EULAR 2022 (VIRTUAL)—A study found oral baricitinib (Olumiant) significantly reduced the time to and frequency of flares in patients aged 2–18 years with juvenile idiopathic arthritis (JIA).1 The findings of the study were presented by Athimalaipet Ramanan, MD, FRCPCH, FRCP, a consultant pediatric rheumatologist at Bristol Royal Hospital for Children and Royal National Hospital for Rheumatic Diseases, Bath, U.K., and Bristol Royal Hospital for Children, Bristol Medical School, Bristol, U.K.
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Baricitinib is a Janus kinase (JAK) ½ selective inhibitor. In May 2018, the U.S. Food & Drug Administration (FDA) approved the agent to treat adults with moderate to severe active RA for whom one or more tumor necrosis factor (TNF) antagonist therapies had proved inadequate.2 In a phase 3 study, Ramanan et al. investigated baricitinib’s safety and efficacy in pediatric patients with JIA for whom conventional or biologic disease-modifying anti-rheumatic drugs (DMARDs) had proved inadequate.
Participants in this double-blind, withdrawal study included patients with extended oligoarticular or polyarticular JIA, enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (jPsA) according to the International League of Associations for Rheumatology (ILAR) criteria.
The study was divided into three periods: a two-week pharmacokinetic and safety assessment; a 12-week, open-label, lead-in period; and a 32-week, double-blind withdrawal period. Safety and dosing were confirmed during the pharmacokinetic and safety assessment period. Patients enrolled in the open-label, lead-in period then received age-based, once-daily doses of baricitinib. Patients who achieved a JIA ACR30 response at week 12 entered the study’s double-blind withdrawal phase. In the double-blind withdrawal period, patients were randomized in a 1:1 ratio to continue baricitinib treatment or begin baricitinib withdrawal, receiving placebo until disease flare or week 32.
The primary study end point was the time to flare during the double-blind withdrawal period. Secondary end points included the proportion of patients experiencing a flare during the double-blind withdrawal period and the JIA ACR30/50/70/90 response rates at week 12. Survival curves were estimated using the Kaplan-Meier method.
In total, 219 patients entered the study’s second phase—the 12-week, open-label, lead-in period—and 163 patients entered the 32-week, double-blind withdrawal period.
At week 12, 76.3% of patients achieved a JIA ACR30 response, 63.5% of patients achieved a JIA ACR50 response, 46.1% of patients achieved a JIA ACR70 response and 20.1% of patients achieved a JIA ACR90 response. During the double-blind withdrawal period, the proportion of patients who experienced a disease flare was significantly lower in the baricitinib treatment group (17.1%) than the placebo group (50.6%; P<0.001).