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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Page 14 of 15

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 S15 S calp Psoriasis Scalp is usually the first site of psoriasis onset, and scalp psoriasis affects approximately 80 percent of p soriasis patients. 1 9–22 S calp psoriasis is particularly associated with marked decrease in quality of life due to desquamation, psychosocial stress, and itching. 23,24 Just as with psoriasis affecting other specialized areas, different assessment instruments are used for scalp psoriasis. Namely, the psoriasis scalp severity index (PSSI) is used to measure severity of scalp psoriasis. PSSI is similar to PASI in that it measures erythema, induration, and scaling, which are graded from 0 to 4 and multiplied by a categorical area score. The distinction is that PSSI measures scalp only. Another tool used to measure severity of scalp psoriasis is the scalp Physician's Global Assessment (PGA), which is a measurement of plaque morphology limited to scalp lesions only. Topical treatments have been variably effective in scalp psoriasis. 20 Topical treatments have significant limitations for scalp psoriasis due partly to the thick scale in plaque psoriasis that prevents deep penetration of topical medications into the dermis. Furthermore, the itching in scalp psoriasis often results in chronic scratching and koebnerization of the lesions. Therefore, in patients with isolated but difficult-to-treat scalp psoriasis recalcitrant to topical therapies or in patients with generalized, moderate-to-severe plaque psoriasis that also involve the scalp, systemic treatments can be considered. Systemic treatments for scalp psoriasis have included traditional agents, such as cyclosporine or methotrexate, but large, randomized, controlled trials assessing their efficacies are lacking. Apremilast has been shown to achieve a scalp PGA of clear or almost clear in 46 percent of apremilast-treated patients compared to 17 percent of patients on placebo (p<0.0001) at Week 16. 25 Biologics, such as etanercept, adalimumab, and infliximab, have shown good efficacy in clearing scalp psoriasis. 26–28 The role of IL-17 inhibitors in scalp psoriasis had not been previously studied. In the poster by Lebwohl et al 29 at the 2015 American Academy of Dermatology meeting, the investigators presented the study design for an ongoing study assessing the efficacy and safety of secukinumab in scalp psoriasis. In this currently ongoing, Phase 3b, multicenter, randomized, double-blind, placebo-controlled, parallel- group study, the investigators aimed to evaluate the efficacy of secukinumab 300mg compared to placebo in patients with moderate-to-severe scalp psoriasis at Week 12 with respect to PSSI 90 response rate. A total of 94 patients across 20 study sites in the United States are randomized 1:1 to placebo or secukinumab 300mg. Adults with psoriasis were included in the study if they had chronic moderate-to-severe scalp psoriasis defined by PSSI score of 12 or greater, modified IGA of 3 or greater, and greater than 30 percent scalp s urface involvement. They also had to be deemed to be candidates for systemic therapy by the investigators. The results of this study are pending and will contribute substantially to our understanding of the role of secukinumab in scalp psoriasis. Pustular Psoriasis Pustular psoriasis is a form of psoriasis that is characterized by sterile pustules. Pustular psoriasis can be categorized into generalized versus localized forms. Generalized pustular psoriasis (GPP) can involve most of the body and is considered a potentially life-threatening condition. Few treatment options currently exist for GPP. Study design and study population: Secukinumab in generalized pustular psoriasis. In a study by Imafuku et al, 30 Japanese investigators evaluated the efficacy and safety of secukinumab in Japanese patients with GPP in a multicenter, single arm, open label Phase 3 study. A total of 12 patients with GPP received secukinumab 150mg at baseline, Weeks 1, 2, 3, and 4. At Week 8, patients without notable improvement based on Clinical Global Impression (CGI) were assigned to secukinumab 300mg, whereas patients with sufficient improvement remained on secukinumab 150mg every four weeks. Results: Secukinumab in generalized pustular psoriasis. Of the 12 enrolled patients, 10 patients continued on 150mg, one patient up-titrated to 300mg at Week 8, and one patient discontinued due to protocol deviation. Primary endpoint was achieved in 10 patients with CGI evaluated as "Very much improved" (9 patients) or "Much improved" (1 patient) at Week 16. The PASI 75 response was achieved by 10 patients at Week 16. The most common adverse events were nasopharyngitis and urticaria. Two patients had experienced liver injury and upper gastrointestinal hemorrhage; no deaths were reported. This is among the few studies investigating the role of biologic agents in treating GPP. In this open-label study, secukinumab was found to be effective in treating GPP in Japanese patients. The role of secukinumab in the treatment of psoriasis involving specialized regions of palms and soles, nail, and scalp is continually elucidated. Its role in GPP illustrates the utility of IL-17A inhibitors for other phenotypes of psoriasis beyond plaque psoriasis. It is important to continually study IL-17 inhibitors for both their efficacy as well as monitoring their long-term safety in the various phenotypes of psoriasis. References 1. Patel DD, Lee DM, Kolbinger F, Antoni C. Effect of IL-17A blockade with secukinumab in autoimmune diseases. Ann

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