2. Academic Validation
  3. [The new pegylated interferon beta-1a (sampeginterferon beta-1a, BCD-054) in the treatment of remitting multiple sclerosis]

[The new pegylated interferon beta-1a (sampeginterferon beta-1a, BCD-054) in the treatment of remitting multiple sclerosis]

  • Zh Nevrol Psikhiatr Im S S Korsakova. 2019;119(10. Vyp. 2):100-109. doi: 10.17116/jnevro201911910100.
A N Boyko 1,  K Z Bakhtiyarova 2,  V A Dudin 3,  L G Zaslavsky 4,  N A Malkova 5,  Ye V Parshina 6,  A S Fedulov 7,  A V Zinkina-Orikhan 8,  Yu N Linkova 8,  R A Ivanov 8,  T V Chernovskaya 8
Affiliations

Affiliations

  • 1 Russian National Medical Research University named after N.I. Pirogov, Moscow, Russia; Federal Center for Cerebrovascular Pathology and Stroke, Moscow, Russia; 'Neuro-Clinic', Moscow, Russia.
  • 2 State Budgetary Healthcare Institution 'Republican Clinical Hospital named after G.G. Kuvatov', Ufa, Republic of Bashkortostan, Russia.
  • 3 Kirov Regional State Clinical Budgetary Healthcare Institution 'Cardiology and Neurology Centre', Kirov, Russia.
  • 4 State Budgetary Healthcare Institution 'Leningrad Regional Clinical Hospital', Saint Petersburg, Russia.
  • 5 State Budgetary Healthcare Institution of Novosibirsk Region 'State Novosibirsk Regional Clinical Hospital', Novosibirsk, Russia.
  • 6 State Budgetary Healthcare Institution of 'Nizhny Novgorod Region Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko', Nizhny Novgorod, Russia.
  • 7 State Institution 'Minsk Research and Development Centre of Surgery, Transplantology, and Haematology', Minsk, Republic Belarus.
  • 8 JSC 'BIOCAD', Saint Petersburg, Russia.
PMID: 31934995 DOI: 10.17116/jnevro201911910100
Abstract

Aim: To evaluate the efficacy and safety of BCD 054 180 μg and 240 μg administered once every 2 weeks for the treatment of remitting multiple sclerosis compared to placebo and low dose interferon beta-1a (LIB) 30 μg administered once weekly. Results of a 20 week blinded interim analysis from a double blind, comparative, randomised, placebo-controlled clinical study are included.

Material and methods: This multinational, multicentre, double blind, comparative, placebo-controlled study enrolled 399 patients with the diagnosis of remitting multiple sclerosis: 114 patients in the sampeginterferon beta 1a and LIB groups each and 57 patients in the placebo group. To ensure the objectivity of data, the study protocol includes a blinded interim analysis to demonstrate the superiority of BCD 054 over placebo based on the number of combined unique active lesions (CUA) on MRI scans after 20 weeks of treatment.

Results and conclusion: An integrated analysis of the efficacy, safety, pharmacokinetics, and pharmacodynamics was performed after 20 weeks of study. Mean CUA per scan was lower in the active treatment groups compared to placebo: 0,986±2,046, 0,619±1,055, 0,665±1,165, 1,673±2,376 (groups 1, 2, 3 and placebo group, respectively). The data for CUA per scan demonstrated the superiority of both BCD 054 180 μg and 240 μg over placebo. Patients receiving active treatment had fewer new and/or enlarging lesions after 20 weeks of treatment. The proportion of patients without new T2-weighted lesions was 74,3%, 86,7%, and 78,1% in groups 1, 2, and 3 compared to 64,9% in the placebo group. Manifestations of flu-like syndrome that is expected for interferon treatment were observed with the same incidence in all the active treatment groups. Its severity, duration or the need for symptomatic treatment did not appear to depend on the type of interferon used.

Keywords

DMT; multiple sclerosis; pegylated interferon beta-1a; sampeginterferon beta-1a; therapy.

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