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Boyko A.N.

Pirogov Russian National Research Medical University;
Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency

Bakhtiyarova K.Z.

Bashkir State Medical University

Boyko O.V.

Federal Center for Brain Research and Neurotechnology

Dudin V.A.

Center for Cardiology and Neurology»

Zaslavsky L.G.

Pavlov First Saint Petersburg State Medical University

Malkova N.A.

State Novosibirsk Regional Clinical Hospital;
Novosibirsk State Medical University

Parshina E.V.

Semashko Nizhny Novgorod Regional Clinical Hospital

Poverennova I.Ye.

Seredavin Samara Regional Clinical Hospital

Sivertseva S.A.

Medical and Sanitary unit «Neftyanik»

Totolyan N.A.

Academician I.P. Pavlov First Saint Petersburg State Medical University

Shchur S.G.

Municipal Filatov Clinical Hospital No. 15

Khabirov F.A.

City Clinical Hospital No. 7;
Kazan State Medical Academy — Branch of the Russian Medical Academy of Continuing Professional Education

Goncharova Z.A.

Rostov State Medical University

Zakharova M.N.

Research Center of Neurology

Bolsun D.D.

AO BIOCAD

Zinkina-Orikhan A.V.

AO BIOCAD

Linkova Yu.N.

AO BIOCAD

Chernovskaya T.V.

JSC «BIOCAD»

Porozova A.A.

JSC «BIOCAD»

Long-term Efficacy and Safety of Sampeginterferon-β1a in the Treatment of Relapsing Remitting Multiple Sclerosis: a Randomized, Double-Blind Clinical Trial 104-Week Results

Authors:

Boyko A.N., Bakhtiyarova K.Z., Boyko O.V., Dudin V.A., Zaslavsky L.G., Malkova N.A., Parshina E.V., Poverennova I.Ye., Sivertseva S.A., Totolyan N.A., Shchur S.G., Khabirov F.A., Goncharova Z.A., Zakharova M.N., Bolsun D.D., Zinkina-Orikhan A.V., Linkova Yu.N., Chernovskaya T.V., Porozova A.A.

More about the authors

Journal: S.S. Korsakov Journal of Neurology and Psychiatry. 2023;123(2): 52‑59

DOI: 10.17116/jnevro202312302152

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Table of contents

LONG-TERM EFFICACY AND SAFETY OF SAMPEGINTERFERON-Β1A IN THE TREATMENT OF RELAPSING REMITTING MULTIPLE SCLEROSIS: A RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL 104-WEEK RESULTS
LONG-TERM EFFICACY AND SAFETY OF SAMPEGINTERFERON-Β1A IN THE TREATMENT OF RELAPSING REMITTING MULTIPLE SCLEROSIS: A RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL 104-WEEK RESULTS

To cite this article:

Boyko AN, Bakhtiyarova KZ, Boyko OV, et al. Long-term Efficacy and Safety of Sampeginterferon-β1a in the Treatment of Relapsing Remitting Multiple Sclerosis: a Randomized, Double-Blind Clinical Trial 104-Week Results. S.S. Korsakov Journal of Neurology and Psychiatry. 2023;123(2):52‑59. (In Russ.)
https://doi.org/10.17116/jnevro202312302152

Подписка 2026 Журнал неврологии и психиатрии им. С.С. Корсакова (S.S. Korsakov Journal of Neurology and Psychiatry)
МСФ на ЯМ
Использование инфографики авторами научных работ
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Abstract:

OBJECTIVE

To assess the efficacy and safety of sampeginterferon-β1a (samPEG-IFN-β1a) 180 μg and 240 μg administered once every 2 weeks compared to placebo and low dose interferon beta-1a (LIB) 30 μg administered once weekly.

MATERIAL AND METHODS

Patients with relapsing-remitting multiple sclerosis aged 18—60 years, with Expanded Disability Status Scale score ≤5.5 were randomized at a ratio of 2:2:2:1 to the following groups: samPEG-IFN-β1a 180 µg, samPEG-IFN-β1a 240 µg, LIB, placebo. After 20 weeks, the placebo group completed the study. After week 52, the final analysis was performed, which included the primary endpoint analysis, the LIB group patients completed their participation in the study. The patients in samPEG-IFN-β1a groups continued to receive therapy with samPEG-IFN-β1a 240 µg until week 100 inclusive. The results of the final analysis after 52 weeks have been previously published. The current article presents a long-term efficacy and safety of samPEG-IFN-β1a after 104 weeks of the trial.

