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

Witold Owczarek; Irena Walecka; Agnieszka Nowakowska; Piotr Ciechanowicz; Adam Reich; Aleksandra Lesiak; Ewa Borkowska; Andrzej Śliwczyński; Joanna Narbutt

doi:10.5114/ada.2021.108442

eISSN: 2299-0046
ISSN: 1642-395X

Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii

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Original paper

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

Witold Owczarek

¹

,

Irena Walecka

²

,

Agnieszka Nowakowska

¹

,

Piotr Ciechanowicz

²

,

Adam Reich

³

,

Aleksandra Lesiak

⁴

,

Ewa Borkowska

⁵

,

Andrzej Śliwczyński

⁶

,

Joanna Narbutt

⁴

Department of Dermatology, Military Institute of Medicine, Warsaw, Poland
Department of Dermatology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland
Department of Dermatology, University of Rzeszow, Rzeszow, Poland
Department of Dermatology, Paediatric and Oncological Dermatology, Medical University of Lodz, Lodz, Poland
Department of Medicine, Medical University of Warsaw, Warsaw, Poland
University of Humanities and Economics in Lodz, Satellite Campus, Warsaw, Poland

Adv Dermatol Allergol 2022; XXXIX (4): 723-728

DOI: https://doi.org/10.5114/ada.2021.108442

Online publish date: 2021/08/16

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AMA

Owczarek W, Walecka I, Nowakowska A, et al. 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. Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii. 2022;39(4):723-728. doi:10.5114/ada.2021.108442.

APA

Owczarek, W., Walecka, I., Nowakowska, A., Ciechanowicz, P., Reich, A.,  & Lesiak, A. et al. (2022). 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. Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii, 39(4), 723-728. https://doi.org/10.5114/ada.2021.108442

Chicago

Owczarek, Witold, Irena Walecka, Agnieszka Nowakowska, Piotr Ciechanowicz, Adam Reich, Aleksandra Lesiak,  and Ewa Borkowska et al. 2022. "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". Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii 39 (4): 723-728. doi:10.5114/ada.2021.108442.

Harvard

Owczarek, W., Walecka, I., Nowakowska, A., Ciechanowicz, P., Reich, A., Lesiak, A., Borkowska, E., Śliwczyński, A.,  and Narbutt, J. (2022). 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. Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii, 39(4), pp.723-728. https://doi.org/10.5114/ada.2021.108442

MLA

Owczarek, Witold et al. "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." Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii, vol. 39, no. 4, 2022, pp. 723-728. doi:10.5114/ada.2021.108442.

Vancouver

Owczarek W, Walecka I, Nowakowska A, Ciechanowicz P, Reich A, Lesiak A et al. 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. Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii. 2022;39(4):723-728. doi:10.5114/ada.2021.108442.

Introduction
Infliximab (IFX) is a monoclonal antibody that binds to and neutralizes TNF-a. 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.

keywords:

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

Witold Owczarek 1 , Irena Walecka 2 , Agnieszka Nowakowska 1 , Piotr Ciechanowicz 2 , Adam Reich 3 , Aleksandra Lesiak 4 , Ewa Borkowska 5 , Andrzej Śliwczyński 6 , Joanna Narbutt 4

psoriasis, biological treatment, infliximab

Witold Owczarek

¹

,

Irena Walecka

²

,

Agnieszka Nowakowska

¹

,

Piotr Ciechanowicz

²

,

Adam Reich

³

,

Aleksandra Lesiak

⁴

,

Ewa Borkowska

⁵

,

Andrzej Śliwczyński

⁶

,

Joanna Narbutt

⁴