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Secukinumab superior to etanercept for plaque psoriasis


 

Secukinumab (AIN457), an interleukin-17A (IL-17A) inhibitor, was more effective in treating moderate-to-severe plaque psoriasis than the anti-tumor necrosis factor etanercept and current standard of care, according to a head-to-head phase 3 study.

Data presented at the 22nd Congress of the European Association of Dermatology and Venereology (EADV) in Istanbul showed that secukinumab was effective in treating psoriasis, with rapid onset and durable responses, and may represent a new treatment alternative for patients.

The FIXTURE study (Full year investigative examination of secukinumab vs. etanercept using 2 dosing regimens to determine efficacy in psoriasis), a randomized, double-blind, placebo-controlled, multicenter, global pivotal study, involved 1,306 patients.

The study met all primary and pre-specified key secondary end points (P<0.0001 for placebo comparisons and P=0.0250 for etancercept comparisons). Both doses of secukinumab showed improved efficacy to etancercept throughout the 52-week study, beginning as early as week two and confirmed by week 12 when the primary end points were assessed.

More patients taking secukinumab experienced almost clear skin (PASI 90) and completely clear skin (PASI 100) compared to etanercept, which are higher standards of skin clearance compared to the standard efficacy measures used in most psoriasis clinical studies. At its peak, the PASI 90 response was over 70 percent and PASI 100 was over 35 percent.

At three weeks of treatment, about 50 percent of patients taking secukinumab had a 50 percent reduction in PASI.

“If you look at the peak response at 16 weeks, 87 percent of patients taking secukinumab achieved PASI 75, which is a very high response,” said Mark Lebwohl, M.D., chairman, department of dermatology, Mount Sinai School Medicine, New York. “Seventy-seven percent of patients reached PASI 75 at 12 weeks of treatment, which was the primary end point of the study.

“Importantly, patients taking secukinumab did do better than those taking (etanercept), which was expected, though (etanercept) also did well,” he said. “In addition, across both the (etanercept) comparison and placebo controlled cohorts, the 300-mg dose of secukinumab was more effective than the 150-mg dose.

“Treating psoriasis can be challenging as not all treatments are appropriate or effective in every patient, so there is a definite need for additional options,” Dr. Lebwohl said.

Disclosures: Dr. Lebwohl has served as a consultant and investigator for Amgen, which manufactures Enbrel (etanercept) and for Novartis, which is developing secukinumab.

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