Novartis Cosentyx® (secukinumab) recommended by NICE for adults with non-radiographic axial spondyloarthritis (nr-axSpA)

• Cosentyx® (secukinumab), a fully human interleukin-17A (IL-17A) inhibitor, is recommended by NICE for adults with non-radiographic axial spondyloarthritis (nr-axSpA)¹, adding to its existing recommendation in ankylosing spondylitis (AS) for adults who have responded inadequately to conventional therapy²

• The NICE recommendation is based on data from the Phase III PREVENT study, which is the largest ever study of a biologic medicine in patients with nr-axSpA³

• Non-radiographic axial spondyloarthritis is a debilitating chronic inflammatory disease characterised by pain and stiffness in the lower back⁴. It affects approximately 165,000 people in the UK and symptoms typically develop around the age of 24⁴

Novartis today announced that the National Institute for Health and Care Excellence (NICE) has recommended the use of Cosentyx® (secukinumab 150 mg) as an option for treating active non-radiographic axial spondyloarthritis with objective signs of inflammation (shown by elevated C-reactive protein or MRI) that is not controlled well enough with non-steroidal anti-inflammatory drugs (NSAIDs) in adults. It is recommended only if tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough¹. The NICE recommendation is based on data from the Phase III PREVENT study, which is the largest ever study of a biologic medicine in patients with nr-axSpA³. In the study, 40.8% of nr-axSpA patients treated with secukinumab 150 mg showed significant relief of symptoms versus placebo (40.8% vs 28.0%; P<.05), as measured by at least a 40% improvement in disease activity according to the Assessment of SpondyloArthritis international Society (ASAS) criteria at Week 16³. Statistically significant improvements in secondary endpoints were also demonstrated, including pain and fatigue, disease burden and health-related quality of life³.

Professor Karl Gaffney, Consultant Rheumatologist and Research Lead, Norfolk and Norwich University Hospitals commented “nr-axSpA is a debilitating condition with symptoms including chronic pain, morning stiffness, fatigue and reduced mobility. If left untreated, nr-axSpA may cause irreversible damage, negatively impacting quality of life and condemning people to a lifetime of back pain. The NICE decision is a key milestone for clinicians and patients who will now have access to an additional treatment option that may help patients.”

Non-radiographic axial spondyloarthritis is part of the axial spondyloarthritis (axSpA) spectrum of long-term inflammatory diseases characterised by chronic inflammatory back pain⁴. It can impact everyday activities including lost time at work, relationships, and generally limit a person’s ability to enjoy a normal and active life⁶. Of those living with the disease, 59% also report experiencing mental health problems⁴. Non-radiographic axial spondyloarthritis commonly affects people under the age of 45, with typical symptom onset at the age of 24⁴. On average, it takes 8.5 years for axSpA patients to receive a diagnosis in the UK⁴ and many patients go on to develop irreversible damage to the spine while waiting for a diagnosis; in severe cases, the spine may fuse together and movement becomes restricted⁴. Axial spondyloarthritis affects approximately 1 in 200 patients in the UK, with 165,000 patients with nr-axSpA alone⁵.

Dr Dale Webb, Chief Executive of the UK’s National Axial Spondyloarthritis Society (NASS) commented “axial SpA is a painful and progressive long-term condition affecting approximately 1 in 200 people in the UK. It usually starts in early adulthood when people are trying to establish careers, start relationships and families. Axial SpA can result in long-term pain, impaired mobility and fatigue. Earlier diagnosis and treatment can have a significant impact on the progression of the condition and people’s long-term outcomes, and NASS welcomes new treatment options.”

“The decision from NICE in nr-axSpA comes on the heels of the Scottish Medicines Consortium (SMC) approval and means secukinumab is now recommended as a much-needed additional treatment option for patients with this debilitating condition in England, Scotland and Wales. The symptoms of nr-axSpA often mean that patients require both practical and emotional support when undergoing treatment and this is available through the Novartis You First patient support programme,” said Caitriona Walsh, Regional Partnership Business Unit Head, Novartis UK.

Secukinumab is an established medicine, supported by more than 14 years of clinical studies including long-term five-year efficacy and safety data across psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS)^{7, 8, 9}, with over 100 studies¹⁰ and more than 400,000 patients treated worldwide since launch¹¹.

Secukinumab is approved in more than 90 countries across multiple indications, including the UK, Europe, the US and Japan (including adults with nr-axSpA, AS, PsA and psoriasis), and China (adults with psoriasis, AS).