Two- and 3-year outcomes of the childhood arthritis and rheumatology research alliance FiRst Line Options for systemic juvenile idiopathic arthritis (sJIA) Treatment (FROST) trial
Authors' conclusion
Although results were limited by loss to follow-up, patients enrolled in FROST demonstrated increasing rates of CID and high rates of glucocorticoid discontinuation during long-term follow-up. Serious adverse events were uncommon and largely related to disease activity.
Study context
- Population
- Patients with new-onset sJIA enrolled in FROST (2016–2019)41 and 32 evaluable at 24 and 36 months
- Participants
- 73 patients
- Comparison
- IL-1 inhibition vs IL-6 inhibition vs Methotrexate vs glucocorticoid (GC) monotherapy
- Primary endpoint
- CID by Wallace/ACR provisional criteria without concurrent GC use
- Follow-up
- 24 and 36 months
Methodological detailsregistry-based prospective cohort, followed longitudinally through the CARRA Registry, four consensus treatment plans, 36-month follow-up, Results limited by loss to follow-up
- Registry-based prospective cohort
- Followed longitudinally through the CARRA Registry
- Four consensus treatment plans
- 36-month follow-up
- Results limited by loss to follow-up
Primary result
As reported in the abstract
Clinical inactive disease (CID) without GC use at 24 months
58.5%
CID without GC use at 36 months
65.5%
Secondary outcomes
cJADAS-10 ≤ 2.5 without fever and without GC use · 24 and 36 months
- Patients achieving
- over 80%
Off GCs · 24 and 36 months
- Patients off GCs
- > 90%
Cumulative CID at any time during follow-up
- By 24 months
- 78.8%
- By 36 months
- 87.6%
Off all disease-modifying antirheumatic drugs (DMARDs) at last follow-up
- Patients off all DMARDs
- 42.5%
Safety
Serious adverse events
- SAE rate per 100 person-years
- 6.6
- Person-years of observation
- 228.2
- Macrophage activation syndrome (MAS) was the most common SAE
sJIA-associated lung disease
- No cases identified
Original publication
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