Autoinflammatory & rare systemic diseases
Disease flares with baricitinib dose reductions and development of flare criteria in patients with CANDLE/PRAAS
Authors' conclusion
We observed disease flares and rebound inflammation with baricitinib dose reductions and proposed flare criteria that can assist in monitoring disease activity and in designing clinical studies in CANDLE/PRAAS.
Study context
- Population
- Patients with CANDLE/PRAAS treated with baricitinib in an open-label expanded-access programme, April 2014 to December 20199 with dose reduction
- Participants
- 10 patients
- Exposure
- >25% vs <25% baricitinib dose reductions; low-dose vs high-dose visits
- Outcome
- Disease flare after baricitinib dose reduction
Methodological detailsretrospective data analysis, two-sided χ2 tests
- Retrospective data analysis
- Two-sided χ2 tests
Main finding
As reported in the abstract
Disease flare after dose reduction
>25% dose reduction
4
events
P < 0.05
- Dose reductions resulting in disease flare (all)
- 7/14 (50%)
Observational data: associations, not effects.
Further findings
| Outcome | Low-dose visits | High-dose visits | P value |
|---|---|---|---|
| Disease flare criteria reached, per visitLow-dose visits vs High-dose visits | 43.14% | 12.75% | P < 0.0001 |
Interferon score as additional flare criterion
- Increased the sensitivity to detect disease flares
Original publication
Disease flares with baricitinib dose reductions and development of flare criteria in patients with CANDLE/PRAAS. Ann Rheum Dis. Published 27 August 2024. doi:10. 1136/ ard-2023-225463
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