A4: Efficacy and Safety of Tocilizumab in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis: 2-Year Data From CHERISH

Background/Purpose: The efficacy and safety of tocilizumab (TCZ), an interleukin-6 receptor inhibitor, were previously demonstrated at week 40 of CHERISH, a phase 3 trial in patients with polyarticular-course juvenile idiopathic arthritis (pcJIA) ([1]). Here we report the efficacy and safety of TCZ over 104 weeks of treatment in patients with pcJIA. Methods: Patients 2 to 17 years old with ≥6 months' active pcJIA who failed methotrexate received open-label TCZ (weight ≥30 kg, 8 mg/kg [n = 119]; weight ≥30 kg, randomly assigned [1:1] to 8 [n = 34] or 10 [n = 35] mg/kg) every 4 weeks for 16 weeks. Patients with ≥JIA American College of Rheumatology (ACR) 30 response at week 16 entered a 24-week, double-blind withdrawal period and were randomly assigned (1:1) to placebo or continuation with TCZ. Patients with JIA ACR30 flare or who completed the withdrawal period entered an open-label extension through week 104. Results: One hundred eighty-eight patients entered the lead-in period, 166 entered the withdrawal period, 160 entered the open-label extension period, and 155 completed 104 weeks. In patients who received continuous TCZ throughout the study (n = 82), JIA ACR responses, improvement in JIA ACR core components, and proportions of patients with inactive disease or remission (1) were maintained through week 104. JADAS-71 scores were maintained through week 104 (Figure); 73% of patients had JADAS-71