The oral Janus kinase 1/2–selective inhibitor baricitinib may be a safe and effective treatment option for patients with juvenile idiopathic arthritis, according to a report published by Ramanan et al in The Lancet. In the phase III JUVE-BASIS trial (ClinicalTrials.gov identifier NCT03773978), researchers randomly assigned 163 patients aged 2 to 17 years with several forms of juvenile idiopathic arthritis who had an inadequate response or an intolerance to standard therapy to receive 4 mg of baricitinib or placebo for 32 weeks following adequate response during a 12-week open-label lead-in period. The primary endpoint of the trial was time to an arthritis flare. The researchers found that patients who received placebo experienced a median time to flare of about 27 weeks compared with a not evaluable time to flare among patients who received baricitinib (hazard ratio = 0.24, 95% confidence interval = 0.13–0.45). They reported that 2.7% (n = 6/220) of the patients who participated in the safety and open-label periods as well as 4.9% (n = 4/82) of the patients who received baricitinib and 3.7% (n = 3/81) of the patients who received placebo in the randomized trial period experienced adverse events such as pulmonary embolism and treatment-related infections. The researchers concluded that baricitinib demonstrated acceptable safety and efficacy in patients with juvenile idiopathic arthritis who may not be candidates for treatment with standard therapies.
August 24, 2023