Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation NIHR HSRIC. Natalizumab (Tysabri) for secondary progressive multiple sclerosis. Birmingham: NIHR Horizon Scanning Research&Intelligence Centre. Horizon Scanning Review. 2015 Authors' objectives Natalizumab (Tysabri) is intended for the treatment of secondary progressive multiple sclerosis (SPMS) in patients who have progressed from relapsing remitting MS. If licensed, natalizumab will offer an additional treatment option for patients with SPMS, a group who currently have few effective therapies available. No disease-modifying drugs are currently licensed specifically for SPMS. Natalizumab is a selective adhesion-molecule inhibitor that binds to the α4-subunit of human integrins, which are highly expressed on the surface of all leukocytes except neutrophils. The interaction between α4β1 and its targets is an important component of pathological inflammation in the brain and disruption of these interactions leads to reduced inflammation. Natalizumab is licensed in the EU for the treatment of highly active relapsing remitting multiple sclerosis (RRMS) in patients aged 18 years and over with high disease activity despite treatment with a beta-interferon or glatiramer acetate; or patients aged 18 years and over with rapidly evolving severe RRMS.
MS is a chronic immune-mediated condition of the central nervous system characterised by demyelination and axonal degeneration. MS is incurable and progressive in the majority of people, resulting in a low incidence but high prevalence. The prevalence of MS in England is approximately 0.16%, equivalent to approximately 85,600 affected people. About 75% of people whose disease pattern begins with relapsing and remitting symptoms later develop SPMS, 30-40% of those with RRMS develop SPMS within ten years of diagnosis. In 2013-14 there were 44,335 admissions for MS in England, resulting in 53,554 bed days and 46,584 finished consultant episodes. In England and Wales, 1,100 deaths due to MS were registered in 2013.
The aim of effective therapy is to relieve symptoms, prevent or delay disability arising from disease progression and promote tissue repair to treat established progression. Natalizumab is currently in one phase III clinical trial comparing its effect on progression of disability against treatment with placebo. This trial is expected to complete in March 2017. Indexing Status Subject indexing assigned by CRD MeSH Antibodies, Monoclonal, Humanized; Humans; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Natalizumab Language Published English Country of organisation England English summary An English language summary is available. Address for correspondence NIHR Horizon Scanning Research&Intelligence Centre, University of Birmingham, Institute of Applied Health Research, Public Health building, Edgbaston, Birmingham B15 2TT
Tel: 0121 414 9077 Email: nihrhsc@contacts.bham.ac.uk AccessionNumber 32016000347 Date abstract record published 03/03/2016 |