Clinical and molecular data to predict flares in DMARD optimization in rheumatoid arthritis: a randomized, controlled, open-label, non-inferiority trial
Primary result · Joint flareResult — go to the resultRisk difference −5.5% 95% CI −16.8% to 5.7%Authors' conclusion
bDMARD dose optimization was not non-inferior to standard therapy on the flare rate but demonstrated similar safety.
Study context
- Population
- RA patients in sustained remission on stable bDMARD therapy, five hospitals in Spainrandomized
- Participants
- 195 patients
- Comparison
- bDMARD dose reduction vs standard care
- Optimizationn = 96
- Controln = 99reference
- Primary endpoint
- Proportion of joint flare between baseline and 12 months (non-inferiority, ITT); identification of predictors for flare and sustained remission
- Follow-up
- 12 months
Methodological detailsphase IV, open-label, non-inferiority, multicentre (five hospitals), 1:1 randomisation
- Phase IV
- Open-label
- Non-inferiority
- Multicentre (five hospitals)
- 1:1 randomisation
Primary result
Joint flare
Risk difference
−5.5%
95% CI −16.8% to 5.7%
P = 0.33
By group
Controlvs Optimization
risk difference −5.5% (95% CI −16.8% to 5.7%); P = 0.33
As reported in the abstract
- Total flares
- 39
Further findings
Predictive models for flare and sustained remission
- Flare model AUC (3v-DAS28-CRP, VAS pain, erosions, systolic blood pressure, haemoglobin)
- 0.84
- Sustained remission model AUC (3v-DAS28-CRP, age, RF)
- 0.77
- Flare model AUC with molecular biomarkers
- 0.91
- Sustained remission model AUC with molecular biomarkers
- 0.88
Safety
- No significant differences in adverse events
Original publication
Clinical and molecular data to predict flares in DMARD optimization in rheumatoid arthritis: a randomized, controlled, open-label, non-inferiority trial. Rheumatology (Oxford). Published 29 January 2026. doi:10.
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