Letter to the Editor
Three-Year Outcomes of Belatacept Studies; Reason to Be Optimistic?
Article first published online: 3 JUL 2012
© Copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons
American Journal of Transplantation
Volume 12, Issue 8, page 2259, August 2012
How to Cite
van den Hoogen, M. W. F. and Pipeleers, L. (2012), Three-Year Outcomes of Belatacept Studies; Reason to Be Optimistic?. American Journal of Transplantation, 12: 2259. doi: 10.1111/j.1600-6143.2012.04165.x
- Issue published online: 27 JUL 2012
- Article first published online: 3 JUL 2012
To the Editor:
In a recent article, Pestana et al. describe the 3-year outcome of the use of belatacept in recipients of extended criteria donor kidneys, the BENEFIT-EXT study (1). Although we welcome these longer term follow-up data, we feel that two important issues need to be discussed.
In the original, 1-year data of the BENEFIT and BENEFIT-EXT studies, a significant advantage regarding cardiovascular risk factors (blood pressure, serum lipids and incidence of NODAT) was observed in belatacept-treated patients, compared with cyclosporine-treated patients (2,3). The 3-year data of the BENEFIT-EXT study showed that this advantage was not sustained, while the paper on the 3-year follow-up data of the BENEFIT study did not address this issue anymore (4). The apparent lack of a sustained benefit regarding cardiovascular risk factors in belatacept-treated patients was neither discussed nor explained by the authors of this paper.
A second and more worrying problem is the incidence of posttransplant lymphoproliferative disorder (PTLD). In 2010, data of the belatacept phase II, BENEFIT and BENEFIT-EXT studies were pooled (5). This analysis showed that in these three studies 16 cases of PTLD occurred in 1425 patients (14 in 949 belatacept-treated patients, 2 in 476 cyclosporine-treated patients, Fisher exact test, p = 0.06). Fourteen of the 16 PTLD cases occurred within the first 18 months posttransplant and two occurred afterwards, one in each group. In the BENEFIT-EXT study, four cases of PTLD (3 in 359 belatacept-treated patients, 1 in 184 cyclosporine-treated patients) have occurred after 3 years of follow-up (1). At least two of those cases (in belatacept-treated patients) were not included in the pooled-data analysis. Overall, PTLD has therefore occurred in at least 16 of 949 belatacept-treated patients and in 2 of 476 cyclosporine-treated patients, p < 0.05). Because PTLD is a potentially lethal condition (7 of 9 patients in BENEFIT-EXT died of their disease) this is an important safety issue.
We feel that the balance between benefits and risks of belatacept as a substitute for cyclosporine might be less optimistic than suggested earlier, especially since the advantages with respect to cardiovascular risk factors seem to diminish with longer follow-up and the incidence of PTLD seems to increase.
The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation.