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.
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