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 Śliwczyñski; Joanna Narbutt

doi:10.5114/ada.2021.108442

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

Postepy Dermatol Alergol. 2022 Aug;39(4):723-728. doi: 10.5114/ada.2021.108442. Epub 2021 Aug 16.

Authors

Witold Owczarek¹, Irena Walecka², Agnieszka Nowakowska¹, Piotr Ciechanowicz², Adam Reich³, Aleksandra Lesiak⁴, Ewa Borkowska⁵, Andrzej Śliwczyñski⁶, Joanna Narbutt⁴

Affiliations

¹ Department of Dermatology, Military Institute of Medicine, Warsaw, Poland.
² Department of Dermatology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland.
³ Department of Dermatology, University of Rzeszow, Rzeszow, Poland.
⁴ Department of Dermatology, Paediatric and Oncological Dermatology, Medical University of Lodz, Lodz, Poland.
⁵ Department of Medicine, Medical University of Warsaw, Warsaw, Poland.
⁶ University of Humanities and Economics in Lodz, Satellite Campus, Warsaw, Poland.

Abstract

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.

Keywords: biological treatment; infliximab; psoriasis.