Novartis’ Cosentyx Receives NICE Recommendation for Non-Radiographic Axial Spondyloarthritis in Adults

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Recently, according to foreign media reports, Novartis' Cosentyx has been recommended by the UK National Institute for Health and Care Excellence (NICE) for the treatment of adult non-radiographic axial spondyloarthritis (nr-axSpA). NICE recommends Cosentyx (secukinumab) as a treatment option for active nr-axSpA in adults with objective signs of inflammation inadequately controlled by nonsteroidal anti-inflammatory drugs (NSAIDs).

Axial spondyloarthritis (axSpA) is a painful, progressive chronic disease that leads to long-term pain, mobility impairment, and fatigue. Early diagnosis and treatment can significantly impact disease progression and long-term prognosis. This recommendation is based on data from the Phase III PREVENT study, an ongoing 2-year, randomized, double-blind, placebo-controlled trial (with a 2-year extension period) designed to evaluate the efficacy and safety of Cosentyx in patients with active nr-axSpA. The study enrolled 555 male and female patients with active nr-axSpA (disease onset before age 45, spinal pain score ≥40/100 on the visual analog scale [VAS], and Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] ≥4), who had received treatment with at least two different nonsteroidal anti-inflammatory drugs (NSAIDs) at maximum tolerated doses for 4 weeks prior to study initiation and may have had an inadequate response to no more than one prior tumor necrosis factor (TNF) inhibitor.

Study data indicate that 40.8% of nr-axSpA patients treated with Cosentyx 150 mg experienced significant symptom relief, compared with 28% in the placebo group. Furthermore, statistically significant improvements were observed in secondary endpoints, including pain and fatigue, disease burden, and health-related quality of life.

Cosentyx is a fully human monoclonal antibody that selectively targets and blocks the activity of circulating interleukin-17A (IL-17A), reducing immune system activity and improving disease symptoms. IL-17A inhibitors are recommended only when tumor necrosis factor-alpha (TNF-α) inhibitors are unsuitable or fail to adequately control the disease.

NICE’s decision on nr-axSpA follows approval by the Scottish Medicines Consortium (SMC), meaning that secukinumab is now recommended as a much-needed additional treatment option for patients in England, Scotland, and Wales suffering from this debilitating condition.

Source:

1.Novartis’ Cosentyx wins NICE backing for non-radiographic axial spondyloarthritis

2.New Novartis PREVENT data show Cosentyx? delivers early relief in axial spondyloarthritis