Baricitinib: A Review in Rheumatoid Arthritis
- 794 Downloads
Baricitinib (Olumiant®) is an oral, targeted synthetic DMARD that inhibits JAK1 and JAK2, which are implicated in the pathogenesis of rheumatoid arthritis (RA). This novel, small molecule is approved for use as monotherapy, or in combination with methotrexate, for the treatment of adults with moderate to severe active RA who responded inadequately to or were intolerant of ≥ 1 DMARD. In pivotal multinational trials, once-daily baricitinib 4 mg, with/without methotrexate (± another csDMARD), improved the signs and symptoms of RA, disease activity and physical function in DMARD-naive patients and in patients with an inadequate response to methotrexate, csDMARDs or TNF inhibitors; baricitinib treatment also slowed structural joint damage in DMARD-naive patients and in those with an inadequate response to methotrexate and csDMARDs. Baricitinib plus methotrexate was more effective than adalimumab plus methotrexate in patients with an inadequate response to methotrexate. The onset of these benefits was generally rapid and sustained over time. Baricitinib was generally well tolerated during up to 5.5 years’ treatment; the most commonly reported adverse drug reactions were upper respiratory tract infections, increased LDL cholesterol, nausea and thrombocytosis. Thus, once-daily baricitinib, as monotherapy or in combination with methotrexate, is an effective and generally well tolerated emerging treatment for patients with moderate to severe active RA who have responded inadequately to or are intolerant of ≥ 1 DMARD, and extends the options available for this population.
During the peer review process, the manufacturer of baricitinib was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
Compliance with Ethical Standards
The preparation of this review was not supported by any external funding.
Conflict of interest
Zaina T. Al-Salama and Lesley J. Scott are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.
- 7.Two new drugs for rheumatoid arthritis. Drug Ther Bull. 2017;55(9):102–5.Google Scholar
- 8.European Medicines Agency. Olumiant (baricitinib) film-coated tablets: EU summary of product characteristics. 2017. http://www.ema.europa.eu/. Accessed 10 Apr 2018.
- 9.Eli Lilly. Olumiant (baricitinib): Japanese prescribing information 2017. https://www.pmda.go.jp. Accessed 10 Apr 2018.
- 10.European Medicines Agency. Olumiant (baricitinib): EU assessment report. 2016. http://www.ema.europa.eu. Accessed 10 Apr 2018.
- 12.Mitchell TS, Moots RJ, Wright HL. Janus kinase inhibitors prevent migration of rheumatoid arthritis neutrophils towards interleukin-8, but do not inhibit priming of the respiratory burst or reactive oxygen species production. Clin Exp Immunol. 2017;189(2):250–8.CrossRefPubMedPubMedCentralGoogle Scholar
- 26.Kavanaugh AF, Helt C, Muram D, et al. Concomitant use of conventional synthetic DMARDs and response to baricitinib [abstract no. THU0078]. Ann Rheum Dis. 2017;76(Suppl 2):228–9.Google Scholar
- 28.Wells AF, Greenwald M, Bradley JD, et al. Efficacy and safety of baricitinib in patients with rheumatoid arthritis and an inadequate response to conventional disease-modifying antirheumatic drugs: a United States subpopulation analysis from two phase 3 trials [abstract no. 1586]. Arthritis Rheumatol. 2016;68(Suppl 10):1965–6.Google Scholar
- 29.Chen YC, Atsumi T, Yoo DH, et al. Baricitinib in East Asian patients with active RA and inadequate response to cDMARDs: post hoc subanalysis of the RA-BUILD study [abstract no. APL16-0633]. Int J Rheum Dis. 2016;19(Suppl. 2):188.Google Scholar
- 30.Tanaka Y, Yoo DH, Li ZG, et al. Baricitinib in East Asian patients with active RA: patient-reported outcomes from post hoc subanalyses of the RA-BEAM and RA-BUILD studies [abstract no. APL16-0636]. Int J Rheum Dis. 2016;19(Suppl. 2):188.Google Scholar
- 31.Tanaka Y, Lee CK, Li ZG, et al. Baricitinib in East Asian patients with active RA and inadequate response to methotrexate: post hoc subanalysis of the RA-BEAM study [abstract no. APL16-0632]. Int J Rheum Dis. 2016;19(Suppl. 2):187–8.Google Scholar
- 32.Kremer JM, Genovese MC, Muram D, et al. Effects of baseline patient characteristics on baricitinib efficacy in patients with rheumatoid arthritis [abstract no. 2632]. Arthritis Rheumatol. 2016;68(Suppl. 10):3557–8.Google Scholar
- 33.Zerbini CAF, Muram D, Arora VK, et al. Effect of BMI on baricitinib efficacy: pooled analysis from two phase 3 rheumatoid arthritis clinical trials [abstract no. 1640]. Arthritis Rheumatol. 2016;68(Suppl. 10):2048–9.Google Scholar
- 35.van Der Heijde D, Schiff M, Tanaka Y, et al. Low rates of radiographic progression of structural joint damage over 2 years of baricitinib treatment in patients with rheumatoid arthritis [abstract no. FRI0087]. Ann Rheum Dis. 2017;76(Suppl 2):510–1.Google Scholar
- 36.Smolen J, Li Z, Klar R, et al. Durability and maintenance of efficacy following prolonged treatment with baricitinib [abstract no. FRI0096]. Ann Rheum Dis. 2017;76(Suppl 2):515–6.Google Scholar
- 37.Takeuchi K, Genovese M, Haraou B, et al. Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study [abstract no. SAT0072]. Ann Rheum Dis. 2017;76(Suppl 2):795–6.Google Scholar
- 38.Genovese M, Smolen J, Takeuchi K, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 5.5 years: an updated integrated safety analysis [abstract no. 511]. Arthritis Rheumatol. 2017;69(510):664–6.Google Scholar
- 39.Winthrop KL, Lindsey S, Weinblatt M, et al. Herpes zoster in patients with moderate to severe rheumatoid arthritis treated with baricitinib [abstract no. 3027]. Arthritis Rheumatol. 2016;68(Suppl. 10):4042–4.Google Scholar
- 40.National Institute for Health and Care Excellence (NICE). Baricitinib for moderate to severe rheumatoid arthritis: technology appraisal guidance (TA466). 2017. https://www.nice.org.uk/guidance/ta466. Accessed 10 Apr 2018.