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Boĭko A.N.

KGBUZ "Krasnoiarskiĭ kraevoĭ Tsentr po profilaktike i bor'be so SPID i infektsionnymi zabolevaniiami"

Bosenko L.P.

Regional Clinical Hospital, Kiev, Ukraine

Vasilovskiy V.V.

Institute of Neurology, Psychiatry and Narcology, Kharkov, Ukraine

Volkova L.I.

Ural State Medical Academy, Ekaterinburg

Zakharova M.N.

Nauchnyĭ tsentr nevrologii RAMN, Moskva

Kotov S.V.

Moskovskiĭ oblastnoĭ nauchno-issledovatel'skiĭ klinicheskiĭ institut im. M.F. Vladimirskogo

Lekomtseva E.V.

Institute of Neurology, Psychiatry and Narcology, Kharkov, Ukraine

Negrich T.I.

Regional Clinical Hospital, Lvov, Ukraine

Parshina E.V.

Patrusheva O.P.

Regional Clinical Hospital, Arkhangelsk, Russia

Prokopenko S.V.

Kafedra nervnykh bolezneĭ, traditsionnoĭ meditsiny Krasnoiarskogo gosudarstvennogo meditsinskogo universiteta im. prof. V.F. Voĭno-Iasenetskogo, Krasnoiarsk

Sazonov D.V.

FGBU "Federal'nyĭ nauchno-klinicheskiĭ tsentr spetsializirovannykh vidov meditsinskoĭ pomoshchi i meditsinskikh tekhnologiĭ FMBA Rossii", Moskva

Timchenko L.V.

Kraevaia klinicheskaia bol'nitsa #1 im. prof. S.V. Ochapovskogo, Krasnodar

Trinitatskiĭ Iu.V.

GBUZ "Rostovskaia oblastnaia klinicheskaia bol'nitsa", Rostov-na-Donu

Khabirov F.A.

Kazanskaia gosudarstvennaia meditsinskaia akademiia Minzdravsotsrazvitiia Rossii;
Respublikanskiĭ kliniko-diagnosticheskiĭ tsentr po demieliniziruiushchim zabolevaniiam Ministerstva zdravookhraneniia Respubliki Tatarstan, Kazan'

Khavunka M.Ya.

City Clinical Hospital №5, Lvov, Ukraine

Chichanovskaia L.V.

Kafedra nervnykh bolezneĭ, meditsinskoĭ genetiki i neĭrokhirurgii Tverskoĭ gosudarstvennoĭ meditsinskoĭ akademii

Sherman M.A.

Kirovskaia gorodskaia klinicheskaia bol'nitsa #1

Ivanov R.A.

JSC BIOCAD, St. Petersburg, Russia

Lin’kova Yu.N.

JSC «BIOCAD», St. Petersburg, Russia

Stukalina E.Yu.

JSC «BIOCAD», St. Petersburg, Russia

Zinkina-Orikhan A.V.

JSC «BIOCAD», St. Petersburg, Russia

Obukhova I.G.

JSC «BIOCAD», St. Petersburg, Russia

Efficacy, tolerability and safety of the treatment with teberif: the results of a 2-year randomized clinical trial of treatment naïve patients with remitting multiple sclerosis, who have not received DMT, after switching from other interferon β-1a

Authors:

Boĭko A.N., Bosenko L.P., Vasilovskiy V.V., Volkova L.I., Zakharova M.N., Kotov S.V., Lekomtseva E.V., Negrich T.I., Parshina E.V., Patrusheva O.P., Prokopenko S.V., Sazonov D.V., Timchenko L.V., Trinitatskiĭ Iu.V., Khabirov F.A., Khavunka M.Ya., Chichanovskaia L.V., Sherman M.A., Ivanov R.A., Lin’kova Yu.N., Stukalina E.Yu., Zinkina-Orikhan A.V., Obukhova I.G.

