Abstract

Background: Cyclosporine (CSA) is required as a prophylaxis of graft-versus-host disease (GVHD) following allogeneic haematopoietic stem cell transplant (HSCT). However, subtherapeutic CSA concentration will increase the incidence of acute GVHD which is one of the major concerns. Objective: This study aims to identify the incidence of patients who achieved therapeutic initial CSA level with a standard intravenous CSA dose of 1.5 mg/kg BD, the occurrence of acute GVHD and factors associated with subtherapeutic CSA at the initial concentration in post-HSCT patients. Method: A retrospective single-centred study was conducted which involved 69 patients who underwent allogeneic HSCT between January 2020 and December 2020 in Hospital Ampang. The factors assessed were patients’ demographics, concurrent medications, liver and renal functions. Mann-Whitney test, Kruskal Wallis test and Spearman correlation test were used to identify the factors associated with sub-therapeutic CSA initial concentration. Result: 17.4% had therapeutic initial CSA level (200-400 ng/mL) and among 69 patients, 37.7% of them developed acute GVHD post-transplantation. Besides, only ethnicity and serum creatinine significantly affected the initial CSA levels. There was no significant association between the initial CSA level and the occurrence of acute GVHD. Conclusion: With the standard intravenous CSA dose of 1.5 mg/kg BD, only 17.4% were able to achieve a therapeutic initial CSA level due to the drug pharmacokinetic variability in different individuals. Hence, this study served as a baseline study for the future prospective clinical study to develop a population pharmacokinetic model in optimising the intravenous CSA dose to achieve the desired therapeutic range and improve the transplant outcomes.

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