Secukinumab provides sustained efficacy, safety in treatment of psoriatic arthritis

Secukinumab demonstrated continued improvement in the treatment of psoriatic arthritis and was well-tolerated among patients in a 3-year extension of the FUTURE 1 study, according to data presented at the American College of Rheumatology Annual Meeting.

Secukinumab (Cosentyx, Novartis) is the first FDA-approved fully human interleukin-17A inhibitor to show 3-year efficacy in patients with psoriatic arthritis, according to a press release from Novartis. The drug is also the only IL-17A inhibitor indicated for ankylosing spondylitis, psoriatic arthritis and psoriasis.

In the FUTURE 1 study, Philip J. Mease, MD, of Swedish Medical Center and the University of Washington in Seattle, and colleagues randomly assigned 606 adults with active psoriatic arthritis to either secukinumab or placebo. Patients in the secukinumab arm received a 10 mg/kg IV loading dose at baseline and Weeks 2 and 4, followed by either 75 mg subcutaneously or 150 mg subcutaneously every 4 weeks. Patients in the placebo arm followed the same dosing schedule.

Philip J. Mease

At Week 16 or Week 24, depending on the clinical response at Week 16, patients in the placebo arm were rerandomized to treatment with subcutaneous secukinumab 75 mg or 150 mg. Patients were eligible for the extension phase of the study at Week 104.

Results were based on efficacy at Week 156 among patients originally randomized to treatment with secukinumab (n = 308). Clinical assessments included ACR20, 50 and 70; 75% of Psoriasis Area and Severity Index (PASI 75); DAS28-CRP; Short Form (36) Health Survey Physical Component Score (SF-36 PCS); Health Assessment Questionnaire-Disability Index (HAQ-DI); dactylitis; and enthesitis. Pre-specified analyses stratified by anti-tumor necrosis factor-alpha (TNF-a) inhibitor status (patients who were treatment-naive vs. those with an inadequate response to the agents) were reported as observed.

The safety analysis was based on exposure-adjusted incidence rate. All patients (n = 587) treated with one or more doses of the study drug at Week 156 were included in this analysis.

The extension study included 457 of 606 original patients, including 308 initially randomized to treatment with secukinumab. Among these patients, 435 completed treatment through Week 156, including 151 patients in the 150 mg IV group, 142 in the 75 mg IV group and 142 in the groups switched from placebo to secukinumab.

Of the measurements evaluated, only improvements in ACR 20, 50 and 70 were considered clinically significant. ACR 20, 50 and 70 response rates were 76.8%, 54.9% and 32.9% in the 150 mg IV group and 65.2%, 39% and 26% in the 75 mg IV group, respectively. Improvements were maintained among patients who had not previously been treated with TNF-a inhibitors and those with an inadequate response to the agents.

The type, incidence and severity of adverse events during the study period (mean exposure to secukinumab, 1,025.1 ± 372.7 days) were consistent with earlier reports. Exposure-adjusted incidence rates for serious infections/infestations, Candida infections, Crohn’s disease, malignant/unspecified tumors and major adverse cardiac events with secukinumab were 1.7, 1.2, 0.1, 0.9 and 0.7 per 100 patient-years, respectively.

“Secukinumab provided sustained improvements in signs and symptoms and multiple clinical domains of active psoriatic arthritis in patients who completed three years of therapy,” the researchers wrote. “Secukinumab was well tolerated with a safety profile consistent with that previously reported.” – by Julia Ernst, MS

Reference:

Mease PJ, et al. Abstract 961. Presented at: American College of Rheumatology Annual Meeting; Nov. 11-16, 2016; Washington.

Disclosures: Mease reports associations with AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Crescendo Bioscience, Corrona, Dermira, Eli-Lilly, Genentech, Janssen, Merck, Novartis, Pfizer, Sun Pharma and UCB.