Autoinflammatory & rare systemic diseases

Disease flares with baricitinib dose reductions and development of flare criteria in patients with CANDLE/PRAAS

Ann Rheum DisPublished Retrospective analysis of an open-label expanded-access programme

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

OutcomeLow-dose visitsHigh-dose visitsP value
Disease flare criteria reached, per visitLow-dose visits vs High-dose visits43.14%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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