Table 6.

Comparison of efficacy and safety in patients with or without preexisting diabetes

OutcomesBelatacept MIBelatacept LICsA
Patient/graft survival
    diabetes, %; difference from CsA (97.3% CI)a90.4; 8.5 (−0.4 to 17.4)92.8; 10.2 (1.5 to 18.9)80.8
        95% CI (%)84.9 to 95.887.6 to 97.973.9 to 87.7
    no diabetes, %; difference from CsA (97.3% CI)a91.3; −0.70 (−5.4 to 4.0)92.8; 0.52 (−3.9 to 5.0)92.9
        95% CI (%)88.1 to 94.689.9 to 95.789.8 to 95.9
Graft loss
    diabetes, %4.43.112.8
    no diabetes, %5.55.63.9
Death
    diabetes, %6.13.15.6
    no diabetes, %2.41.62.9
Composite renal impairment endpoint
    diabetes, %; difference from CsA (97.3% CI)a58.6; −27.0 (−39.2 to −14.8)64.0; −21.8 (−35.1 to −8.6)87.2
    95% CI (%)49.4 to 67.754.1 to 74.081.1 to 93.2
    no diabetes, %; difference from CsA (97.3% CI)a63.5; −14.7 (−28.0 to −1.4)63.9; −13.5 (−39.3 to 12.3)78.5
    95% CI (%)57.8 to 69.258.5 to 69.473.6 to 83.3
Mean iothalamate GFR (measured)b
    diabetes, mean; difference from CsA (97.3% CI)c59.8; 14.3 (6.0 to 22.7)62.5; 17.1 (8.2 to 25.9)45.4
    no diabetes, mean; difference from CsA (97.3% CI)c58.4; 10.2 (5.4 to 14.9)55.0; 6.8 (2.2 to 11.4)48.2
Total SAEs
    diabetes, %60.554.667.2
    no diabetes, %59.552.661.4
Serious cardiac disorders
    diabetes, %8.84.110.4
    no diabetes, %5.93.64.6
Serious infections
    diabetes, %29.820.630.4
    no diabetes, %26.325.026.4
Neoplasms (total)
    diabetes, %3.53.15.6
    no diabetes, %3.52.31.4
  • For patients with preexisting diabetes: n = 114 (MI), n = 97 (LI), n = 125 (CsA). For patients without preexisting diabetes: n = 289 (MI), n = 304 (LI), n = 280 (CsA). CI, confidence interval; CsA, cyclosporine; LI, less intensive; MI, more intensive; SAEs, serious adverse events.

  • a The DerSimonian-Laird model was used to assess risk difference with a random effect of study.

  • b Measured GFR analysis with imputation.

  • c Estimated difference evaluated using an analysis of covariance with a random effect of study.