Secukinumab Phase III Data Confirm Significant Efficacy in Patients with Psoriatic Arthritis

Results from the Phase III FUTURE 1 study for secukinumab in psoriatic arthritis (PsA) were published online in The New England Journal of Medicine (NEJM). Secukinumab is the first interleukin-17A (IL-17A) antagonist to demonstrate efficacy in a Phase III study in patients with active PsA, a painful, debilitating condition causing inflammation of joints and skin. Secukinumab met the primary endpoint 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.

Results showed half of patients (50.0% and 50.5%) in both secukinumab-treated dose groups (150 mg and 75 mg; p<0.001) achieved ACR 20 response compared with only 17.3% of placebo patients. Exploratory analyses showed more secukinumab-treated patients in the 150mg and 75mg dose groups experienced ACR 20 responses by Week 1 versus placebo (p<0.001). In an additional exploratory analysis, a majority of secukinumab-treated patients achieving ACR 20 responses at Week 24 also maintained the response at Week 52 with continued treatment.

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% (150mg), 60.4% (75mg), and 58.4% (placebo) of patients reported an AE. Serious adverse event (SAE) rates were 4.5%, 2.5%, and 5.0%, respectively.
The study enrolled 606 patients with active PsA, including patients who had been previously treated with DMARDs (disease-modifying anti-rheumatic drugs) and patients who had an inadequate response or did not tolerate anti-TNFs. In the study, patients received an intravenous loading dose every two weeks for the first four weeks of treatment followed by monthly subcutaneous doses of 75mg or 150mg compared to placebo. The intravenous loading period was designed to provide high systemic exposure for induction of response, in keeping with the initial proof of concept study in PsA with secukinumab.

Secukinumab is not indicated for PsA.