Long-term efficacy and safety of subcutaneous tocilizumab in clinical trials of polyarticular or systemic juvenile idiopathic arthritis
Authors' conclusion
Patients with pJIA or sJIA experienced long-term disease control with SC-TCZ treatment. Long-term safety was consistent with the known tocilizumab safety profile.
Study context
- Population
- Patients with pJIA or sJIA from two 52-week phase 1b core trials of subcutaneous tocilizumab (SC-TCZ) with adequate response per investigator assessment
- Participants
- 44 vs 38
- Comparison
- pJIA vs sJIA
- pJIAn = 44
- sJIAn = 38
- Outcome
- Inactive disease per ACR provisional criteria, by body weight (<30 / ≥30 kg)
Methodological detailsbody weight-based dosing
- Body weight-based dosing
Main finding
As reported in the abstract
Further findings
Mean ∼, μg/ml
| Outcome | pJIA | sJIA |
|---|---|---|
| Tocilizumab trough concentrations, maintained within range expected to provide clinical benefit · over 3 years | 10 | 75 |
Pharmacodynamic parameters (IL-6, soluble IL-6 receptor, ESR, CRP)
- Maintained throughout the long-term extension (LTE) at levels achieved in the core trials
Safety
Serious adverse events in the LTE · up to 5 years
- Serious adverse events in the LTE: serious infections: pJIA 5, sJIA 1
Original publication
Long-term efficacy and safety of subcutaneous tocilizumab in clinical trials of polyarticular or systemic juvenile idiopathic arthritis. Rheumatology (Oxford). Published 29 March 2024. doi:10.
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