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Effectiveness of infliximab biosimilars in the treatment of moderate to severe chronic plaque psoriasis: experience of real-world data from the register of the program “Treatment of moderate and severe forms of plaque psoriasis (B.47)” of the National Health Fund in Poland

INTRODUCTION: Infliximab (IFX) is a monoclonal antibody that binds to and neutralizes TNF-α. IFX (Remicade) was approved by the U.S. Food and Drug Administration in 2006 for the treatment of severe plaque psoriasis. In 2013 two infliximab biosimilars: Remsima and Inflectra were also registered. The...

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Autores principales: Owczarek, Witold, Walecka, Irena, Nowakowska, Agnieszka, Ciechanowicz, Piotr, Reich, Adam, Lesiak, Aleksandra, Borkowska, Ewa, Śliwczyñski, Andrzej, Narbutt, Joanna
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Termedia Publishing House 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9454371/
https://www.ncbi.nlm.nih.gov/pubmed/36090728
http://dx.doi.org/10.5114/ada.2021.108442
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author Owczarek, Witold
Walecka, Irena
Nowakowska, Agnieszka
Ciechanowicz, Piotr
Reich, Adam
Lesiak, Aleksandra
Borkowska, Ewa
Śliwczyñski, Andrzej
Narbutt, Joanna
author_facet Owczarek, Witold
Walecka, Irena
Nowakowska, Agnieszka
Ciechanowicz, Piotr
Reich, Adam
Lesiak, Aleksandra
Borkowska, Ewa
Śliwczyñski, Andrzej
Narbutt, Joanna
author_sort Owczarek, Witold
collection PubMed
description INTRODUCTION: Infliximab (IFX) is a monoclonal antibody that binds to and neutralizes TNF-α. IFX (Remicade) was approved by the U.S. Food and Drug Administration in 2006 for the treatment of severe plaque psoriasis. In 2013 two infliximab biosimilars: Remsima and Inflectra were also registered. The introduction of biosimilar drugs is associated with a significant reduction in treatment costs. AIM: To evaluate the efficacy of treatment with biosimilar IFX with non-medical switch option in patients with plaque psoriasis under the drug program “Treatment of moderate and severe plaque psoriasis” of the Ministry of Health in Poland. MATERIAL AND METHODS: The group of 91 adult patients with moderate to severe plaque psoriasis, unresponsive or with contraindications to the standard treatment were qualified to the drug program (in 2016–2018). Efficacy of treatment with biosimilar IFX was evaluated using the Psoriasis Area and Severity Index, body surface area and Dermatology Life Quality Index scoring performed at week 0, 14, 46 and 94. RESULTS: The mean change in PASI, DLQI, and BSA scores at week 14 was 89.92%, 93.75% and 90.91%, respectively. By week 14, 83.52% of patients achieved PASI75, 49.45% PASI ≥ 90 and 26.37% PASI100. At week 46, 84.62% of patients achieved PASI75, 54.95% PASI ≥ 90, and 21.98% PASI100. At week 94 of therapy, 80.22% of patients achieved PASI75, 48.35% PASI ≥ 90, and 18.68% PASI100. At week 94 of therapy, PASI100 was maintained by 37.5% of patients who achieved PASI100 at week 14. CONCLUSIONS: 94-week therapy with biosimilar infliximab results in high and sustained clinical efficacy in patients with moderate to severe psoriasis.
