Cosentyx effective in patients with palmoplantar psoriasis
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VANCOUVER, British Columbia — Cosentyx was efficacious and had an acceptable safety profile in patients with palmoplantar psoriasis, with a higher dose more effective, according to research presented at the World Congress of Dermatology.
“Treatment of palmoplantar psoriasis is often difficult and not as easy as other parts of the body to respond to treatments, even biologics,” Alice B. Gottlieb, MD, PhD, professor and chair of dermatology, Tufts University School of Medicine, Boston, said during her presentation.
Palmoplantar psoriasis, defined by Gottlieb as plaque psoriasis on the palms and soles, can occur in up to 40% of patients with moderate-to-severe plaque type psoriasis and can have a greater effect on the quality of life, Gottlieb said.
To evaluate Cosentyx (secukinumab, Novartis), Gottlieb and colleagues conducted the GESTURE study, a double-blind, randomized, placebo-controlled, parallel-group, multicenter phase 3b study. The study included 205 patients with chronic, moderate-to-severe, non-pustular palmoplantar psoriasis, who were randomly assigned 1:1:1 to secukinumab 300 mg, secukinumab 150 mg or placebo, given subcutaneously for 76 weeks.
The primary objective was superiority of secukinumab 150 mg and/or 300 mg compared with placebo, as assessed by palmoplantar psoriasis investigator global assessment (ppIGA) of 0 or 1 (0=clear, 1=almost clear/minimal) at week 16. Patients who received placebo and did not achieve ppIGA 0 or 1 at week 16 were re-randomized 1:1 to receive 300 mg or 150 mg secukinumab.
Evaluation of palmoplantar Psoriasis Area and Severity Index (ppPASI) over time was a secondary endpoint.
Both endpoints were met at week 16, with ppIGA 0 to 1 response in patients with both doses of secukinumab superior to the placebo-treated patients (P<.001), including non-responder imputation, 33.3%, 22.1%, 1.5%; and multiple imputation of 39.4%, 23.1% and 1.5% for secukinumab 300 mg, 150 mg and placebo, respectively, the researchers wrote.
At week 16, the ppPASI reduction from baseline was greatest with secukinumab 300 mg at
–54.6%, compared with –35.3% for 150 mg and –4.1% for placebo.
Common adverse events were similar to those reported in previous phase 3 studies of secukinumab in psoriasis and included headache, nasopharyngitis and upper respiratory tract infection.
“This is the largest double-blind, randomized, placebo-controlled study of plantar psoriasis with any treatment,” Gottlieb said. “The 300 mg dose is better than the 150 mg dose, with roughly a third of patients achieving [ppIGA] of 0 or 1 at week 16. I’m very happy to have this as an option for my patients.” — by Bruce Thiel
Reference:
Gottlieb A. FC24-07: Secukinumab Efficacy and Safety in Subjects with Moderate to Severe Palmoplantar Psoriasis in a Phase 3B Study (GESTURE). Presented at: 23rd World Congress of Dermatology; June 8-13, 2015; Vancouver, British Columbia.
Disclosure: Gottlieb reports financial relationships with Abbott Labs, AbbVie, Actelion, Adros, Amgen, Astellas, Beirsdorf, Bristol-Myers Squibb, Cangite, Catabasis, Celgene Corp., Centecor, Coronado, CSL Behring Biotherapies for Life, Dermipsor, GlaxoSmithKline, Incyte, Janssen, Karyopharm, Levia, Lilly, Merck, Novartis, Novo Nordisk, Pfizer, Sanofi Aventis, TEVA, UCB, Vertx and Xenoport.