The Journal of dermatological treatment · 2020
Efficacy and safety of biosimilar rituximab in the treatment of pemphigus vulgaris: a single center experience of 12 cases.
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Bardazzi Federico, Loi Camilla, Vara Giulio, Patrizi Annalisa, Di Altobrando Ambra
Аннотация
OBJECTIVE: Rituximab, a chimeric monoclonal antibody that targets the CD-20 molecule on B-cells' surface, has led to significant advances in the treatment of autoimmune pemphigus in recent decades. The aim of the study was to assess the clinical efficacy as well as safety data for biosimilar rituximab with emphasis on the treatment of pemphigus vulgaris.
METHODS: A total of 12 individuals with pemphigus vulgaris treated with biosimilar rituximab were followed for at least 1 year. We assessed patient characteristics, disease history, pemphigus disease area index (PDAI) score, anti-desmoglein (Dsg)1 and anti-Dsg3 antibody level, clinical response, and any adverse events during each clinical follow-up visit. We also recorded time to achieve complete remission, duration of complete remission and time to relapse.
RESULTS: A consistent decrease in the PDAI score was observed (p<.0001), as well as a significant decrease of anti-Dsg3 values. In addition, the clinical response of this population confirmed that the equivalent is not inferior to Rituximab (p=.521).
CONCLUSIONS: The introduction or the switch to Rixathon, a rituximab biosimilar, appears to be safe and may provide an opportunity to reduce health system costs because of its similarity to the reference drug in terms of safety and efficacy.
METHODS: A total of 12 individuals with pemphigus vulgaris treated with biosimilar rituximab were followed for at least 1 year. We assessed patient characteristics, disease history, pemphigus disease area index (PDAI) score, anti-desmoglein (Dsg)1 and anti-Dsg3 antibody level, clinical response, and any adverse events during each clinical follow-up visit. We also recorded time to achieve complete remission, duration of complete remission and time to relapse.
RESULTS: A consistent decrease in the PDAI score was observed (p<.0001), as well as a significant decrease of anti-Dsg3 values. In addition, the clinical response of this population confirmed that the equivalent is not inferior to Rituximab (p=.521).
CONCLUSIONS: The introduction or the switch to Rixathon, a rituximab biosimilar, appears to be safe and may provide an opportunity to reduce health system costs because of its similarity to the reference drug in terms of safety and efficacy.