Autoinflammatory & rare systemic diseases
Long-term safety and effectiveness of canakinumab in patients with monogenic autoinflammatory diseases: results from the interim analysis of the RELIANCE registry
Authors' conclusion
Data from this analysis confirm the long-term safety and effectiveness of canakinumab for the treatment of CAPS, FMF, TRAPS and MKD/HIDS.
Study context
- Population
- Paediatric (aged ≥2 years) and adult patients with cryopyrin-associated periodic syndromes (CAPS), familial Mediterranean fever (FMF), TRAPS or mevalonate-kinase deficiency (MKD)/hyperimmunoglobulin-D syndrome (HIDS) receiving canakinumab as part of routine care72 (43.1%) children
- Participants
- 168 participants
- Exposure
- CAPS vs FMF vs TRAPS vs MKD/HIDS
- CAPSn = 91
- FMFn = 54
- TRAPSn = 16
- MKD/HIDSn = 7
- Outcome
- Disease activity (PGA) and remission under canakinumab
- Follow-up
- Baseline to Month 30
Methodological detailsnon-interventional, open-label, multicentre, interim analysis
- Non-interventional
- Open-label
- Multicentre
- Interim analysis
Main finding
As reported in the abstract
baseline to Month 30
Stable proportion in remission
≈70%
Observational data: associations, not effects.
Further findings
Dosing
- Trend to receive >SD of canakinumab in pooled population
Safety
Serious infections and serious adverse drug-reactions (CAPS cohort)
- More common in patients receiving higher than the recommended starting dose
Original publication
Long-term safety and effectiveness of canakinumab in patients with monogenic autoinflammatory diseases: results from the interim analysis of the RELIANCE registry. RMD Open. Published 15 February 2024. doi:10.
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