Secukinumab shows benefit in psoriatic arthritis patients

October 20, 2015

Secukinumab may be an important new therapeutic treatment option for patients with psoriatic arthritis (PsA), according to a study published online in The New England Journal of Medicine.

Secukinumab may be an important new therapeutic treatment option for patients with psoriatic arthritis (PsA), according to a study published online in The New England Journal of Medicine.

FUTURE 1, the first multicenter, randomized, placebo-controlled phase 3 study, evaluated the efficacy and safety of secukinumab in PsA. Secukinumab is the first interleukin-17A (IL-17A) antagonist to demonstrate efficacy in a phase 3 study in patients with active PsA, a painful, debilitating condition causing inflammation of joints and skin. PsA is part of a family of long-term diseases impacting joints, known as spondyloarthritis (SpA). 

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“There is a high unmet need for new treatment options for patients with PsA and approximately 45% of people are dissatisfied with their treatments,” says Cathryn M. Clary, MD, head, US clinical development & medical affairs at Novartis.

In FUTURE 1, patients received an intravenous loading dose of 10 mg/kg every 2 weeks for the first 4 weeks of treatment, followed by monthly subcutaneous doses of 75 mg or 150 mg compared to placebo. The results showed secukinumab met the primary end point based on a significantly higher percentage of secukinumab patients who achieved at least a 20% reduction in the American College of Rheumatology response criteria (ACR 20) at Week 24 versus placebo. ACR is a standard tool used to assess improvement of PsA signs and symptoms such as tender and swollen joints, pain and disability. In addition, secukinumab met all pre-specified secondary end points, including improvements in skin and joint diseases and reduction of joint structural damage progression.

Results showed half of patients (50.0% and 50.5%) in both secukinumab-treated dose groups (150 mg and 75 mg; P<.001) achieved ACR 20 response compared with only 17.3% of placebo patients. Exploratory analyses showed more secukinumab-treated patients in the 150-mg and 75-mg dose groups experienced ACR 20 responses by Week 1 versus placebo (P<.001). In an additional exploratory analysis, a majority of secukinumab-treated patients achieving ACR20 responses at Week 24 also maintained the response at Week 52 with continued treatment.

 

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Secukinumab was well tolerated in the study, with a safety profile generally consistent with that observed in the psoriasis clinical trial program. The most common adverse events (AEs) for either secukinumab dose were the common cold (nasopharyngitis, 8.2%), headache (5.4%) and upper respiratory tract infections (5.4%). In FUTURE 1, 64.9% (150 mg), 60.4% (75 mg) and 58.4% (placebo) of patients reported an AE. Serious adverse event (SAE) rates were 4.5%, 2.5%, and 5.0%, respectively.

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PsA is part of a spectrum of long-term diseases impacting joints, known as spondyloarthritis (SpA). Approximately 30% of patients with psoriasis have psoriatic arthritis, which is a debilitating, long-lasting inflammatory disease linked with significant disability and poor quality of life.

“If approved by FDA, secukinumab warrants inclusion on managed care and hospital formularies on par with other efficacious therapies for patients who are managing their disease,” Dr Clary said.

Secukinumab (Cosentyx) was approved in January 2015 for the treatment of adults with moderate-to-severe plaque psoriasis.