The Committee for Medicinal Products for Human Use ( CHMP ) has recommended the approval of Cosentyx ( Secukinumab ) in Europe to treat ankylosing spondylitis ( AS ) and psoriatic arthritis ( PsA ) patients.
Following two separate regulatory submissions, Cosentyx is now recommended for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy, such as non-steroidal anti-inflammatory drugs ( NSAIDs ), and for the treatment of active PsA in adult patients alone or in combination with Methotrexate ( MTX ) when the response to previous disease modifying anti-rheumatic drug ( DMARD ) therapy has been inadequate.
Cosentyx is the first of a new class of medicines called interleukin-17A ( IL-17A ) inhibitors to be recommended for ankylosing spondylitis and psoriatic arthritis, conditions that affect around five million people in Europe. Both are life-long, painful and debilitating inflammatory diseases that affect the joints and/or spine. If not treated effectively, both conditions can lead to irreversible joint and/or spinal damage caused by years of inflammation.
Ankylosing spondylitis is a painful, progressively debilitating condition caused by inflammation of the spine. Up to 70% of patients with severe ankylosing spondylitis develop spinal fusion over 10 to 15 years, which significantly reduces mobility and quality of life.
Ankylosing spondylitis occurs in approximately 1.78 million people in Europe and typically affects young men and women aged 25 or older.
Psoriatic arthritis, closely associated with psoriasis, is part of a family of long-term diseases impacting joints. Psoriatic arthritis occurs in approximately 3.1 million people in Europe. As many as one in four people with psoriasis may have undiagnosed psoriatic arthritis.
Pivotal phase III studies in the Cosentyx clinical trial program, that provided key data for the CHMP submission, were MEASURE 1 and MEASURE 2 in ankylosing spondylitis, and FUTURE 1 and FUTURE 2 in psoriatic arthritis.
These are all ongoing multi-center, randomized, placebo-controlled studies that have been designed to evaluate the efficacy and safety of Cosentyx in ankylosing spondylitis and psoriatic arthritis.
Cosentyx phase III studies have consistently demonstrated significant improvements in the signs and symptoms of ankylosing spondylitis and psoriatic arthritis. Clinical improvements were seen as early as week 3 and through to week 52, with benefits reported across the spectrum of patients who have either never taken or who have had prior treatment with anti-TNF therapies.
The safety profile of Cosentyx was shown to be consistent to that reported in clinical trials across multiple indications involving more than 9,600 patients.
For patients with ankylosing spondylitis and psoriatic arthritis, the recommended dose is Cosentyx 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2 and 3, followed by monthly maintenance dosing starting at week 4.
For PsA patients with concomitant moderate-to-severe plaque psoriasis, or who are anti-TNF inadequate responders, the recommended dose is Cosentyx 300 mg.
Cosentyx is a human monoclonal antibody that selectively neutralizes circulating IL-17A. Research has shown that IL-17A plays an important role in driving the body's immune response in psoriasis and spondyloarthritis conditions, including psoriatic arthritis and ankylosing spondylitis.
In January 2015, Cosentyx ( at a recommended dose of 300 mg ) became the first IL-17A inhibitor approved in the EU and US for the treatment of moderate-to-severe plaque psoriasis. ( Xagena )
Source: Novartis, 2015