Long-term Tofacitinib in Juvenile Idiopathic Arthritis Save

The long-term safety and efficacy of tofacitinib in patients with juvenile idiopathic arthritis (JIA) has been established in an ongoing long term extension (LTE) study.

In the inception phase 3 trial, 225 patients with JIA enrolled in a 44-week randomised withdrawal study found that tofacitinib reduced the flare risk by 54%, and that JIA-ACR30 responses were seen as early as week 2 and by week 18, 77% of patients were JIA-ACR30 responders.  This trial included 184 (82%) with polyarticular course JIA, 20 (9%) with psoriatic arthritis, and 21 (9%) with enthesitis-related arthritis. 

Of those JIA patients continuing the LTE on open-label tofacitinib, the median (range) duration of treatment was  41.6 (1–103) months). Key safety signal seen included:

• Serious AEs - 34 (15.1%) 

• Serious infections - 10 patients (3 herpes zoster)

• New uveitis - 2 patients 

Patients with polyarticular course JIA had JIA-ACR70/90 response rates of 60% and 34%, respectively, at month 1, and improved over time. Disease flares were seen in <5% through to month 48. 

This LTE study establishes the safety and efficacy of tofacitinib through month 48.