April 29, 2020: “Novartis, a leader in rheumatology and immuno-dermatology, announced the European Commission (EC) has approved Cosentyx® (secukinumab) for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA).
“This approval of Cosentyx for non-radiographic axial spondyloarthritis means clinicians across Europe now have an effective new treatment option to help patients gain relief from the burden of this painful, debilitating disease and achieve a better quality of life both at home and at work,” said Atul Deodhar, MD, Professor of Medicine and Medical Director of Rheumatology Clinics at Oregon Health & Science University, USA, and an investigator in the PREVENT clinical trial.
The approval is based on data from the Phase III PREVENT study, in which Cosentyx met the primary endpoint. In the study, 41.5% of nr-axSpA patients treated with Cosentyx 150 mg showing a significant and clinically meaningful reduction in disease activity versus placebo (41.5% vs 29.2%: p<0.05), as measured by at least a 40% improvement in ASAS40 at week 16, with improvements continued through week 52.
Statistically significant improvements in secondary endpoints were also demonstrated, including pain, disease burden and health-related quality of life. PREVENT is the largest ever study of a biologic in patients with nr-axSpA.
“Whether a patient has nr-axSpA or AS, the condition has a significant impact on their everyday life.
We, therefore, welcome the news that Cosentyx has gained approval for the treatment of this form of axial spondyloarthritis because it enables patients to realize relief from their symptoms earlier in the spectrum of disease,” said Eric Hughes, Global Development Unit Head, Immunology, Hepatology & Dermatology at Novartis.
“This is a firm demonstration of our commitment to reimagine medicine for patients and a step forward in our plans to expand Cosentyx across ten indications over the next ten years.”
Novartis is working closely with all stakeholders to ensure that eligible European patients can start benefitting from Cosentyx as quickly as possible.
Novartis has also submitted Cosentyx for review by the US Food and Drug Administration (FDA) and the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with nr-axSpA.
AxSpA is a spectrum of the long-term inflammatory disease characterized by chronic inflammatory back pain.
The axSpA spectrum includes AS, in which joint damage is generally visible on x-ray, and nr-axSpA, in which joint damage is not visible on x-ray.
Both parts of the disease spectrum have a comparable symptom burden, including nocturnal waking caused by pain, spinal pain, morning stiffness, fatigue and functional disability.
If left untreated, axSpA impairs activity, leads to lost work time and has a significant impact on quality of life, including family relationships.
Cosentyx is the first and only fully-human biologic that directly inhibits IL-17A, a cornerstone cytokine involved in the inflammation and development of PsO, PsA and AS
Cosentyx is backed by robust clinical evidence, including five-year data across three indications of PsO, PsA and AS, as well as data from real world evidence.
These data strengthen the unique position of Cosentyx as a rapid and long-lasting comprehensive treatment across axSpA, PsA and psoriatic disease, with more than 300,000 patients treated worldwide with Cosentyx since launch.
PREVENT is an ongoing two-year randomized, double-blind, placebo-controlled Phase III study (with a two-year extension phase) to investigate the efficacy and safety of Cosentyx, in patients with active nr-axSpA.
The study enrolled 555 male and female adult patients with active nr-axSpA (with onset before 45 years of age, spinal pain rated as >=40/100 on a visual analog scale (VAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4) and who had been taking at least two different non-steroidal anti-inflammatory drugs (NSAIDs) at the highest dose up to 4 weeks prior to study start.
Patients may have previously taken a TNF inhibitor (not more than one) but had an inadequate response.
Of the 555 patients enrolled in the study, 501 (90.3%) were biologic naïve. Patients were allocated to one of three treatment groups:
Cosentyx 150 mg subcutaneously with loading dose (induction: 150 mg secukinumab subcutaneously weekly for 4 weeks, then maintenance with 150 mg secukinumab monthly); Cosentyx 150 mg no loading dose (150 mg secukinumab subcutaneously monthly), or placebo (induction of subcutaneously weekly for 4 weeks, followed by maintenance of once-monthly)
The primary endpoints are the proportion of patients achieving an ASAS40 response with Cosentyx 150 mg at Weeks 16 and 52 in TNF-naive patients.
Secondary endpoints include among others change in BASDAI over time and change in the Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP).”