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Infliximab MRI relaxation time in solution

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Zuzanna Bober Z., Piotr Bar P., Grzegorz Pasternak G., Sabina Galiniak S., Dorota Bartusik-Aebisher D., Rafał Filip R., David Aebisher D.
European Journal of Clinical and Experimental Medicine
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2019
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issue 1
22-25
EN
Introduction. The use of Quantitative Magnetic Resonance Imaging to drug monitoring in vitro or in vivo can provides a powerful means to map the effects of drugs on tissue activity. Aim. The purpose of this study was to measure relaxation time of antibody phantom. For this purpose, infliximab sample was used. Material and methods. The selected methods to detect relaxation time of antibody was Magnetic Resonance Imaging technique. We detected spin-lattice (T1 ) relaxation time and discuss differences where compare to water. Results. The measurements ofspin-lattice (T1 ) relaxation time showed significant differences. The results obtained in phantom indicate that we can use this result for measurements of relaxation time in vitro. Conclusion. Infliximab is approved for severe cases of rheumatoid arthritis, together with methotrexate, for pronounced psoriasis and psoriasis-arthritis, ankylosing spondylitis as well as for chronic inflammatory bowel disease. We conclude, that Quantitative Magnetic Resonance Imaging can be used to monitor drug effects
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Monitoring of infliximab treatment in inflammatory bowel diseases – basic knowledge and current data based on clinical trials in a population of Polish patients

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Pękala A.
European Journal of Clinical and Experimental Medicine
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2022
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issue 3
251-259
EN
Introduction and aim. Infliximab is the oldest biological drug belonging to the group of tumor necrosis factor antagonists. Despite the availability of many new biological therapies, this drug still plays an important role in the treatment of inflammatory bowel diseases. However, a significant problem related to pharmacotherapy is the high inter-individual variability of the response. Material and methods. This study presents results of the research on the treatment with infliximab in the inflammatory bowel disease (IBD) patients including our own experience in Polish IBD patients. Analysis of the literature. Therapeutic failure while using infliximab can be attributed partly to inadequate serum concentrations of the drug and the development of anti-drug antibodies. Many studies have attempted to find a relationship between the specific level of infliximab and the achieved healing effect. These analyses show that the optimal level of the drug differs depending on the type of disease, its phenotype, and therapeutic goal and that the optimization of infliximab therapy remains an open topic. Two studies involving the population of Polish IBD patients examined the level of infliximab during and after induction, as well as the frequency of anti-drug antibodies. Two studies involving a population of Polish IBD patients examined the level of infliximab during and after induction, as well as the frequency of anti-drug antibodies. These studies demonstrated the need for monitoring infliximab treatment at weeks 6 and 14. Conclusion. Reactive monitoring is believed to enable the most rational treatment decisions; however, experts also recommend that proactive monitoring should measure infliximab concentrations at the end of induction and at least once during maintenance treatment.
3
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Infliximab in therapy of inflammatory bowels diseases

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Piotr Bar P., Sabina Galiniak S., Dorota Bartusik-Aebisher D., Rafał Filip R., David Aebisher D.
European Journal of Clinical and Experimental Medicine
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2019
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issue 1
79-82
EN
Introduction. Infliximab is a monoclonal antibody that acts against tumor necrosis factor TNF-α. The drug is used in the treatment of autoimmune diseases. Aim. This article reviewed the efficacy and safety of infliximab for the treatment in severe ulcerative colitis. This review included studies that evaluated the clinical use of infliximab. Material and methods. This meta-analysis was performed according to systematic literature search of three major bibliographic databases (Scopus, PubMed, and Cochran). Results. Infliximab has been approved by the US Food and Drug Administration (FDA) as a medicine to treat Leśniowski and Crohn’s disease, ulcerative colitis, psoriasis, psoriatic arthritis, ankylosing spondylitis, and rheumatoid arthritis. However, further trials are required to compare other parameters of efficacy such as the clinical response with infliximab. Conclusion. In patients suffering from Crohn’s disease or ulcerative colitis under infliximab maintenance therapy, sustained good trough levels are associated with: better response and remission rates, more mucosal healing and less loss of response.
4
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Subcutaneous administration of infliximab-attenuated silica-induced lung fibrosis

