Adalimumab for Treatment of Moderate to Severe Chronic Plaque Psoriasis of the Hands and Feet

Abstract

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.

Treatment of Nail Psoriasis: Common Concepts and New Trends

“…In a RCT of palmoplantar psoriasis, 28 of 36 patients with nail involvement received adalimumab therapy for 16 weeks and showed a higher mean percentage of NAPSI improvement compared to placebo-treated group (50% versus 8%). At week 16, patients from the placebo group were switched to receive active treatment, and a mean improvement of 38% was reported in NAPSI at week 28 [57]. …”

Incomplete Data in Randomized Dermatology Trials: Consequences and Statistical Methodology

“…This is sometimes called nonresponder imputation (NRI) and is used extensively in dermatology trials [1,3,4,14,15,16,17,18,19,20,21,22,23,24,25]. It is viewed as a conservative way of handling missing data since it may be rationalized by the assumption that subjects prematurely withdraw from trials due to lack of efficacy [20].…”

“…This ‘last observation carried forward' (LOCF) imputation is also commonly used in dermatology trials [1,14,21,23,24,26,27,28,29], but it implicitly assumes that all missing responses remain constant after their last observed values have been recorded.…”

“…Studies which explore treatment effect on psoriasis, for example, often incorporate measures of the Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA), and Dermatology Life Quality Index (DLQI). Studies can be found which explore treatment effect in terms of PGA scores [1] after a certain number of weeks, the change in PASI or DLQI [2,3] over a period of time, or total clearance of symptoms by a set follow-up time [4]. The most common primary outcome in psoriasis trials is the binary PASI 75, an indicator of whether a decrease in PASI score of at least 75% from baseline has been achieved.…”

Evidence and suggested therapeutic approach in psoriasis of difficult-to-treat areas: Palmoplantar psoriasis, nail psoriasis, scalp psoriasis, and intertriginous psoriasis

“…Many studies (RCTs, open-label, and retrospective studies) are available showing statistically significant efficacy of adalimumab[212223] (LOE 2 and 4), etanercept[242526] (LOE 4), and ustekinumab[272829] (LOE 3).…”