ABSTRACT
Objectives
In TRANSFORM, de novo kidney transplant recipients received either everolimus in combination with reduced-exposure calcineurin inhibitor (EVR+rCNI) at standard EVR pre-dose concentrations of 3–8 ng/mL or mycophenolic acid plus standard-exposure CNI (MPA+sCNI). The authors analyzed the incidence of wound healing adverse events (WHAEs) over the 2-year study period Citation15.
Methods
Patients were randomized to either EVR+rCNI or MPA+sCNI, both combined with induction therapy and steroids Citation19.
Results
The safety population consisted of 2,026 patients (EVR+rCNI: 1,014, MPA+sCNI: 1,012). The proportion of patients with at least 1 WHAE was comparable between EVR+rCNI and MPA+sCNI treatment groups [20.6% vs. 17.3%; risk ratio (RR): 1.19; 95% confidence interval (CI): 0.99, 1.43] at month 24. The numerical difference between EVR+rCNI and MPA+sCNI was mainly caused by an increased proportion of EVR patients with lymphocele and wound dehiscence [7.5% vs. 5.1% (RR: 1.46; 95% CI: 1.04, 2.05) and 3.9% vs. 1.8% (RR: 2.22; 95%CI: 1.28, 3.84), respectively] Citation20.
Conclusion
The immediate introduction of EVR+rCNI after kidney transplantation was associated with an overall comparable incidence of WHAEs versus current standard-of-care over the 24-month study period. There was an increased relative risk of experiencing lymphocele and wound dehiscence but the absolute risks were rather low in both groups Citation21.
CT.gov identifier
NCT01950819.
Acknowledgments
The manuscript was prepared with assistance from a professional medical writer (Edgar A. Mueller, 3P Consulting), funded by Novartis.
Authors’ contributions
All authors except Peter Bernhardt and Maria Pilar Hernandez Gutierrez participated in the performance of the research (i.e. they recruited patients, collected data and participated in data analysis/interpretation). Maria Pilar Hernandez Gutierrez provided statistical support. Peter Bernhardt provided medical input and was involved in designing the study. All authors critically reviewed the manuscript and approved the final version for publication.
Declaration of interest
F Citterio has received consulting honoraria and travel grants from Novartis, Astellas, Pfizer and Bristol Myers Squibb. M Henry has received consulting honoraria from Novartis. MP Hernandez Gutierrez and P Bernhardt are employees of Novartis. Y Watarai has received consulting honoraria and travel grants from Novartis, Astellas and Chugai Pharma. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials in the manuscript apart from those disclosed.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Supplementary material
Supplemental data for this article can be accessed here.