Safety and effectiveness of abatacept in juvenile idiopathic arthritis: results from the PRINTO/PRCSG registry
Authors' conclusion
Abatacept was well tolerated in patients with JIA, with no new safety signals identified and with well-controlled disease activity, including some patients achieving inactive disease or remission.
Study context
- Population
- Children with JIA starting or currently receiving abatacept, PRINTO/PRCSG registry; enrolment from January 2013569 analysed
- Participants
- 587 children
- Outcome
- Serious adverse events, IR per 100 patient-years
- Follow-up
- Over 5 years
Methodological detailsongoing observational registry, as-observed analysis, interim analysis
- Ongoing observational registry
- As-observed analysis
- Interim analysis
Main finding
As reported in the abstract
Incidence rate (IR) per 100 patient-years of serious AEs
5.52
95% CI 4.27, 7.01
Observational data: associations, not effects.
Further findings
cJADAS10 low disease activity and inactive disease · month 3, sustained over 5 years
- Achieved cJADAS10 low disease activity and inactive disease
- 55.9%
- Low disease activity (72/354)
- 20.3%
- Inactive disease (126/354)
- 35.6%
- As-observed analysis
Safety
Events of special interest, IR per 100 patient-years
- IR per 100 patient-years
- 3.62 (95% CI 2.63, 4.86)
Serious infections · over 5 years
- Serious infections, n
- 18
- IR per 100 patient-years
- 1.48 (95% CI 0.88, 2.34)
Original publication
Safety and effectiveness of abatacept in juvenile idiopathic arthritis: results from the PRINTO/PRCSG registry. Rheumatology (Oxford). Published 18 January 2024. doi:10.
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