Safety outcomes in patients with rheumatoid arthritis treated with abatacept: results from a multinational surveillance study across seven European registries

Table 4 Incidence rates/1000 patient-years (95% CI), number of events, and patient-years of exposure for malignancies

	ATTRA (n = 335)	DANBIO (n = 1213)	ROB-FIN (n = 362)	ORA (n = 976)	GISEA (n = 433)	BIOBADASER (n = 350)	SCQM^a (n = 1053)
Overall malignancy
IR per 1000 p-y (95% CI)	9 (3, 16)	19 (15, 24)	7 (3, 16)	13 (NR)	3^b (NR)	14 (7, 27)	9 (6, 12)
Number of events (p-y)	8 (NR)	70 (3642)	6 (NR)	92 (NR)	NR (NR)	8 (578)	32 (3683)
Breast
IR per 1000 p-y (95% CI)	2 (0, 9)	2 (1, 4)	2 (0, 9)	NR (NR)	NR	1.7 (0, 12)	NR
Number of events (p-y)	2 (NR)	6 (2939)	2 (NR)	NR	NR (NR)	1 (578)	NR (NR)
Lung
IR per 1000 p-y (95% CI)	1 (0, 8)	2 (1, 4)	1.2 (0, 7)	NR (NR)	NR	2 (0, 12)	NR
Number of events (p-y)	1 (NR)	8 (3775)	1 (NR)	NR	NR	1 (578)	NR
Lymphoma
IR per 1000 p-y (95% CI)	1 (0, 8)	1 (0, 2)	0 (0, 5)	0.7 (NR)	NR	0	NR
Number of events (p-y)	1 (NR)	3 (3779)	0 (NR)	5 (NR)	NR (NR)	0 (578)	NR (NR)

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
^aIR is by exposure group with mid-imputed dates of occurrence
^bCalculated IR using first- and second-line abatacept counts from November 2015

ISSN: 1478-6362