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BASINGSTOKE, 17 June, 2021 – Eli Lilly and Company Limited announced today that NICE has published the final appraisal document (FAD) recommending Taltz® (ixekizumab) as an option for treating adults with:

• active ankylosing spondylitis that is not controlled well enough with conventional therapy, or

• active non-radiographic axial spondyloarthritis with objective signs of inflammation that is not controlled well enough with nonsteroidal anti-inflammatory drugs (NSAIDs).

Ixekizumab is recommended only if tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough, and the company provides ixekizumab according to the commercial arrangement.1 The FAD is now available on the NICE website and the expected publication date of final technology appraisal guidance is 21st July 2021.

AxSpA is an inflammatory arthritis characterised by inflammation of the sacroiliac joints (sacroiliitis), inflammation of the spine, or both, resulting in chronic back pain, fatigue and significantly reduced function and quality of life.2

Dr. Dale Webb, Chief Executive Officer, NASS (National Axial Spondyloarthritis Society) said:

“Around 1 in 200 people have axSpA and the chronic pain, impaired mobility and fatigue it causes can have a significant impact on daily life for people living with the condition. Most people experience their first symptoms before the age of 45 but there are often delays in an accurate diagnosis and appropriate treatment being made available. We welcome this new treatment option to help people manage this long-term condition.”

“Many patients living with axSpA suffer from chronic back pain and associated functional disability, which has a detrimental impact on their quality of life. We’re very pleased that NICE is recommending ixekizumab as a new treatment option,” said Jyun Yan Yang, Senior Medical Director Lilly, UK and Northern Europe. “This approval reflects Lilly’s continued commitment to rheumatology and providing innovative solutions to meet patient needs.”

Dr Raj Sengupta Consultant Rheumatologist, Royal National Hospital for Rheumatic Diseases said: “This is good news for patients in the UK. As axial spondyloarthritis is a long-term condition, it is vitally important that clinicians have a range of treatment options available to help manage disease progression.”  

Based on the Assessment of Spondyloarthritis International Society (ASAS), classification criteria for axSpA is divided into two subsets, termed radiographic(r)-axSpA (synonymous with the older term ankylosing spondylitis (AS)) and non-radiographic (nr)-axSpA. R-axSpA and nr-axSpA result in a similar burden of disease on health-related quality of life.3

The diagnosis of axSpA, usually made by a rheumatologist, relies on clinical pattern recognition aided by laboratory and imaging features. Patients with back pain for at least three months who are under 45 years of age may be diagnosed with axSpA if they have sacroiliitis on imaging and at least one SpA feature (inflammatory back pain, arthritis, enthesitis, uveitis, dactylitis, psoriasis, Crohn’s disease, ulcerative colitis, good response to NSAIDS, family history of SpA, HLA-B27, elevated CRP) and meet one of the imaging criteria below:

• When definitive structural damage of the sacroiliac joints is visible on x-ray the disease is classified as r-axSpA.4

The distinguishing characteristic of nr-axSpA is inflammation of the sacroiliac joints or spine that may be detected with magnetic resonance imaging (MRI) without definitive structural damage of the sacroiliac joints visible on x-ray.

The European Commission marketing authorisation was granted in June 2020 for ixekizumab in axSpA and was based on findings from three randomised placebo-controlled trials designed to assess the efficacy and safety in both r-axSpA and nr-axSpA, COAST V, COAST W, and COAST X. In all three studies ixekizumab demonstrated significant reduction of the signs and symptoms of axSpA as assessed by the proportion of patients achieving the primary endpoint of ASAS 40 at week 16 compared to placebo:5 6 7

The safety profile of ixekizumab in axSpA was consistent with that in patients with active psoriatic arthritis and moderate to severe psoriasis, with the most frequently reported adverse events being upper respiratory tract infections (most frequently nasopharygitis) and injection site reactions. The majority of adverse events were mild to moderate in nature.

For further information please contact:

Sarah Davies/Lilly UK Press Office

Phone: +44 (0)1256 775374


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Last Updated: 17-Jun-2021