Extended report Figure 2 Disease Activity Score 28 (DAS28) based on erythrocyte sedimentation rates (ESR). A. DAS28 (ESR) mean changes from baseline at days 197 and 365. Error bars represent standard error of the mean. B. European League Against Rheumatism (EULAR) good responses, low DAS (LDAS; DAS28 (3.2) and DAS28 (ESR)-defined remission at day 197 and at day 365. Data are presented for the intent-to-treat population with a last-observation carried forward analysis for mean changes in DAS28 (ESR), LDAS and DAS28 (ESR)-defined remission. Good EULAR responses were presented for the intent-to-treat population with patients who discontinued the study prematurely considered as non-responders subsequent to the time of discontinuation. Error bars show standard error of the mean. *Adjustment based on covariance with treatment as factor and baseline as covariant. 1100 Figure 3 American College of Rheumatology (ACR) responses over 1 year. Proportion of patients with ACR 20, 50 and 70 responses was assessed on each visit day. Data are presented for the intent-to-treat population with a last-observation carried forward analysis. *Infliximab was administered on days 1, 15, 43, 85 and then every 56 days thereafter. Abatacept dosing occured at each visit day presentation following the assesment of efficacy. improvement in physical function (HAQ-DI responses: 61.5 vs 40.9%, respectively, p = 0.001). Similarly, significantly more patients in the infliximab group vs the placebo group achieved a HAQ-DI response (58.8 vs 40.9%, p = 0.005). At day 365, HAQ- DI responses were maintained in the abatacept and infliximab groups (57.7 and 52.7%, respectively, estimate of difference (95% CI) = 5.0 (–6.5, 16.5)). Health-related quality of life Patients in the abatacept group experienced statistically significantly greater improvements from baseline in the PCS (p,0.001) and MCS (p = 0.004) of the SF-36, and in each of the eight individual subscales compared with placebo, following 6 months of treatment (fig 4A). Patients in the infliximab group also experienced significantly greater improvements from base- line in the PCS (p = 0.002) and MCS (p = 0.027), and all eight subscales of the SF-36 at day 197 compared with patients in the placebo group. At day 365, greater improvements from baseline in the PCS were observed with abatacept vs infliximab (difference of 1.93, 95% CI = 0.02, 3.84). Improvements in the MCS (difference of 1.92, 95% CI = –0.30, 4.15) and in all eight subscales were also numerically higher with abatacept vs infliximab (fig 4B). Safety A summary of safety for all patients who received at least one dose of study medication is presented in table 2 (excluding the original placebo group between days 197–365). Summary of safety for days 1–197 During days 1–197, AEs were reported by a similar proportion of patients in the abatacept (82.7%), placebo (83.6%) and infliximab (84.8%) groups. Two deaths were reported: one patient in the abatacept group due to a cerebrovascular accident, and one patient in the infliximab group due to fibrosarcoma. Overall, the frequency of AEs, related AEs and discontinuations due to AEs or SAEs was similar for the abatacept and placebo Ann Rheum Dis 2008;67:1096–1103. doi:10.1136/ard.2007.080002