Figure 4 Health-related quality of life. A. Mean change in physical and mental component summary (PCS and MCS, respectively) scores and the individual subscales of the Short Form-36 (SF-36) from day 1 to day 197. B. Mean change in PCS and MCS scores and the individual subscales of the SF-36 from day 1 to day 365; Data are presented for the intent-to-to treat population with a last observation carried forward analysis. groups. Between days 1–197, SAEs were lower with abatacept vs placebo (5.1 vs 11.8%), the difference was largely attributed to a higher frequency of gastrointestinal disorders, bacterial Table 2 Summary of safety to day 197 and day 365 Extended report infections and musculoskeletal disorders in the placebo group. For the infliximab vs placebo groups during the same period, the frequency of AEs (84.8 vs 83.6%), related AEs (44.8 vs 41.8%) and SAEs (11.5 vs 11.8%) were similar; however, a higher proportion of patients in the infliximab group compared with the placebo group reported related SAEs (4.8 vs 2.7%), discontinued due to AEs (4.8 vs 0.9%), and discontinued due to SAEs (2.4 vs 0%). The higher frequency of SAEs in the infliximab vs placebo groups was largely due to an increase in serious infections (4.2 vs 2.7%, respectively). The most frequently reported AEs were primarily infections and infestations, and most were of mild to moderate intensity. Acute infusional AEs (within 3 h of the start of dosing) were reported in 5.1, 10.0 and 18.2% of the abatacept, placebo and infliximab groups, respectively (table 3). Infections and infesta- tions were reported in 48.1, 51.8 and 52.1% of the abatacept, placebo and infliximab groups, respectively. Serious infections were lower in the abatacept group (1.3%) than in the placebo (2.7%) and infliximab (4.2%) groups at day 197 (table 4), with patients originating from Latin America (abatacept, 8.3%; placebo, 16.7%; infliximab, 25.0%) and Europe (abatacept, 8.3%; placebo, 8.3%; infliximab, 33.3%). Between days 1–197, two opportunistic infections occurred (a pseudo- monal lung infection and a Pneumocysitis jiroveci pneumonia) in the infliximab group. Autoimmune symptoms or disorders were uncommon (,1%), occurring at a similar frequency across groups (table 2). Malignancies were reported for four patients, including one abatacept-treated patient (bladder cancer), one placebo-treated patient (non-melanomatous skin cancer) and two infliximab- treated patients (malignant anorectal neoplasm and fibrosar- coma in one patient for each). Summary of safety for days 1–365 for abatacept and infliximab groups During the entire 12-month, double-blind period (days 1–365), SAEs, related SAEs, and discontinuations due to SAEs were lower with abatacept than infliximab (SAEs: 9.6 vs 18.2%; related SAEs: 3.2 vs 8.5%; and discontinuations due to SAEs: 2.6 vs 3.6%, respectively (table 2)). Overall, AEs, related AEs and discontinuations due to AEs were also lower with abatacept than with infliximab (AEs: 89.1 vs 93.3%; related AEs: 46.2 vs 58.2%: and discontinuations due to AEs: 3.2 vs 7.3%, respectively). An additional infliximab-treated patient with Deaths SAEs Related SAEs Discontinuations due to SAEs AEs Related AEs Discontinuations due to AEs Serious infections Autoimmune symptoms and disorders Malignant neoplasms Days 1–197 Abatacept + MTX (n = 156) n (%)* 1 (0.6) 8 (5.1) 3 (1.9) 2 (1.3) 129 (82.7) 64 (41.0) 3 (1.9) 2 (1.3) 1 (0.6) 1 (0.6) Placebo + MTX (n = 110) Infliximab + MTX (n = 165) n (%)* 0 13 (11.8) 3 (2.7) 0 92 (83.6) 46 (41.8) 1 (0.9) 3 (2.7) 1 (0.9) 1 (0.9) n (%)* 1 (0.6) 19 (11.5) 8 (4.8) 4 (2.4) 140 (84.8) 74 (44.8) 8 (4.8) 7 (4.2) 1 (0.6) 2 (1.2) Days 1–365 Abatacept + MTX (n = 156) n (%)* 1 (0.6) 15 (9.6) 5 (3.2) 4 (2.6) 139 (89.1) 72 (46.2) 5 (3.2) 3 (1.9) 2 (1.3) 1 (0.6) Infliximab + MTX (n = 165) n (%)* 2 (1.2) 30 (18.2) 14 (8.5) 6 (3.6) 154 (93.3) 96 (58.2) 12 (7.3) 14 (8.5) 1 (0.6) 2 (1.2) *More than one AE or SAE could be reported in each patient; percentages represent the proportion of patients who reported >1 event. AE, adverse event; MTX, methotrexate; SAE, serious adverse event. Ann Rheum Dis 2008;67:1096–1103. doi:10.1136/ard.2007.080002 1101