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Boyko A.N.

N.I. Pirogov Russian National Research Medical University;
Federal Center for Cerebrovascular Pathology and Stroke;
Neuro-Clinic LLC (Yusupov Hospital)

Bakhtiyarova K.Z.

Republican Clinical Hospital named after G.G. Kuvatov», Ufa, Russia

Dudin V.A.

Kirov Regional State Clinical Budgetary Healthcare Institution 'Cardiology and Neurology Centre', Kirov, Russia

Zaslavsky L.G.

State Budgetary Healthcare Institution 'Leningrad Regional Clinical Hospital', Saint Petersburg, Russia

Malkova N.A.

State Novosibirsk Regional Clinical Hospital

Parshina E.V.

Semashko Nizhny Novgorod Regional Clinical Hospital

Fedulov A.S.

State Institution 'Minsk Research and Development Centre of Surgery, Transplantology, and Haematology', Minsk, Republic Belarus

Zinkina-Orikhan A.V.

JSC «BIOCAD», St. Petersburg, Russia

Lin’kova Yu.N.

JSC «BIOCAD», St. Petersburg, Russia

Ivanov R.A.

JSC BIOCAD, Saint Petersburg, Russia

Chernovskaya T.V.

JSC 'BIOCAD', Saint Petersburg, Russia

The new pegylated interferon beta-1a (sampeginterferon beta-1a, BCD-054) in the treatment of remitting multiple sclerosis

Authors:

Boyko A.N., Bakhtiyarova K.Z., Dudin V.A., Zaslavsky L.G., Malkova N.A., Parshina E.V., Fedulov A.S., Zinkina-Orikhan A.V., Lin’kova Yu.N., Ivanov R.A., Chernovskaya T.V.

More about the authors

Journal: S.S. Korsakov Journal of Neurology and Psychiatry. 2019;119(10‑2): 100‑109

DOI: 10.17116/jnevro2019119102100

Views: 7981

Downloaded: 320

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To cite this article:

Boyko AN, Bakhtiyarova KZ, Dudin VA, et al. . The new pegylated interferon beta-1a (sampeginterferon beta-1a, BCD-054) in the treatment of remitting multiple sclerosis. S.S. Korsakov Journal of Neurology and Psychiatry. 2019;119(10‑2):100‑109. (In Russ.)
https://doi.org/10.17116/jnevro2019119102100

 
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Objective. To evaluate the efficacy and safety of BCD 054 180 μg and 240 μg administered once every 2 weeks for the treatment of remitting multiple sclerosis compared to placebo and low dose interferon beta-1a (LIB) 30 μg administered once weekly. Results of a 20 week blinded interim analysis from a double blind, comparative, randomised, placebo-controlled clinical study are included. Material and methods. This multinational, multicentre, double blind, comparative, placebo-controlled study enrolled 399 patients with the diagnosis of remitting multiple sclerosis: 114 patients in the sampeginterferon beta 1a and LIB groups each and 57 patients in the placebo group. To ensure the objectivity of data, the study protocol includes a blinded interim analysis to demonstrate the superiority of BCD 054 over placebo based on the number of combined unique active lesions (CUA) on MRI scans after 20 weeks of treatment. Results and conclusion. An integrated analysis of the efficacy, safety, pharmacokinetics, and pharmacodynamics was performed after 20 weeks of study. Mean CUA per scan was lower in the active treatment groups compared to placebo: 0,986±2,046, 0,619±1,055, 0,665±1,165, 1,673±2,376 (groups 1, 2, 3 and placebo group, respectively). The data for CUA per scan demonstrated the superiority of both BCD 054 180 μg and 240 μg over placebo. Patients receiving active treatment had fewer new and/or enlarging lesions after 20 weeks of treatment. The proportion of patients without new T2-weighted lesions was 74,3%, 86,7%, and 78,1% in groups 1, 2, and 3 compared to 64,9% in the placebo group. Manifestations of flu-like syndrome that is expected for interferon treatment were observed with the same incidence in all the active treatment groups. Its severity, duration or the need for symptomatic treatment did not appear to depend on the type of interferon used.

Keywords:

sampeginterferon beta-1a
multiple sclerosis
therapy
DMT
pegylated interferon beta-1a

Authors:

Boyko A.N.

N.I. Pirogov Russian National Research Medical University;
Federal Center for Cerebrovascular Pathology and Stroke;
Neuro-Clinic LLC (Yusupov Hospital)

Bakhtiyarova K.Z.

Republican Clinical Hospital named after G.G. Kuvatov», Ufa, Russia

Dudin V.A.

Kirov Regional State Clinical Budgetary Healthcare Institution 'Cardiology and Neurology Centre', Kirov, Russia

Zaslavsky L.G.

State Budgetary Healthcare Institution 'Leningrad Regional Clinical Hospital', Saint Petersburg, Russia

Malkova N.A.

State Novosibirsk Regional Clinical Hospital

Parshina E.V.

Semashko Nizhny Novgorod Regional Clinical Hospital

Fedulov A.S.

State Institution 'Minsk Research and Development Centre of Surgery, Transplantology, and Haematology', Minsk, Republic Belarus

Zinkina-Orikhan A.V.

JSC «BIOCAD», St. Petersburg, Russia

Lin’kova Yu.N.

JSC «BIOCAD», St. Petersburg, Russia

Ivanov R.A.

JSC BIOCAD, Saint Petersburg, Russia

Chernovskaya T.V.

JSC 'BIOCAD', Saint Petersburg, Russia

List of references:

  1. Pozzilli C, Prosperini L, Sbardella E, Paolillo A. Interferon after 10 years in patients with multiple sclerosis. Neurological Sciences. 2006;27(5):369-372. https://doi.org/10.1007/s10072-006-0697-5
  2. Salmon P, Le Cotonnec J-Y, Galazka A, Abdul-Ahad A, Darragh A. Pharmacokinetics and Pharmacodynamics of Recombinant Human Interferon-β in Healthy Male Volunteers. J Inreferon and Cytokine Research. 1996;16:759-764.
  3. Kieseier BC, Arnold DL, Balcer LJ, Boyko A, Pelletier J, Liu S, Zhu Y, Seddighzadeh A, Hung S, Deykin A, Sheikh SI, Calabresi PA. Peginterferon beta-1a in multiple sclerosis: 2-year results from ADVANCE. Mult Scler. 2015;21(8):1025-1035. https://doi.org/10.1177/1352458514557986
  4. Baker DP, Lin EY, Lin K, Pellegrini M, Petter RC, Chen LL, Arduini RM, Brickelmaier M, Wen D, Hess DM, Chen L, Grant D, Whitty A, Gill A, Lindner DJ, Pepinsky RB. Nterminally PEGylated human interferon-beta-1a with improved pharmacokinetic properties and in vivo efficacy in a melanoma angiogenesis model. Bioconjug Chem. 2006;17:179-188.
  5. Kappos L, Wiendl H, Selmaj K, Arnold DL, Havrdova E, Boyko A, Kaufman M, Rose J, Greenberg S, Sweetser M, Riester K, O’Neill G, Elkins J. Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis. The New England Journal of Medicine. 2015;373(15):1418-1428. https://doi.org/10.1056/NEJMoa1501481
  6. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Published: May 28, 2009 (v4.03: June 14, 2010) U.S. Department of health and human services National Institutes of Health National Cancer Institute. https://www.eortc.be/services/doc/ctc/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf

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