Table 2.
ATTRA | DANBIO | ROB-FIN | ORA | GISEA | BIOBADASER | SCQMa | |
---|---|---|---|---|---|---|---|
Number of patients | 335 | 1213 | 362 | 976 | 433 with 770b total reported events | 350 |
959 infection cohort 1053 malignancy cohort |
Patient-years of exposure | 862 | 4513 | 530 | 6119 | NR | NR |
1902 infection cohort 3683 malignancy cohort |
Age (years), mean (SD) | 52.1 (11.4) | 57.2 (12.7) | 54.7 (13.5) | 58.0 (14.0) |
First-line: 58.1 (NR) Second-line: 58.5 (NR) Other lines: 57.5 (NR) |
57.5 (13.5) | 58 (13) |
Female, n (%) | 270 (81) | 941 (78) | 308 (85) | 771 (79) | 654 (85) | 276 (79) | ~ 79% |
Duration of RA (years), mean (SD) | 8.1 (7.4) | 10.1 (9.9) | 12.8 (11.0) | 14.0 (10.0) |
First-line: 9.2 (NR) Second-line: 11.3 (NR) Other lines: 13.3 (NR) |
NR | ~ 11 (NR) |
ATTRA Anti-TNF Therapy in Rheumatoid Arthritis, BIOBADASER Spanish Register of Adverse Events of Biological Therapies in Rheumatic Diseases, DANBIO Danish Rheumatologic Database, GISEA Italian Group for the Study of Early Arthritis, NR not reported, ORA Orencia and Rheumatoid Arthritis, RA rheumatoid arthritis, ROB-FIN National Registry of Biological Treatment in Finland, SCQM Swiss Clinical Quality Management, SD standard deviation
aPatient populations differed for the different outcomes; baseline characteristics of the patient populations for each outcome were similar
bTotal for first-line, second-line, and other lines of treatment from 2007 to November 2015