Baseline characteristics and disease activity at Week 0, Week 24, and Week 76. Data are reported as mean values ± SD unless otherwise indicated.
| Characteristics | Week 0 All Groups, n = 301 | Week 24 All Groups, n = 201 | Week 76 All Groups, n = 144 |
|---|---|---|---|
| Age, yrs | 51 ± 12 | 51 ± 12 | 53 ± 11 |
| Female, % | 83 | 83 | 83 |
| Duration of RA, yrs | 5.6 ± 4.4 | 5.9 ± 4.5 | 5.9 ± 4.4 |
| ACPA-positivea, % | 69 | 67 | 69 |
| RF-positiveb, % | 71 | 70 | 74 |
| Prednisone use, % | 49 | 51 | 46 |
| Background DMARD use | |||
| MTX monotherapy, % | 69 | 79 | 75 |
| MTX + other DMARD, % | 29 | 20 | 24 |
| Tender joints, of 68 | 22 ± 12 | 7 ± 9 | 6 ± 8 |
| Swollen joints, of 66 | 16 ± 8 | 5 ± 6 | 4 ± 4 |
| HAQ-DIc | 1.16 ± 0.67 | 0.78 ± 0.64 | 0.74 ± 0.63 |
| High-sensitivity CRPd, mg/l | 13 ± 19 | 6 ± 12 | 5 ± 12 |
| ESR, mm/h | 39 ± 18 | 27 ± 19 | 26 ± 18 |
| DAS28-CRP | 5.5 ± 0.9 | 3.3 ± 1.2 | 2.9 ± 1.2 |
| DAS28-ESR | 6.3 ± 0.8 | 4.0 ± 1.3 | 3.6 ± 1.3 |
| CDAI | 37 ± 12 | 14 ± 11 | 11 ± 9 |
| SDAI | 39 ± 12 | 15 ± 11 | 11 ± 9 |
↵a ACPA positivity (ULN = 5 U/ml).
↵b RF positivity (ULN = 14 IU/ml).
↵c Scores on the HAQ-DI range from 0 to 3, with higher scores indicating greater disability.
↵d High-sensitivity C-reactive protein (ULN = 3 mg/l). ACPA: anticyclic citrullinated peptide antibody; CDAI: Clinical Disease Activity Index; CRP: C-reactive protein; DAS28-CRP: Disease Activity Score for 28 joints based on the CRP level; DAS28-ESR: DAS for 28 joints based on the erythrocyte sedimentation rate; DMARD: disease-modifying antirheumatic drugs; HAQ-DI: Health Assessment Questionnaire–Disability Index; MTX: methotrexate; RA: rheumatoid arthritis; RF: rheumatoid factor; SDAI: Simplified Disease Activity Index; ULN: upper limit of normal.