Ten-year safety and clinical benefit from open-label etanercept treatment in children and young adults with juvenile idiopathic arthritis
Authors' conclusion
Etanercept treatment up to 10 years was well tolerated, consistent with the known safety profile, with durable response in the participants still on active treatment.
Study context
- Population
- Participants with JIA (eoJIA, enthesitis-related arthritis (ERA) or PsA) who received ≥1 etanercept dose (0.8 mg/kg weekly; maximum 50 mg) in CLIPPER84 completed 120 months
- Participants
- 109 participants
- Comparison
- eoJIA vs ERA vs PsA
- eoJIAn = 55
- ERAn = 31
- PsAn = 23
- Outcome
- Occurrence of malignancy
Methodological details8-year extension, single-group
- 8-year extension
- Single-group
Main finding
As reported in the abstract
Malignancy
- Malignancy reported (Hodgkin's disease in 18-year-old patient with eoJIA treated with MTX for 8 years)
- 1
Further findings
JIA ACR50 response from Month 2 onwards
- Participants achieving JIA ACR50 (n = 127)
- Over 45%
Juvenile Arthritis DAS (JADAS) remission
- Participants achieving JADAS remission
- 42 (33%)
ACR clinical remission
- Participants achieving ACR clinical remission
- 34 (27%)
Active tuberculosis and deaths
- No cases of active tuberculosis or deaths
Safety
TEAEs (excluding infections/ISRs), number (incidence rate per 100 patient-years)
- Year 1
- 193 (173.81)
- Year 10
- 9 (27.15)
- TE infections and serious infections also decreased
Original publication
Ten-year safety and clinical benefit from open-label etanercept treatment in children and young adults with juvenile idiopathic arthritis. Rheumatology (Oxford). Published 4 May 2023. doi:10.
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