TY - JOUR
T1 - Adalimumab for treatment of moderate to severe chronic plaque psoriasis of the hands and feet
T2 - Efficacy and safety results from REACH, a randomized, placebo-controlled, double-blind trial
AU - Leonardi, Craig
AU - Langley, Richard G.
AU - Papp, Kim
AU - Tyring, Stephen K.
AU - Wasel, Norman
AU - Vender, Ronald
AU - Unnebrink, Kristina
AU - Gupta, Shiraz R.
AU - Valdecantos, Wendell C.
AU - Bagel, Jerry
PY - 2011/4
Y1 - 2011/4
N2 - 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 wasmaintained 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.
AB - 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 wasmaintained 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.
UR - http://www.scopus.com/inward/record.url?scp=79953863873&partnerID=8YFLogxK
U2 - 10.1001/archdermatol.2010.384
DO - 10.1001/archdermatol.2010.384
M3 - Article
C2 - 21173304
AN - SCOPUS:79953863873
SN - 0003-987X
VL - 147
SP - 429
EP - 436
JO - Archives of Dermatology
JF - Archives of Dermatology
IS - 4
ER -