Table 1.
Pretabalumab baseline demographics and clinical characteristics a
| Tabalumab (60 mg) | Tabalumab (60 mg/120 mg) | |
|---|---|---|
| ( N = 60) | ( N = 121) | |
| Males, n (%) | 9 (15) | 22 (18) |
| Age, yr | 53 ± 12 | 52 ± 12 |
| Duration of RA, yr | 9 ± 7 | 10 ± 8 |
| Swollen joint count (28) | 10.2 ± 6.5 | 12.2 ± 6.3 |
| Tender joint count (28) | 13.1 ± 8.1 | 16.1 ± 7.6 |
| Physician’s Global Assessment (VAS) | 48 ± 21 | 57 ± 22 |
| Patient’s Global Assessment of Disease Activity (VAS) | 55 ± 23 | 63 ± 23 |
| Patient’s Global Assessment of Pain (VAS) | 55 ± 23 | 60 ± 23 |
| HAQ-DI | 1.5 ± 0.7 | 1.7 ± 0.6 |
| CRP, mg/dl | 2.2 ± 1.9 | 2.3 ± 2.4 |
| DAS28 | 5.5 ± 1.3 | 5.9 ± 1.1 |
| Prior TNF exposure, n (%) | 17 (28) | 58 (48) |
| Prior HCQ exposure, n (%) | 25 (42) | 33 (27) |
| Prior SSZ exposure, n (%) | 14 (24) | 36 (30) |
| Weekly dose of MTX, mg | 16 ± 4 | 16 ± 5 |
| Daily dose of prednisone dose, mg | 7 ± 3 | 7 ± 3 |
| Concomitant prednisone, n (%) | 38 (64) | 92 (76) |
aCRP, C-reactive protein; DAS28, Disease Activity Score in 28 joints; HAQ-DI, Health Assessment Questionnaire–Disability Index; HCQ, Hydroxychloroquine; MTX, Methotrexate; RA, Rheumatoid arthritis; RCT, Randomized control trial; SSZ, Sulfasalazine; TNF, Tumor necrosis factor; VAS, Visual analogue scale. Data are mean ± SD unless noted otherwise. For patients assigned to receive tabalumab in RCT1 or RCT2, pretabalumab baseline data were collected at week 0 of RCT1 or RCT2. For patients assigned to receive placebo in RCT1 or RCT2, pretabalumab baseline data were collected either before patients received an optional 80-mg tabalumab rescue dose at week 16 in RCT1 or at open-label extension study entry. Numbers in bold denote pretabalumab RA activity levels that were greater for the 60-mg/120-mg tabalumab group compared to the 60-mg tabalumab group.