Real Life Evaluation of An In-Line System for Extracorporeal Photopheresis
DE FUSCO Giulia
Transfusion Medicine. Dell’Angelo General Hospital, Mestre (Venice), Italy.
POLESE Francesca
Transfusion Medicine. Dell’Angelo General Hospital, Mestre (Venice), Italy.
TIDORE Gianni
Transfusion Medicine. Dell’Angelo General Hospital, Mestre (Venice), Italy.
COLUCCIA Enza
Transfusion Medicine. Dell’Angelo General Hospital, Mestre (Venice), Italy.
GESSONI Gianluca *
Transfusion Medicine. Dell’Angelo General Hospital, Mestre (Venice), Italy.
*Author to whom correspondence should be addressed.
Abstract
Background: Extracorporeal Photopheresis (ECP) is considered as a first line therapy in erythrodermic Cutaneous T Cells Lymphoma (CTCL) and a consolidated second line treatment in steroid resistant Graft versus Host Disease (GvHD). ECP consists of collecting, using a cell separator, a small aliquot of a patient's mononuclear cells, sending them into apoptosis by treatment with 8-MOP and UVA rays and reinfusing them into the patient, inducing an immunomodulatory action whose precise mechanisms of action are not yet fully understood. There are two methods of performing ECP: “in-line” methods and “off-line” methods. For “in-line” methods, all the phases of ECP (leukapheresis, photo activation, reinfusion) are achieved sequentially in extracorporeal circulation using a single instrument and a single sterile disposable kit, without disconnection from patient’s blood circulation. In this paper we report our real-life experience with a recently licensed in-line ECP system proposed by Fresenius-Kabi.
Methods: ECP procedures (n=395) were performed in 21 patients using an Amicus cells separator and a Phelix UV irradiator with Amicus software 4.51 and Phelix software 1.0, with a targeted 2000 mL of whole blood (WB) processed and 1.5 J/cm2 of UVA light delivered to the collected mononuclear cells (MNCs). We evaluated the characteristics and costs of the adopted system, the functionality of the procedures performed, the characteristics of the products obtained. We also recorded the operational problems and adverse events that occurred.
Results: From September 2023 to April 2025, we performed 395 ECP procedures in 21 patients: 19 with GvHD and 2 with CTCL. Each patient underwent a median of 15 ECP procedures (IQR 12), the processed volume was 1992 mL (IQR 13 mL), the flow rate was 41 ml/min (IQR 15 ml/min), the CE2 was 71% (IQR 9%). The median cost was estimated at 885 Euro each ECP. We observed 8 (2%) adverse events.
Conclusions: In our experience the ECP procedure performed with the Amicus system was safe and well tolerated, as matter of facts we observed only few adverse events. Procedure duration was around two hours. Collection efficiency (CE2) for MNC was satisfactory with minimal RBC and platelets contamination.
Keywords: Cutaneous T cells lymphoma, extracorporeal photopheresis, graft versus host disease, In-line ECP