Demographics and baseline disease characteristics (full analysis set)
| GP2013 | RTX-EU | RTX-US | |
| n=133 | n=87 | n=92 | |
| Age (years) | 54.4±11.8 | 52.7±12.5 | 55.0±10.8 |
| Age groups | |||
| 18–44 (%) | 25 (18.8) | 21 (24.1) | 17 (18.5) |
| 45–64 (%) | 80 (60.2) | 50 (57.5) | 53 (57.6) |
| 65 or more (%) | 28 (21.1) | 16 (18.4) | 22 (23.9) |
| Sex, no (%) of patients | |||
| Female (%) | 111 (83.5) | 73 (83.9) | 78 (84.8) |
| Male (%) | 22 (16.5) | 14 (16.1) | 14 (15.2) |
| Weight (kg) | 73.2±17.0 | 72.5±17.2 | 79.5±16.5 |
| BMI (kg/m2) | 27.4±6.2 | 27.3±6.0 | 29.7±6.6 |
| Duration of RA (years) | 10.5±8.1 | 10.8±7.1 | 11.0±8.3 |
| Prior csDMARDs | 2.3±1.7 | 2.1±1.1 | 1.9±1.2 |
| Number of prior TNFi therapies (%) | |||
| 1 (%) | 109 (82.0) | 70 (80.5) | 73 (79.3) |
| 2 (%) | 18 (13.5) | 16 (18.4) | 13 (14.1) |
| >2 (%) | 6 (4.5) | 1 (1.1) | 6 (6.5) |
| Dose of MTX (mg/week) | 15.1±4.9 | 14.7±5.2 | 15.2±5.0 |
| Prednisolone (mg/day) | 6.5±2.7 | 6.7±2.6 | 6.5±3.1 |
| CRP (mg/L) | 17.9±19.9 | 19.5±20.9 | 22.3±29.5 |
| Erythrocyte sedimentation rate (mm/hour) | 48.3±19.1 | 46.4±18.4 | 50.0±22.2 |
| B cell count (CD19+ cells/µL)* | 243±148 | 275±148 | 224±126 |
| Serum IgG (g/L) | 12.4±2.9 | 12.7±3.0 | 11.6±3.3 |
| Serum IgM (g/L) | 1.6±0.9 | 1.6±0.9 | 1.5±0.9 |
| Serum IgA (g/L) | 3.2±2.0 | 3.6±1.5 | 3.0±1.3 |
| DAS28 (CRP) | 5.8±0.9 | 5.9±0.9 | 5.9±1.0 |
| DAS28 (ESR) | 6.7±0.9 | 6.6±0.9 | 6.7±0.9 |
| Anti-CCP antibodies (ACPA) positive (%) | 120 (90.2) | 75 (86.2) | 86 (93.5) |
| RF positive (%) | 126 (94.7) | 81 (93.1) | 86 (93.5) |
| Positive RF and/or anti-CCP (%) | 131 (98.5) | 85 (97.7) | 90 (97.8) |
| Swollen joint count (SD) | 16.0±9.1 | 14.8±9.2 | 15.0±8.1 |
| Tender joint count (SD) | 23.9±13.3 | 22.1±12.5 | 23.5±14.3 |
| HAQ Disability Index | 1.9±0.5 | 1.8±0.6 | 1.9±0.6 |
*In the PK set. Except where indicated otherwise, values in the table represent the mean±SD.
BMI, body mass index; CCP, cyclic citrullinated peptide; CRP, C reactive protein; csDMARDs, conventional synthetic disease modifying antirheumatic drugs; DAS28, Disease Activity Score in 28 joints; ESR, erythrocyte sedimentation rate; HAQ, Health Assessment Questionnaire; MTX, methotrexate; RA, rheumatoid arthritis; RF, rheumatoid factor; RTX, rituximab; TNFi, tumour necrosis factor inhibitor.