Two pivotal phase III studies ( FUTURE 1 and FUTURE 2 ) of Secukinumab ( AIN457 ) in psoriatic arthritis ( PsA ) met primary and key secondary endpoints.
Endpoints included improving signs and symptoms of psoriatic arthritis ( improving peripheral joint disease and preventing joint damage versus placebo ), while delivering clear or almost clear skin ( PASI 90 ).
Secukinumab is an investigational medicine that works by stopping the action of interleukin-17A ( IL-17A ), a protein that is central to the development of inflammatory diseases.
FUTURE 1 and FUTURE 2 enrolled a combined total of more than 1,000 patients.
Psoriatic arthritis is a long-lasting, complex condition involving joint inflammation ( arthritis ), and usually occurs in combination with psoriasis.
There are many different features of psoriatic arthritis that affect the skin, joints and tendons, resulting in irreversible joint damage in many patients. It is linked with significant disability, poor quality of life, reduced life expectancy.
Although TNF ( tumor-necrosis-factor ) inhibitors, the current standard of care for psoriatic arthritis, can improve clinical symptoms, responses may diminish over time. Furthermore, many patients with psoriatic arthritis do not respond to or tolerate these agents.
FUTURE 1 and FUTURE 2 are randomized, placebo-controlled, multicenter studies designed to demonstrate efficacy of Secukinumab in psoriatic arthritis compared to placebo and to assess safety and tolerability.
The American College of Rheumatology response criteria ( ACR20 ) was the primary endpoint in the studies.
Secukinumab was well tolerated in both studies. The observed safety profile was consistent with previously reported results from the large psoriasis clinical trial program involving nearly 4,000 patients. ( Xagena )
Source: Novartis, 2014