Baseline characteristics and disease activity of patient populations
| Baricitinib | |||||
|---|---|---|---|---|---|
| Placebo once daily (N=98) | 1 mg once daily (N=49) | 2 mg once daily (N=52) | 4 mg once daily (N=52) | 8 mg once daily (N=50) | |
| Age, years* | 49±12 | 53±11 | 51±13 | 53±10 | 53±11 |
| Gender, % female | 87 | 86 | 85 | 71 | 82 |
| Duration of RA, years | 5.4±4.3 | 5.5±3.9 | 5.5±4.4 | 5.3±4.5 | 6.6±5.0 |
| Anti-CCP antibody,† % positive | 62 | 76 | 67 | 71 | 74 |
| RF‡,% positive | 65 | 71 | 67 | 77 | 80 |
| Methotrexate dose, mg/week | 16.3±4.3 | 18.2±13.4 | 14.9±4.1 | 16.3±4.8 | 15.7±4.2 |
| Concomitant cDMARDs for RA, % patients | |||||
| Methotrexate | 100 | 100 | 100 | 98 | 100 |
| Hydroxychloroquine | 16 | 22 | 21 | 13 | 14 |
| Sulfasalazine | 14 | 8 | 13 | 17 | 18 |
| Prednisone use, % patients | 52 | 43 | 52 | 38 | 58 |
| Duration of morning joint stiffness, minutes | 101.7±110.7 | 91.4±78.4 | 73.1±42.2 | 103.9±145.1 | 95.8±97.8 |
| Tender joints (68 count) | 22.2±12.1 | 21.4±10.9 | 23.0±12.6 | 19.9±12.7 | 24.4±13.8 |
| Swollen joints (66 count) | 15.8±8.6 | 15.2±6.6 | 17.0±9.3 | 14.8±7.5 | 16.1±7.9 |
| Tender joints (28 count) | 14.1±6.2 | 14.0±5.5 | 14.5±6.4 | 13.1±6.4 | 15.7±6.2 |
| Swollen joints (28 count) | 11.8±5.4 | 11.9±4.6 | 12.1±6.0 | 11.2±4.8 | 11.6±4.6 |
| HAQ-DI§ | 1.2±0.7 | 1.3±0.7 | 1.1±0.7 | 1.0±0.6 | 1.3±0.7 |
| hsCRP, mg/L¶ | 14.0±23.5 | 11.2±12.4 | 12.0±22.1 | 11.4±16.9 | 14.3±15.6 |
| ESR, mm/h | 39.9±20.9 | 38.2±17.6 | 36.5±14.6 | 35.4±17.2 | 43.3±18.2 |
| DAS28-hsCRP | 5.5±0.9 | 5.5±0.8 | 5.4±0.9 | 5.3±1.0 | 5.8±0.8 |
| DAS28-ESR | 6.3±0.8 | 6.3±0.8 | 6.2±0.8 | 6.0±0.9 | 6.6±0.8 |
| CDAI | 37.1±12.3 | 37.7±10.6 | 37.7±12.2 | 35.2±12.2 | 39.7±12.0 |
| SDAI | 38.6±12.5 | 38.8±10.8 | 38.9±12.2 | 36.3±12.2 | 41.1±12.1 |
*Data reported as mean values±SD unless otherwise indicated.
†Anti-CCP antibody positivity (>upper limit of normal (ULN)=5 EU/mL).
‡RF positivity (>ULN=14 IU/mL).
§Scores on the HAQ-DI range from 0 to 3, with higher scores indicating greater disability.
¶hsCRP (ULN=3 mg/L).
Anti-CCP, anticyclic citrullinated peptide; CDAI, clinical disease activity index; cDMARDs, conventional disease-modifying antirheumatic drugs; DAS28-ESR, Disease Activity Score for 28-joint counts based on the ESR; DAS28-hsCRP, Disease Activity Score for 28-joint counts based on the hsCRP level; DMARDs, disease-modifying antirheumatic drugs; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire–Disability Index; hsCRP, high-sensitivity C reactive protein; RA, rheumatoid arthritis; RF, rheumatoid factor; SDAI, simplified disease activity index.