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Zh Nevrol Psikhiatr Im S S Korsakova. 2017;117(2. Vyp. 2):107-113. doi: 10.17116/jnevro201711722107-113.

[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].

[Article in Russian; Abstract available in Russian from the publisher]

Author information

1
Pirogov Russian National Research Medical University, Moscow, Russia.
2
Regional Clinical Hospital, Kiev, Ukraine.
3
Institute of Neurology, Psychiatry and Narcology, Kharkov, Ukraine.
4
Regional Clinical Hospital #1, Yekaterinburg, Russia.
5
Neurology Research Center, Moscow, Russia.
6
Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.
7
Regional Clinical Hospital, Lvov, Ukraine.
8
N.A. Semashko Nizhny Novgorod Regional Clinical Hospital, Nizhny Novgorod, Russia.
9
Regional Clinical Hospital, Arkhangelsk, Russia.
10
Krasnoyarsk State Medical University n.a. professor V.F. Voyno-Yasenetsky of Ministry of Health' Krasnoyarsk, Russia.
11
'Siberian Regional Medical Center', Novosibirsk, Russia.
12
Ochapovsky Regional Clinical Hospital #1, Krasnodar, Russia.
13
Rostov Regional Hospital, Rostov-on-Don, Russia.
14
Republican Neurological Center, Kazan, Russia.
15
City Clinical Hospital #5, Lvov, Ukraine.
16
Tver State Medical University, Tver, Russia.
17
City Clinical Hospital #1, Kirov, Russia.
18
JSC 'BIOCAD', St. Petersburg, Russia.

Abstract

in English, Russian

AIM:

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:

BCD-033; interferon-beta 1; remitting multiple sclerosis; teberif

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