Baseline demographics and clinical parameters (ITT population)
| Tabalumab | |||||||
|---|---|---|---|---|---|---|---|
| Placebo (N=36) | 1 mg (N=30) | 3 mg (N=20) | 10 mg (N=15) | 30 mg (N=18) | 60 (mg N=13) | 120 mg (N=26) | |
| Gender, n (%) | |||||||
| Male | 6 (16.7) | 4 (13.3) | 6 (30.0) | 3 (20.0) | 3 (16.7) | 1 (7.7) | 8 (30.8) |
| Female | 30 (83.3) | 26 (86.7) | 14 (70.0) | 12 (80.0) | 15 (83.3) | 12 (92.3) | 18 (69.2) |
| Age, years | 50.6±11.7 | 54.6±11.7 | 53.4±10.8 | 51.2±13.8 | 54.5±11.8 | 44.4±13.8 | 50.7±12.0 |
| Race/ethnicity, n (%) | |||||||
| Caucasian | 25 (69.4) | 22 (73.3) | 13 (65.0) | 8 (53.3) | 11 (61.1) | 5 (38.5)* | 17 (65.4) |
| Hispanic | 8 (22.2) | 5 (16.7) | 6 (30.0) | 6 (40.0) | 6 (33.3) | 5 (38.5) | 8 (30.8) |
| East Asian | 2 (5.6) | 2 (6.7) | 1 (5.0) | 0 | 1 (5.6) | 3 (23.1) | 1 (3.8) |
| West Asian | 0 | 0 | 0 | 1 (6.7) | 0 | 0 | 0 |
| African | 1 (2.8) | 1 (3.3) | 0 | 0 | 0 | 0 | 0 |
| Disease duration, years | 6.2±7.2 | 9.3±7.9 | 8.4±7.0 | 9.0±6.7 | 11.7±7.0* | 10.1±9.3 | 9.9±11.6 |
| CRP above ULN at baseline, n (%) | 28 (77.8) | 21 (70.0) | 15 (75.0) | 12 (80.0) | 15 (83.3) | 12 (92.3) | 19 (73.1) |
| HAQ-DI | 1.8±0.5 | 1.7±0.5 | 1.8±0.5 | 1.7±0.6 | 1.5±0.9 | 1.8±0.6 | 1.7±0.5 |
| DAS28-CRP | 6.2±1.0 | 6.4±0.8 | 6.1±1.0 | 6.2±1.0 | 6.1±0.8 | 6.1±0.9 | 5.9±0.7 |
| MTX dose, mg/week | 16.8±4.5 | 15.7±4.6 | 14.9±4.2 | 16.0±4.4 | 14.7±3.3 | 16.2±3.9 | 14.8±3.5 |
| Prednisone dose, mg/day | 6.6±2.2 | 7.6±2.6 | 8.1±2.1 | 7.1±2.0 | 6.8±2.2 | 6.0±2.4 | 5.6±2.0 |
| CD20 B-cell counts, cells/μl | 193.4±130.3 | 220.8±133.2 | 208.1±171.8 | 189.5±64.1 | 220.1±181.6 | 212.5±122.1 | 187.4±110.0 |
All values are mean±SD, unless otherwise noted.
*p<0.05 versus placebo.
CRP, C reactive protein; CRP; HAQ-DI, Health Assessment Questionnaire-Disability Index; DAS28-CRP, Disease Activity Score based on 28-joint count; ITT, Intent-to-treat population; MTX, methotrexate; ULN, upper limit of normal.