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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 P.V.

Ochapovsky Regional Clinical Hospital №1, Krasnodar, Russia

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

Lin’kova Yu.N.

JSC «BIOCAD», St. Petersburg, Russia

Zinkina-Orikhan A.V.

JSC «BIOCAD», St. Petersburg, Russia

Tursunova K.B.

Poliklinika #51;
Institut mozga cheloveka RAN, Sankt-Peterburg

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

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 P.V., Trinitatskiĭ Iu.V., Khabirov F.A., Khavunka M.Ya., Chichanovskaia L.V., Sherman M.A., Lin’kova Yu.N., Zinkina-Orikhan A.V., Tursunova K.B.

More about the authors

Journal: S.S. Korsakov Journal of Neurology and Psychiatry. 2017;117(2‑2): 107‑113

DOI: 10.17116/jnevro201711722107-113

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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
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

To cite this article:

Boĭko AN, Bosenko LP, Vasilovskiy VV, et al. . 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. S.S. Korsakov Journal of Neurology and Psychiatry. 2017;117(2‑2):107‑113. (In Russ.)
https://doi.org/10.17116/jnevro201711722107-113

Подписка 2025-2 (S.S. Korsakov Journal of Neurology and Psychiatry (special issues))
 
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Objective. To prove the equivalent efficacy of teberif (BCD-033, interferon beta-1) and rebif (interferon beta-1a) in patients with remitting multiple sclerosis (RMS). Material and methods. A multicenter double blind placebo-controlled comparative randomized III phase study included 163 patients with RMS. Patients were randomized into three equal groups (teberif, rebif or placebo). Results and conclusion. After 52 weeks, the equivalent efficacy of teberif and the brand drug rebif was shown. The result of assessment of the primary endpoint, which was combined unique active (CUA) lesion (the total of MRI T1-weighted lesions and new or newly enlarging T2-weighted lesions, without double counting of lesions with both activities), showed no significant differences (0.727±1.042 and 0.652±1.059 (p=0.7354, t-Student test) in the teberif and rebif groups, respectively. No between-group differences were found for other MRI indices and clinical parameters related with relapses. Teberif was shown to have a favorable safety and tolerability profile comparable to that of rebif. The results suggest the therapeutic equivalency of the drugs and form the basis for using the bioanalogue of interferon-beta 1 in patients with RMS.

Keywords:

remitting multiple sclerosis
interferon-beta 1
BCD-033
teberif

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 P.V.

Ochapovsky Regional Clinical Hospital №1, Krasnodar, Russia

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

Lin’kova Yu.N.

JSC «BIOCAD», St. Petersburg, Russia

Zinkina-Orikhan A.V.

JSC «BIOCAD», St. Petersburg, Russia

Tursunova K.B.

Poliklinika #51;
Institut mozga cheloveka RAN, Sankt-Peterburg

List of references:

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  2. Boĭko AN, Boĭko OV, Gusev EI. The choice of the optimal drug for pathogenic treatment of multiple sclerosis: a current state of the problem (a review). Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova. 2014;10(2):77-91.
  3. Blumhardt LD. Interferon beta-1a. In: Hawkins CP, Wolinsky JS, eds. Principles of Treatments in Multiple Sclerosis. Oxford: Butterworth Heinemann; 2000;38-70.
  4. PRISMS Study Group. Randomised double-blind placebo-controlled study of interferon beta-1 a in relapse-remitting multiple sclerosis. Lancet. 1998;352:1498-1504. doi:10.1185/03007991003604018
  5. ertolotto A, Deisenhammer F, Gallo P et al. Immunogenicity of interferon beta: differences among products. J Neurol. 2004;25(suppl 2):15-24. doi:10.1007/s00415-004-1204-7
  6. Sorensen PS. Neutralizing antibodies against interferon-beta. Ther Adv Neurol Disord. 2008;1:62-78. doi:10.1177/1756285608095144
  7. Antonetti H, Finocchiaro O, Mascia M et al. A comparison of the biologic activity of two recombinant IFN-beta preparations used in the treatment of relapsing — remitting multiple sclerosis. J Interferon Cytokine Res. 2002;22:1181-1184.
  8. Walther EU, Hohlfeld R. (November 1999). Multiple sclerosis: side effects of interferon beta therapy and their management. Neurology. 53(8):1622-1627. doi:10.1212/wnl.53.8.1622
  9. Polman CH, Reingold SC, Banwell B, Clanet M et al. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011;69(2):292-302.
  10. Sorensen FIS. Neutralizing antibodies against interferon-beta. Ther Adv Neurol Disord. 2008;1:62-78.

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