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Abstract Objective: Familial Mediterranean Fever (FMF) is an autoinflammatory disorder affecting people in the region of Mediterranean Sea. It is caused by mutations in the MEFV gene that encodes the pyrin protein which regulates the inflammatory response. The aim of the current study is to discuss the relationship between serum interleukin-4 (IL-4) and its gene polymorphism, namely rs79071878, and FMF occurrence, severity and response to treatment. Methods: Fifty Egyptian children diagnosed as having FMF were included in our study and were divided equally into two groups according to disease activity together with forty controls, age and sex- matched. Serum IL-4 levels were measured by enzyme linked immunosorbent assay (ELISA). The IL-4 rs79071878 polymorphism was determined by polymerase chain reaction (PCR) analysis. Results: There was no significant difference in genotype distribution of IL-4 gene rs79071878 between patients and controls(p=0.286) and had no correlation with FMF severity or response to colchicine therapy. Serum IL-4 level had no significant difference between children with FMF attack and those in attack-free period compared to controls (p= 0. 794) and had no correlation with any of demographic, or clinical characteristics, severity or response to colchicine therapy. Conclusion:Serum IL-4 level and its gene polymorphism had not significantly increased the risk of FMF, disease severity or response to treatment in the Egyptian children |