Table 4

Patients’ responses and remissions at week 12 (ITT set)

		ABX464 100 mg (N=19)	ABX464 50 mg (N=21)	Placebo (N=20)
ACR20 response	N	19	21	20
	Yes	3 (15.8%)	9 (42.9%)	4 (20.0%)
	95% CI	3.4 to 39.6	21.8 to 66.0	5.7 to 43.7
	p-value*	0.731	0.112
ACR50 response	N	19	21	20
	Yes	2 (10.5%)	5 (23.8%)	1 (5.0%)
	95% CI	1.3 to 33.1	8.2 to 47.2	0.1 to 24.9
	p-value*	0.514	0.076
ACR70 response	N	19	21	20
	Yes	1 (5.3%)	4 (19.0%)	1 (5.0%)
	95% CI	0.1 to 26.0	5.4 to 41.9	0.1 to 24.9
	p-value*	0.970	0.155
Categorical DAS28-CRP response	N	19	21	20
	Yes	6 (31.6%)	14 (66.7%)	8 (40.0%)
	95% CI	12.6 to 56.6	43.0 to 85.4	19.1 to 63.9
	p-value*	0.583	0.085
DAS28-ESR remission	N	19	21	20
	Yes	0	2 (9.5%)	0
	95% CI	82.4 to 100.0	1.2 to 30.4	83.2 to 100.0
	p-value*	NC	0.095
Low disease activity	N	19	21	20
	Yes	2 (10.5%)	4 (19.0%)	2 (10.0%)
	95% CI	1.3 to 33.1	5.4 to 41.9	1.2 to 31.7
	p-value*	0.956	0.408
SDAI remission	N	19	21	20
	Yes	0	1 (4.8%)	0
	95% CI	82.4 to 100.0	0.1 to 23.8	83.2 to 100.0
	p-value*	NC	0.243
CDAI remission	N	19	21	20
	Yes	0	3 (14.3%)	0
	95% CI	82.4 to 100.0	3.0 to 36.3	83.2 to 100.0
	p-value*	NC	0.039
ACR/EULAR remission	N	19	21	20
	Yes	0	1 (4.8%)	0
	95% CI	82.4 to 100.0	0.1 to 23.8	83.2 to 100.0
	p-value*	NC	0.243

*χ² test ABX-464 versus placebo. NC—no statistics from χ² test produced because response has fewer than two non missing levels.
ACR, American College of Rheumatology; CDAI, clinical disease activity score; DAS, disease activity score; ESR, erythrocyte sedimentation rate; EULAR, European League Against Rheumatism; SDAI, simplified disease activity score.