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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S14 SUPPLEMENT TO THE JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY [JUNE 2016 • VOLUME 9 • NUMBER 6 • SUPPLEMENT 1] t herapy. The study excluded other forms of psoriasis such as pustular psoriasis or palmoplantar pustulosis. Overall, the baseline characteristics across the study groups were well balanced in the GESTURE study. The patients averaged approximately 50 years of age with m ales comprising between 50 to 59 percent of the study group population. The mean body weight was approximately 84kg. With regard to baseline ppIGA score, the secukinumab 150mg group had a relatively greater proportion of those with severe disease compared to the placebo and secukinumab 300mg group. In addition, the proportion of patients with prior exposure to biologic psoriasis therapy was lower in the secukinumab 300mg group (9%) compared to secukinumab 150mg group (13%) and the placebo (13%). Results: The GESTURE study evaluating secukinumab in palmoplantar psoriasis. The GESTURE study is the largest randomized, double-blind, placebo controlled trial of a biologic in palmoplantar psoriasis to date. 1 2 The primary endpoint of assessing two doses of secukinumab against placebo in achieving ppIGA 0/1 was met. Specifically, one-third of patients receiving secukinumab 300mg achieved clear or almost clear palms and soles at Week 16. Similar to the Phase 3 studies, efficacy of secukinuamb 300mg was numerically higher than that of secukinumab 150mg. The secondary endpoint of assessing percentage change in ppPASI over time was also met for both doses of secukinumab. Specifically, palmoplantar disease improved by more than 50 percent in patients on secukinumab 300mg at Week 16, as compared to 35- percent improvement in those receiving secukinumab 150mg at Week 16. Both doses of secukinumab were superior to placebo in achieving palmoplantar disease improvement. In the GESTURE study, the safety results were consistent with previous studies, 2–5 and no new safety signal was identified. In this difficult population with palmoplantar disease, secukinumab offers a new and effective treatment option. Nail Psoriasis The lifetime involvement of nail psoriasis can occur in up to 90 percent of patients with psoriasis. 13 Nail psoriasis is associated with significant functional impairment and psychosocial impairment. 14 In addition, studies have shown that nail psoriasis may be associated with psoriatic arthritis and may predict the onset of psoriatic arthritis in many patients. 14–16 For example, Dalbeth et al 15 showed that nails with onycholysis and hyperkeratosis at baseline were more likely to have corresponding distal phalangeal bone erosion and proliferation on magnetic resonance imaging (MRI). Because IL-17A is known to play a critical pathogenic r ole in plaque psoriasis, elucidating the effect of secukinumab on nail psoriasis is of high clinical importance. 2,17 Study design and study population: The TRANSFIGURE study evaluating secukinumab in n ail psoriasis. TRANSFIGURE is a double-blind, randomized, placebo-controlled, parallel-group Phase 3b study evaluating secukinumab in patients with moderate- to-severe psoriasis with nail involvement. 18 The patients were randomized 1:1:1 to receive either secukinumab 300mg, secukinumab 150mg, or placebo up to Week 76. At Week 16, all subjects receiving placebo were re- randomized 1:1 to either 300mg or 150mg secukinumab. The primary objective is to determine the superiority of secukinumab 300mg and 150mg over placebo by total fingernail Nail Psoriasis Severity Index (NAPSI) percent change from baseline at Week 16. The primary efficacy endpoint is the total fingernail NAPSI—the sum of NAPSI scores of all 10 fingernails. The secondary objectives included NAPSI, PASI 75, and IGA 2011 modified version (mod 2011) 0/1 response over time as well as safety and tolerability. Patients were included in the study if they had chronic moderate-to-severe psoriasis with significant nail involvement (defined by fingernail NAPSI ≥16 and ≥4 fingernails involved). The patients also had to have psoriasis that was inadequately controlled by topical treatment and/or phototherapy and/or previous systemic therapy. Results: The TRANSFIGURE study evaluating secukinumab in nail psoriasis. Secukinumab 300mg and secukinumab 150mg resulted in superior efficacy to placebo as measured by NAPSI percent change at Week 16 (p<0.0001). Specifically, the mean NAPSI percent change was -45.4 percent for secukinumab 300mg, -38.9 percent for secukinumab 150mg, and -11.2 percent for placebo. With regard to secondary endpoints, the responses for PASI 75 and modified IGA score of clear or almost clear were significantly higher for both secukinumab 300mg (PASI 75: 87.1% and IGA 0/1: 74.0%) and secukinumab 150mg (PASI 75: 77.0% and IGA 0/1: 68.3%), compared to placebo (PASI 75: 5.1% and and IGA 0/1 3.1%) (p<0.0001). Furthermore, both doses of secukinumab also achieved significantly higher PASI 90 responses compared to placebo (72.5% in secukinumab 300mg, 54.0% in secukinumab 150mg, and 1.7% in placebo, p<0.0001). Finally, the most common adverse events that were reported across secukinumab and placebo arms were nasopharyngitis, headache, and upper respiratory tract infections. The safety profile of secukinumab in the TRANSFIGURE study is similar to that of other Phase 3 studies in plaque psoriasis using secukinumab. It is important to note that, among prospective, placebo-controlled trials evaluating nail psoriasis, secukinumab in the TRANSFIGURE study achieved the highest efficacy at Week 16 reported to date.

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