Frequency of real-world reported adverse drug reactions in rheumatoid arthritis patients

Eline L. Giraud*, Naomi T. Jessurun, Florence P. A. M. van Hunsel, Eugene P. van Puijenbroek, Astrid van Tubergen, Peter M. Ten Klooster, Harald E. Vonkeman

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Objectives To describe the cumulative incidences of adverse drug reactions (ADRs) associated with disease-modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis (RA) patients from real-world data (RWD), using the DREAM-RA registry, and to compare these with incidence frequencies mentioned in the Summary of Product Characteristics (SmPC). Methods All ADRs in patients with recorded use of adalimumab, etanercept, hydroxychloroquine, leflunomide, oral and subcutaneous methotrexate, and sulfasalazine from a single center participating in the DREAM-RA registry (n = 1,098 patients) that were directly sent to the Netherlands Pharmacovigilance Center Lareb were assessed. Cumulative incidences were calculated, described and compared to the most recently revised SmPCs. Results In total, 14 ADRs (>= 5 case reports) associated with the use of one of the included DMARDs were reported with a higher estimated cumulative incidence compared to the SmPC. For hydroxychloroquine and sulfasalazine, 5 ADRs (>= 5 case reports) mentioned with an 'unknown' incidence in the SmPC were reported as 'common' in this study. Conclusions Although ADR data in the DREAM-RA registry were partly comparable with data in the SmPCs, RWD from this patient registry provided an added value to the currently available information on the incidences of ADRs associated with DMARDs in RA patients as described in SmPCs.

Original languageEnglish
Pages (from-to)1617-1624
Number of pages8
JournalExpert opinion on drug safety
Issue number12
Early online date12 Oct 2020
Publication statusPublished - 1 Dec 2020


  • Adverse drug reactions
  • patient registry
  • real-world data
  • rheumatoid arthritis
  • SmPC
  • RISK
  • SEX


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