In the pharmacokinetic and safety assessment and open-label, lead-in parts of the study, 126 patients (57.3%) reported treatment-emergent adverse events, and six patients (2.7%) reported at least one serious adverse event. The most common treatment-emergent adverse events in both groups were nasopharyngitis (n=19; 8.6%), headache (n=14; 6.4%), arthralgias (n=12; 5.5%), upper respiratory tract infection (n=11; 5%) and nausea (n=11; 5%). Serious adverse events included arthralgias (n=1; 0.5%), joint destruction (n=1; 0.5%), joint effusion (n=1; 0.5%), JIA (n=1; 0.5%), musculoskeletal chest pain (n=1; 0.5%) and decreased appetite (n=1; 0.5%). One case of herpes virus (0.5%) and one case of herpes zoster (0.5%) were also reported.
In the study’s double-blind withdrawal period, at least one treatment-emergent adverse event was reported for patients who received placebo (n=38; 46.9%) and for patients treated with baricitinib (n=54; 65.9%). Three (3.7%) and four (4.9%) serious adverse events occurred in patients who received placebo and baricitinib, respectively. Due to the study design, the mean number of weeks of exposure was higher in the baricitinib group (26.3 weeks) compared with the placebo group (18.9 weeks) during this study period.
No deaths, cardiovascular events or uveitis were reported, and no new safety signals were identified during the study.
In this study, baricitinib significantly reduced time to JIA flare and frequency of JIA flares in young patients, with improved JIA ACR response scores in most patients within 12 weeks. The safety findings were consistent with the known safety profile of baricitinib in adults with RA.
These results support the use of baricitinib to treat patients aged 2–18 years with signs and symptoms of JIA for whom conventional or biologic DMARDs have proved inadequate.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- Ramanan A, Quartier P, Okamoto N, et al. Baricitinib in juvenile idiopathic arthritis: A phase 3, double-blind, placebo-controlled, withdrawal, efficacy and safety study [LB0002]. Ann Rheum Dis. 2022:81(suppl 1): 207–208.
- New drug application approval letter: Olumiant (baricitinib). U.S. Food & Drug Administration. 2018 May 31.
