Safety outcomes in patients with rheumatoid arthritis treated with abatacept: results from a multinational surveillance study across seven European registries
Authors' conclusion
Despite heterogeneity between registries in terms of design, data collection, and ascertainment of safety outcomes, as well as the possibility of under-reporting of adverse events in observational studies, the safety profile of abatacept reported here was largely consistent with previous findings in patients with RA treated with abatacept, with no new or increased risks of infection or malignancy.
Study context
- Population
- Patients with rheumatoid arthritis (RA) treated with abatacept in seven European RA quality registries (ATTRA, DANBIO, ROB-FIN, ORA, GISEA, BIOBADASER, SCQM)78–85% female
- Participants
- Over 5,000 patients
- Outcome
- Incidence of prespecified infection and malignancy outcomes (IRs per 1000 p-y)
Methodological detailssingle-arm, multinational, seven European RA registries
- Single-arm
- Multinational
- Seven European RA registries
Main finding
As reported in the abstract
- Incidence rates (IRs) for infections requiring hospitalization across the registries ranged from 4 to 100 events per 1000 p-y
- IRs for overall malignancy ranged from 3 to 19 per 1000 p-y
Observational data: associations, not effects.
Safety
Infections requiring hospitalization, IR per 1000 p-y
- Range across registries
- 4 to 100
Overall malignancy, IR per 1000 p-y
- Range across registries
- 3 to 19
Original publication
Safety outcomes in patients with rheumatoid arthritis treated with abatacept: results from a multinational surveillance study across seven European registries. Arthritis Res Ther. Published 12 June 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →