Journal of Clinical and Aesthetic Dermatology

Plaque-type Psoriasis Supplement 2016

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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A Novel Paradigm for Treatment of Moderate-to-severe Plaque-type Psoriasis [JUNE 2016 • VOLUME 9 • NUMBER 6 • SUPPLEMENT 1] SUPPLEMENT TO THE JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY S13 associated with disproportionately greater pain, functional limitations, and significant impairment of health-related quality of life. 7 Compared to plaque psoriasis involving other regions, those with palmoplantar psoriasis suffer from more discomfort and disability. 8 It was generally recognized that palmoplantar psoriasis poses a treatment challenge. 9 Therapies that achieve a certain level of response in other parts of the body often perform relatively poorly in the palmoplantar regions. Patients with palmoplantar involvement but little plaque psoriasis elsewhere on the body are less likely to participate in pivotal trials for new systemic therapies because these trials usually require a body surface area (BSA) of 10 percent or greater. Few trials have examined the effect of systemic therapies on palmoplantar psoriasis. 10,11 These studies uniformly showed that the currently available systemic medications yield lower efficacy in palmoplantar psoriasis than in generalized psoriasis. Janagond et al 11 performed a head-to-head study comparing efficacy of 0.4mg/kg/week of methotrexate (or 28mg/week in a 70kg patient) to that of acitretin 0.5mg/kg/day (or 35mg/day in a 70kg patient). In this study where 111 patients were randomized to either methotrexate or acitretin, the primary endpoint was the proportion of patients achieving 75-percent improvement or greater on the palmoplantar Psoriasis Area and Severity Index (PPPASI 75). At Week 12, 24 percent of patients in the methotrexate group achieved PPPASI, as compared to eight percent in the acitretin group (p=0.029). Thus, 28mg/week of methotrexate appears to be significantly superior to 35mg/day of acitretin in improving palmoplantar psoriasis in the short-term. Infliximab was among the first biologics evaluated for its efficacy in the treatment of palmoplantar psoriasis. In a small, randomized, controlled trial, 24 participants were randomized to receive infliximab 5mg/kg at Weeks 0, 2, and 6 versus placebo. At Week 14, 33 percent in infliximab achieved modified PPPASI 75 versus eight percent in placebo (p=0.317). 10 Study design and study population: The GESTURE study evaluating secukinumab in palmoplantar psoriasis. The investigational program for secukinumab for palmoplantar psoriasis included GESTURE, a double-blind, randomized, placebo- controlled, parallel-group multicenter Phase 3b study. The primary objective of the study was to assess the percentage of patients achieving palmoplantar psoriasis Investigator's Global Assessment (ppIGA) score of 0/1 (i.e., clear or almost clear/minimal and a reduction of at least 2 points from baseline on the ppIGA scale) at Week 16 (Table 1). In this study, 205 patients were randomized to secukinumab 300mg, secukinumab 150mg, and placebo, with primary endpoint evaluated at Week 16. After 16 weeks, the non-responders from the placebo group are then randomized to secukinumab 300mg, secukinumab 150mg, and placebo. The study follows up with participants until Week 140. The inclusion criteria for the study are as follows: having chronic moderate-to-severe palmoplantar psoriasis with a ppIGA score of 3 or greater on a 5-point scale at baseline; one or more psoriasis plaques outside of the palms and soles; and psoriasis inadequately controlled by topical treatment, phototherapy, and/or systemic TABLE 1. Palmoplantar Investigator's Global Assessment (ppIGA) 0 = Clear No signs of psoriasis, postinflammatory hyperpigmentation may be present 1 = Almost clear/minimal Coloration: normal to pink Thickening: none Scaling: none to minimal focal 2 = Mild Coloration: pink to light red Thickening: just detectable to mild Scaling: predominantly fine scaling 3 = Moderate Coloration: dull to bright red, clearly distinguishable Thickening: clearly distinguishable to moderate Scaling: moderate 4 = Severe Coloration: bright to deep dark red Thickening: severe with hard edges Scaling: severe/coarse covering almost all/all lesions, numerous fissures

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