Table 1.
Baseline patient demographics and disease characteristics for Period I
| FKB327 n = 366* |
RP n = 362 |
Total N = 728† |
|
|---|---|---|---|
| Mean age (SD), years | 53.0 (12.0) | 53.6 (12.3) | 53.3 (12.2) |
| Gender, n (%) | |||
| Male | 85 (23.2) | 78 (21.5) | 163 (22.4) |
| Female | 281 (76.8) | 284 (78.5) | 565 (77.6) |
| Race, n (%) | |||
| White | 311 (85.0) | 308 (85.1) | 619 (85.0) |
| Black or African-American | 2 (0.5) | 4 (1.1) | 6 (0.8) |
| Other‡ | 53 (14.5) | 50 (13.8) | 103 (14.1) |
| Mean disease duration (SD), years | 8.6 (8.3) | 8.3 (7.6) | 8.5 (8.0) |
| Rheumatoid factor status, n (%) | |||
| Positive | 277 (75.7) | 277 (76.5) | 554 (76.1) |
| Negative | 88 (24.0) | 83 (22.9) | 171 (23.5) |
| Missing | 1 (0.3) | 2 (0.6) | 3 (0.4) |
| Mean DAS28-CRP (SD) | 6.1 (0.9) | 6.1 (0.9) | 6.1 (0.9) |
| Mean CRP level (SD), mg/L | 25.0 (26.7) | 26.6 (28.4) | 25.8 (27.6) |
| Mean tender joint count (68-joint count; SD) | 26.2 (14.5) | 25.9 (14.5) | 26.1 (14.5) |
| Mean swollen joint count (66-joint count; SD) | 16.2 (9.1) | 16.0 (9.0) | 16.1 (9.0) |
| Mean patient assessment of disease activity (SD) | 68.0 (17.9) | 68.2 (18.2) | 68.1 (18.0) |
| Mean physician assessment of disease activity (SD) | 68.4 (14.6) | 66.4 (15.0) | 67.4 (14.8) |
| Mean patient assessment of pain (SD) | 66.7 (18.7) | 67.9 (18.6) | 67.3 (18.6) |
| Mean Health Assessment Questionnaire score (SD) | 1.8 (0.5) | 1.8 (0.5) | 1.8 (0.5) |
| Prior medication for RA | |||
| At least one biologic, n (%) | 65 (17.8) | 67 (18.5) | 132 (18.1) |
| At least one DMARD,§ n (%) | 236 (64.5) | 229 (63.3) | 465 (63.9) |
| At least one TNF inhibitor, n (%) | 22 (6.0) | 27 (7.5) | 49 (6.7) |
| Concomitant medication for RA | |||
| Mean MTX dose (SD), mg/week | 15.8 (5.0) | 15.8 (4.6) | 15.8 (4.8) |
| At least one oral steroid and at least one NSAID, n (%) | 137 (37.4) | 149 (41.2) | 286 (39.3) |
*n = 365 for CRP level, tender joint count, swollen joint count, patient assessment of disease activity, patient assessment of pain, and Health Assessment Questionnaire; n = 364 for DAS28-CRP and physician assessment of disease activity
†n = 727 for CRP level, tender joint count, swollen joint count, patient assessment of disease activity, patient assessment of pain and Health Assessment Questionnaire; n = 726 for DAS28-CRP and physician assessment of disease activity
‡Includes the categories American Indian or Alaska Native (n = 2), Asian (n = 2), and other (n = 99)
§Both biologic and non-biologic DMARDs were included
CRP C-reactive protein, DAS28-CRP disease activity score 28 based on C-reactive protein, DMARD disease-modifying anti-rheumatic drug, MTX methotrexate, NSAID non-steroidal anti-inflammatory drug, RA rheumatoid arthritis, RP reference product, SD standard deviation, TNF tumor necrosis factor