Authors' objectives: Masitinib is intended to be used as second and subsequent line therapy for the treatment of active rheumatoid arthritis in patients who are refractory to methotrexate, or any disease modifying antirheumatic drug (DMARD), including at least one biologic drug if previously failed methotrexate, or methotrexate in combination with any DMARD (including biologics). If licenced, it will provide an additional, oral treatment option for this patient group. Masitinib is a highly selective tyrosine kinase inhibitor that targets the c-Kit, Lyn and Fyn signalling pathways. Masitinib does not currently have Marketing Authorisation in the EU for any indication. Rheumatoid arthritis is a chronic, inflammatory, multi-system, progressive autoimmune disease with an estimated prevalence in England of around 0.86%, equivalent to approximately 346,000 people. Rheumatoid arthritis leads to progressive disability and a decrease in quality of life and functional status. Approximately one third of people stop work within two years of onset and after ten years, 30% of patients are severely disabled. Clinical management of rheumatoid arthritis includes physical therapy, surgical interventions and a range of pharmacological treatments, including: non-biologic therapies (corticosteroids, non-steroidal anti-inflammatory drugs and conventional DMARDs, including methotrexate), and biologic DMARDs (etanercept, infliximab, adalimumab, golimumab, abatacept and rituximab), usually in combination with methotrexate. Masitinib is currently in a phase III clinical trial investigating its effect on a composite measure of rheumatoid arthritis signs and symptoms in comparison to methotrexate.

Project Status: Completed

Year Published: 2015

URL for published report: http://www.hsric.nihr.ac.uk/topics/masitinib-for-rheumatoid-arthritis-second-and-subsequent-line/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Horizon Scanning Centre

Contact Address: The NIHR Horizon Scanning Centre, Department of Public Health, Epidemiology, and Biostatistics, School of Health and Population Sciences, University of Birmingham, 90 Vincent Drive, Edgbaston, Birmingham, B15 2SP. United Kingdom. Tel: +44 121 414 7831, Fax: +44 121 2269

Contact Name: c.packer@bham.ac.uk

Contact Email: c.packer@bham.ac.uk

Copyright: NIHR Horizon Scanning Research&Intelligence Centre (NIHR HSRIC)