移植後の急性拒絶反応の抑制を目的としたBasiliximabの使用に関する全国実態調査

抄録

【Objective】 To evaluate the safety, effectiveness, and dose administration of basiliximab in suppressing acute rejection in organ transplants other than kidney transplants in Japan.

【Design】 A retrospective, multi-center, non-interventional chart review study.

【Methods】 Data were collected from patients who received basiliximab as induction therapy during organ transplantation (liver, heart, lung, small intestine, pancreas, and islet) between January 1, 2016, and December 31, 2020 (patients before 2016 were included for small intestine). The primary endpoint was the incidence of adverse events within six months post-transplant. Secondary endpoints included the evaluation of effectiveness over six months post-transplant for each organ transplant and administered dose of basiliximab.

【Results】 A total of 320 patients were included across organ transplant indications. The incidence of adverse events was 77.2%, with common events being anemia, increased AST/ALT/CRP, and CMV viremia. The incidence of adverse drug reactions was 30.6%, with severe reactions (Grade 3 or 4) reported in 10.9% and 4.7%, respectively. Acute rejection occurred in 23.1% of liver transplants and 50% of small intestine transplants, and with lower rates in other organ transplants. Basiliximab was administered at a total dose of 40 mg (or 20 mg in pediatric) in two divided doses of 20 mg (or 10 mg in pediatric) each, on the day of transplant and four days post-transplant.

【Conclusion】 Induction therapy using basiliximab could be considered applicable as the treatment option for organ transplants other than kidney transplants, with an acceptable safety and effectiveness profile.