Fri0078 impact of the Implementation of Flush Serum on Trough Levels of Infliximab in Patients With Inflammatory Joint Disease

Abstract

Background:The administration of intravenous biological therapies is based on the manufacturer’s instructions and the administration guidelines of Spanish Medicine Agency. We observed that a considerable amount of the solution remains in the tubing of the equipment after the administration of the drug. This amount depends on the drug and the solution used for the infusion. In the particular case of Infliximab is around 7% of the total solution to infuse, so it could potentially have a relevant therapeutic impact.Objectives:To assess the variation in serum trough levels of Infliximab after the systematic application of flush physiological serum after drug administration.Methods:The study was divided into two phases: a first phase in which the clinical and analytical variables (including the serum trough levels of infliximab) were measured before the application of the flush serum and a second stage in which the same variables were measured after the systematic implementation of an infusion of 50ml of 0.9% sodium chloride following the administration of infliximab.Results:A total of 35 patients were collected, including 6 rheumatoid arthritis (13.3%), 9 psoriatic arthritis (20%) and 20 ankylosing spondylitis (AS) (44.4%). Overall, 18 patients were women (40%), the mean age was 57.6 years (12.6) and the BMI was 30.5 (13.1). The mean dose of infliximab was 4.3 mg/kg (1.1) and the mean number of years of treatment was 10 (5).23 patients were taking infliximab on monotherapy (51.1%). The mean serum trough levels of infliximab pre-intervention with the dragging serum was 3.13 mg/dl (3.1), while postintervention levels were 3.66 mg/dl (3.9) (p = 0.071). In the subgroup of patients with AS there was a significant decrease in BASDAI between the pre and post intervention visit (3.4 vs 2.6, p <0.05).Conclusion:The use of flush serum after infliximab infusion increased serum drug levels. In the subgroup of patients with AS there was a clinically significant improvement measured by BASDAI.References:[1] Ficha técnica de Inflectra®. Disponible en: https://cima.aemps.es/cima/pdfs/es/ft/98067002/FT_98067002.pdf[2] Ficha técnica de Remicade®. Disponible en: https://cima.aemps.es/cima/dochtml/ft/99116001/FT_99116001.html[3] Grupo de Trabajo de Enfermeria de la Sociedad Española de Reumatología (GTESER). Manual de terapias parenterales y procedimientos en el paciente reumatológico 2018. Madrid, 2018.[4] Herrero Massari F, Lozano Serrano V, Rodruiguez Arteaga E. Guía de Manejo de Fármacos Biológicos para Enfermería en los Hospitales de Día. 2010[5] Moots RJ1, Xavier RM2, Mok CC3, Rahman MU4, Tsai WC5, Al-Maini MH6, Pavelka K7, Mahgoub E4, Kotak S4, Korth-Bradley J4, Pedersen R4, Mele L4, Shen Q4, Vlahos B4. The impact of anti-drug antibodies on drug concentrations and clinical outcomes in rheumatoid arthritis patients treated with adalimumab, etanercept, or infliximab: Results from a multinational, real-world clinical practice, non-interventional study. PLoS One. 2017 Apr 27;12(4):e0175207. doi: 10.1371/journal.pone.0175207. eCollecti...