Novartis announced that it will present 33 scientific abstracts at the Annual European Congress of Rheumatology (EULAR 2016) in London, UK. This includes new long-term analyses suggesting Cosentyx® (secukinumab) may lead to higher responses than Humira (adalimumab) in improving the signs and symptoms of people living with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) at 52 weeks. These analyses are from two studies using the Matching-Adjusted Indirect Comparisons (MAIC) method. MAIC is a valid and accepted method for comparative effectiveness research.
To directly compare Cosentyx versus Humira, Novartis plans to initiate new head-to-head studies in patients with AS and PsA. These will be the first ever adequately powered long-term head-to-head studies with biologic medicines to differentiate the effectiveness of treatment in these conditions.
"There is an urgent need for new ankylosing spondylitis and psoriatic arthritis treatments because a significant number of patients do not respond well to anti-TNF therapy, the current standard of care," said Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "There is a growing body of evidence that supports the potential of Cosentyx to become a gold standard of care for patients living with these debilitating conditions."
Also presented at the Annual European Congress of Rheumatology (EULAR 2016) were two-year data showing that up to 80% of AS patients on Cosentyx had no radiographic progression in the spine on x-ray assessment. A similar proportion of patients with PsA (84%), who were on Cosentyx for two years, also had no evidence of progression.
More than 9,600 patients have been treated with Cosentyx in clinical trials across multiple indications, and over 20,000 patients with psoriasis have already been treated in the post-marketing setting. The safety profile of Cosentyx was shown to be consistent with that seen in clinical trials across multiple indication.
Cosentyx is a fully human monoclonal antibody that selectively neutralizes circulating IL-17A. Research suggests that IL-17A may play an important role in driving the body's immune response in psoriasis, AS and PsA.
In Europe, Cosentyx is approved for the first-line systemic treatment of moderate-to-severe plaque psoriasis in adult patients. In the US, Cosentyx is approved as a treatment for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy). In addition, Cosentyx is the first IL-17A inhibitor with positive Phase III results for the treatment of active AS and PsA and is now approved in Europe, the US, and other countries for these conditions. Cosentyx is also approved for the treatment of PsA and pustular psoriasis in Japan.
