New data showing Cosentyx® (secukinumab) delivers sustained improvements in the signs and symptoms of psoriatic arthritis (PsA) over three years – including patient-reported pain. These findings were presented at the 2016 Annual Meeting of the American College of Rheumatology (ACR) in Washington DC, United States, at which Novartis presented 28 abstracts in total.
Cosentyx is the first approved fully human interleukin-17A (IL-17A) inhibitor to demonstrate three-year efficacy in patients with PsA, a life-long inflammatory disease that affects the skin and joints. Cosentyx is also the only IL-17A inhibitor indicated for ankylosing spondylitis (AS), PsA, and psoriasis – this is significant as up to eight in 10 patients diagnosed with PsA already have psoriasis.
“Joint pain severely impacts the lives of many people living with psoriatic arthritis. The knowledge that Cosentyx delivers lasting pain relief, reduces swelling and helps keep joints moving is important as it means it could help improve both patient overall quality of life and mobility,” said Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. “Cosentyx provides much-needed pain relief and also delivers high and long-lasting skin clearance for psoriasis, which the majority of people with psoriatic arthritis also suffer from.”
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 PsA patients achieved an ACR 20 response (American College of Rheumatology response criteria) with Cosentyx. 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 Cosentyx. Importantly, a component of this measure includes patient-reported pain. Cosentyx has previously shown79% of AS patients achieved an ASAS 20 response (Assessment of Spondyloarthritis International Society response criteria) at two years. Previous data also show up to 80% of AS and 84% of PsA patients treated with Cosentyx at two years had no radiographic progression in the spine or joints respectively, as shown by X-ray assessment. Cosentyx continues to have a favorable safety profile, which was consistent with that shown in Phase III studies.
In addition, analyses, using Matching-Adjusted Indirect Comparison (MAIC) presented at ACR show Cosentyx may improve the signs and symptoms of AS and PsA more than Humira® (adalimumab). In a new MAIC for AS, the ASAS 20 response rates at Week 52 were higher for Cosentyx (74%) than for Humira® (65%). Likewise, in the MAIC for PsA patients, ACR 20 response rates at Week 48 were higher for Cosentyx (72%) than for Humira® (56%).
Following these MAIC analyses, Novartis plans to initiate new head-to-head clinical trials to directly compare Cosentyx versus Humira® in patients with AS and PsAs. These will include 850 patients and will be the first ever adequately powered head-to-head studies with biologic medicines to differentiate the effectiveness of treatment in these conditions.