Development and validation of a predictive model for the risk of serious infection in patients with rheumatoid arthritis initiating a biologic or targeted synthetic DMARD: a nationwide cohort study
Authors' conclusion
RAISE delivers personalized 6-, 12-, 18- and 24-month infection risk estimates using routinely available data, improving on the scope and relevance of earlier prediction tools.
Study context
- Population
- Adults with rheumatoid arthritis (RA) initiating a b/tsDMARD, France, 2010–2023median follow-up 12.5 months
- Comparison
- Derivation vs Validation
- Outcome
- Serious infection (requiring hospitalization)
Methodological detailsnationwide cohort study, French National Health Data System, random split: derivation (66%) and validation (34%) cohorts, internal (hold-out) validation, LASSO variable selection, multivariable Cox model, 500 bootstrap resamples, no external validation
- Nationwide cohort study
- French National Health Data System
- Random split: derivation (66%) and validation (34%) cohorts
- Internal (hold-out) validation
- LASSO variable selection
- Multivariable Cox model
- 500 bootstrap resamples
- No external validation
Performance
As reported in the abstract
Predictors of serious infection (multivariable Cox)
Adjusted hazard ratio (95% CI)
Rituximab
2.20(1.98–2.44)
Infliximab
1.75(1.56–1.97)
Corticosteroids ≥7.5 mg/day
1.45(1.33–1.58)
Prior infection
1.62(1.48–1.77)
Pulmonary disease
1.51(1.40–1.64)
Diabetes
1.34(1.23–1.46)
- Discrimination (C-index), moderate
- 0.71
- Calibration (mean absolute error)
- ≤0.07
Further findings
Events
| Outcome | Derivation | Validation |
|---|---|---|
| Serious infections · median follow-up 12.5 months (IQR 5.3-33.3) | 4,657 | 2,359 |
Original publication
Development and validation of a predictive model for the risk of serious infection in patients with rheumatoid arthritis initiating a biologic or targeted synthetic DMARD: a nationwide cohort study. Rheumatology (Oxford). Published 3 December 2025. doi:10.
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