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

Abstract:

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.

journal_name

Expert Opin Drug Saf

authors

Giraud EL,Jessurun NT,van Hunsel FPAM,van Puijenbroek EP,van Tubergen A,Ten Klooster PM,Vonkeman HE

doi

10.1080/14740338.2020.1830058

subject

Has Abstract

pub_date

2020-12-01 00:00:00

pages

1617-1624

issue

12

eissn

1474-0338

issn

1744-764X

journal_volume

19

pub_type

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