[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].

Autor:	Boyko AN; Pirogov National Medical Research University, Moscow, Russia.; Federal Center for Brain Research and Neurotechnologies, Moscow, Russia., Bakhtiyarova KZ; Kuvatov Republican Clinical Hospital, Ufa, Russia., Boyko OV; Federal Center for Brain Research and Neurotechnologies, Moscow, Russia., Dudin VA; Center for Cardiology and Neurology, Kirov, Russia., Zaslavskii LG; Leningrad Regional Clinical Hospital, St. Petersburg, Russia., Malkova NA; Regional Clinical Hospital, Novosibirsk, Russia., Parshina EV; Semashko Regional Clinical Hospital, Nizhny Novgorod, Russia., Poverennova IY; Seredavin Regional Clinical Hospital, Samara, Russia., Sivertseva SA; Medical and Sanitary Unit «Neftyanik», Tyumen, Russia., Totolyan NA; Pavlov First Saint Petersburg State Medical University, St. Petersburg, Russia., Shchur SG; Filatov Moscow City Clinical Hospital No. 15, Moscow, Russia., Khabirov FA; Republican Clinical Neurological Center, Kazan, Russia., Goncharova ZA; Rostov State Medical University, Rostov-on-Don, Russia., Zakharova MN; Research Center of Neurology, Moscow, Russia., Bolsun DD; JSC «BIOCAD», St. Petersburg, Russia., Zinkina-Orikhan AV; JSC «BIOCAD», St. Petersburg, Russia., Lin'kova YN; JSC «BIOCAD», St. Petersburg, Russia., Chernovskaya TV; JSC «BIOCAD», St. Petersburg, Russia., Porozova AA; JSC «BIOCAD», St. Petersburg, Russia.
Jazyk:	ruština
Zdroj:	Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova [Zh Nevrol Psikhiatr Im S S Korsakova] 2023; Vol. 123 (2), pp. 52-59.
DOI:	10.17116/jnevro202312302152
Abstrakt:	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.
Databáze:	MEDLINE
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