Table 5.
Summary of the Belatacept trials
| Study | Phase II | Benefit | Benefit-EXT | ||||||
| Author | Vincenti | Vincenti | Durrbach | ||||||
| Induction | Basiliximab | Basiliximab | Basiliximab | ||||||
| Study drug | MI bela | LI bela | CsA | MI bela | LI bela | CsA | MI bela | LI bela | CsA |
| Maintenance | MMF + steroids | MMF + steroids | MMF + steroids | ||||||
| Demographics | |||||||||
| No. of patients | 74 | 71 | 73 | 225 | 230 | 231 | 193 | 193 | 192 |
| Age (yr) | 47 | 42 | 46 | 44 | 43 | 44 | 57 | 56 | 56 |
| Deceased donor (%) | 69 | 73 | 78 | 42 | 100 | 100 | 100 | ||
| Female (%) | 27 | 32 | 33 | 31 | 35 | 25 | 35 | 26 | 37 |
| Re-transplantation (%) | 1 | 6 | 3 | 4 | 3 | 6 | Not reported | ||
| PRA > 20% (%) | 1 | 3 | 1 | 11 | 13 | 8 | 0 | 1 | 3 |
| African-American (%) | 8 | 9 | 8 | 7 | 10 | 8 | 14 | 14 | 12 |
| CIT (h) | 20 | 20 | 18 | 16.3 | Not reported | ||||
| CIT (> 24 h) (%) | Not reported | Not reported | 39 | 43 | 44 | ||||
| Delayed graft function (%) | Not reported | 16 | 14 | 18 | 47 | 47 | 49 | ||
| Endpoints 6-12 mo | 6 mo | 12 mo | 12 mo | ||||||
| Acute rejection (%) | 7 | 6 | 8 | 22 | 17 | 7 | 18 | 18 | 14 |
| Acute Rejection (Grade II) (%) | 4 | 5 | 6 | 17 | 11 | 4 | 14 | 15 | 12 |
| Measured GFR (mL/min) | 66 | 62 | 54 | 65 | 63 | 50 | 52 | 50 | 45 |
| NODAT (%) | Not reported | 7 | 4 | 10 | 2 | 5 | 9 | ||
| CAN (Stage II or III) (%) | 8 | 9 | 9 | 4 | 6 | 7 | 10 | 12 | 4 |
| Endpoints 12 mo | |||||||||
| Graft survival (%) | 99 | 100 | 95 | 98 | 98 | 96 | 91 | 91 | 89 |
| Patient survival (%) | 96 | 99 | 97 | 97 | 98 | 97 | 96 | 98 | 96 |
| Cancer | 2 | 0 | 2 | 4 | 3 | 1 | 4 | 4 | 6 |
| PTLD | 2 | 0 | 0 | 1 | 1 | 0 | 3 | 3 | 0 |
| Endpoints 2 yr | |||||||||
| Acute rejection | 24 | 17 | 9 | 17 | 18 | 15 | |||
| Measured GFR (mL/min) | 65 | 68 | 51 | 52 | 50 | 45 | |||
| Graft survival (%) | 94 | 95 | 91 | 83 | 84 | 93 | |||
| Patient survival (%) | 97 | 97 | 94 | 93 | 94 | 94 | |||
| Endpoints 3 yr | |||||||||
| Acute rejection (%) | 24 | 17 | 10 | 18 | 19 | 16 | |||
| Measured GFR (mL/min) | 65 | 66 | 44 | 43 | 42 | 32 | |||
| Patient/graft survival (%) | 92 | 92 | 89 | 80 | 82 | 80 | |||
CsA: Cyclosporine; MI: More intensive; LI: Less intensive; PTLD: Post-transplant lymphoproliferative disorder; NODAT: New onset of diabetes mellitus after transplantation; CIT: Cold ischemia time; GFR: Glomerular filtration rate.