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spelling pubmed-94543712022-09-10 Effectiveness of infliximab biosimilars in the treatment of moderate to severe chronic plaque psoriasis: experience of real-world data from the register of the program “Treatment of moderate and severe forms of plaque psoriasis (B.47)” of the National Health Fund in Poland Owczarek, Witold Walecka, Irena Nowakowska, Agnieszka Ciechanowicz, Piotr Reich, Adam Lesiak, Aleksandra Borkowska, Ewa Śliwczyñski, Andrzej Narbutt, Joanna Postepy Dermatol Alergol Original Paper INTRODUCTION: Infliximab (IFX) is a monoclonal antibody that binds to and neutralizes TNF-α. IFX (Remicade) was approved by the U.S. Food and Drug Administration in 2006 for the treatment of severe plaque psoriasis. In 2013 two infliximab biosimilars: Remsima and Inflectra were also registered. The introduction of biosimilar drugs is associated with a significant reduction in treatment costs. AIM: To evaluate the efficacy of treatment with biosimilar IFX with non-medical switch option in patients with plaque psoriasis under the drug program “Treatment of moderate and severe plaque psoriasis” of the Ministry of Health in Poland. MATERIAL AND METHODS: The group of 91 adult patients with moderate to severe plaque psoriasis, unresponsive or with contraindications to the standard treatment were qualified to the drug program (in 2016–2018). Efficacy of treatment with biosimilar IFX was evaluated using the Psoriasis Area and Severity Index, body surface area and Dermatology Life Quality Index scoring performed at week 0, 14, 46 and 94. RESULTS: The mean change in PASI, DLQI, and BSA scores at week 14 was 89.92%, 93.75% and 90.91%, respectively. By week 14, 83.52% of patients achieved PASI75, 49.45% PASI ≥ 90 and 26.37% PASI100. At week 46, 84.62% of patients achieved PASI75, 54.95% PASI ≥ 90, and 21.98% PASI100. At week 94 of therapy, 80.22% of patients achieved PASI75, 48.35% PASI ≥ 90, and 18.68% PASI100. At week 94 of therapy, PASI100 was maintained by 37.5% of patients who achieved PASI100 at week 14. CONCLUSIONS: 94-week therapy with biosimilar infliximab results in high and sustained clinical efficacy in patients with moderate to severe psoriasis. Termedia Publishing House 2021-08-16 2022-08 /pmc/articles/PMC9454371/ /pubmed/36090728 http://dx.doi.org/10.5114/ada.2021.108442 Text en Copyright: © 2022 Termedia Sp. z o. o. https://creativecommons.org/licenses/by-nc-sa/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) License, allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
spellingShingle Original Paper
Owczarek, Witold
Walecka, Irena
Nowakowska, Agnieszka
Ciechanowicz, Piotr
Reich, Adam
Lesiak, Aleksandra
Borkowska, Ewa
Śliwczyñski, Andrzej
Narbutt, Joanna
Effectiveness of infliximab biosimilars in the treatment of moderate to severe chronic plaque psoriasis: experience of real-world data from the register of the program “Treatment of moderate and severe forms of plaque psoriasis (B.47)” of the National Health Fund in Poland
title Effectiveness of infliximab biosimilars in the treatment of moderate to severe chronic plaque psoriasis: experience of real-world data from the register of the program “Treatment of moderate and severe forms of plaque psoriasis (B.47)” of the National Health Fund in Poland
title_full Effectiveness of infliximab biosimilars in the treatment of moderate to severe chronic plaque psoriasis: experience of real-world data from the register of the program “Treatment of moderate and severe forms of plaque psoriasis (B.47)” of the National Health Fund in Poland
title_fullStr Effectiveness of infliximab biosimilars in the treatment of moderate to severe chronic plaque psoriasis: experience of real-world data from the register of the program “Treatment of moderate and severe forms of plaque psoriasis (B.47)” of the National Health Fund in Poland
title_full_unstemmed Effectiveness of infliximab biosimilars in the treatment of moderate to severe chronic plaque psoriasis: experience of real-world data from the register of the program “Treatment of moderate and severe forms of plaque psoriasis (B.47)” of the National Health Fund in Poland
title_short Effectiveness of infliximab biosimilars in the treatment of moderate to severe chronic plaque psoriasis: experience of real-world data from the register of the program “Treatment of moderate and severe forms of plaque psoriasis (B.47)” of the National Health Fund in Poland
title_sort effectiveness of infliximab biosimilars in the treatment of moderate to severe chronic plaque psoriasis: experience of real-world data from the register of the program “treatment of moderate and severe forms of plaque psoriasis (b.47)” of the national health fund in poland
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9454371/
https://www.ncbi.nlm.nih.gov/pubmed/36090728
http://dx.doi.org/10.5114/ada.2021.108442
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