Three year positive data for Cosentyx (secukinumab) as a treatment for psoriatic arthritis presented at ACR meeting by Novartis.

Novartis announced 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.

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 shown 79% 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 PsA. 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.