Correspondence on: "Real-world safety data of first-line drugs for rheumatoid arthritis: insights from the Portuguese Reuma.pt database".

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 denominato...

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Publicado en:ARP Rheumatology Vol. 5; no. 2; pp. 135 - 138
Autores principales: Choudhuri, B., Prakash, J.
Formato: Artículo
Publicado: Sociedade Portuguesa de Reumatologia Apr-Jun2026
Materias:
Acceso en línea:Ver este registro en EBSCOhost
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        atl: Correspondence on: "Real-world safety data of first-line drugs for rheumatoid arthritis: insights from the Portuguese Reuma.pt database".
      aug:
        au:
          Choudhuri, B.
          Prakash, J.
        affil:
          Department of Critical Care, Emergency Medicine & Rheumatology, Parkview Super-specialty Hospital, Kolkata, West Bengal, India.
          Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, India.
      su:
        Antirheumatic agents
        Medical registries
        Data quality
        Medical records
        Methotrexate
        Rheumatoid arthritis
        Drug utilization
        Adverse health care events
      sug:
        subj:
          Antirheumatic agents
          Medical registries
          Data quality
          Medical records
          Methotrexate
          Rheumatoid arthritis
          Drug utilization
          Adverse health care events
      ab: 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.
      pubtype: Academic Journal
      doctype: Article
      src: R
    language: English
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