TABLE 2.
Alemtuzumab induction with steroid-free protocol
| Reference | Study design | Organ | N | Maintenance | Steroid free | Induction and dose |
Major endpoints | Results | Follow-up |
|---|---|---|---|---|---|---|---|---|---|
| Gruessner et al. (12) |
Prospective observational with historical control |
SPK/PAK/PTA | 75 | MMF | Yes | Alemtuzumab and Thymoglobulin 30 mg×4 and 1.25 mg/kg×1 vs. NR |
Patient survival Graft survival Rejection Serious infection Creatinine clearance |
No difference No difference 41% vs 9% in SPK (P > 0.0003) No difference No difference |
6 mo |
| Kaufman et al. (10) |
Retrospective review with historical control |
SPK | 50 | Tac, sirolimus | Yes | Alemtuzumab vs. Thymoglobulin 30 mg×1 vs. 1 mg/ kg×6 |
Patient survival Kidney graft survival Pancreas graft survival Rejection Viral infection |
91% vs. 92% at 3 yr 91% vs. 86% at 3 yr 92% vs. 97% at 3 yr 8% vs. 5% in 2 yr 10% vs. 40% in 3 yr |
22–41 mo |
| Thai et al. (38) |
Retrospective review |
SPK/PAK/PTA | 60 | Tac | Yes | Alemtuzumab vs. none 30 mg×1 vs. none |
Patient survival Kidney graft survival Pancreas graft survival Rejection CMV infection |
95% at 1 yr 90% at 1 yr 93% at 1 yr 30% in 18 mo 12% in study period |
17–33 mo |
| Clatworthy et al. (39) |
Retrospective review |
SPK | 54 | Tac, MMF | Yes | Alemtuzumab subQ vs. Alemtuzumab IV 30 mg subQ×2 vs. 20 mg IV×2 |
Patient survival Kidney graft survival Pancreas graft survival Rejection Adverse reaction |
100% subQ group at 1 yr 100% subQ group at 1 yr 95% subQ group at 1 yr 14% subQ group in study period No reaction in subQ group |
2 yr |
| Magliocca et al. (20) |
Retrospective review with historical control |
SPK | 105 | Tac, MMF, Pred | No | Alemtuzumab vs. Basiliximab 30 mg×2 vs. 20 mg×2 |
Patient survival Kidney graft survival Pancreas graft survival Renal rejection Pancreas rejection CMV infection |
99% vs. 95% at 2 yr 93% vs. 90% at 2 yr 91% vs. 85% at 2 yr 20% vs. 31% in 2 yr (P = 0.09) 27% vs. 18% in 2 yr (P = 0.12) 29% vs. 16% at 2 yr (P = 0.002) |
2 yr |
| Muthusamy et al. (32) |
Retrospective review with historical control |
SPK/PAK/PTA | 102 | Tac, MMF | Yes | Alemtuzumab vs. none 30 mg×2 vs. none |
Patient survival Kidney graft survival Pancreas graft survival Rejection CMV infection BK nephropathy |
97% at 1 yr 89% at 1 yr 94% at 1 yr 25% in study period 6% in study period 4% in study period |
8–41 mo |
| Pascual et al. (28) |
Retrospective review with historical control |
SPK | 97 | Tac, MMF, Pred | No | Alemtuzumab vs. Basiliximab 30 mg×2 vs. 20 mg×2 |
Same as Magliocca et al. (20) C4d negative ACR AMR |
3% vs. 15% in 2 yr (P = 0.017) 18% vs. 14% in 2 yr (P = 0.6) |
2 yr |
| Farney et al. (14) |
Randomized prospective study |
SPK/PAK | 42 | Tac, MMF, pred early steroid withdrawal or rapid steroid taper |
No | Alemtuzumab vs. Thymoglobulin 30 mg×1 vs. 1.5 mg/kg×3–7 |
Patient survival Kidney graft survival Pancreas graft survival Rejection |
88% vs. 86% 89% vs. 93% 26% vs. 36% in 3 yr (P = 0.29) |
Median 2 yr |
SPK, simultaneous kidney-pancreas transplantation; PAK, pancreas after kidney transplantation; PTA, pancreas transplant alone; CMV, cytomegalovirus; Tac, tacrolimus; MMF, mycophenolate mofetil; Pred, prednisone; ACR, acute cellular rejection; AMR, antibody-mediated rejection.