Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etanercept in patients with moderately active rheumatoid arthritis despite DMARD therapy

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Table 2 Key secondary endpoints: rates of CDAI and SDAI LDA and remission, ACR responses, improvements in HAQ-DI (primary analysis set; LOCF imputation)

	Placebo-etanercept (N = 104)	Etanercept-etanercept (N = 106)
CDAI LDA (score ≤10), n (%)
Week 2	9 (9.1)	13 (12.3)
Week 8	16 (15.4)	31 (29.2)
Week 12	22 (21.2)	27 (25.5)
Week 24	43 (41.3)	49 (46.2)
CDAI remission (score ≤2.8), n (%)
Week 2	1 (1.0)	2 (1.9)
Week 8	0 (0.0)	3 (2.8)
Week 12	1 (1.0)	4 (3.8)
Week 24	4 (3.8)	9 (8.5)
SDAI LDA (score ≤11), n (%)
Week 2	8 (8.2)	13 (12.4)
Week 8	15 (14.4)	32 (30.2)
Week 12	22 (21.2)	25 (23.6)
Week 24	41 (39.4)	48 (45.3)
SDAI remission (score ≤3.3), n (%)
Week 2	1 (1.0)	1 (1.0)
Week 8	0 (0.0)	6 (5.7)
Week 12	2 (1.9)	6 (5.7)
Week 24	7 (6.7)	11 (10.4)
ACR20 response, n (%)
Week 2	15 (14.9)	30 (28.6)
Week 8	24 (23.1)	53 (50.0)
Week 12	30 (28.8)	43 (40.6)
Week 24	48 (46.2)	53 (50.0)
ACR50 response, n (%)
Week 2	3 (3.0)	6 (5.7)
Week 8	5 (4.8)	21 (19.8)
Week 12	13 (12.5)	22 (20.8)
Week 24	30 (28.8)	35 (33.0)
ACR70 response, n (%)
Week 2	0 (0.0)	2 (1.9)
Week 8	0 (0.0)	6 (5.7)
Week 12	1 (1.0)	6 (5.7)
Week 24	13 (12.5)	17 (16.0)
Change from baseline in HAQ-DI, mean score change (SD)
Week 2	−0.09 (0.39)	−0.27 (0.43)
Week 8	−0.21 (0.42)	−0.37 (0.47)
Week 12	−0.20 (0.43)	−0.39 (0.54)
Week 24	−0.45 (0.52)	−0.48 (0.58)

CDAI: Clinical Disease Activity Index; SDAI: Simplified Disease Activity Index; LDA: low disease activity; ACR: American College of Rheumatology; HAQ-DI: Health Assessment Questionnaire Disability Index; LOCF: last observation carried forward; SD: standard deviation.