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Clinical Effectiveness Of An Inteferon Beta 1a Biosimilar: Results From An Open-label, Multicenter, Observational Study | 14126
Journal of Biotechnology & Biomaterials
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Introduction: Blastoferon® is a pharmaceutical
product of interferon beta 1a currently marketed in
Argentina and Latin America as a biosimilar to the
innovator interferon beta 1a for the treatment of MS.
Although regulatory requirements for biosimilars are
on debate, there is consensus about the necessity to
obtain evidence of the eff ectiveness of these drugs on
clinical grounds. Th e aim of this study was to assess
the clinical eff ectiveness of Blastoferon® from an openlabel,
multicentre, retrospective, observational, postmarketing
Methods: We evaluated a cohort of all adult
relapsing-remitting MS patients from 4 LatinAmerican
centers that were treated with Blastoferon®
for a minimum of 12 months. Baseline clinical and
demographic data, relapses and EDSS scores during
treatment were collected for analysis. Clinical outcome
measures of eff ectiveness were the proportion of relapsefree
patients, the progression of disability as assessed by
EDSS score and the annualized relapse rate. Wilcoxon
signed-rank test was used to compare relapse rate and
EDSS score before and aft er interferon treatment.
Results: Our cohort included data from 78 MS
patients treated for a median of 25 months (range: 12-
57). Th e median time of disease was 6 years (range:
1-33). Fift y-eight (74.3%) patients remained relapsefree
during the period of treatment with Blastoferon®.
Th e mean annualized relapse rate in the 2 years before
treatment was 0.59 (95%CI: 0.49-0.68). Aft er 25 months
of treatment, these fi gures drop to 0.15 (95%CI: 0.08-
0.21). Th e drop in relapse rate was highly signifi cant
(Wilcoxon signed-rank test: z=6.43, p<0.00001). Th e
median EDSS score at treatment onset was 2 (range:
0-7.5), whereas the median of this score aft er treatment
was 3 (range: 0-8.5). However, this diff erence was not
signifi cant (Wilcoxon signed-rank test: z=0.95, p=0.34).
Conclusion: Treatment of relapsing-remitting MS
with Blastoferon® reduced the relapse-rate of the disease
Dr. Marcelo Kauffman is a neurologist with MSc and PhD degrees in Molecular Biology. He has been the person in charge of the pre-clinical and clinical development of Blastoferon as an advisor of Bio Sidus S.A. Clinical Research Department. He has been the author of 5 papers presenting the results of the different preclinical and clinical Blastoferon studies. Currently, he holds the position of Chief of the Neurogenetic Clinic of Hospital JM Ramos Mejia in Buenos Aires, Argentina and is a lecturer in the School of Medicine of the University of Buenos Aires.
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