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Table 5 Primary outcomes in RCTs, nRCTs, and open-label studies of infliximab

From: Efficacy and safety of TNF inhibitors in the treatment of juvenile idiopathic arthritis: a systematic literature review

JIA categories

Patients, n

Time point

JIA-ACR 30/50/70/90, % of patients

Exposure, PY

SAE, n (%)

SAE/100PY

NCT00036374 (RCT with OLE) [14, 16]

Multiple

PBO/IFX 6 mg/kg + MTX: 62

14 weeks

49/34/12/NR

NR

3 (5)

NR

IFX 3 mg/kg + MTX: 60

14 weeks

64/50/22/NR

NR

NR

NR

IFX 3 or 6 mg/kg + MTX: 112 (AEP)

16 weeks

73/NR/NR/NR

NR

NR

NR

IFX 3 or 6 mg/kg + MTX: 112 (AEP)

52 weeks

NR/70/52/NR

NR

NR

NR

IFX 3 or 6 mg/kg + MTX: 78 (OLE)

52 weeks

85/81/60/41

NR

NR

NR

IFX 3 or 6 mg/kg + MTX: 78 (OLE)

204 weeks

44/40/33/24

NR

17 (21.8)

NR

  1. ACR   American College of Rheumatology, AEP   all-evaluable population, IFX   Infliximab, JIA   Juvenile idiopathic arthritis, MTX   Methotrexate, n   Number of patients included in the analysis at the indicated timepoint, NR   Not reported, nRCT   Nonrandomized controlled trial, OLE  Open-label extension, PBO   Placebo, PY   Patient-years, RCT   Randomized controlled trial, SAE   Serious adverse event