Measure | Baseline | Change from baseline to month 6 | Remission at month 6 | LDAS at month 6 | ||||
---|---|---|---|---|---|---|---|---|
N | Mean (SD) | N | Mean (95% CI) | N | Percent (95% CI) | N | Percent (95% CI) | |
Primary inefficacy | ||||||||
DAS28 (ESR) | 129 | 5.6 (1.3) | 113 | −1.5 (−1.7, –1.2) | 119 | 17.6 (10.8, 24.5) | 119 | 29.4 (21.2, 37.6) |
DAS28 (CRP) | 35 | 5.2 (1.3) | 26 | −1.3 (−2.0, –0.7) | 32 | 12.5 (1.0, 24.0) | 32 | 34.4 (17.9, 50.8) |
CDAI | 140 | 32.1 (13.1) | 129 | −13.9 (−16.3, –11.5) | 136 | 2.9 (0.1, 5.8) | 136 | 27.9 (20.4, 35.5) |
Secondary inefficacy | ||||||||
DAS28 (ESR) | 249 | 5.6 (1.1) | 219 | −1.4 (−1.6, –1.2) | 240 | 10.4 (6.6, 14.3) | 240 | 25.0 (19.5, 30.5) |
DAS28 (CRP) | 74 | 5.5 (1.3) | 55 | −1.6 (−2.0, –1.3) | 68 | 20.6 (11.0, 30.2) | 68 | 38.2 (26.7, 49.8) |
CDAI | 295 | 32.5 (13.0) | 279 | −15.4 (−17.1, –13.8) | 288 | 4.2 (1.9, 6.5) | 288 | 29.5 (24.2, 34.8) |
Safety and tolerability | ||||||||
DAS28 (ESR) | 91 | 5.5 (1.3) | 84 | −1.5 (−1.8, –1.2) | 98 | 18.4 (10.7, 26.0) | 98 | 29.6 (20.6, 38.6) |
DAS28 (CRP) | 27 | 4.8 (1.4) | 22 | −1.5 (−2.2, –0.9) | 26 | 30.8 (13.0, 48.5) | 26 | 42.3 (23.3, 61.3) |
CDAI | 121 | 30.4 (13.4) | 115 | −15.2 (−17.6, –12.8) | 119 | 8.4 (3.4, 13.4) | 119 | 38.7 (29.9, 47.4) |