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

Table 4

Change from baseline to Week 24 in disease activity measures and subject reported outcomes.

	FAS	SC-TCZM	SC-TCZC
DAS28-ESR
	47	14	33
Mean change (SD)	−4.4 (1.5)	−4.3 (1.1)	−4.4 (1.7)
			,
ACR20 response at Week 24
(%)	43 (91.5%)	12 (85.7%)	31 (93.9%)
95% CI	79.6% to 97.6%	57.2% to 98.2%	79.8% to 99.2%
	ACR50 response at Week 24
(%)	36 (76.6%)	11 (78.6%)	25 (75.8%)
95% CI	62.0% to 87.7%	49.2% to 95.3%	57.7% to 88.9%
			()
ACR70 response at Week 24
(%)	25 (53.2%)	9 (64.3%)	16 (48.5%)
95% CI	38.1% to 67.9%	35.1% to 87.2%	30.8% to 66.5%
			(
SDAI
	45	12	33
Mean change (SD)	−31.6 (16.5)	−34.1 (14.2)	−30.7 (17.3)
CDAI
	46	13	33
Mean change (SD)	−30.0 (15.1)	−33.6 (13.1)	−28.6 (15.8)
TJC28
	47	14	33
Mean change (SD)	−11.1 (7.6)	−11.4 (7.3)	−10.9 (7.8)
SJC28
	47	14	33
Mean change (SD)	−8.8 (6.0)	−9.5 (6.3)	−8.45 (5.9)
Physician’s global assessment of disease activity (VAS)
	46	13	33
Mean change (SD)	−48.8 (21.3)	−55.5 (24.4)	−46.2 (19.8)
Patient’s global assessment of disease (VAS)
	47	14	33
Mean change (SD)	−48.6 (25.9)	−52.3 (26.7)	−47.0 (25.8)
Patient’s global assessment of pain (VAS)
	47	14	33
Mean change (SD)	−41.9 (27.0)	−47.0 (31.0)	−39.7 (25.3)
FACIT-F
	47	14	33
Mean change (SD)	12.6 (10.5)	15.6 (10.5)	11.4 (10.5)
HAQ-DI
	47	14	33
Mean change (SD)	−0.78 (0.59)	−0.79 (0.70)	−0.77 (0.54)

test used to test the hypothesis of no change from baseline to Week 24; Rank Sum test used to test the hypothesis of no change from baseline between the subgroups; ’s Exact test used to test the hypothesis of no difference between subgroups at Week 24; ACR20/50/70 20%/50%/70% improvement in the American College of Rheumatology response scores; CDAI, Clinical Disease Activity Index; DAS28-ESR, disease activity score (28 joints)-erythrocyte sedimentation rate; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; FAS, full analysis set; HAQ-DI, Health Assessment Questionnaire-Disability Index; SC-TCZC, subcutaneous tocilizumab combination therapy subgroup (including MTX); SC-TCZM, subcutaneous tocilizumab monotherapy subgroup (including DMARD(s) but excluding MTX); SDAI, Simplified Disease Activity Index; SJC28, swollen joint count (28 joints); TJC, tender joint count (28 joints); VAS, visual analogue scale; CI, confidence intervals.