Demographic and baseline characteristics of patients in RA-BEAM (MTX-IR patients with established RA) and RA-BEGIN (csDMARD-naïve patients with early RA) stratified by averaged hsCRP
| RA-BEAM | RA-BEGIN | |||||||||||
| hsCRP ≤5 mg/L | hsCRP >5 mg/L | hsCRP ≤5 mg/L | hsCRP >5 mg/L | |||||||||
| PBO (n=63) | Bari 4 mg (n=262) | ADA (n=158) | PBO (n=257) | Bari 4 mg (n=149) | ADA (n=107) | MTX (n=56) | Bari 4 mg (n=73) | Bari 4 mg ± MTX (n=120) | MTX (n=81) | Bari 4 mg (n=54) | Bari 4 mg ± MTX (n=47) | |
| Age, years | 52.9±10.6 | 53.2±12.2 | 52.3±12.6 | 52.9±12.0 | 52.2±12.2 | 53.2±11.1 | 49.8±12.5 | 51.4±12.5 | 47.7±14.4 | 50.7±14.0 | 47.7±11.4 | 49.5±13.3 |
| Female, n (%) | 50 (79.4) | 202 (77.1) | 121 (76.6) | 202 (78.6) | 113 (75.8) | 78 (72.9) | 41 (73.2) | 53 (72.6) | 89 (74.2) | 55 (67.9) | 44 (81.5) | 34 (72.3) |
| BMI, kg/m2 | 26.2±5.1 | 25.6±5.2 | 25.3±4.5 | 27.3±6.8 | 29.0±6.5 | 28.1±5.9 | 24.9±4.4 | 26.0±5.9 | 25.1±5.6 | 28.1±7.3 | 27.5±7.2 | 29.0±5.6 |
| Smoker, yes, n (%) | 13 (20.6) | 56 (21.4) | 28 (17.7) | 54 (21.0) | 36 (24.2) | 30 (28.0) | 6 (10.7) | 15 (20.5) | 30 (25.0) | 20 (24.7) | 16 (29.6) | 6 (12.8) |
| Duration of RA from diagnosis, years | 7.6±7.0 | 8.4±8.1 | 6.9±6.6 | 9.2±7.8 | 8.9±9.3 | 10.0±9.3 | 0.8±1.9 | 2.0±4.4 | 1.0±2.1 | 1.2±3.8 | 1.2±2.6 | 2.3±4.1 |
| hsCRP, mg/L | 6.3±5.9 | 17.9±18.6 | 17.0±16.2 | 20.1±18.3 | 30.1±26.8 | 26.5±21.8 | 14.8±13.9 | 19.2±17.9 | 17.5±18.6 | 27.0±22.0 | 24.6±21.4 | 43.3±39.1 |
| HAQ-DI | 1.4±0.7 | 1.4±0.7 | 1.5±0.7 | 1.5±0.7 | 1.8±0.7 | 1.7±0.7 | 1.5±0.7 | 1.6±0.8 | 1.5±0.7 | 1.7±0.7 | 1.6±0.7 | 1.9±0.7 |
| RF-positive*, n (%) | 57 (90.5) | 238 (90.8) | 144 (91.1) | 238 (92.6) | 134 (89.9) | 99 (92.5) | 56 (100) | 73 (100) | 113 (94.2) | 76 (93.8) | 53 (98.1) | 45 (95.7) |
| ACPA-positive†, n (%) | 53 (84.1) | 233 (88.9) | 141 (89.2) | 223 (86.8) | 133 (89.3) | 96 (89.7) | 53 (94.6) | 67 (91.8) | 110 (91.7) | 74 (91.4) | 49 (90.7) | 42 (89.4) |
| Pain assessment | 55.2±22.1 | 60.0±21.7 | 57.7±22.1 | 58.8±22.1 | 63.6±22.2 | 62.9±24.3 | 60.4±25.0 | 62.0±23.3 | 61.4±23.9 | 67.1±24.2 | 60.9±20.7 | 69.5±15.3 |
| mTSS | 34.4±43.2 | 43.4±50.1 | 41.4±47.5 | 44.7±50.2 | 40.5±51.6 | 49.5±58.5 | 11.4±24.5 | 10.3±20.1 | 11.4±20.7 | 11.0±14.2 | 12.9±29.9 | 13.2±21.8 |
Data are mean±SD or n (%).
Averaged hsCRP in RA-BEAM calculated as the mean of postbaseline measurements at weeks 4, 12, 16, 20 and 24 and in RA-BEGIN as the mean of postbaseline measurements at weeks 4, 12, 16, 20, 24, 32, 40 and 52.
*RF-positive >14 units/mL (ULN).
†ACPA-positive >10 units/mL (ULN).
ACPA, anticyclic citrullinated peptide antibody; ADA, adalimumab; Bari, baricitinib; BMI, body mass index; csDMARDs, conventional synthetic disease-modifying antirheumatic drugs; HAQ-DI, Health Assessment Questionnaire-Disability Index; hsCRP, high-sensitivity C reactive protein; mITT, modified intent-to-treat; mTSS, modified Total Sharp Score; MTX-IR, inadequate response to methotrexate; n, number of mITT completers; PBO, placebo; RA, rheumatoid arthritis; RF, rheumatoid factor; ULN, upper limit of normal.