AC-CUTE: An Open-Label Study to Evaluate Progression of Structural Joint Damage and Inflammation in Subjects with Moderate to Severe Rheumatoid Arthritis

Table 1

Demographics and baseline characteristics.

	FAS; ()	SC-TCZM; ()	SC-TCZC; ()
Female, , (%)	41 (78.9)	15 (88.2)	26 (74.3)
Mean age, years (SD)	56.9 (11.5)	59.2 (12.8)	55.7 (10.9)
Body weight, KG (SD)	78.2 (19.9)	72.9 (16.8)	80.9 (21.1)
Mean duration of RA, years (SD)	7.8 (8.3)	11.2 (8.8)	6.1 (7.6)
Mean SJC28 (SD)	10.7 (6.5)	12.7 (4.9)	9.7 (7.0)
Mean TJC28 (SD)	13.2 (6.2)	12.5 (5.4)	13.5 (6.7)
Mean DAS28-ESR/CRP (SD)	6.4 (1.1)	6.7 (1.0)	6.2 (1.1)
Mean TSS (SD)	16.9 (23.2)	27.4 (32.3)	11.6 (14.9)
Mean X-ray erosion score (SD)	7.4 (9.5)	10.6 (12.3)	5.8 (7.5)
Mean X-ray JSN score (SD)	9.5 (14.4)	16.8 (20.6)	5.9 (8.2)
Mean MRI erosion score (SD)	8.9 (6.7)	9.9 (8.3)	8.4 (5.8)
Mean MRI cartilage loss score (SD)	6.3 (9.5)	9.2 (11.6)	4.8 (7.9)
Mean MRI synovitis score (SD)	4.5 (4.0)	4.3 (5.0)	4.6 (3.5)
Mean MRI osteitis score (SD)	6.6 (10.3)	5.3 (8.1)	7.3 (11.3)
Mean MTX dose, mg/week (SD)	16.9 (6.0)	N/A	16.9 (6.0)
Oral steroid use, (%)	26 (50.0%)	6 (35.3%)	20 (57.1%)
cDMARD use, (%)	44 (84.6%)	10 (58.8%)	34 (97.1%)
Prior use of anti-TNF therapy, (%)	4 (7.7%)	3 (17.7%)	1 (2.9%)

cDMARD: conventional disease-modifying antirheumatic drug, DAS28-ESR: disease activity score (28 joints)–erythrocyte sedimentation rate, FAS: full analysis set, TSS: Genant-modified total Sharp Score, MTX: methotrexate, RA: rheumatoid arthritis, SC-TCZC: subcutaneous tocilizumab combination therapy subgroup (including MTX), SC-TCZM: subcutaneous tocilizumab monotherapy subgroup (including DMARD(s) but excluding MTX), SJC28: swollen joint count (28 joints), TJC: tender joint count (28 joints), and TNF: tumour necrosis factor.