[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].

Autor:	Boyko AN; Pirogov Russian National Research Medical University, Moscow, Russia., Bosenko LP; Regional Clinical Hospital, Kiev, Ukraine., Vasilovskiy VV; Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine, Kharkov, Ukraine., Volkova LI; Regional Clinical Hospital #1, Yekaterinburg, Russia., Zakharova MN; Neurology Research Center, Moscow, Russia., Kotov SV; Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia., Lekomtseva EV; Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine, Kharkov, Ukraine., Negrich TI; Regional Clinical Hospital, Lvov, Ukraine., Parshina EV; Semashko Nizhny Novgorod Regional Clinical Hospital, Nizhny Novgorod, Russia., Patrusheva OP; Regional Clinical Hospital, Arkhangelsk, Russia., Prokopenko SV; Prof. V.F. Voyno-Yasenetsky Krasnoyarsk State Medical University, Krasnoyarsk, Russia., Sazonov DV; Siberian Regional Medical Center, Novosibirsk, Russia., Timchenko LV; Ochapovsky Regional Clinical Hospital #1, Krasnodar, Russia., Trinitatskiy YV; Rostov Regional Hospital, Rostov-on-Don, Russia., Khabirov FA; Republican Neurological Center, Kazan, Russia., Khavunka MY; City Clinical Hospital #5, Lvov, Ukraine., Chichanovskaya LV; Tver State Medical University, Tver, Russia., Sherman MA; FSBEI HE Kirov SMU MOH Russia, Kirov, Russia., Ivanov RA; JSC 'BIOCAD', St. Petersburg, Russia., Lin'kova YN; JSC 'BIOCAD', St. Petersburg, Russia., Stukalina EY; JSC 'BIOCAD', St. Petersburg, Russia., Zinkina-Orikhan AV; JSC 'BIOCAD', St. Petersburg, Russia., Obukhova IG; JSC 'BIOCAD', St. Petersburg, Russia.
Jazyk:	ruština
Zdroj:	Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova [Zh Nevrol Psikhiatr Im S S Korsakova] 2019; Vol. 119 (2. Vyp. 2), pp. 73-85.
DOI:	10.17116/jnevro20191192273
Abstrakt:	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 2 nd 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.
Databáze:	MEDLINE
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