Table 1

Description of the abatacept clinical trials included in the current analysis

Study name	Study design	Malignancy screening and exclusions	Duration of double-blind period (months)	Abatacept	Placebo	Open-label extension
Study name	Study title	Malignancy screening and exclusions	Duration of double-blind period (months)	Abatacept	Placebo	Open-label extension
IM101100 Phase IIB	Randomised, dose-ranging, placebo-controlled, double-blind	Mammography requiring further investigation. Complete evaluation before dosing; history of cancer within the past 5 years; excluding NMSC cured by local resection	12	220	119	219
IM101101 Phase IIB	Randomised, placebo-controlled, double blind	Mammography requiring further investigation. Complete evaluation before dosing; history of cancer within the past 5 years; excluding NMSC cured by local resection	12	85	36	80
AIM IM101102 Phase III	Randomised, placebo controlled, double-blind; Abatacept in inadequate responders to methotrexate	Subjects with a mammogram that is suspicious for malignancy; history of cancer within the past 5 years; excluding NMSC cured by local resection	12	433	219	539
ASSURE IM101031 Phase III	Randomised, placebo-controlled, double-blind; Abatacept Study of Safety in Use with other RA thErapies	Subjects with a mammogram that is suspicious for malignancy; history of cancer within the past 5 years; excluding NMSC cured by local resection	12	959	482	1184
ATTAIN IM101029 Phase III	Randomised, placebo-controlled, double-blind; Abatacept Trial in Treatment of Anti-TNF INadequate responders	Subjects with a mammogram that is suspicious for malignancy; history of cancer within the past 5 years; excluding NMSC cured by local resection	6	258	133	317
	Total double-blind 5 core above			1955	989	2689†
ATTEST IM101043	Abatacept or infliximab versus placebo, a Trial for Tolerability, Efficacy and Safety in Treating RA	History of cancer within the past 5 years; excluding NMSC cured by local resection	12	156	110	236* (132 abatacept, 104 placebo, 136 infliximab)
ARRIVE IM101064	Abatacept Researched in Rheumatoid arthritis patients with an Inadequate anti-TNF response to Validate Effectiveness	History of cancer within the past 5 years; excluding NMSC cured by local resection	6 (open-label)	1046		530

*IM101043, without infliximab arm; †Number represents total number of abatacept exposed patients exposed during both double-blind and open-label; five core trials N = 2689; overall N = 4134.
NMSC, non-melanoma skin cancer; RA, rheumatoid arthritis; TNF, tumour necrosis factor.