A 52-week, open-label study evaluating the safety and efficacy of tabalumab, an anti-B-cell-activating factor monoclonal antibody, for rheumatoid arthritis

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.

ISSN: 1478-6362