Rabbit-ATG or basiliximab induction for rapid steroid withdrawal after renal transplantation (Harmony): an open-label, multicentre, randomised controlled trial

Thomusch, Oliver; Wiesener, Michael S.; Opgenoorth, Mirian; Pascher, Andreas; Woitas, Rainer P.; Witzke, Oliver; Jaenigen, Bernd; Rentsch, Markus; Wolters, Heiner; Rath, Thomas; Cingöz, Tülay; Benck, Urs; Banas, Bernhard; Hugo, Christian

doi:10.1016/s0140-6736(16)32187-0

Cited by 133 publications

(137 citation statements)

References 34 publications

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“…In our cohort, corticosteroid withdrawal showed a beneficial effect on glucose metabolism without compromising allograft outcome. This is in line with the recently published HARMONY trial [40]. However, studies investigating the benefit of corticosteroid withdrawal or avoidance for PTDM risk yielded conflicting results [41].…”

Section: Discussionsupporting

confidence: 81%

Dynamics of Glucose Metabolism After Kidney Transplantation

Guthoff¹,

Wagner²,

Weichbrodt³

et al. 2017

Kidney Blood Press Res

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Background/Aims: Posttransplantation diabetes mellitus (PTDM) impacts patient and allograft survival after kidney transplantation. Prediabetes, which is an independent risk factor for PTDM, is modifiable also in a post-transplant setting. Understanding the risks and dynamics of impaired glucose metabolism after transplantation is a key component for targeted intervention. Methods: A retrospective chart analysis of all adult non-diabetic renal allograft recipients (n=251, 2007-2014) was performed. Longitudinal follow-up included fasting plasma glucose and HbA1c, as well as data on allograft function and immunosuppression at consecutive time points (months 3-6 to >5 years post transplantation). Results: Throughout follow-up, median prevalence of prediabetes and PTDM was 53.3 [52.4-55.7]% and 15.4 [15.0-16.5]%, respectively. Continuously high fluxes between states of glucose metabolism, with individual patients’ state deteriorating or improving over time, resulted in a high number of incident patients even long after transplantation. The greatest number of patients shifted between normal glucose tolerance and prediabetes, followed by those between prediabetes and PTDM. Conclusion: Prediabetes and PTDM are highly prevalent after kidney transplantation and incidences remain relevant throughout follow-up. Patient fluxes into and out of the prediabetic state show that glucose metabolism is highly dynamic after transplantation. This provides a continuous opportunity for intervention in an aim to reduce diabetes-associated complications.

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Section: Discussionsupporting

confidence: 81%

Dynamics of Glucose Metabolism After Kidney Transplantation

Guthoff¹,

Wagner²,

Weichbrodt³

et al. 2017

Kidney Blood Press Res

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“…In the cyclosporin era, studies reported an increased rate of acute rejection (AR) and graft loss after steroid withdrawal compared with those after CSM . However, more recent immunosuppressive regimens have made SWA more feasible, and the safety of SWA therapy has been confirmed in patients receiving a calcineurin inhibitor or mycophenolate mofetil and induction with an IL‐2 receptor antagonist, alemtuzumab, or a polyclonal antibody [rabbit antithymocyte globulin (ATG)] . Recently, meta‐analyses, including trials conducted with new immunosuppressants, have corroborated the aforementioned finding that there was no difference in graft survival between patients on CSM and those on a steroid‐sparing protocol …”

Section: Introductionmentioning

confidence: 99%

Steroid withdrawal or avoidance is safe in high‐risk kidney transplants: A systematic review and meta‐analysis

Song

Jiang

Liu

et al. 2019

The Kaohsiung J of Med Scie

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The present study is aimed to assess the safety and efficacy of steroid withdrawal or avoidance (SWA) in high‐risk kidney transplant (HRKT). We performed a systematic review of the literature and pooled analysis of the available data concerning SWA following HRKT. HRKT is associated with patients undergoing repeat kidney transplantation, in African American recipients, or in patients with panel‐reactive antibody levels >20%. Seven cohort studies and one randomized controlled trial, involving a total of 22 075 patients, were included. Pooled analysis to estimate the risk ratio (RR) and 95% confidence interval (CI) demonstrated comparable graft loss (RR = 0.91, 95% CI 0.76‐1.09) between the SWA and corticosteroid maintenance groups, but with reduced mortality in the SWA group (RR = 0.90, 95% CI 0.84‐0.98). A subanalysis suggested that SWA was not associated with increased graft loss in patients undergoing steroid withdrawal within 1 week of transplantation, in African American recipients, or in patients with follow‐up >5 years. Additionally, SWA was associated with reduced death in those undergoing withdrawal within 1 week (RR = 0.90, 95% CI 0.84‐0.98), in African Americans (RR = 0.90, 95% CI 0.83‐0.98), and in those with follow‐up extended to >5 years (RR = 0.91, 95% CI 0.84‐0.98). SWA was not associated with an increased risk of acute rejection (RR = 0.95, 95% CI 0.75‐1.21) or cytomegalovirus infection (RR = 1.86, 95% CI 1‐3.47); however, it was associated with a reduced risk of posttransplant diabetes mellitus (RR = 0.60, 95% CI 0.37‐0.97). SWA following HRKT is safe in terms of graft survival and rejection, and patients undergoing an SWA regimen had a lower risk of death and posttransplant diabetes mellitus. Future prospective studies are required to confirm these findings.

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“…CNI withdrawal, similarly, confers a higher risk of acute rejection (but not graft failure) . In patients with a low immunological risk profile, rapid steroid withdrawal has been nevertheless shown to be achievable after basiliximab or rabbit antithymocyte globulin induction therapy, with less post‐transplantation diabetes …”

Section: Maintenance Immunosuppression Therapymentioning

confidence: 99%