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 patients | 989 | 1955 | 2689 | 4134 |
| No of person-years of follow-up | 794 | 1688 | 7282 | 8388 |
| Total malignancies (excluding NMSC) | 5 | 10 | 46 | 51 |
| 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 cancer | 2 | 1 | 5 | 7 |
| 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 cancer | 0 | 0 | 2 | 2 |
| 0.03 (0.00 to 0.10) | 0.02 (0.00 to 0.09) | |||
| Lung cancer | 0 | 4 | 13 | 13 |
| 0.24 (0.09 to 0.64) | 0.18 (0.10 to 0.31) | 0.15 (0.08 to 0.27) | ||
| Lymphoma | 0 | 1 | 4 | 5 |
| 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.