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Immunogenicity of Human Interferon-Beta-Containing Pharmaceuticals

V. D. Nazarov1*, S. V. Lapin1, A. V. Mazing1, E. P. Evdoshenko2, and A. A. Totolian1,3

1Center for Molecular Medicine, Pavlov First Saint Petersburg State Medical University, 197022 St. Petersburg, Russia; E-mail: Nazarov19932@mail.ru

2Saint Petersburg Center of Multiple Sclerosis and Autoimmune Diseases Clinical Hospital No. 31, 197110 St. Petersburg, Russia; E-mail: centerms@gmail.com

3Saint Petersburg Pasteur Research Institute of Epidemiology and Microbiology (St. Petersburg Pasteur Institute), 197101 St. Petersburg, Russia; E-mail: pasteur@pasteurorg.ru

* To whom correspondence should be addressed.

Received June 13, 2016; Revision received August 29, 2016
Multiple sclerosis is a severe autoimmune disease with inflammatory component that continues to be resistant to treatment. One of the approaches retarding its progression is based on using nonspecific therapy with human interferon-beta (IFN-β)-containing pharmaceuticals. Neutralizing antibodies (NAbs) against genetically engineered pharmaceuticals developed by the patient’s immune system, which reduce their therapeutic and biological activity, pose a serious problem. Cell lines sensitive to IFN-β activity also quantifying NAb level are applied because direct measurement of IFN-β antiviral activity is complicated. This study was aimed at standardization and validation of a reporter cell system for measuring anti-human IFN-β NAb titers, and evaluation data were obtained with samples from 33 patients with multiple sclerosis.
KEY WORDS: multiple sclerosis, immunogenicity, interferon-beta, neutralizing antibodies, titer

DOI: 10.1134/S000629791611016X