Baseline characteristic | Tabalumab 120/Q4W | Tabalumab 90/Q2W | Placebo |
---|---|---|---|
N=153 | N=148 | N=155 | |
Age, mean years±SD | 54.2±11.6 | 51.3±11.7 | 54.0±11.1 |
Female, n (%) | 124 (81.0) | 126 (85.1) | 131 (84.5) |
Race, n (%) | |||
White | 119 (78.8) | 108 (74.0) | 112 (74.2) |
Black | 14 (9.3) | 16 (11.0) | 18 (11.9) |
Asian | 10 (6.6) | 9 (6.2) | 13 (8.6) |
American Indian/Alaska native | 8 (5.3) | 9 (6.2) | 6 (4.0) |
Multiracial | 0 | 4 (2.7) | 2 (1.3) |
Geographic region, n (%) | |||
North America | 89 (58.2) | 90 (60.8) | 89 (57.4) |
Central/South America | 25 (16.3) | 21 (14.2) | 25 (16.1) |
Eastern Europe | 20 (13.1) | 18 (12.2) | 18 (11.6) |
Western Europe | 8 (5.2) | 8 (5.4) | 7 (4.5) |
Rest of world* | 11 (7.2) | 11 (7.4) | 16 (10.3) |
Weight, mean kg | 79.6 | 80.3 | 77.6 |
Body mass index, mean kg/m2 | 29.9 | 29.9 | 29.3 |
Time since RA diagnosis, mean years±SD | 8.1±4.3 | 7.9±3.9 | 8.7±4.2 |
Swollen joint count (66), mean±SD | 19.5±12.2 | 19.8±12.2 | 18.3±11.7 |
Tender joint count (68), mean±SD | 28.6±15.8 | 30.1±17.1 | 28.7±15.7 |
PhGA (VAS), mean±SD | 62.3±17.3 | 63.9±17.0 | 62.4±19.0 |
PtGA (VAS), mean±SD | 63.7±23.0 | 65.3±21.6 | 68.1±20.1 |
Patient assessment of pain (VAS), mean±SD | 62.8±22.2 | 66.0±21.6 | 65.1±21.6 |
C reactive protein, mg/L, mean±SD | 16.29 | 14.57 | 19.11 |
HAQ-DI, mean±SD | 1.67±0.58 | 1.68±0.60 | 1.66±0.56 |
DAS28-CRP, mean±SD | 5.84±1.02 | 5.88±1.04 | 5.89±0.97 |
Only RF+, n (%) | 11 (7.2) | 8 (5.4) | 9 (5.8) |
Only anti-CCP+, n (%) | 19 (12.4) | 15 (10.1) | 13 (8.4) |
Both RF+ and anti-CCP+, n (%) | 114 (74.5) | 112 (75.7) | 117 (76.0) |
Absolute CD20+ B-cell count (cells/μL) mean±SD | 223±171 | 210±154 | 223±153 |
Number of previous TNF treatment failures, n (%) | |||
0 | 3 (2.0) | 1 (0.7) | 4 (2.6) |
1 | 94 (61.4) | 95 (64.2) | 86 (55.5) |
2 | 30 (19.6) | 27 (18.2) | 42 (27.1) |
≥3 | 26 (17.0) | 25 (16.9) | 23 (14.8) |
Background DMARDS, n (%) | |||
1 | 140 (91.5) | 136 (93.2) | 133 (86.9) |
2 | 13 (8.5) | 10 (6.8) | 17 (11.1) |
≥3 | 0 | 0 | 3 (2.0) |
Background corticosteroids, n (%) | 82 (53.6) | 85 (57.4) | 86 (55.5) |
Mean daily dose of background medications | |||
Methotrexate, mg/week | 15.5 (n=131) | 15.5 (n=126) | 15.8 (n=135) |
Hydroxychloroquine, mg/day | 376.5 (n=17) | 360.0 (n=10) | 336.8 (n=19) |
Sulfasalazine, mg/day | 1419.6 (n=8) | 1900.0 (n=10) | 1590.9 (n=11) |
*Rest of world=Russia, Australia, Japan, Korea, Malaysia, New Zealand, South Africa and Taiwan.
120/Q4W=120 mg subcutaneous (SQ) tabalumab injection every 4 weeks; 90/Q2W=90 mg SQ tabalumab injection every 2 weeks.
ACR, American College of Rheumatology; CCP, cyclic citrullinated peptide; DAS28-CRP, Disease Activity Score based on a 28 joint count and C reactive protein level; DMARD, disease-modifying antirheumatic drug; EULAR-28, European League Against Rheumatism Responder Index in 28 joints; HAQ-DI, Health Assessment Questionnaire-Disability Index; PhGA, physician global assessment; PtGA, patient global assessment; RA, rheumatoid arthritis; RF, rheumatoid factor; TNF, tumour necrosis factor; VAS, visual analogue scale.