Double-blind, placebo-controlled randomized trial with adalimumab for treatment of juvenile onset ankylosing spondylitis (JoAS): significant short term improvement

Table 2 Efficacy: primary and secondary endpoints

Endpoint	Number (%)		Odd's ratio (95% CI)	P-value*
	Adalimumab (n = 17)	Placebo (n = 15)
Primary endpoint
ASAS40 week 4	7 (41)	3 (20)	2.3 (0.6 to 13.8)	0.20
week 8	9 (53)	3 (20)	3.6 (0.9 to 21.9)*	0.05
week 12	9 (53)	5 (33)	1.6 (0.5 to 9.5)	0.26
Secondary endpoint
ASAS20 week 4	9 (53)	10 (59)	4 (27)	4 (27)
week 8	2.4 (0.7 to 13.7)	3.0 (0.9 to 17.6)	0.13	0.07
week 12	9 (53)	5 (33)	1.6 (0.5 to 9.5)	0.26
PedACR30 week 4	9 (53)	4 (27)	2.4 (0.7 to 13.7)	0.13
week 8	13 (76)	5 (33)	5.1 (1.4 to 30.7)	0.01
week 12	11 (65)	6 (40)	2.0 (0.7 to 11.5)	0.16
PedACR70 week 4	5 (29)	1 (6.7)	6.8 (0.6 to 57.1)	0.10
week 8	7 (41)	2 (13)	4.1 (0.8 to 26.8)	0.08
week 12	9 (53)	4 (27)	2.4 (0.7 to 13.7)	0.13

In this intention to treat analysis one patient of each group who discontinued prematurely was labeled as non-responder. * Chi square test.

ISSN: 1478-6362