Premium
Safety and efficacy of eculizumab for the prevention of antibody‐mediated rejection after deceased‐donor kidney transplantation in patients with preformed donor‐specific antibodies
Author(s) -
Glotz Denis,
Russ Graeme,
Rostaing Lionel,
Legendre Christophe,
Tufveson Gunnar,
Chadban Steve,
Grinyó Josep,
Mamode Nizam,
Rigotti Paolo,
Couzi Lionel,
Büchler Matthias,
Sandrini Silvio,
Dain Bradley,
Garfield Mary,
Ogawa Masayo,
Richard Tristan,
Marks William H.
Publication year - 2019
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/ajt.15397
Subject(s) - medicine , eculizumab , thymoglobulin , immunosuppression , transplantation , surgery , kidney transplantation , clinical endpoint , gastroenterology , clinical trial , antibody , immunology , complement system
The presence of preformed donor‐specific antibodies in transplant recipients increases the risk of acute antibody‐mediated rejection ( AMR ). Results of an open‐label single‐arm trial to evaluate the safety and efficacy of eculizumab in preventing acute AMR in recipients of deceased‐donor kidney transplants with preformed donor‐specific antibodies are reported. Participants received eculizumab as follows: 1200 mg immediately before reperfusion; 900 mg on posttransplant days 1, 7, 14, 21, and 28; and 1200 mg at weeks 5, 7, and 9. All patients received thymoglobulin induction therapy and standard maintenance immunosuppression including steroids. The primary end point was treatment failure rate, a composite of biopsy‐proved grade II / III AMR (Banff 2007 criteria), graft loss, death, or loss to follow‐up, within 9 weeks posttransplant. Eighty patients received transplants (48 women); the median age was 52 years (range 24‐70 years). Observed treatment failure rate (8.8%) was significantly lower than expected for standard care (40%; P < .001). By 9 weeks, 3 of 80 patients had experienced AMR , and 4 of 80 had experienced graft loss. At 36 months, graft and patient survival rates were 83.4% and 91.5%, respectively. Eculizumab was well tolerated and no new safety concerns were identified. Eculizumab has the potential to provide prophylaxis against injury caused by acute AMR in such patients (Eudra CT 2010‐019631‐35).