Award Title: Tofacitinib for treating active ankylosing spondylitis (ID3865)
Funder: Department of Health and Social Care

Abstract: Axial spondyloarthritis belongs to a clinically heterogeneous group of inflammatory rheumatologic diseases which share common genetic, histological and clinical features (also including psoriatic arthritis, arthritis associated with inflammatory bowel disease, reactive arthritis and undifferentiated spondyloarthritis). Axial spondyloarthritis involves inflammation of the sacroiliac joints and spine. If inflammation is visible on xray (as erosions, thickening of the bone, or fusion of joints), the disease is classified as radiographic axial spondyloarthritis (also known as ankylosing spondylitis). If x-rays of the sacroiliac joints and spine are normal, but there are other objective signs of inflammation (elevated C-reactive protein or evidence on magnetic resonance imaging) the disease is classified as nonradiographic axial spondyloarthritis._x000D_
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The clinical symptoms of axial spondyloarthritis can vary from person to person, but usually develop slowly over several months or years. The main symptoms can include back pain, usually inflammatory in nature, arthritis (inflammation of the joints in other parts of the body), enthesitis (inflammation where a bone is joined to a tendon), and fatigue. Extra-articular manifestations include uveitis, inflammatory bowel disease and psoriasis. The onset of symptoms typically occurs in the third decade of life, but it can be 7– 10 years before a diagnosis is made. Many patients with mild disease may remain undiagnosed. _x000D_
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Around 200,000 people have been diagnosed as having ankylosing spondylitis in the UK. The prevalence is thought to range from 0.05% to 0.23%, representing approximately 2,300 new diagnoses each year in England and Wales. Ankylosing spondylitis is about 3 times more common in men than in women.[1],[2]_x000D_
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Conventional therapy for radiographic axial spondyloarthritis includes antiinflammatory treatment with non-steroidal anti-inflammatory drugs (NSAIDs) and physiotherapy. Tumour necrosis factor-alpha (TNF-alpha) inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab and infliximab) are typically used when the disease has not responded adequately to conventional therapy. NICE technology appraisal TA383 recommends adalimumab, certolizumab pegol, etanercept, golimumab and infliximab as treatment options for adults with severe active ankylosing spondylitis in adults whose disease has responded inadequately to, or who cannot tolerate NSAIDs. Biosimilar versions of adalimumab, etanercept and infliximab are available. Infliximab is only recommended if the least expensive infliximab product is used. NICE technology appraisal 407 recommends the interleukin17A (IL-17A) inhibitor secukinumab as an alternative to, or after inadequate response to TNF-alpha inhibitors._x000D_
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References_x000D_
1 National Ankylosing Spondyloarthritis Society: Facts & Figures. Available at https://nass.co.uk/about-as/as-facts-and-figures/ Accessed December 2020_x000D_
2 Department of Health (2006) The musculoskeletal services framework. Accessed December 2020

Lay Abstract: To appraise the clinical and cost effectiveness of tofacitinib within its marketing authorisation for treating active ankylosing spondylitis.

Research Activity Codes: 6.1 PHARMACEUTICALS
Health Categories: MUSCULOSKELETAL