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 CDAI
| RA-BEAM | RA-BEGIN | |||||||||||
| CDAI ≤10 | CDAI >10 | CDAI ≤10 | CDAI >10 | |||||||||
| PBO (n=61) | Bari 4 mg (n=171) | ADA (n=98) | PBO (n=257) | Bari 4 mg (n=236) | ADA (n=164) | MTX (n=53) | Bari 4 mg (n=72) | Bari 4 mg ± MTX (n=104) | MTX (n=81) | Bari 4 mg (n=53) | Bari 4 mg ± MTX (n=62) | |
| Age, years | 54.6±12.4 | 53.0±11.9 | 52.1±11.8 | 52.5±11.5 | 52.7±12.3 | 53.2±12.2 | 50.9±13.7 | 50.3±13.0 | 45.9±13.4 | 49.7±13.2 | 51.3±13.0 | 51.0±13.0 |
| Female, n (%) | 49 (80.3) | 134 (78.4) | 73 (74.5) | 202 (78.6) | 179 (75.8) | 125 (76.2) | 37 (69.8) | 55 (76.4) | 73 (70.2) | 58 (71.6) | 42 (79.2) | 49 (79.0) |
| BMI, kg/m2 | 28.0±6.2 | 26.3±5.6 | 26.1±5.2 | 26.8±6.6 | 27.2±6.2 | 26.6±5.4 | 27.1±6.3 | 27.7±6.6 | 25.8±5.3 | 26.5±6.6 | 25.3±6.3 | 26.8±6.7 |
| Smoker, yes, n (%) | 8 (13.1) | 39 (22.8) | 18 (18.4) | 58 (22.6) | 53 (22.5) | 38 (23.2) | 8 (15.1) | 18 (25.0) | 20 (19.2) | 16 (19.8) | 11 (20.8) | 15 (24.2) |
| Duration of RA from diagnosis, years | 8.8±7.3 | 9.0±8.4 | 7.8±7.4 | 8.9±7.8 | 8.3±8.6 | 8.5±8.2 | 0.5±1.0 | 1.5±3.3 | 1.1±2.2 | 1.4±4.0 | 2.0±4.4 | 1.8±3.7 |
| hsCRP, mg/L | 13.7±14.5 | 18.9±19.4 | 18.6±16.7 | 17.9±17.2 | 25.0±24.6 | 22.0±20.0 | 17.2±14.6 | 19.8±16.3 | 26.6±28.7 | 25.2±22.6 | 24.2±23.5 | 22.0±28.1 |
| CDAI | 28.5±10.6 | 33.2±10.6 | 32.4±13.3 | 38.8±12.4 | 41.0±11.4 | 40.3±11.9 | 38.6±13.7 | 35.3±13.1 | 37.9±12.1 | 39.7±12.6 | 42.3±11.3 | 42.9±13.5 |
| HAQ-DI | 1.2±0.7 | 1.4±0.7 | 1.3±0.7 | 1.6±0.6 | 1.7±0.7 | 1.7±0.6 | 1.6±0.7 | 1.5±0.8 | 1.6±0.7 | 1.7±0.7 | 1.7±0.6 | 1.7±0.7 |
| RF-positive*, n (%) | 55 (90.2) | 157 (91.8) | 90 (91.8) | 238 (92.6) | 211 (89.4) | 150 (91.5) | 50 (94.3) | 72 (100) | 100 (96.2) | 79 (97.5) | 52 (98.1) | 57 (91.9) |
| ACPA-positive†, n (%) | 53 (86.9) | 150 (87.7) | 89 (90.8) | 221 (86.0) | 212 (89.8) | 145 (88.4) | 47 (88.7) | 68 (94.4) | 98 (94.2) | 77 (95.1) | 46 (86.8) | 53 (85.5) |
| Pain assessment | 47.6±23.2 | 58.3±21.7 | 55.2±24.5 | 60.6±21.1 | 63.6±21.9 | 62.5±21.8 | 62.4±24.4 | 59.4±24.2 | 61.2±22.4 | 65.5±25.1 | 64.1±19.3 | 68.0±21.2 |
| mTSS | 34.3±41.5 | 35.9±42.7 | 34.7±42.0 | 44.7±50.6 | 47.1±55.4 | 50.2±56.4 | 8.4±21.4 | 7.4±12.8 | 8.6±16.2 | 13.1±17.6 | 17.0±34.6 | 17.6±26.4 |
Data are mean±SD or n (%).
Averaged CDAI responses 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; CDAI, Clinical Disease Activity 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.