Tofacitinib effective for juvenile idiopathic arthritis through 4 years
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Key takeaways:
- Polyarticular course JIA “generally improved over time” through 48 months of tofacitinib treatment.
- Safety was “generally consistent” with findings observed in a phase 3 study.
Tofacitinib’s benefits in patients with juvenile idiopathic arthritis extend through at least 48 months, with no new safety findings, according to data published in Annals of the Rheumatic Diseases.
The findings come from a long-term extension analysis of patients with JIA who completed previous phase 1 and phase 3 studies.
“In [the phase 3] study, there was a rapid and profound improvement of disease,” Hermine I. Brunner, MD, MSc, MBA, of the Cincinnati Children’s Hospital Medical Center and the University of Cincinnati College of Medicine, and colleagues wrote. “While double-blind, randomized controlled trials represent the gold-standard approach for determining the short-term efficacy and safety of therapies, long-term data are required to better understand the risk-to-benefit profile of a medication for the treatment of a chronic disease.”
To examine the long-term efficacy and safety of tofacitinib (Xeljanz, Pfizer) in JIA, Brunner and colleagues conducted an interim analysis of a long-term extension study ongoing in 22 countries. The analysis included 225 patients with JIA, including 185 with polyarticular course JIA. There were also 19 participants with juvenile psoriatic arthritis and 21 with enthesitis-related arthritis, but the researchers stated that the small numbers limited interpretation of those results.
Efficacy outcome measures included improvement in JIA-ACR 70/90 criteria; flare rate and disease activity assessed via the 27-joint Juvenile Arthritis Disease Activity Score (JADAS27); and inactive disease, defined as a JADAS score of 1 or below. Participants received tofacitinib (Xeljanz, Pfizer) 5 mg, or an equivalent weight-based lower dose, twice per day over a median period of 41.6 months.
At month 1, those with polyarticular course JIA demonstrated JIA-ACR70 and JIA-ACR90 response rates of 60% and 33.6%, respectively. Those responses “generally improved over time,” Brunner and colleagues wrote. According to the researchers, fewer than 5% of patients experienced a flare through month 48. The mean JADAS27 score was 22 at baseline, 6.2 at 1 month, and 2.8 at 48 months. Disease was inactive in 28% of patients at 1 month and 46.8% of patients at 48 months.
Meanwhile, the safety profile was “generally consistent” with data reported in the phase 3 study, the researchers wrote. Overall, 89.3% (n = 201) of study participants experienced adverse events, with 15.1% (n = 34) demonstrating severe adverse events. Ten patients developed serious infections, while three had herpes zoster. Two participants developed uveitis, a number that the researchers said was “reassuring.”
“Tofacitinib appears to be an effective oral option for patients with JIA with an established safety profile,” Brunner and colleagues wrote. “The final results of this [long-term extension] study will provide greater insight into the long-term benefit-to-risk profile of tofacitinib in patients with JIA and will include an assessment of patients with [systemic JIA] with active systemic features.”
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