New data have shown that secukinumab (Cosentyx, Novartis) delivered sustained improvements in the signs and symptoms of psoriatic arthritis (PsA)––including patient-reported pain––during three years of treatment.
Secukinumab 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. Secukinumab is also the only IL-17A inhibitor indicated for PsA, ankylosing spondylitis (AS), and psoriasis, which is significant, according to Novartis, as up to 80% of patients diagnosed with PsA already have psoriasis.
In the first year of the three-year open-label extension study, which was a continuation of a two-year double-blind trial, 77% of PsA patients achieved at least 20% improvement in American College of Rheumatology response criteria (ACR20) with secukinumab. Most of the patients (95%) completed the first year of the extension trial. The new data showed that response rates were consistent from year 1 (69.4%) to year 3 (76.8%) and that this was independent of whether patients received anti-tumor necrosis factor (TNF) therapy before being treated with secukinumab.
The components of the ACR response criteria include patient-reported pain. Previously, 79% of secukinumab-treated AS patients had achieved an ASAS20 response (Assessment of Spondyloarthritis International Society response criteria) at two years. Previous data also showed that up to 80% of AS and 84% of PsA patients treated with secukinumab at two years had no radiographic progression in the spine or joints, respectively.
In addition, analyses using matching-adjusted indirect comparison (MAIC) showed that secukinumab may improve the signs and symptoms of AS and PsA more than adalimumab (Humira, AbbVie). In a new MAIC for AS, the ASAS20 response rates at week 52 were higher for secukinumab (74%) than for adalimumab (65%). Likewise, in the MAIC for PsA patients, ACR20 response rates at week 48 were higher for secukinumab (72%) than for adalimumab (56%).
Novartis plans to initiate new head-to-head clinical trials to directly compare secukinumab with adalimumab in patients with AS and PsA. These studies will include a total of 850 patients and will be the first adequately powered head-to-head studies with biologic medications to differentiate treatment efficacy in these diseases.
Secukinumab is a fully human monoclonal antibody that selectively neutralizes IL-17A. It is the first IL-17A inhibitor approved for the treatment of patients with active AS and PsA in the United States.
Source: Novartis; November 14, 2016.