Authors' objectives: Baricitinib is an inhibitor of janus kinase 1 and 2, having the potential to disrupt cytokine-mediated activity through mediating signalling pathways involved in inflammatory diseases. Baricitinib is intended for the treatment of rheumatoid arthritis (RA) in patients who have not responded adequately to disease modifying anti-rheumatic drugs (DMARDs) or who have not previously been treated with methotrexate. If licensed, baricitinib will be the first JAK1/2 inhibitor to be licensed in the treatment of this condition and will offer an additional oral treatment option for patients. In phase III clinical trials, baricitinib was administered orally at either 2mg or 4mg once daily through week 24, until loss of treatment response. RA is a chronic, inflammatory, multi-system, progressive autoimmune disease. Synovial joints, typically the small joints of the hands and feet, are often affected bilaterally and symmetrically. Clinical features of synovitis include pain (usually worse after periods of rest or inactivity), swelling, stiffness and loss of function. Affected joints are tender, warm and give a 'boggy' feel on palpation. Extra-articular presentations may include lymphadenopathy, whilst systemic features include morning stiffness, malaise, fatigue, fever and weight loss. Other presenting features of RA include rheumatoid nodules (over extensor surfaces, which occur in approximately one third of patients). Symptoms may be insidious, palindromic or explosive in onset. The estimated prevalence of RA in England is 0.86%, equivalent to around 346,000 people, and there are approximately 12,000 new diagnoses each year in the UK. RA is more common in females than in males and the peak age of onset is 40-70 years. Disease is severe in around 15% of patients and around 10% of patients with RA (approximately 34,600 people) are eligible to receive biological treatment after the failure of conventional DMARDs. Baricitinib is currently undergoing five phase III clinical trials assessing its effect on disease response and safety. All trials are expected to be complete by March 2021.

Project Status: Completed

Year Published: 2015

URL for published report: http://www.hsric.nihr.ac.uk/topics/baricitinib-for-moderate-to-severe-rheumatoid-arthritis/

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 Centre (NIHR HSC)