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.

Horneff et al. Arthritis Research & Therapy 2012 14:R230   doi:10.1186/ar4072