Table 2

Summary of safety at year 2

Double-blind period* (year 1)Open-label period (year 2)
Abatacept plus methotrexate (N=256)Methotrexate (N=253)Abatacept plus methotrexate (N=459)
AE (n (%))217 (84.8)211 (83.4)345 (75.2)
 Discontinuations due to AE8 (3.1)11 (4.3)11 (2.4)
 Infections132 (51.6)139 (54.9)218 (47.5)
 Malignancies1 (0.4)0 (0.0)0 (0.0)
 Autoimmune events§6 (2.3)5 (2.0)6 (1.3)
Serious AE (n (%))20 (7.8)20 (7.9)29 (6.3)
 Discontinuations due to serious AE3 (1.2)3 (1.2)4 (0.9)
 Serious infections5 (2.0)5 (2.0)8 (1.7)
 Malignancies1 (0.4)0 (0.0)0 (0.0)
Deaths** (n (%))2 (0.8)4 (1.6)2 (0.4)
  • * 509 Patients were randomly assigned to receive either abatacept plus methotrexate or methotrexate during the double-blind period.

  • 459 Patients completed the 1-year trial and received at least one dose of abatacept plus methotrexate during the year 2 open-label period.

  • In year 2, most frequently reported adverse events (AE) (≥5% of patients) were upper respiratory tract infection (9.4%), nasopharyngitis (8.7%), flu (7.4%), urinary tract infection (5.7%) and hypertension (5.0%).

  • § Original abatacept plus methotrexate group (n): moderate psoriasis (1), Sjögren's syndrome (2), mild atrophic gastritis (1); original methotrexate-alone group: mild psoriasis (1), vasculitis (1).

  • Serious infections (n): pneumonia (3); appendiceal abscess (1), folliculitis (1), lobar pneumonia (1), septic shock (1), subcutaneous abscess (1) and urinary tract infection (1).

  • ** Original abatacept plus methotrexate group (one due to pneumonia); original methotrexate alone group (one due to pneumonia with septic shock).