| Sumario: | This correspondence addresses methodological considerations in a study analyzing adverse event (AE) reports from the Portuguese Reuma.pt registry on first-registered disease-modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis (RA). It highlights the need for reporting exposure denominators (e.g., number of patients treated, patient-years), clarifying the definition of “first-line” therapy as used in the registry versus clinical guidelines, and standardizing seriousness and causality assessments according to established pharmacovigilance frameworks such as the WHO-Uppsala Monitoring Centre system. The authors also emphasize addressing missing data on key clinical covariates (e.g., methotrexate dose, comorbidities, concomitant medications) and suggest patient-level sensitivity analyses to avoid bias from multiple AE reports per individual. These recommendations aim to improve interpretability, reproducibility, and cross-cohort comparability of real-world safety data from Reuma.pt and similar registries.
|
|---|