Designing of an ELISA Method for the Measurement of Serum Antibodies against Interferon-beta and the Study of the Frequency of these Antibodies in Patients with Multiple Sclerosis Treated with CinnoVex

Document Type : Original Article (s)

Authors

1 MSc Student, Department of Immunology, School of Medicine AND Student Research Committee, Isfahan University of Medical Sciences, Isfahan, Iran

2 Associate Professor, Department of Neurology, School of Medicine AND Neuroscience Research Center, Isfahan University of Medical Sciences, Isfahan, Iran

3 Assistant Professor, Department of Immunology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran

Abstract

Background: Multiple sclerosis (MS) is a demyelinating disease of the central nervous system. Interferon-beta (IFN-β) was the first disease modifying drug to be approved for the treatment of MS. Some MS patients treated with IFN-β develop antibodies to the drug. Anti-IFN-β antibodies can reduce both bioactivity and clinical efficacy of IFN-β. The objective of this study was to develop an enzyme-linked immunosorbent assay (ELISA) method for the measurement of anti-IFN-β antibodies in MS patients treated with CinnoVex (a recombinant Interferon beta 1-a). Methods: An Indirect ELISA protocol was developed and validated for the measurement of anti-IFN-β antibodies. Sera were studied for anti-IFN-β antibodies from 40 healthy individuals and 42 MS patients treated with CinnoVex for at least 6 months. Findings: Patients were considered positive for Anti-IFN-β antibodies, if they had a positive sample with an optical density of more than 1.2. Anti-IFN-β antibodies were found in 12 MS patients treated with CinnoVex. 31.1% of MS patients treated with CinnoVex developed anti-IFN-β antibodies. Conclusion: ELISA is a simple, fast and inexpensive test for the assessment of anti-IFN-β antibodies in MS patients treated with IFN-β. Keywords: Multiple sclerosis, Interferon beta 1a, Antibodies, Enzyme-linked immunosorbent assay