| Autor: |
Eduardo Perusquía-Ortega, Roger Carrillo, Arturo Violante-Villanueva, Pablo Antonio Ysunza, Pacheco-Aispuro, R. Meixueiro-Montes de Oca, R. Flores-Hernandez |
| Rok vydání: |
2015 |
| Předmět: |
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| Zdroj: |
Journal of Multiple Sclerosis. |
| ISSN: |
2376-0389 |
| DOI: |
10.4172/2376-0389.1000145 |
| Popis: |
In order to appropriately support the equivalence between a biosimilar and the referenced biopharmaceutical it is essential to carry out equivalence or non-inferiority clinical studies. The objective of this paper was to study the therapeutic bioequivalence of IFN β-1A biosimilar vs. IFN β-1A innovator. The efficacy and safety of these drugs was assessed in Mexican patients under treatment for relapsing-remitting multiple sclerosis (RRMS). A parallel, multicenter, prospective and comparative study was carried out. Fifty patients with confirmed RRMS were studied. The following parameters were considered for the diagnosis of confirmed RRMS: Magnetic Resonance Imaging (MRI) demonstrating demyelinating lesions; expanded disability status scale (EDSS) scores between 0 – 5.5; and McDonald’s criteria compatible with MS. Patients were randomly divided into 2 groups of 25 patients each. Patients from the first group were treated with Avonex ®, 30 mg-per-week. Patients from the second group were treated with Axuareb® at the same dose. All patients were followed for a period of 24 months. Forty-five patients (90%) out of the initially recruited 50 patients completed the follow-up period. Annual relapse rates were 11% and 8% for Avonex and Axuareb, respectively. The proportions of relapse-free, improvement and detriment showed non-significant differences (p>0.05) between groups. The incidence of side effects showed a non-significant difference (p>0.05) between groups. SF-36 data of physical and mental status demonstrated non-significant differences between groups after the follow-up period. Although, MRI findings demonstrated a significant increase (p |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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