S Usuki1, S Uno2, H Sugamori2, H Tanaka2, A Aikawa3. 1. Astellas Pharma Inc., Tokyo, Japan. Electronic address: shoko.usuki@astellas.com. 2. Astellas Pharma Inc., Tokyo, Japan. 3. Department of Nephrology, Faculty of Medicine, Toho University, Tokyo, Japan.
Abstract
This study investigated the safety and effectiveness of conversion from cyclosporine- to prolonged-release tacrolimus (PR-T)-based immunosuppression in kidney transplant recipients (KTRs) in Japanese routine clinical practice. MATERIALS AND METHODS: This was a prospective observational study of stable KTRs who were converted from cyclosporine to PR-T according to local clinical practice. Clinical data were collected up to 12 months postconversion. Study outcomes included conversion dosing ratios, PR-T dose and trough levels, change in estimated glomerular filtration rate between conversion and month 12, graft/patient survival, and rejection rate (Kaplan-Meier). Outcomes of ongoing preconversion hypertrichosis, gingival hypertrophy, and cyclosporine-related renal toxicity were detailed. Data for adverse drug reactions were collected. RESULTS: Overall, 266 patients (mean ± SD age 51.9 ± 13.5 years) were included. The mean ± SD conversion ratio (PR-T:cyclosporine, mg:mg) was 0.029 ± 0.017. After an initial decrease between conversion and month 3, mean ± SD PR-T daily dose remained stable up to month 12 (2.4 ± 1.5 mg at months 3 and 12), as did tacrolimus trough blood levels (3.5 ± 1.8 vs 3.6 ± 1.7 ng/mL, respectively). Estimated glomerular filtration rate was stable over 12 months (mean ± SD change from conversion to month 12 was 0.3 ± 7.8 mL/min/1.73m2). Month 12 Kaplan-Meier patient and graft survival rates were 99.6% and 95.5%, respectively. Eight patients reported 9 rejection episodes. PR-T demonstrated potential to improve cyclosporine-related renal toxicity, hypertrichosis, and gingival hypertrophy. Postconversion, 46 adverse drug reactions were reported in 39 patients (14.7%); there was 1 death. CONCLUSIONS: Conversion from cyclosporine to PR-T in Japanese stable KTRs was effective and tolerable over 12 months, with low rates of rejection reported.
This study investigated the safety and effectiveness of conversion from cyclosporine- to prolonged-release tacrolimus (PR-T)-based immunosuppression in kidney transplant recipients (KTRs) in Japanese routine clinical practice. MATERIALS AND METHODS: This was a prospective observational study of stable KTRs who were converted from cyclosporine to PR-T according to local clinical practice. Clinical data were collected up to 12 months postconversion. Study outcomes included conversion dosing ratios, PR-T dose and trough levels, change in estimated glomerular filtration rate between conversion and month 12, graft/patient survival, and rejection rate (Kaplan-Meier). Outcomes of ongoing preconversion hypertrichosis, gingival hypertrophy, and cyclosporine-related renal toxicity were detailed. Data for adverse drug reactions were collected. RESULTS: Overall, 266 patients (mean ± SD age 51.9 ± 13.5 years) were included. The mean ± SD conversion ratio (PR-T:cyclosporine, mg:mg) was 0.029 ± 0.017. After an initial decrease between conversion and month 3, mean ± SD PR-T daily dose remained stable up to month 12 (2.4 ± 1.5 mg at months 3 and 12), as did tacrolimus trough blood levels (3.5 ± 1.8 vs 3.6 ± 1.7 ng/mL, respectively). Estimated glomerular filtration rate was stable over 12 months (mean ± SD change from conversion to month 12 was 0.3 ± 7.8 mL/min/1.73m2). Month 12 Kaplan-Meier patient and graft survival rates were 99.6% and 95.5%, respectively. Eight patients reported 9 rejection episodes. PR-T demonstrated potential to improve cyclosporine-related renal toxicity, hypertrichosis, and gingival hypertrophy. Postconversion, 46 adverse drug reactions were reported in 39 patients (14.7%); there was 1 death. CONCLUSIONS: Conversion from cyclosporine to PR-T in Japanese stable KTRs was effective and tolerable over 12 months, with low rates of rejection reported.