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Boyko A.N.
Pirogov Russian National Research Medical University;
Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency
Bakhtiyarova K.Z.
Bashkir State Medical University
Boyko O.V.
Federal Center for Brain Research and Neurotechnology
Dudin V.A.
Center for Cardiology and Neurology»
Zaslavsky L.G.
Pavlov First Saint Petersburg State Medical University
Malkova N.A.
State Novosibirsk Regional Clinical Hospital;
Novosibirsk State Medical University
Parshina E.V.
Semashko Nizhny Novgorod Regional Clinical Hospital
Totolyan N.A.
Academician I.P. Pavlov First Saint Petersburg State Medical University
Shchur S.G.
Municipal Filatov Clinical Hospital No. 15
Khabirov F.A.
City Clinical Hospital No. 7;
Kazan State Medical Academy — Branch of the Russian Medical Academy of Continuing Professional Education
Zakharova M.N.
Research Center of Neurology
Zinkina-Orikhan A.V.
AO BIOCAD
Chernovskaya T.V.
JSC «BIOCAD»
Porozova A.A.
JSC «BIOCAD»
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
Journal: S.S. Korsakov Journal of Neurology and Psychiatry. 2023;123(2): 52‑59
Views: 1770
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To cite this article:
Boyko AN, Bakhtiyarova KZ, Boyko OV, et al. . 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. S.S. Korsakov Journal of Neurology and Psychiatry.
2023;123(2):52‑59. (In Russ.)
https://doi.org/10.17116/jnevro202312302152
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.
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.
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.
Treatment with samPEG-IFN-β1a is an effective and safe first-line therapy for relapsing-remitting multiple sclerosis patients.
Keywords:
Authors:
Boyko A.N.
Pirogov Russian National Research Medical University;
Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency
Bakhtiyarova K.Z.
Bashkir State Medical University
Boyko O.V.
Federal Center for Brain Research and Neurotechnology
Dudin V.A.
Center for Cardiology and Neurology»
Zaslavsky L.G.
Pavlov First Saint Petersburg State Medical University
Malkova N.A.
State Novosibirsk Regional Clinical Hospital;
Novosibirsk State Medical University
Parshina E.V.
Semashko Nizhny Novgorod Regional Clinical Hospital
Totolyan N.A.
Academician I.P. Pavlov First Saint Petersburg State Medical University
Shchur S.G.
Municipal Filatov Clinical Hospital No. 15
Khabirov F.A.
City Clinical Hospital No. 7;
Kazan State Medical Academy — Branch of the Russian Medical Academy of Continuing Professional Education
Zakharova M.N.
Research Center of Neurology
Zinkina-Orikhan A.V.
AO BIOCAD
Chernovskaya T.V.
JSC «BIOCAD»
Porozova A.A.
JSC «BIOCAD»
Received:
11.01.2023
Accepted:
16.01.2023
List of references:
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