Safety and Efficacy of Real-World Use of Everolimus for Kidney Transplant Patients: Post-Marketing Surveillance in Japan
1Sapporo City General Hospital, Sapporo, Japan
2Nagoya Daini Red Cross Hospital, Nagaya, Japan
3Osaka City University, Osaka, Japan
4Novartis Pharma K.K., Tokyo, Japan.
Meeting: 2018 American Transplant Congress
Abstract number: B134
Keywords: Immunosuppression, Kidney transplantation, Safety
Session Information
Session Name: Poster Session B: Kidney Immunosuppression: Induction Therapy
Session Type: Poster Session
Date: Sunday, June 3, 2018
Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-7:00pm
Location: Hall 4EF
Background and purpose: After the approval of everolimus (EVR) in 2011 in Japan to prevent organ rejection in kidney transplant (KTx) patients, no data on real-world use for Japanese KTx patients has been reported. In accordance with the Good Post Surveillance Practice ordinance of the Ministry of Health, Labor and Welfare, a drug use surveillance was conducted to evaluate the safety and efficacy of EVR in KTx patients.
Method: An open-label, prospective, observational post-marketing surveillance study was conducted across 27 institutes nationwide, with the observation period of up to 2 years after the start of the treatment with EVR.
Result: A total of 315 de novo and maintenance KTx patients, including 86 immunologically high risk patients such as ABO incompatible KTx patients (27%), were enrolled. The mean age was 49.0 years and the median time after transplantation to introduction of EVR was 11.0 months. The incidence of adverse drug reactions (ADRs; disorders, symptoms, and abnormal laboratory findings for which a causal relationship to EVR cannot be ruled out) of EVR was 53.02%(167/315 patients), half of which occurred within 3 months after the start of the drug treatment (28.89%, 91/315). ADRs with an incidence of ≥5% were stomatitis, hyperlipidemia and proteinuria. The incidence of ADRs was higher in a population who started EVR treatment over 10 years after transplantation (62.86%, 22/35), though the results by time after transplantation were not statistically different compared to all categories (p=0.2121). Patient and graft survival rates were 99.05% and 98.1%, respectively. Rejection rate was 7.94%, half of which were observed in patients who started EVR treatment within 1 month after transplantation (15/108). No difference in rejection rate was seen in ABO incompatible patients compared to ABO compatible/mismatch patients (9.30% vs 8.38%/4.84%, p=0.9980). However, rejection rate was statistically different by MHC-DR type with 1.69% (1/59), 8.38 (14/167), and 15.15% (10/66) in patients with 0, 1, and 2 mismatch, respectively (p=0.0073).
Conclusion: The safety results in the surveillance showed no newly identified safety concern in patients who have received EVR in clinical practice in Japan. The good efficacy of EVR was observed in the majority of the patients including ABO incompatible patients.
CITATION INFORMATION: Harada H., Watarai Y., Uchida J., Kamisawa O. Safety and Efficacy of Real-World Use of Everolimus for Kidney Transplant Patients: Post-Marketing Surveillance in Japan Am J Transplant. 2017;17 (suppl 3).
To cite this abstract in AMA style:
Harada H, Watarai Y, Uchida J, Kamisawa O. Safety and Efficacy of Real-World Use of Everolimus for Kidney Transplant Patients: Post-Marketing Surveillance in Japan [abstract]. https://atcmeetingabstracts.com/abstract/safety-and-efficacy-of-real-world-use-of-everolimus-for-kidney-transplant-patients-post-marketing-surveillance-in-japan/. Accessed May 16, 2025.« Back to 2018 American Transplant Congress