Wound healing adverse events in kidney transplant recipients receiving everolimus with reduced calcineurin inhibitor exposure or current standard-of-care: insights from the 24-month TRANSFORM study. Issue 10 (2nd October 2020)

• Record Type: Journal Article
• Authors: Citterio, Franco; Henry, Mitchell; Kim, Dean Y; Kim, Myoung Soo; Han, Duck-Jong; Kenmochi, Takashi; Mor, Eytan; Tisone, Giuseppe; Bernhardt, Peter; Hernandez Gutierrez, Maria Pilar; Watarai, Yoshihiko
• Is Part Of: Expert opinion on drug safety. Volume 19:Issue 10(2020)
• Page Start: 1339
• Page End: 1348
• Publication Date: 2020-10-02
• Subjects: Calcineurin inhibitor -- everolimus -- kidney transplantation -- randomized -- safety -- wound healing; Drugs -- Side effects -- Periodicals; Drugs -- Toxicology -- Periodicals; Chemotherapy -- Periodicals; 615.704
• DOI: 10.1080/14740338.2020.1792441
• Languages: English
• ISSNs: 1474-0338

Abstract

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 15 . Methods: Patients were randomized to either EVR+rCNI or MPA+sCNI, both combined with induction therapy and steroids 19 . 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] 20 . 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 21 . CT.gov identifier: NCT01950819.