Table 4.
Clinical responses to infliximab
| Change from baselinea | Median (IQR) | p-valueb | |
|---|---|---|---|
| Infliximab | Placebo | ||
| TNF-alpha high subsetb | |||
| FEV1 | 0.0 (-4.0, 4.0) | -2.3 (-6.0, 1.0) | 0.11 |
| CRQ | 8.0 (0.0, 21.5) | 4.0 (-1.5, 19.0) | 0.34 |
| 6MWD | 0.0 (-39.0, 41.0) | 21.2 (-49.4, 41.7) | 0.93 |
| Dyspnea | 0.0 (0.0, 2.0) | 0.0 (0.0, 2.8) | 0.98 |
| log2(CRP) | 0.1 (-1.1, 0.9) | -0.7 (-1.5, 0.2) | 0.10 |
| CRP high subsetc | |||
| FEV1 | -1.8 (-4.0, 4.0) | -2.1 (-6.0, 2.0) | 0.51 |
| CRQ | 17.0 (0.0, 28.5) | 4.0 (0.0, 24.0) | 0.38 |
| 6MWD | 3.4 (-55.6, 66.0) | 0.0 (-47.7, 35.0) | 0.67 |
| Dyspnea | 0.0 (-3.0, 2.0) | 0.0 (0.0, 2.0) | 0.40 |
| log2(CRP) | -1.1 (-1.9, -0.2) | -0.4 (-1.0, 0.4) | 0.075 |
aChanges from baseline in the indicated parameter in combined infliximab (3 mg/kg + 5 mg/kg) or placebo treatment, within the specified T54 COPD subpopulation.
bMann-Whitney p-value for combined infliximab group vs placebo group within the indicated T54 COPD subpopulation.
cTNF-alpha high subset = top quartile for baseline serum TNF-alpha levels (> 6.8 pg/ml).
dCRP high subset = top quartile for baseline serum CRP levels (> 6.9 ug/ml).
CRP, C-reactive protein; CRQ, chronic respiratory questionnaire; FEV1, forced expiratory volume in 1 second; IQR, interquartile range; MWD, minute walk distance; TNF-alpha, tumor necrosis factor-alpha.