Table 1.

Summary of AE reported in the 5-year study period.

AEDB 24-week Period SC ABA + MTX, n = 744DB 24-week Period IV ABA + MTX, n = 731LTE 174-week Period SC ABA + MTX, n = 1372LTE 5-year Period SC ABA + MTX, n = 1373
n (%)IR (95% CI)n (%)IR (95% CI)n (%)IR (95% CI)n (%)IR (95% CI)
All AE503 (67.6)279.35 (255.46–304.86)478 (65.4)265.67 (242.38–290.59)1147 (83.6)107.73 (101.59–114.15)1240 (90.3)96.54 (91.25–102.07)
SAE31 (4.2)9.02 (6.31–12.90)36 (4.9)11.14 (8.04–15.44)238 (17.3)8.76 (7.71–9.95)353 (25.7)7.73 (6.96–8.58)
Death1 (0.1)0.29 (0.01–1.64)5 (0.7)1.51 (0.49–3.53)21 (1.5)0.71 (0.44–1.09)41 (3.0)0.75 (0.53–1.03)
AE leading to discontinuation16 (2.2)4.75 (2.72–7.72)25 (3.4)7.62 (4.93–11.26)56 (4.1)1.90 (1.43–2.47)97 (7.1)1.87 (1.52–2.28)
  • Includes data through 56 days after the last dose date of the LTE period. Includes all deaths reported during the LTE period including those that occurred > 56 days after the last dose date, regardless of timing of death. AE: adverse event; DB: double-blind; ABA: abatacept; IR: incidence rate (events per 100 patient-yrs); IV: intravenous; LTE: longterm extension; MTX: methotrexate; SAE: serious AE; SC: subcutaneous.