Pretransplantation GAD-autoantibody status to guide prophylactic antibody induction therapy in simultaneous pancreas and kidney transplantation
Ringers J, van der Torren CR, et al.Transplantation 2013; 96(8): 745-52
Aims
To assess the safety and efficacy of daclizumab or antithymocyte clobulin (ATG) prohylaxis in combination with triple immunotherapy in simultaneous pancreas-kidney transplant recipients (SPKT).
Interventions
Patients received prophylactic therapy with either daclizumab or a single bolus of ATG-Fresenius.
Participants
39 type 1 diabetic patients scheduled for primary SPKT.
Outcomes
The study outcomes were the incidence of early (<6 months) and steroid resistant acute rejection episodes and time to first rejection after induction therapy. Secondary outcomes included the timing of rejection episodes, graft and patient survival, long term follow up, autoimmunity, and immune phenotyping.
Follow-up
3 years.
CET Conclusions
Both ATG and Daclizumab reduced acute rejection rates compared to no induction. ATG and Daclizumab reduced acute rejection rates similarly, except in the case of pre-existing, circulating GAD auto-antibodies (anti-islet antibodies); in this scenario ATG was significantly better at reducing acute rejection. Three-year graft and patient survival were comparable between all groups.
Data analysis
Modified intention-to-treat analysis
Trial registration
Current Controlled Trials - ISRCTN44138942