Abstract
This report describes the results of 2 international randomized trials (total of 508 kidney transplant recipients). The primary objective was to assess the noninferiority of rabbit anti-thymocyte globulin (rATG, Thymoglobulin®) versus interleukin-2 receptor antagonists (IL2RAs) for the quadruple endpoint (treatment failure defined as biopsy-proven acute rejection, graft loss, death, or loss to follow-up) to serve as the pivotal data for United States (US) regulatory approval of rATG. The pooled analysis provided an incidence of treatment failure of 25.1% in the rATG and 36.0% in the IL2RA treatment groups, an absolute difference of −10.9% (95% confidence interval [CI] −18.8% to −2.9%) supporting noninferiority (noninferiority margin was 10%) and superiority of rATG to IL2RA. In a meta-analysis of 7 trials comparing rATG with an IL2RA, the difference in the proportion of patients with BPAR at 12 months was −4.8% (95% CI −8.6% to −0.9%) in favor of rATG. In conclusion, a rigorous reanalysis of patient-level data from 2 prior randomized, controlled trials comparing rATG versus IL-2R monoclonal antibodies provided support for regulatory approval for rATG for induction therapy in renal transplant, making it the first T cell–depleting therapy approved for the prophylaxis of acute rejection in patients receiving a kidney transplant in the United States.
Original language | English (US) |
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Pages (from-to) | 2252-2261 |
Number of pages | 10 |
Journal | American Journal of Transplantation |
Volume | 19 |
Issue number | 8 |
DOIs | |
State | Published - Aug 2019 |
Keywords
- autoimmunity
- clinical research/practice
- clinical trial
- immunosuppressant – polyclonal preparations: rabbit antithymocyte globulin
- immunosuppression/immune modulation
- immunosuppressive regimens – induction
- kidney (allograft) function/dysfunction
- kidney transplantation/nephrology
ASJC Scopus subject areas
- Immunology and Allergy
- Transplantation
- Pharmacology (medical)