TABLE 2.
CLINICAL ENDPOINT DATA
| Abatacept (n = 11) | Placebo (n = 11) | P Value | |
| FEV1, L | |||
| Before randomization (V4) | 3.01 ± 0.84 | 3.03 ± 0.86 | 0.97 |
| End of treatment intervention (V10) | 2.89 ± 0.83 | 2.99 ± 0.88 | 0.79 |
| Change (V10 − V4) | −0.12 ± 0.17 | −0.04 ± 0.27 | 0.40 |
| FEV1, % predicted | |||
| Before randomization (V4) | 85.7 ± 14.9 | 85.5 ± 10.5 | 0.97 |
| End of treatment intervention (V10) | 82.0 ± 14.6 | 85.5 ± 9.60 | 0.51 |
| Change (V10 − V4) | −3.70 ± 5.0 | 0 ± 5.60 | 0.12 |
| PC20, mg/ml | |||
| Before randomization (V4) | 5.87 ± 11.41 | 1.46 ± 2.12 | 0.19 |
| End of treatment (V9) | 7.06 ± 12.33 | 1.45 ± 1.80 | 0.17 |
| Change (V9 − V4) | 0.65 ± 4.9 | 0.09 ± 1.89 | 0.92 |
| Asthma Control Questionnaire | |||
| Before randomization (V4) | 0.87 ± 0.50 | 1.03 ± 0.58 | 0.51 |
| End of treatment (V9) | 0.77 ± 0.61 | 0.95 ± 0.84 | 0.57 |
| Change (V9 − V4) | −0.10 ± 0.62 | −0.08 ± 0.78 | 0.94 |
Definition of abbreviation: PC20 = provocative concentration of methacholine sufficient to induce a 20% decline in FEV1; V = visit.
FEV1, PC20, and Asthma Control Questionnaire scores are shown for the 11 participants in each arm of the study who completed the trial. The two subjects who withdrew after the first infusion of study drug are not included in the analysis. Data are presented as the mean ± standard deviation.