Tofacitinib for JIA safe, effective up to 4 years

In the treatment of patients with juvenile idiopathic arthritis (JIA), tofacitinib appears to maintain its efficacy for up to 48 months, with the safety findings consistent with the known safety profile of the drug, according to the results of a long-term extension (LTE) study.

The LTE study included 225 patients with JIA who completed phase 1/3 index studies or discontinued for reasons excluding treatment-related serious adverse events (AEs). These patients received tofacitinib 5 mg twice daily or equivalent weight-based doses.

Safety outcomes included AEs, serious AEs, and AEs of special interest. Efficacy outcomes were improvement since tofacitinib initiation per the JIA-American College of Rheumatology (ACR)70/90 criteria, JIA flare rate, and disease activity measured using the Juvenile Arthritis Disease Activity Score (JADAS)27, with inactive disease corresponding to JADAS ≤1.0.

Over a median treatment duration of 41.6 months, AEs occurred in 201 patients (89.3 percent) and serious AEs in 34 (15.1 percent). Ten patients who had serious infections, three had herpes zoster, and two had newly developed uveitis.

Among patients with polyarticular course JIA, JIA-ACR70/90 response rates at month 1 were 60.0 percent (78 of 130) and 33.6 percent (47 of 140), respectively, and generally improved over time. JIA flare events were documented in fewer than 5 percent of patients through month 48.

Mean JADAS27 decreased from 22.0 at baseline to 6.2 at month 1 and 2.8 at month 48, with inactive disease reported in 28.8 percent and 46.8 percent of patients at months 1 and 48, respectively.