Abstract
BackgroundData on real-world use of everolimus (EVR) in Japanese maintenance kidney transplant (KTx) patients are limited. This post-marketing surveillance study was conducted to assess the safety and effectiveness of EVR, and identify factors affecting renal impairment.MethodsAdult maintenance KTx patients were enrolled within 14 days of initiating EVR. Patient medical data were collected using electronic data capture case report forms at 6 months, 1, and 2 years after initiating EVR, or at discontinuation.ResultsAll patients receiving EVR in Japan during the surveillance period were enrolled (N = 263). Mean time from transplantation to EVR initiation was 75.7 months. Decreased renal function (31.56%) was the primary reason for initiating EVR. In combination with EVR, the mean daily dose of tacrolimus and cyclosporine could be reduced to ~ 79 and ~ 64%, by 2 years, respectively. Incidences of serious adverse events and adverse drug reactions were 15.97 and 49.43%, respectively. Two-year graft survival rate was 95.82% and low in patients with baseline estimated glomerular filtration rate (eGFR; modification of diet in renal disease) < 30 mL/min/1.73 m2 (69.57%; P < 0.0001) and urinary protein/creatinine ratio (UPCR) ≥ 0.55 g/gCr (84.21%; P = 0.0206). Throughout the survey, mean eGFR values were stable (> 55 mL/min/1.73 m2). Renal impairment was influenced by patient and donor age, eGFR, and UPCR at baseline.ConclusionsNo new safety concerns for the use of EVR in adult maintenance KTx patients were identified. Early EVR initiation may be considered in these patients before renal function deterioration occurs.
Highlights
Current immunosuppressive protocols with calcineurin inhibitors (CNIs) provide good short-term efficacy but their long-term use is associated with chronic nephrotoxicity [1, 2], CNI arteriolopathy [3], diabetes [4, 5], and cardiovascular complications [6]
Adverse events (AEs) were the primary reason for EVR discontinuation and the most common adverse drug reactions (ADRs) reported were stomatitis, proteinuria, hyperlipidemia, and peripheral edema
Even though blood CNI concentrations were measured at various time points, mean CNI C0 levels were not reported due to a lack of data
Summary
Current immunosuppressive protocols with calcineurin inhibitors (CNIs) provide good short-term efficacy but their long-term use is associated with chronic nephrotoxicity [1, 2], CNI arteriolopathy [3], diabetes [4, 5], and cardiovascular complications [6]. Several studies have reported the efficacy and safety of everolimus (EVR) as a maintenance immunosuppressant in kidney transplant (KTx) patients [10,11,12,13,14]. In a previous post-marketing surveillance (PMS) study in Japan, efficacy and safety of EVR in both de novo and maintenance KTx patients was reported up to 2 years. The current PMS study was planned to assess the safety and effectiveness of EVR in adult maintenance KTx patients and to identify factors responsible for subsequent renal impairment. Data on real-world use of everolimus (EVR) in Japanese maintenance kidney transplant (KTx) patients are limited. This post-marketing surveillance study was conducted to assess the safety and effectiveness of EVR, and identify factors affecting renal impairment. EVR initiation may be considered in these patients before renal function deterioration occurs
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