More about the authors

Journal: S.S. Korsakov Journal of Neurology and Psychiatry. 2019;119(2‑2): 73‑85

DOI: 10.17116/jnevro20191192273

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Table of contents

EFFICACY, TOLERABILITY AND SAFETY OF THE TREATMENT WITH TEBERIF: THE RESULTS OF A 2-YEAR RANDOMIZED CLINICAL TRIAL OF TREATMENT NAÏVE PATIENTS WITH REMITTING MULTIPLE SCLEROSIS, WHO HAVE NOT RECEIVED DMT, AFTER SWITCHING FROM OTHER INTERFERON Β-1A
EFFICACY, TOLERABILITY AND SAFETY OF THE TREATMENT WITH TEBERIF: THE RESULTS OF A 2-YEAR RANDOMIZED CLINICAL TRIAL OF TREATMENT NAÏVE PATIENTS WITH REMITTING MULTIPLE SCLEROSIS, WHO HAVE NOT RECEIVED DMT, AFTER SWITCHING FROM OTHER INTERFERON Β-1A

To cite this article:

Boĭko AN, Bosenko LP, Vasilovskiy VV, et al. . Efficacy, tolerability and safety of the treatment with teberif: the results of a 2-year randomized clinical trial of treatment naïve patients with remitting multiple sclerosis, who have not received DMT, after switching from other interferon β-1a. S.S. Korsakov Journal of Neurology and Psychiatry. 2019;119(2‑2):73‑85. (In Russ.)
https://doi.org/10.17116/jnevro20191192273

Подписка 2026 Журнал неврологии и психиатрии им. С.С. Корсакова. Спецвыпуски (S.S. Korsakov Journal of Neurology and Psychiatry (special issues))
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Recommended articles:
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Abstract:

Objectives. To evaluate efficacy, safety, and tolerability of the treatment with teberif/interferon β-1a, to analyze safety, tolerability and dynamics of key efficacy variables after switching from referent drug rebif to biosimilar teberif in patients with remitting multiple sclerosis (RMS). Material and methods. During the main period of the international multicenter randomized study patients were randomized to receive treatment with teberif for 52 weeks, or rebif for 52 weeks, or placebo for 16 weeks to evaluate efficacy and safety of treatment. After the main study period, patients were group-independently switched to take open-label teberif treatment during the next 48 weeks. Results and conclusion. The analysis of multiple evaluation parameters of the efficiency during the 1st study period (blinded) and the 2nd study period (open-label) has shown that teberif and rebif demonstrate equivalent efficacy and stable 2-year efficacy of teberif was proven. There were no significant differences between teberif and rebif for all safety, and tolerability parameters. Switching from rebif to teberif didn’t influence treatment efficacy. The 2-year study results confirmed a biosimilar teberif’s benign tolerability and expected safety profile to other interferons β-1a in patients with RMS.

Keywords:

remitting multiple sclerosis
interferon β-1a
BCD-033
teberif
biosimilar

Authors:

Boĭko A.N.

KGBUZ "Krasnoiarskiĭ kraevoĭ Tsentr po profilaktike i bor'be so SPID i infektsionnymi zabolevaniiami"

Bosenko L.P.

Regional Clinical Hospital, Kiev, Ukraine

Vasilovskiy V.V.

Institute of Neurology, Psychiatry and Narcology, Kharkov, Ukraine

Volkova L.I.

Ural State Medical Academy, Ekaterinburg

Zakharova M.N.

Nauchnyĭ tsentr nevrologii RAMN, Moskva

Kotov S.V.

Moskovskiĭ oblastnoĭ nauchno-issledovatel'skiĭ klinicheskiĭ institut im. M.F. Vladimirskogo

Lekomtseva E.V.

Institute of Neurology, Psychiatry and Narcology, Kharkov, Ukraine

Negrich T.I.

Regional Clinical Hospital, Lvov, Ukraine

Parshina E.V.

Patrusheva O.P.

Regional Clinical Hospital, Arkhangelsk, Russia

Prokopenko S.V.