RESULTS

The annualized relapse rate over the second year was 0.16 in the samPEG-IFN-β1a 180 μg group and 0.09 in the samPEG-IFN-β1a 240 μg group. By week 104, the proportion of relapse-free patients was 77.0% (87/113) and 83.3% (95/114) in the samPEG-IFN-β1a 180 μg and 240 μg groups, respectively. There were no negative dynamics of MRI markers, neurological deficit parameters and cognitive functions by scales and tests. The safety profile of samPEG-IFN-β1a was consistent with the known safety profile of IFN-β therapy.

CONCLUSION

Treatment with samPEG-IFN-β1a is an effective and safe first-line therapy for relapsing-remitting multiple sclerosis patients.

Keywords:

multiple sclerosis
relapsing-remitting multiple sclerosis
pegylated IFN-β
sampeginterferon-β1a

Authors:

Boyko A.N.

Pirogov Russian National Research Medical University;
Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency

Bakhtiyarova K.Z.

Bashkir State Medical University

Boyko O.V.

Federal Center for Brain Research and Neurotechnology

Dudin V.A.

Center for Cardiology and Neurology»

Zaslavsky L.G.

Pavlov First Saint Petersburg State Medical University

Malkova N.A.

State Novosibirsk Regional Clinical Hospital;
Novosibirsk State Medical University

Parshina E.V.

Semashko Nizhny Novgorod Regional Clinical Hospital

Poverennova I.Ye.

Seredavin Samara Regional Clinical Hospital

Sivertseva S.A.

Medical and Sanitary unit «Neftyanik»

Totolyan N.A.

Academician I.P. Pavlov First Saint Petersburg State Medical University

Shchur S.G.

Municipal Filatov Clinical Hospital No. 15

Khabirov F.A.

City Clinical Hospital No. 7;
Kazan State Medical Academy — Branch of the Russian Medical Academy of Continuing Professional Education

Goncharova Z.A.

Rostov State Medical University

Zakharova M.N.

Research Center of Neurology

Bolsun D.D.

AO BIOCAD

Zinkina-Orikhan A.V.

AO BIOCAD

Linkova Yu.N.

AO BIOCAD

Chernovskaya T.V.

JSC «BIOCAD»

Porozova A.A.

JSC «BIOCAD»

Received:

11.01.2023

Accepted:

16.01.2023

Close metadata

References:

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  4. Reuss R. PEGylated interferon beta-1a in the treatment of multiple sclerosis — an update. Biologics. 2013;7:131-138.  https://doi.org/10.2147/BTT.S29948
  5. Furber KL, Van Agten M, Evans C, et al. Advances in the treatment of relapsing-remitting multiple sclerosis: the role of pegylated interferon beta-1a. Degener Neurol Neuromusc Dis. 2017;7:47-60.  https://doi.org/10.2147/DNND.S71986
  6. Boyko AN, Bakhtiiarova KZ, Dudin VA, et al. The new pegylated interferon beta-1a (sampeginterferon beta-1a, BCD-054) in the treatment of remitting multiple sclerosis. Zhurnal Nevrologii i Psikhiatrii im. S.S. Korsakova. 2019;119(10-2):100-109. (In Russ.). https://doi.org/10.17116/jnevro201911910100
  7. Kieseier BC, Arnold DL, Balcer LJ, et al. Peginterferon beta-1a in multiple sclerosis: 2-year results from ADVANCE. Mult Scler. 2015;21(8):1025-1035. https://doi.org/10.1177/1352458514557986
  8. Vermersch P, Czlonkowska A, Grimaldi LM, et al. Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase3 trial. Mult Scler. 2014;20(6):705-716.  https://doi.org/10.1177/1352458513507821
  9. Maurelli M, Bergamaschi R, Antonini A, et al. Interferon-beta injection site reactions in patients with multiple sclerosis. J Dermatolog Treat. 2018;29(8):831-834.  https://doi.org/10.1080/09546634.2018.1467539
  10. Cohan SL, Hendin BA, Reder AT, et al. Interferons and Multiple Sclerosis: Lessons from 25 Years of Clinical and Real-World Experience with Intramuscular Interferon Beta-1a (Avonex). CNS Drugs. 2021;35(7):743-767.  https://doi.org/10.1007/s40263-021-00822-z
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