Intravenous Golimumab in Children With Polyarticular-Course Juvenile Idiopathic Arthritis: Long-Term Extension of an Open-Label Phase III Study
An erratum to this article was published (J Rheumatol, 1 Oct 2025 ↗)
Authors' conclusion
GO-VIVA LTE participants experienced adequate PK exposure and stable safety and immunogenicity. The majority of participants experienced no more than minimal residual disease activity. Data suggest IV golimumab treatment provided durable clinical response through week 116, with an acceptable risk-benefit profile.
Study context
- Population
- Children with active polyarticular-course juvenile idiopathic arthritis (pcJIA) despite MTX who continued intravenous (IV) golimumab after week 52 in GO-VIVA112 entered long-term extension (LTE)
- Participants
- 127 children
- Outcome
- Median steady-state trough golimumab concentrations
- Follow-up
- Week 52 through week 244
Methodological detailssingle-group
- Single-group
Main finding
As reported in the abstract
Generally maintained from week 52 through week 244 (range)
0.3-0.6 μg/mL
Further findings
Antigolimumab antibody rate · week 52
- Antigolimumab antibody rate
- 39.2% [49/125]
Antigolimumab antibody rate · week 244
- Antigolimumab antibody rate (consistent with week 52)
- 44.8% [56/125]
JIA-ACR 30/50/70/90 response rates · week 52
- JIA-ACR 30
- 75.6% [96/127]
- JIA-ACR 50
- 74% [94/127]
- JIA-ACR 70
- 65.4% [83/127]
- JIA-ACR 90
- 48.8% [62/127]
- Nonresponder imputation
JIA-ACR 30/50/70/90 response rates · week 116
- JIA-ACR 30
- 72.4% [92/127]
- JIA-ACR 50
- 71.7% [91/127]
- JIA-ACR 70
- 63.8% [81/127]
- JIA-ACR 90
- 50.4% [64/127]
- Generally maintained from week 52
- Nonresponder imputation
cJADAS10 · week 116
- Median cJADAS10
- 1.6
- cJADAS10 ≤ 5 (minimal disease activity)
- 56.7% (72/127)
Safety
Serious adverse events and serious infections (rates per 100 patient-years) · through week 252
- Serious adverse events
- 7.7
- Serious infections
- 3.9
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →