Secukinumab for the treatment of scalp, nail, and palmoplantar psoriasis
Presenters: Hawkes JE1,2, Lebwohl M2, Elewski B3, Kircik L2,4, Reich K5, Muscianisi E6, Gottlieb A7
Affiliations: 1The Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY; 2Icahn School of Medicine at Mount Sinai, New York, NY; 3University of Alabama, Birmingham, AL; 4Indiana University School of Medicine, Indianapolis, IN; 5Dermatologikum Hamburg, Hamburg, Germany; 6Novartis Pharmaceuticals Corporation, East Hanover, NJ 7New York Medical College, Valhalla, NY
Background/Objective: Psoriasis is a chronic, immune-mediated, systemic condition that commonly affects the scalp, nails, palms, and soles. Although psoriasis in these areas accounts for a small percentage of total body surface area, it often results in significant dysfunction and quality of life impairment. For instance, the highly visible nature of scalp psoriasis can cause embarrassment and discomfort. Psoriatic nail disease is often overlooked, causing cosmetic concerns and difficulty with tasks requiring manual dexterity. Palmoplantar psoriasis causes significant functional impairment compared with other psoriasis subtypes and can be recalcitrant to traditional systemic therapies. Until recently, there has been limited clinical research focused on less common and hard-to-treat subtypes or clinical features of psoriatic disease. Secukinumab, a human monoclonal antibody that selectively binds to and neutralizes interleukin-17A, has demonstrated efficacy for chronic plaque psoriasis in a structured Phase III development plan. Here we present a review of the efficacy and safety of secukinumab in patients with psoriasis affecting the scalp, nails, palms, and soles of the feet.
Methods: In three separate clinical trials designed specifically for each of these hard-to-treat areas, inclusion criteria included patients with moderate-to-severe scalp psoriasis (Psoriasis Scalp Severity Index [PSSI] ?12), patients with moderate-to-severe psoriasis with significant nail involvement (Nail Psoriasis Severity Index [NAPSI] ?16 with ?4 fingernails involved), and patients with moderate-to-severe palmoplantar psoriasis (palmoplantar Investigator’s Global Assessment [ppIGA] ?3), respectively. In all trials, patients received secukinumab 300mg or 150mg at baseline, Weeks 1, 2 and 3, and then every four weeks beginning at Week 4.
Results: The primary endpoint of each trial was met. In 102 patients with scalp psoriasis, PSSI 90-percent improvement response rates were significantly greater with secukinumab 300mg versus placebo at Week 12 (52.9% vs. 2.0%; P<0.001). One in 198 patients with nail psoriasis, mean NAPSI percent change from baseline to Week 16 was significantly greater in secukinumab 300mg (-45.3%) and secukinumab 150mg (-37.9%) groups compared to placebo (-10.8%; both P<0.0001). In 205 patients with nonpustular palmoplantar psoriasis, ppIGA0/1 was achieved at Week 16 by significantly more patients with secukinumab 300mg (33.3%) and secukinumab 150mg (22.1%) than with placebo (1.5%; both P<0.001). The safety of secukinumab in these trials was consistent with the safety profile observed in previous clinical trials, and no new safety signals were identified.
Conclusion: Secukinumab is a safe and effective treatment option in chronic plaque psoriasis and these hard-to-treat psoriasis subtypes as demonstrated in specifically designed prospective clinical trials.
Funding: This research was sponsored by Novartis Pharma AG, Basel, Switzerland, and Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.