Patients randomised to placebo in Part 2 (n=61) | Patients randomised to golimumab in Part 2 (n=68) | |
JIA ACR30 response | 45/61 (73.8) | 47/68 (69.1) |
JIA ACR50 response | 45/61 (73.8) | 47/68 (69.1) |
JIA ACR70 response | 42/61 (68.9) | 44/68 (64.7) |
JIA ACR90 response | 32/61 (52.5) | 33/68 (48.5) |
Inactive disease status | 27/64 (42.2) | 33/69 (47.8) |
Clinical remission* | 33/76 (43.4) | 35/78 (44.9) |
JADAS71-ESR, mean±SD | 5.2±10.8 | 5.1±11.8 |
Data reported as n/N (%) and using observed data unless otherwise noted; week 96 is the latest follow-up time point to describe these efficacy results because the number of patients decreased considerably over time beyond week 96. At week 16, 76 patients were randomised to receive placebo; 10 patients remained on placebo through the week-48 database lock, 33 patients crossed over to golimumab before week 48 and 33 patients crossed over to golimumab after week 48. After week 48, no data imputation was performed for study visits that occurred after the study termination date.
*Patients who achieved protocol-defined clinical remission at any time from week 24 through the final database lock.
JADAS71-ESR, Juvenile Arthritis Disease Activity Score using erythrocyte sedimentation rate; JIA ACR30/50/70/90, ≥30%/50%/70%/90% improvement in the American College of Rheumatology juvenile idiopathic arthritis response criteria.