Table 2 Summary of safety for all patients who entered the long-term extension and received at least one dose of abatacept
Double-blind period (days 1–169)Abatacept + DMARDs (n = 258)*Cumulative period (days 1–729)Abatacept + DMARDs (n = 357)†
Patients with AEs, n (%)205 (79.5)329 (92.2)
AEs/100 patient-years436.5308.7
Discontinuations due to AEs, n (%)10 (3.9)25 (7.0)
Patients with SAEs, n (%)28 (10.9)103 (28.9)
SAEs/100 patient-years25.623.4
Discontinuations due to SAEs, n (%)8 (3.1)18 (5.0)
Patients with infections‡, n (%)97 (37.6)234 (65.5)
Infections‡/100 patient-years108.889.4
Patients with serious infections‡, n (%)6 (2.3)25 (7.0)
Serious infections‡/100 patient-years5.35.0
Deaths, n (%)1 (0.4)2 (0.6)
  • *All patients who received at least one dose of study medication during the double-blind period.

  • †All patients who were randomised to abatacept and received one dose of study medication, plus all patients who were randomised to placebo and entered the long-term extension (and subsequently received one dose of study medication).

  • ‡All infections classified as under the system organ class of infections and infestations.

  • DMARD, disease-modifying anti-rheumatic drug; AE, adverse event; SAE, serious adverse event.