Novartis PREVENT data show Cosentyx helps patients realize early and lasting relief in axial spondyloarthritis - Seite 2

“With these new data and the recent first-in-class European approval of Cosentyx in non-radiographic axial spondyloarthritis, we are continuing to build on our heritage in the axial spondyloarthritis disease spectrum,” said Eric Hughes, Global Development Unit Head, Immunology, Hepatology & Dermatology at Novartis. “This fourth indication for Cosentyx further demonstrates our commitment to reimagine care for more patients.”

Cosentyx is the first fully-human interleukin (IL)-17A inhibitor indicated for patients in Europe with nr-axSpA and is backed by five years of clinical data supporting long-term safety and efficacy across moderate-to-severe plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS).

In April 2020, Novartis received approval of Cosentyx from the European Commission for the treatment of nr-axSpA⁴. 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.  

About axSpA
AxSpA is a spectrum of long-term inflammatory disease characterized by chronic inflammatory back pain⁵. 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^5,6. Both parts of the disease spectrum have a comparable symptom burden, including nocturnal waking caused by pain, spinal pain, morning stiffness, fatigue and functional disability⁷. If left untreated, axSpA impairs activity, leads to lost work time and has a significant impact on quality of life, including family relationships⁷.

About Cosentyx
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^8-11.

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^12-14. 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 launch¹⁵.

About PREVENT
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).