Table 2.
Efficacy endpoints in randomized trials of everolimus with reduced-exposure cyclosporine versus MMF with standard-exposure cyclosporine.
| Parameter | A2310 [9] | A2411 [5] | ||||
|---|---|---|---|---|---|---|
| 12 months | 24 months | 12 months | ||||
| MMF | Everolimus 1.5 mg | MMF | Everolimus 1.5 mg | MMF | Everolimus 1.5 mg | |
| Number of patients | 271 | 282 | 271 | 282 | 84 | 92 |
| Composite efficacy failurea, % | 33.6 | 35.1b | 41.3 | 39.4c | 41.7 | 32.6 |
| AR associated with HDC, % | 2.6 | 3.9 | 5.2 | 4.3 | 1.2 | 2.2 |
| BPAR, ISHLT grade ≥ 3A, % | 24.7 | 22.3 | 27.3 | 24.1 | 29.8 | 22.8d |
| BPAR treated with antibody, % | No data | No data | No data | No data | 2.4 | 5.4 |
| Graft loss/re-transplant, % | 1.8 | 1.4 | 3.7 | 2.5 | Composite: 11.9 | Composite: 10.9 |
| Death, % | 4.8 | 7.8e | 9.2 | 10.6e | ||
| Loss to followup, % | 3.7 | 3.2 | 5.2 | 3.5 | No data | No data |
AR: acute rejection; BPAR: biopsy proven acute rejection; HDC: hemodynamic compromise; ISHLT: International Society of Heart and Lung Transplantation; MMF: mycophenolate mofetil.
aDefined as BPAR grade ≥ 3A (or any BPAR in A2310), acute rejection associated with hemodynamic compromise, graft loss/retransplant, death, or loss to followup.
b P = 0.002 for noninferiority (noninferiority margin 13%); P = 0.705 for no-difference test.
cNoninferior to the MMF group (noninferiority margin 13%).
d P = 0.005 for noninferiority.
eIncluding one death in a patient who never received everolimus.