Table 3.
Summary of central and local biopsy collection and rejection events
| Rejection/Biopsy Characteristic | Central Read Only | Local Read Only | Central or Local Read |
|---|---|---|---|
| B=234 | B=309 | B=380 | |
| I=78 | I=83 | I=98 | |
| P=71 | P=73 | P=88 | |
| ACR 1A or higher, n (%) | |||
| Biopsiesa | 7 (3%) | 16 (5.2%) | 20 (5.3%) |
| Infliximab patientsb | 4 (5.1%) | 10 (12.05%) | 11 (11.2%) |
| Placebo patientsc | 3 (4.2%) | 5 (6.85%) | 7 (7.95%) |
| P valued | >0.1 | 0.27 | 0.45 |
| Borderline or higher ACR, n (%) | |||
| Biopsiesa | 19 (8.1%) | 64 (20.7%) | 77 (20.3%) |
| Infliximab patientsb | 10 (12.8%) | 24 (28.9%) | 29 (29.6%) |
| Placebo patientsc | 5 (7%) | 23 (31.5%) | 26 (29.5%) |
| P valued | 0.24 | 0.73 | 0.1 |
| Locally treated rejection | B=234, I=78, P=71 | ||
| Number of biopsiesa | n/a | 62 (15.9%) | n/a |
| Infliximab patientsb | 16 (16.2%) | ||
| Placebo patientsc | 24 (27%) | ||
| 0.07 | |||
B, biopsy; I, infliximab; P, placebo; n/a, not applicable.
a
Percentage of biopsies is calculated on the basis of the column total of B biopsies.
b
Percentage of Infliximab patients is calculated on the basis of the column total of I patients.
c
Percentage of Placebo patients is calculated on the basis of the column total of P patients.
d
P value results from a chi-square or Fisher’s exact test.