Kafedra nervnykh bolezneĭ, traditsionnoĭ meditsiny Krasnoiarskogo gosudarstvennogo meditsinskogo universiteta im. prof. V.F. Voĭno-Iasenetskogo, Krasnoiarsk

Sazonov D.V.

FGBU "Federal'nyĭ nauchno-klinicheskiĭ tsentr spetsializirovannykh vidov meditsinskoĭ pomoshchi i meditsinskikh tekhnologiĭ FMBA Rossii", Moskva

Timchenko L.V.

Kraevaia klinicheskaia bol'nitsa #1 im. prof. S.V. Ochapovskogo, Krasnodar

Trinitatskiĭ Iu.V.

GBUZ "Rostovskaia oblastnaia klinicheskaia bol'nitsa", Rostov-na-Donu

Khabirov F.A.

Kazanskaia gosudarstvennaia meditsinskaia akademiia Minzdravsotsrazvitiia Rossii;
Respublikanskiĭ kliniko-diagnosticheskiĭ tsentr po demieliniziruiushchim zabolevaniiam Ministerstva zdravookhraneniia Respubliki Tatarstan, Kazan'

Khavunka M.Ya.

City Clinical Hospital №5, Lvov, Ukraine

Chichanovskaia L.V.

Kafedra nervnykh bolezneĭ, meditsinskoĭ genetiki i neĭrokhirurgii Tverskoĭ gosudarstvennoĭ meditsinskoĭ akademii

Sherman M.A.

Kirovskaia gorodskaia klinicheskaia bol'nitsa #1

Ivanov R.A.

JSC BIOCAD, St. Petersburg, Russia

Lin’kova Yu.N.

JSC «BIOCAD», St. Petersburg, Russia

Stukalina E.Yu.

JSC «BIOCAD», St. Petersburg, Russia

Zinkina-Orikhan A.V.

JSC «BIOCAD», St. Petersburg, Russia

Obukhova I.G.

JSC «BIOCAD», St. Petersburg, Russia

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References:

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  5. Cohen BA, Rivera VM. PRISMS: the story of a pivotal clinical trial series in multiple sclerosis. Curr Med Res Opin. 2010;26(4):827-838. https://doi.org/10.1185/03007991003604018
  6. Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O’Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011;69(2):292-302. https://doi.org/10.1002/ana.22366
  7. Chow S-C, Shao J, Wang H. Sample Size Calculations in Clinical Research. 2nd ed. Boca Raton (FL): Chapman & Hall/CRC; 2008. https://doi.org/10.1002/sim.3468
  8. Sorensen PS. Neutralizing antibodies against interferon-beta. Ther Adv Neurol Disord. 2008;1:62-78. https://doi.org/10.1177/1756285608095144
  9. Boyko AN, Bosenko LP, Vasilovskiy VV, Volkova LI, Zakharova MN, Kotov SV, Lekomtseva EV, Negrich TI, Parshina EV, Patrusheva OP, Prokopenko SV, Sazonov DV, Timchenko PV, Trinitatskiy YuV, Khabirov FA, Khavunka MYa, Chichanovskaya LV, Sherman MA, Lin’kova YuN, Zinkina-Orikhan AV, Tursunova KB. A comparative placebo-controlled clinical study on the efficacy and safety of interferon beta-1a for subcutaneous injections in patients with remitting multiple sclerosis: results of the first year of observations. Zhurnal Nevrologii i Psikhiatrii im. S.S. Korsakova. 2017;117(2):107-113. (In Russ.) https://doi.org/10.17116/jnevro201711722107-113
  10. Gold R, Rieckmann P, Chang P, Abdalla J. PRISMS Study Group. The long-term safety and tolerability of high-dose interferon beta-1a in relapsing-remitting multiple sclerosis: 4-year data from the PRISMS study. Eur J Neurol. 2005;12(8):649-656. https://doi.org/10.1111/j.1468-1331.2005.01083.x
  11. Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Lancet. 1998;352(9139):1498-1504. https://doi.org/10.1016/S0140-6736(98)03334-0
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