Table 4

Incidence of malignancies in the abatacept clinical trial experience

Placebo DB*†Abatacept DB*†Abatacept 5 core RA RCT† (DB+OL)‡Abatacept cumulative§ (DB+OL)‡
No of patients989195526894134
No of person-years of follow-up794168872828388
Total malignancies (excluding NMSC)5104651
0.63 (0.26 to 1.5)0.59 (0.32 to 1.1)0.63 (0.46 to 0.84)0.61 (0.45 to 0.80)
Breast cancer2157
0.25 (0.06 to 1.01)0.06 (0.01 to 0.43)0.07 (0.02 to 0.16)0.08 (0.03 to 0.17)
Colorectal cancer0022
0.03 (0.00 to 0.10)0.02 (0.00 to 0.09)
Lung cancer041313
0.24 (0.09 to 0.64)0.18 (0.10 to 0.31)0.15 (0.08 to 0.27)
Lymphoma0145
0.06 (0.01 to 0.43)0.05 (0.01 to 0.14)0.06 (0.02 to 0.14)
  • Unless otherwise indicated, values represent number of cancer cases and incidence rates per 100 person-years (95% CI). *DB, double blind; randomisation 2 : 1 abatacept to placebo. †Includes the five core rheumatoid arthritis (RA) studies: ATTAIN, ASSURE, AIM and two phase II studies. ‡OL, open label, December 2006 data lock. §Includes the five core RA studies and the ATTEST and ARRIVE studies.

  • NMSC, non-melanoma skin cancer; RCT, randomised controlled trial.