque Psoriasis of the Hands and Feet: Efficacy and Safety Results From REACH, a Randomized, Placebo-Controlled, Double-blind Trial | Dermatology | JAMA Dermatology | JAMA Network
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April 11, 2011

Adalimumab for Treatment of Moderate to Severe Chronic Plaque Psoriasis of the Hands and Feet: Efficacy and Safety Results From REACH, a Randomized, Placebo-Controlled, Double-blind Trial

Author Affiliations

Author Affiliations: Central Dermatology, St Louis, Missouri (Dr Leonardi); Dalhousie University, Halifax, Nova Scotia, Canada (Dr Langley); Probity Medical Research, Waterloo, Ontario, Canada (Dr Papp); The University of Texas Health Center at Houston (Dr Tyring); Stratica Medical, Edmonton, Alberta, Canada (Dr Wasel); Dermatrials Research, Hamilton, Ontario, Canada (Dr Vender); Abbott GmbH & Co KG, Ludwigshafen, Germany (Dr Unnebrink); Abbott Laboratories, Abbott Park, Illinois (Drs Gupta and Valdecantos); and Psoriasis Treatment Center of Central New Jersey, East Windsor (Dr Bagel).

Arch Dermatol. 2011;147(4):429-436. doi:10.1001/archdermatol.2010.384

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 Identifier: NCT00735787