Table 1.
Baseline characteristics and disease activity of patients included in analysis
| Placebo (N = 80) | Baricitinib 2-mg (N = 80) | Baricitinib 4-mg (N = 80) | |
|---|---|---|---|
| Female, % | 81 | 77 | 78 |
| Rescued, % | 28 | 3 | 5 |
| ACR20 at week 12, % | 37 | 74 | 66 |
| ACR50 at week 12, % | 13 | 41 | 35 |
| BMI | 29.63 (7.20) | 29.31 (7.26) | 29.34 (8.47) |
| Disease duration, yearsa | 7.09 (7.98) | 7.74 (7.37) | 8.74 (8.01) |
| DAS28-ESR | 6.16 (0.98) | 6.25 (0.98) | 6.23 (0.85) |
| HAQ-DI | 1.46 (0.63) | 1.43 (0.65) | 1.49 (0.58) |
| Swollen joint count, of 66 | 12.30 (6.15) | 13.67 (9.66) | 13.97 (7.42) |
| Tender joint count, of 68 | 25.05 (16.55) | 23.84 (14.65) | 24.05 (13.89) |
| mTSS | 15.33 (34.24) | 20.05 (30.50) | 26.18 (39.67) |
| Patient pain | 57.80 (22.61) | 59.53 (20.77) | 55.25 (22.69) |
| RF, IU/mL, meanb (CV) | 48.71 (315.05%) | 66.16 (237.16%) | 56.88 (318.90%) |
| ACPA, U/mL, meanb (CV) | 64.28 (4237.03%) | 71.99 (1693.91%) | 69.24 (6787.05%) |
| Biomarkers, meanb (CV) | |||
| C1M | 38.88 (72.15%) | 38.95 (56.62%) | 41.94 (62.12%) |
| C2M | 0.30 (39.21%) | 0.33 (42.14%) | 0.33 (41.55%) |
| C3M | 15.21 (37.42%) | 16.06 (30.55%) | 16.90 (41.19%) |
| C4M | 35.69 (35.05%) | 37.33 (30.12%) | 38.33 (32.00%) |
| CRP | 9.77 (153.11%) | 8.86 (141.93%) | 9.05 (128.21%) |
| CTX-I | 0.30 (68.56%) | 0.31 (71.17%) | 0.30 (72.00%) |
| Osteocalcin | 16.90 (49.05%) | 15.93 (53.32%) | 17.89 (51.33%) |
Data are mean (SD) unless otherwise stated
ACPA anti-citrullinated peptide antibody; ACR20/50 20/50% improvement according to the criteria of the American College of Rheumatology; BMI body mass index; CV coefficient of variation (statistical measure of dispersion of data relative to the mean since these biomarker data follow a lognormal distribution; thus, the standard deviation does not adequately capture the nature of the dispersion of the data; C1M metalloproteinase-derived fragments of type I, of type II (C2M), type III (C3M), and type IV (C4M) collagen; CRP C-reactive protein; CTX-I C-terminal telopeptide of type I collagen; DAS28 Disease Activity Score 28 joints; ESR erythrocyte sedimentation rate; HAQ-DI Health Assessment Questionnaire-Disability Index; mTSS modified Total Sharp Score; RF rheumatoid factor; SD standard deviation
aTime from RA diagnosis
bMean for ACPA, RF, and biomarkers was calculated as the geometric mean