Risk stratified monitoring for methotrexate toxicity in immune mediated inflammatory diseases: prognostic model development and validation using primary care data from the UK
Authors' conclusion
A prognostic model was developed and validated that uses information collected during routine clinical care and may be used to risk stratify the frequency of monitoring blood test during long term methotrexate treatment.
Study context
- Population
- Adults (≥18 years) with an IMID prescribed MTX by their GP for ≥6 months during 2007–19, UK primary care (Clinical Practice Research Datalink (CPRD) Gold and CPRD Aurum)
- Participants
- 13,110 vs 23,999
- Exposure
- Development vs Validation
- Developmentn = 13,110
- Validationn = 23,999
- Outcome
- Discontinuation of MTX owing to abnormal monitoring blood test result
Methodological detailsprognostic model development and validation, Cox regression, bootstrapping to shrink predictor effects for optimism, multiple imputation
- Prognostic model development and validation
- Cox regression
- Bootstrapping to shrink predictor effects for optimism
- Multiple imputation
Main finding
As reported in the abstract
Prognostic model performance (11 candidate predictors, 17 parameters)
| Group | Value | Optimism adjusted R2 | Optimism adjusted Royston D statistic | Calibration slope (entire follow-up), 95% CI 0.85 to 1.02 | Royston D statistic (entire follow-up), 95% CI 0.67 to 0.83 |
|---|---|---|---|---|---|
| Development | 854 events | 0.13 | 0.79 | ||
| Validation | 1486 events | 0.94 | 0.75 |
Value
Development854 events
Validation1486 events
Optimism adjusted R2
Development0.13
Validation— not stated in the abstract
Optimism adjusted Royston D statistic
Development0.79
Validation— not stated in the abstract
Calibration slope (entire follow-up), 95% CI 0.85 to 1.02
Development— not stated in the abstract
Validation0.94
Royston D statistic (entire follow-up), 95% CI 0.67 to 0.83
Development— not stated in the abstract
Validation0.75
Observational data: associations, not effects.
Further findings
Model performance in clinically relevant subgroups (age group, IMID type, MTX dose)
- The prognostic model performed well in predicting outcomes in clinically relevant subgroups
Original publication
Risk stratified monitoring for methotrexate toxicity in immune mediated inflammatory diseases: prognostic model development and validation using primary care data from the UK. BMJ. Published 30 May 2023. doi:10.
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