Baricitinib Demonstrates Adequate Safety Profile in Moderate to Severe Rheumatoid Arthritis
Baricitinib 4 mg and 2 mg once daily had an acceptable safety profile with up to 5.5 years of long-term exposure. Image Credit: Joubert/Science Source
Baricitinib has a demonstrated acceptable safety profile in adults with moderate to severe rheumatoid arthritis (RA) who have been treated for up to 5.5 years, according to the results of an integrated analysis published in The Journal of Rheumatology.1
Janus kinase (JAK) inhibitors offer an alternative treatment option to conventional and biologic disease-modifying antirheumatic drugs for the treatment of RA. Baricitinib is a JAK inhibitor that has previously demonstrated clinical efficacy and acceptable safety in phase 3 trials.2-5 However, in order to fully understand the drug's safety profile over time, researchers pooled data from 8 phase 3, 2, and 2b trials and 1 long-term extension study containing 3492 patients who received 2 mg or 4 mg of baricitinib for 6637 total patient-years of exposure (median 2.1 years, maximum 5.5 years).1
They found that baricitinib was generally well tolerated and there were no differences in mortality rates, adverse events leading to drug discontinuation, malignancies, major adverse cardiovascular events, or serious infections in patients who received baricitinib compared with patients who received placebo. Few patients discontinued the trials as a result of adverse events. They did find, however, that the infection risk, particularly for herpes zoster, was elevated as with other JAK inhibitors and clinicians should monitor such infections. Long-term risks of malignancy and the potential risk for deep vein thrombosis or pulmonary embolism do warrant further evaluation.
“Overall, in the context of demonstrated efficacy in patients with active RA, baricitinib 4 mg and 2 mg once daily had an acceptable safety profile through up to 5.5 years of long-term exposure,” concluded the authors.1
- Smolen JS, Genovese MC, Takeuchi T, et al. Safety profile of baricitinib in patients with active rheumatoid arthritis with over 2 years median time in treatment [published online September 15, 2018]. J Rheumatol. doi:10.3899/jrheum.171361
- Taylor PC, Keystone EC, van der Heijde D, et al. Baricitinib versus placebo or adalimumab in rheumatoid arthritis. N Engl J Med. 2017;376:652-662.
- Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with refractory rheumatoid arthritis. N Engl J Med. 2016;374:1243-1252.
- Dougados M, van der Heijde D, Chen YC, et al. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. Ann Rheum Dis. 2017;76:88-95.
- Fleischmann R, Schiff M, van der Heijde D, et al. Baricitinib, methotrexate, or combination in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment. Arthritis Rheumatol. 2017;69:506-517.