A Randomized Prospective Study Comparing Anti–T-Lymphocyte Igs to Basiliximab in Highly Sensitized Kidney Transplant Patients

• Published in: Kidney international reports 2020-08, Vol.5 (8), p.1207-1217
• Main Authors: Kamar, Nassim, Lepage, Benoit, Couzi, Lionel, Albano, Laetitia, Durrbach, Antoine, Pernin, Vincent, Esposito, Laure, Hebral, Anne Laure, Darres, Amandine, Lequintrec, Moglie, Cassuto, Elisabeth, Merville, Pierre, Congy, Nicolas, Del Bello, Arnaud
• Format: Article
• Language: English
• Subjects: basiliximab; Clinical Research; DSA; Grafalon; highly sensitized; Human health and pathology; induction therapy; Infectious diseases; kidney transplantation; Life Sciences
• ISSN: 2468-0249; 2468-0249
• DOI: 10.1016/j.ekir.2020.05.020

Two prospective studies that were performed before the era of highly sensitive solid-phase assays have shown a lower incidence of acute rejection in highly sensitized kidney-transplant patients given polyclonal antibodies compared with those given anti-CD25 monoclonal antibodies. This prospective pilot randomized French multicenter study aimed to compare anti–T-lymphocyte Ig (ATLG) (n = 32) and basiliximab (n = 27) in highly sensitized kidney-transplant patients without preformed donor-specific antibodies (pDSAs) as assessed by a Luminex Single-Antigen flow bead assay. Only patients with a calculated panel reactive antibody ≥50%, with at least 1 antibody with a mean fluorescence intensity ≥5000 and without a historical pDSA and without a pDSA on the day of transplantation were included. Treatment failure as defined by biopsy-proven acute rejection, patient lost to follow-up, graft loss, and death was observed in 18.8% (95% confidence interval [CI], 8.9%–37.1%) and 18.8% (95% CI, 8.9%–37.1%) in patients who received ATLG and 14.8% (95% CI, 5.8%–34.8%) and 28.2% (95% CI, 14.2%–51.2%) of patients who received basiliximab, respectively at 6 (P = 0.66) and 12 (P = 0.62) months post-transplantation. One T cell–mediated rejection was observed in ATLG-treated patients (3.1%). One antibody-mediated rejection due to a de novo donor-specific antibody (DSA) occurred in basiliximab-treated patients (3.7%). Patient survival, graft survival, kidney parameters, and infection rate were similar in the 2 groups. This pilot study indicates that in highly sensitized kidney-transplant patients without pDSAs, both ATLG and basiliximab can be used efficiently and safely. However, because of the lack of power, these results should be interpreted with caution. [Display omitted]