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
London, UK, 17 June 2021– 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).
Notes to editors
About Cosentyx® (secukinumab)
Secukinumab is indicated in the UK for the treatment of: moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy; moderate-to-severe plaque psoriasis in children and adolescents from the age of six years who are candidates for systemic therapy; active psoriatic arthritis (PsA) (alone or in combination with methotrexate) in adults when response to previous disease-modifying antirheumatic drug therapy has been inadequate; active ankylosing spondylitis (AS) in adults who have responded inadequately to conventional therapy; active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs)2. Secukinumab is a fully human biologic that directly inhibits interleukin-17A (IL-17A)2, a cornerstone cytokine involved in the inflammation and development of these conditions8, 12, 13.
About the PREVENT study3
PREVENT is an ongoing two-year randomised, double-blind, placebo-controlled Phase III study (with a two-year extension phase) to investigate the efficacy and safety of secukinumab, in patients with active non-radiographic axial spondyloarthritis (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 analogue 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 four weeks prior to study start.
The primary endpoints were the proportion of patients achieving an ASAS40 response with secukinumab 150 mg at Weeks 16 and 52 in tumor necrosis factor-naïve patients. Secondary endpoints included, among others, change in BASDAI over time and change in the Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP).
In the study, 40.8% of nr-axSpA patients treated with secukinumab 150 mg showed a significant relief of symptoms versus placebo (40.8% vs 28.0%; P<0.05), as measured by at least a 40% improvement in disease activity according to the Assessment of SpondyloArthritis international Society (ASAS) criteria at Week 16. Statistically significant improvements in secondary endpoints were also demonstrated including pain, disease burden and health-related quality of life.
The trial demonstrated a safety profile of secukinumab consistent with previous clinical trials, with no new or unexpected safety signals detected. The most frequent treatment-emergent adverse events up to Week 20 were nasopharyngitis, diarrhoea, headache and upper respiratory tract infection in both the secukinumab and placebo groups. Most adverse events reported during the entire treatment period were mild or moderate in severity across all treatment groups.
About the axSpA disease spectrum
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-ray4. In axSpA, the body’s immune system is overactive (inflammation), resulting in spinal pain14. The prevalence of axSpA in adults is similar to that of rheumatoid arthritis15. Of those with axSpA, approximately 50% have AS and 50% have nr-axSpA16. Both parts of the disease spectrum have a comparable symptom burden, including: pain that is bad enough to cause people to wake up at night – especially in the second half of the night; fatigue and severe tiredness that does not improve with sleep or rest; stiffness and pain in the morning that can last more than 30 minutes then eases either on its own or with activity; difficulties getting out of bed, getting dressed, walking or with other everyday tasks6. If left untreated, nr-axSpA can impact everyday activities including lost time at work, relationships, and generally limit a person’s ability to enjoy a normal and active life6.
Non-radiographic axial spondyloarthritis most commonly affects people under the age of 45 with onset of symptoms around the age of 244. On average, it takes 8.5 years to get a diagnosis in the UK and many 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.
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Deodhar A, Blanco R, Dokoupilova E, et al. Secukinumab improves signs and symptoms of non-radiographic axial spondyloarthritis: primary results of a randomized controlled phase III study. Arthritis Rheumatol. 2020;73(1):110-120.
Yu Q, Genco M & Khan MPH. Decision Resources Group. Axial Spondyloarthritis: Disease Landscape & Forecast. February 2019.
Mease PJ, Heijde DV, Karki C, et al. Characterization of Patients With Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis in the US-Based Corrona Registry. Arthritis Care Res (Hoboken). 2018;70:1661-1670.
Baraliakos X, Braun J, Deodhar A, et al. Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study. RMD Open. 2019;5:e001005.
Mease PJ, Kavanaugh A, Reimold A, et al; FUTURE 1 study group. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study. ACR Open Rheumatol. 2020;2(1):18-25.
Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018;32:1507-1514.
Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717-24.
Sieper J, Poddubnyy D and Miossec P. The IL-23-IL-17 pathway as a therapeutic target in axial spondyloarthritis. Nat Rev Rheumatol. 2019;15:747-757.
Garrido-Cumbrera M, Poddubnyy D, Gossec L, et al. The European Map of Axial Spondyloarthritis: Capturing the Patient Perspective—an Analysis of 2846 Patients Across 13 Countries. Curr Rheum Reports. 2019;21(5):19.
Strand V, Rao SA, Shillington AC, et al. Prevalence of axial spondyloarthritis in United States rheumatology practices: Assessment of SpondyloArthritis International Society criteria versus rheumatology expert clinical diagnosis. Arthritis Care Res (Hoboken). 2013;65(8):1299-1306.