Baricitinib superior to placebo in controlling juvenile idiopathic arthritis flares
Click Here to Manage Email Alerts
Key takeaways:
- Fewer than 50% of patients receiving baricitinib experienced a disease flare during the withdrawal period.
- Time to flare was longer in patients receiving baricitinib than those receiving placebo.
Patients with juvenile idiopathic arthritis who receive baricitinib demonstrate a “significantly” longer time to disease flare vs. placebo, according to data published in The Lancet.
“This phase 3 study fulfills an important need in having an oral alternative to injectable biologics for our patient population,” A.V. Ramanan, FMedSci, of the University of Bristol, told Healio.
To investigate the efficacy and safety profile of baricitinib (Olumiant, Eli Lilly & Co.) in patients with JIA, Ramanan and colleagues conducted the phase 3, randomized, double-blind, placebo-controlled, multicenter JUVE-BASIS trial. Stretching across 75 sites in 20 countries, the study included patients aged 2 to 17 years with polyarticular JIA, extended oligoarticular JIA, enthesitis-related arthritis and juvenile psoriatic arthritis. Patients were excluded if they had systemic JIA, persistent oligoarticular JIA, anterior uveitis or a recent serious infection.
In all, 219 patients received baricitinib during the 12-week, open-label lead-in period. Following that, 82 patients were randomized to receive baricitinib, while 81 were randomized to placebo, for up to 32 weeks during the placebo-controlled, double-blind withdrawal period. The primary outcome was the time to disease flare during a period of withdrawal. Secondary endpoints included the percentage of patients who experienced a flare during the withdrawal period, as well as JIA-ACR30, 50, 70, 90 and JIA-ACR100 responses. The researchers additionally assessed the safety profile of baricitinib by cataloguing adverse and serious adverse events.
Time to flare was “significantly shorter” among patients who received placebo, compared with those who received baricitinib (HR = 0.241; 95% CI, 0.12-0.453), the researchers wrote. The median time to flare in the placebo group was 27.14 weeks. However, researchers could not effectively analyze the time to flare in those receiving baricitinib because fewer than 50% of patients experienced a flare during the trial period, they wrote.
Regarding safety, six patients (3%) out of the 220 who receive at least one dose of baricitinib experienced an adverse event during the screening period. During the withdrawal period, four patients (5%) randomized to the baricitinib group experienced adverse events (IR = 9.7 per 100 patient-years; 95% CI, 2.7-24.9). Meanwhile, three patients in the placebo group experienced adverse events (IR = 10.2; 95% CI, 2.1-29.7).
“Baricitinib is effective in management of children with JIA, including those who have been refractory to biologics,” Ramanan said. “The once-a-day oral medication offers an important alternative option to children and adolescents who do not prefer injectable agents.”
Collapse
Read more about
Click Here to Manage Email Alerts