New data showing Secukinumab ( Cosentyx ) delivers sustained improvements in the signs and symptoms of psoriatic arthritis over three years, including patient-reported pain, were presented at the 2016 Annual Meeting of the American College of Rheumatology ( ACR ).
Secukinumab is the first approved fully human interleukin-17A ( IL-17A ) inhibitor to demonstrate three-year efficacy in patients with psoriatic arthritis, a life-long inflammatory disease that affects the skin and joints.
In the first year of the three-year open-label extension study, which is a continuation of the two-year double-blind study previously reported, 77% of patients with psoriatic arthritis achieved an ACR 20 response ( American College of Rheumatology response criteria ) with Secukinumab.
Completion rates for the extension study were high with 95% patients completing the first year of the extension trial.
These new data show that response rates were consistent from Year 1 ( 69.4% ) to Year 3 ( 76.8% ) and this was independent of whether patients received an anti-TNF prior to receiving Secukinumab.
Importantly, a component of this measure includes patient-reported pain.
Secukinumab has previously shown 79% of patients with spondyloarthritis achieved an ASAS 20 response ( Assessment of Spondyloarthritis International Society response criteria ) at two years.
Previous data also show up to 80% of spondyloarthritis and 84% of patients with psoriatic arthritis treated with Secukinumab at two years had no radiographic progression in the spine or joints respectively, as shown by X-ray assessment.
Secukinumab has continued to have a favorable safety profile, which was consistent with that shown in phase III studies.
FUTURE 1 is a two-year, multi-center, randomized, placebo-controlled phase III pivotal study to evaluate the efficacy of in Secukinumab in patients with active PsA.
FUTURE 1 enrolled 606 patients with active PsA and assessed Secukinumab with intravenous loading ( 10 mg/kg ) and subcutaneous ( 75 mg and 150 mg ) maintenance dosing.
The primary endpoint assessed superiority of Secukinumab against placebo in the proportion of patients achieving the ACR 20 response at Week 24.
From Week 16, patients in the placebo arm of the study were re-randomized to receive Secukinumab 75 mg or 150 mg at either Week 16 or Week 24, based on clinical response.
At Week 104, patients could enter the extension phase of the study.
Source: Novartis, 2016