By Ed Susman
MIAMI BEACH, Fla -- March 7, 2013 -- A dose-intensive regimen of 4-weekly injections of the investigative agent secukinumab showed superior efficacy, compared with placebo, among patients with plaque psoriasis, according to a study presented here on March 4 at the 71st Annual Meeting of the American Academy of Dermatology (AAD).
“Secukinumab treatment has demonstrated therapeutic benefit in patients with moderate-to-severe plaque psoriasis,” wrote Alice. B. Gottlieb, MD, Tufts Medical Center, Boston, Massachusetts, and colleagues in their e-poster presentation.
“Psoriasis is accompanied by psoriatic arthritis in 6% to 42% of patients, which makes treatment of these patients more challenging,” the researchers explained.
The phase 2 randomised study included patients with both moderate-to-severe plaque psoriasis and psoriatic arthritis. Sixty-six patients were given a single 150-mg subcutaneous injection of secukinumab at the start of the trial, but did not receive further mediation; 138 patients received a monthly dose of secukinumab at the start of the trial, and at week 4 and week 8; 133 patients were dosed at the start of the trial and at weeks, 1, 2, and 4; and 67 patients were given placebo.
When patients were not receiving active medication on the regular schedule they were given placebo injections.
At the end of 12 weeks, 54.5% of patients on the intensified treatment schedule had achieved a Psoriasis Area and Severity Index (PASI75) goal compared with 42% of patients who received a monthly dose. Both those achievements were statistically significantly better than placebo-treated patients who achieved barely a 1.5% PASAI75 (P <.001).
About 10.6% of patients on the single dose of secukinumab recorded a PASI75, which was not statistically significant when compared with placebo (P =.225).
Among patients who had both psoriasis and psoriatic arthritis the pattern was similar, with about 50% of the intensive early treatment patients achieving a PASI75 (P <.002) and 44.4% of the monthly treated patients achieving a PASI75 (P <.005). No placebo patients achieved the PASI75 goal.
The study was opened to adults who had been diagnosed with plaque psoriasis for at least 6 months and had moderate to severe disease (PASI score of ·12) and at least 10% of body surface involved. They also had to have a history of uncontrolled treatment despite other topical and systemic therapies.
Most adverse events were mild or moderate in severity. The overall study safety analysis did not reveal any safety signal.
Funding for this study was provided by Novartis Pharma AG.
[Presentation title: Secukinumab Efficacy in Patients With Moderate-to-Severe Plaque Psoriasis and Psoriatic Arthritis: A Phase II, Double-Blind, Randomized Trial. Abstract 6394]
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