Abatacept Safety Outcomes Across 7 European Registries Save

A multinational registry analysis of rheumatoid arthritis (RA) receiving abatacept (ABA) has shown that the safety profile of ABA remains unchanged with no new or increased risks of infection or malignancy.

Data on treatment related infection, malignancy and hospitalization risks were collected from 7 European RA quality registries were collected including the ATTRA (Anti-TNF Therapy in Rheumatoid Arthritis [Czech Republic]), DANBIO (Danish Rheumatologic Database), ROB-FIN (National Registry of Antirheumatic and Biological Treatment in Finland), ORA (Orencia and Rheumatoid Arthritis [France]), GISEA (Italian Group for the Study of Early Arthritis), BIOBADASER (Spanish Register of Adverse Events of Biological Therapies in Rheumatic Diseases), and the SCQM (Swiss Clinical Quality Management) system. ABA exposure was represented as patient-years (p-y) and event  incidence rates (IRs) were calculated as the number of events per 1000 p-y.

The study included over 5000 RA patients exposed to ABA. Baseline characteristics were largely consistent across registries.

Infections requiring hospitalization (serious infections; SIE) ranged from 4 to 100 events per 1000 p-y.  This equates to < 1 per 100 PY.

Opportunistic infections ranged from 0 to 14 per 1000 p-y.  Similarly the risk of tuberculosis was very low at 0 - 6 per 1000 p-y.

The overall malignancy risk ranged from 3 to 19 per 1000 p-y.  There was wide variabilty in results presumably form methodological differences between registries.  According to most proposed treatment algorithms, RA patients given abatacept would most likely have been exposed to, on average, 2 or more prior biologic treatments, which would further confound attribution.