Table 3.
Outcomes: composite end point (death, graft loss and AR) by 6 months (primary end point) and 12 months and AR up to month 12
| Composite end point | Basiliximab + belatacept HD + MMF | Belatacept HD + MMF | Belatacept LD + MMF | Tac + MMF | Tac (n = 50) |
|---|---|---|---|---|---|
| (n = 50) | (n = 48) | (n = 49) | (n = 53) | ||
| 6 months (primary end point), n (%) | 24 (48.0) | 20 (41.7) | 23 (46.9) | 8 (15.1) | 19 (38.0) |
| Difference from Tac + MMF, % (95% CI) | 32.9 (16.1–49.8) | 26.6 (9.6–43.5) | 31.8 (14.8–48.5) | — | — |
| Difference from Tac, % (95% CI) | 10.0 (−8.7–29.6) | 3.7 (−15.3–23.2) | 8.9 (−9.8–28.4) | — | — |
| AR, n | 20 | 15 | 15 | 5 | 15 |
| Death, n | 4 | 4 | 6 | 1 | 3 |
| Graft loss, n | 2 | 2 | 6 | 4 | 3 |
| Survival with a functioning graft, n (%) | 45 (90.0) | 43 (89.6) | 38 (77.6) | 49 (92.5) | 45 (90.0) |
| (95% CI) | (81.7–98.3) | (80.9–98.2) | (65.9–89.2) | (85.3–99.6) | (81.7–98.3) |
| 12 months, n (%) | 26 (52.0) | 23 (47.9) | 26 (53.1) | 10 (18.9) | 20 (40.0) |
| AR, n | 22 | 16 | 16 | 7 | 15 |
| Death, n | 4 | 7 | 10 | 1 | 4 |
| Graft loss, n | 2 | 2 | 8 | 4 | 4 |
| Survival with a functioning graft, n (%) | 45 (90.0) | 40 (83.3) | 33 (67.3) | 49 (92.5) | 44 (88.0) |
| (95% CI) | (81.7–98.3) | (72.8–93.9) | (54.2–80.5) | (85.3–99.6) | (79.0–97.0) |
| AR (centrally read) up to month 12, n (%) | |||||
| Patients with AR | 22 (44.0) | 16 (33.3) | 16 (32.7) | 7 (13.2) | 15 (30.0) |
| Treated, n/N (%) | 12/22 (54.5) | 12/16 (75.0) | 8/16 (50.0) | 5/7 (71.4) | 12/15 (80.0) |
| Corticosteroids only, n (%) | 12 (24.0) | 7 (14.6) | 8 (16.3) | 4 (7.5) | 10 (20.0) |
| Initial lymphocyte-depleting therapy, n (%) | 0 (0) | 3 (14.6) | 0 (0) | 0 (0) | 0 (0) |
| Grade of AR, n (%) | |||||
| I | 15 (30.0) | 7 (14.6) | 7 (14.3) | 6 (11.3) | 7 (14.0) |
| II | 7 (14.0) | 8 (16.7) | 8 (16.3) | 1 (1.9) | 6 (12.0) |
| III | 0 (0) | 1 (2.1) | 1 (2.0) | 0 (0) | 2 (4.0) |
| Death or graft loss in patients with AR, n | 1 | 1 | 6 | 1 | 1 |
AR, acute rejection; CI, confidence interval; HD, high dose, LD, low dose; MMF, mycophenolate mofetil; Tac, tacrolimus.