TY - JOUR
T1 - Frequency of real-world reported adverse drug reactions in rheumatoid arthritis patients
AU - Giraud, Eline L.
AU - Jessurun, Naomi T.
AU - van Hunsel, Florence P.A.M.
AU - van Puijenbroek, Eugene P.
AU - van Tubergen, Astrid
AU - Ten Klooster, Peter M.
AU - Vonkeman, Harald E.
PY - 2020/12
Y1 - 2020/12
N2 - 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.
AB - 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.
KW - Adverse drug reactions
KW - DMARD
KW - patient registry
KW - real-world data
KW - rheumatoid arthritis
KW - SmPC
UR - http://www.scopus.com/inward/record.url?scp=85092449677&partnerID=8YFLogxK
U2 - 10.1080/14740338.2020.1830058
DO - 10.1080/14740338.2020.1830058
M3 - Article
C2 - 32990050
AN - SCOPUS:85092449677
VL - 19
SP - 1617
EP - 1624
JO - Expert opinion on drug safety
JF - Expert opinion on drug safety
SN - 1474-0338
IS - 12
ER -