Table 3.
Incidence rates/1000 patient-years (95% CI), number of events, and patient-years of exposure for infections
| ATTRA (n = 335) | DANBIO (n = 1213) | ROB-FIN (n = 362) | ORAa (n = 976) | GISEA (n = 433) | BIOBADASER (n = 350) | SCQMb (n = 959/974) | |
|---|---|---|---|---|---|---|---|
| Infections requiring hospitalization | |||||||
| IR per 1000 p-y (95% CI) | 6 (0, 12) | 100 (87, 115) | 84 (62, 110) | 38c (NR) | 43d (NR) | 15 (8, 29) | 4 (2, 8) |
| Number of events (p-y) | 5 (NR) | 196 (1955) | 49 (NR) | 298 (NR) | NR (NR) | 9 (578) | 7 (1902) |
| Opportunistic infections | |||||||
| IR per 1000 p-y (95% CI) | 0 | 1 (0, 3) | NR | NRd | NR | 14 (7, 27) | NR |
| Number of events (p-y) | 0 (0) | 2 (2233) | NR (NR) | NR (NR) | NR (NR) | 8 (578) | NR (NR) |
| Tuberculosis | |||||||
| IR per 1000 p-y (95% CI) | 6 (0, 12) | 1 (0, 3) | 0 (0, 6) | NR | NR | 0 | 1.5 (1, 5) |
| Number of events (p-y) | 5 (NR) | 2 (2230) | 0 (0) | NR (NR) | NR (NR) | 0 (0) | 3 (1941) |
ATTRA Anti-TNF Therapy in Rheumatoid Arthritis, BIOBADASER Spanish Register of Adverse Events of Biological Therapies in Rheumatic Diseases, CI confidence interval, DANBIO Danish Rheumatologic Database, GISEA Italian Group for the Study of Early Arthritis, IR incidence rate, NR not reported, ORA Orencia and Rheumatoid Arthritis, p-y patient-years, ROB-FIN National Registry of Biological Treatment in Finland, SCQM Swiss Clinical Quality Management
aNo CIs were provided in the report submitted by the French Society of Rheumatology to health authorities
bThe sample size for infections requiring hospitalization was 959; for tuberculosis, the sample size was 974. IRs are by exposure group with mid-imputed dates of occurrence
cIntravenous antibiotic therapy and/or hospitalization
dCalculated IR from the final study report from GISEA
dFor ORA, NR means not reported in the report submitted to the French Health Authorities by the French Society of Rheumatology