Characteristic Mean (SD) age, years Female, n (%) Caucasian, n (%) Mean (SD) disease duration, years Median (min, max) methotrexate dose, mg/week Previous DMARD, n (%) 1–2 3–4 >4 Patients receiving oral corticosteroid, n (%) Median (min, max) oral corticosteroid dose, mg/day* RF positive, n (%) Median (min, max) CRP, mg/l Mean (SD) ESR, mm/h Mean (SD) total RF, IU/ml† Mean (SD) SJC (66 joints) Mean (SD) TJC (68 joints) Mean (SD) DAS28–CRP Mean (SD) DAS28–ESR Mean (SD) HAQ–DI Mean (SD) FACIT–F 51.7 (11.24) 106 (82.2) 122 (94.6) 7.93 (7.230) 15.0 (7.5, 25) 87 (67.4) 36 (27.9) 6 (4.7) 75 (58.1) 6.4 (1.6, 15.0) 108 (83.7) 8.3 (0, 98) 47.1 (25.38) 326.5 (593.60) 16.2 (7.41) 28.7 (13.36) 5.83 (0.794) 6.59 (0.828) 1.7 (0.67) 25.2 (10.00) 53.6 (11.50) 108 (82.4) 129 (98.5) 9.07 (8.987) 15.0 (7.5, 25) 88 (67.2) 32 (24.4) 11 (8.4) 84 (64.1) 5.0 (1.6, 12.8) 111 (84.7) 8.3 (0, 68) 44.4 (23.69) 250.4 (492.71) 15.7 (6.88) 26.6 (12.59) 5.63 (0.800) 6.41 (0.782) 1.5 (0.65) 29.5 (9.54) Extended report RF status, the ACR20 response in ofatumumab and placebo groups, respectively, was 50% (54/108) versus 26% (29/111) for seropositive patients and 48% (10/21) versus 30% (6/20) for seronegative patients. When examined by anti-CCP status, Table 1 Demographics and baseline disease characteristics Ofatumumab 700 mg (n=129) Placebo (n=131) *Prednisolone equivalent dose. †At screening. CRP, C-reactive protein; DAS28, disease activity score based on 28 joints; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; FACIT–F, functional assessment of chronic illness therapy–fatigue; HAQ–DI, health assessment questionnaire disability index; RF, rheumatoid factor; SJC, swollen joint count; TJC, tender joint count. from the study were imputed as non-responders. For continuous endpoints, data were imputed by carrying forward the last value recorded before taking disallowed medication or withdrawal (last observation carried forward). The intent-to-treat (ITT) pop- ulation comprised all randomly assigned patients who received at least one infusion of the study drug. The safety population was identical to the ITT population except that patients were analysed according to their actual treatment in case this differed from their randomised treatment. RESULTS Disposition of patients and baseline characteristics A total of 344 patients was screened and 265 were enrolled and randomly assigned; the reasons for screening failure are shown in ﬁgure 1. Of the 265 randomly assigned patients, 260 (98%) were exposed to investigational product and were included in the safety and ITT populations (ﬁgure 1). One patient was ran- domly assigned to placebo but received ofatumumab and was included in the placebo group for the ITT population (based on randomised treatment) and in the ofatumumab group for the safety population (based on actual treatment received). Demographics and baseline RA characteristics were balanced between the two groups (table 1). Most patients were women (82%) and RF positive (84%), with a mean age of 53 years. At baseline, mean RA duration was 8.5 years, mean DAS28–CRP was 5.7 and mean DAS28–ESR was 6.5 (table 1). Clinical response At week 24, a greater proportion of patients administered ofatumumab 700 mg achieved the primary endpoint of ACR20 compared with placebo (50% and 27%, respectively, p<0.001). In addition, signiﬁcantly greater improvements in ACR50 and ACR70 were observed with ofatumumab ver- sus placebo (ACR50 27% and 11%, p<0.001; ACR70 13% and 2%, p=0.001) (table 2 and ﬁgure 2). When examined by Figure 1 Disposition of patients up to week 24. *Patients could have more than one reason for screening failure. †One patient was randomly assigned to placebo but received ofatumumab. This patient is included in the placebo group for the intent-to-treat population, but in the ofatumumab group for the safety population. Ann Rheum Dis 2011;70:2119–2125. doi:10.1136/ard.2011.151522 2121