Comparison of long-term efficacy, tolerability and drug survival rates of baricitinib as monotherapy or combination therapy in rheumatoid arthritis (RA) patients: data from a real-world prospective cohort study
Authors' conclusion
In this real-world cohort, baricitinib demonstrated sustained long-term effectiveness, drug survival and an acceptable safety profile.
Study context
- Population
- RA patients initiating baricitinib, single-centre prospective cohort, 2017–2023; high baseline disease activity (mean DAS28-ESR 4.0)
- Participants
- 219 patients
- Exposure
- Baricitinib monotherapy vs baricitinib combined with methotrexate (MTX)
- Monotherapy (MONO)n = 165
- COMBOn = 54reference
- Outcome
- Boolean remission
Methodological detailssingle-centre, observational, real-world, Kaplan-Meier, linear mixed-effects models
- Single-centre
- Observational
- Real-world
- Kaplan-Meier
- Linear mixed-effects models
Main finding
As reported in the abstract
Boolean remission, whole cohort (n=72)
33%
Observational data: associations, not effects.
Further findings
- Drug survival — Median drug survival, whole cohort · similar for both regimens
- 36 months · log-rank p=0.82
Disease activity · 6 months
- Rapid and sustained improvement in both groups, stabilising in the low range by 6 months
Safety
Discontinuation due to AEs
- Patients discontinuing due to AEs
- 10.9%
Thrombotic events
- Thrombotic events
- 4
- All in patients with pre-existing cardiovascular risk factors
- No new safety signals
Original publication
Comparison of long-term efficacy, tolerability and drug survival rates of baricitinib as monotherapy or combination therapy in RA patients: data from a real-world prospective cohort study. RMD Open. Published 17 December 2025. doi:10.
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