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Zhang H., Sui J.-N., Gao L., Guo J.
International Journal of Occupational Medicine and Environmental Health
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2017
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vol. 31
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issue 4
503-515
EN
Objectives To investigate the influence of the anti-tumor necrosis factor-α infliximab (IFX) in the case of rats with silicosis. Material and Methods Forty-eight Wistar rats were randomly divided into 3 groups. The study group (N = 16) – silicosis was induced by intratracheal instillation of 50 mg silica on day 1, and IFX was subcutaneously administered at a dose of 15 mg/kg of body weight from day 2 to day 6, the vehicle group (N = 16) – silica used as the study group but without IFX, the sham group (N = 16) – 1 ml of saline was intratracheal-used. Eight rats in each group were euthanized on day 7 and on day 14, respectively. Lung tissue sections were stained with hematoxylin and eosin or Masson’s trichromedye. The nuclear factor-κB p65 (NF-κB p65) positioning in the lung tissues were determined by immunohistochemical staining. Levels of tumor necrosis factor α (TNF-α) in rat serum and bronchoalveolar lavage fluid were measured with enzyme linked immunosorbent assay. The inducible nitric oxide synthase (iNOS) mRNA in the lung tissues was measured by quantitative real-time polymerase chain reaction, as well as inhibitor protein-κB (I-κB) and NF-κB p65 expression were measured quantitatively by western blotting. Results Silica installation increased the lung tissues inflammation reaction, oxidative stress and pulmonary fibrosis. Infliximab treatment significantly improved silica-induced lung pathological changes (inflammatory cells, collagen deposition), decreased the TNF-α inhibited NF-κB signaling (I-κB, NF-κB p65) as well as oxidant status (iNOS). Conclusions Infliximab may improve silica-induced pulmonary inflammation by decreasing the TNF-α, inhibiting NF-κB signaling (I-κB, NF-κB p65) as well as oxidant status (iNOS), which suggest that IFX has potential role in the treatment of silica-induced lung damage. Int J Occup Med Environ Health 2018;31(4):503–515
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Management of the National Drug Administration Through the Use of Biosimilar Medicines. Expenditures, Numbers of Reimbursed Packages and Shares of Biosimilar Products in the Infliximab Market a Year Prior to and a Year after the Introduction of the National Drug Policy 2018–2022

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Barszczewska O., Piechota A., Suchecka J.
Problemy Zarządzania
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2020
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issue 3/2020 (89)
121-138
PL
Cel: oszczędności wynikające ze stosowania leków biopodobnych (biosymilarów) są istotnym zagadnieniem w zarządzaniu gospodarką lekową państwa. We wrześniu 2018 roku Rada Ministrów przyjęła dokument Polityka Lekowa Państwa (PLP) 2018–2022. W dokumencie przedstawionym przez Ministerstwo Zdrowia jednym z priorytetów jest zwiększenie użycia leków biopodobnych. Celem artykułu jest ocena zmian (i ich dynamiki) w wydatkach na infliksimab i udziałach biosymilarów w rynku infliksimabu przed i po ogłoszeniu PLP. Metodologia: w analizie wykorzystano przykład leku biologicznego infliksimab (lek oryginalny Remicade), szeroko stosowanego w dermatologii, gastrologii i reumatologii. Okres wybrany do analizy to rok przed wejściem w życie dokumentu Polityka Lekowa Państwa (rok I), czyli wrzesień 2017 – sierpień 2018 r. oraz rok po (rok II), czyli wrzesień 2018 – sierpień 2019 roku. Podstawą analizy porównawczej były dane statystyczne dotyczące miesięcznych wydatków oraz liczby opakowań zrefundowanych przez Narodowy Fundusz Zdrowia (NFZ). Pierwsze leki biopodobne do infliksimabu były refundowane już od początku 2014 roku. W związku z powyższym rynek infliksimabu jest silnie zdominowany przez biosymilary. W analizie wykorzystano jednopodstawowe i łańcuchowe indeksy dynamiki. Wyniki: wykazano, że liczba sprzedanych opakowań i wydatki na lek oryginalny były niższe w roku II, po wprowadzeniu PLP. Dla leków biopodobnych zauważono odwrotne zjawisko – wzrost wydatków i liczby sprzedanych opakowań biosymilarów w roku II. Ograniczenia/implikacje badawcze: należy jednak podkreślić, że artykuł dotyczy tylko jednego przykładu – rynek infliksimabu i że na sprzedaż leków biopodobnych może wpływać wiele innych ważnych czynników. Oryginalność/wartość: analiza może być wsparciem i asumptem do podsumowania działań Ministerstwa Zdrowia oraz planowania dalszych działań z zakresie implementacji biosymilarów. JEL: H51, H75, I15, I18 Acknowledgements This research received no funds. Suggested Citation: Barszczewska, O., Piechota, A., & Suchecka, J. (2020). Management of the National Drug Administration Through the Use of Biosimilar Medicines. Expenditures, Numbers of Reimbursed Packages and Shares of Biosimilar Products in the Infliximab Market a Year Prior to and a Year After the Introduction of the National Drug Policy 2018–2022. Problemy Zarządzania (Management Issues), 18(3), 121–138.
EN
Purpose: Savings resulting from the use of biosimilar medicines (biosimilars) are important to the management of national drug administration. In September 2018, the Council of Ministers adopted the National Drug Policy (NDP) for 2018–2022. One of the priorities of the document set forth by the Ministry of Health was to increase the proportional use of biosimilars. The purpose of this article is to assess the changes and the dynamics in infliximab (Remicade®) expenditures and the share of biosimilars within the infliximab market before and after the announcement of the NDP. Design/methodology/approach: The analysis is based on the example of infliximab, a biological medicine widely used in dermatology, gastroenterology and rheumatology. The analysis period encompasses data for one year before the document was adopted, i.e. the period from September 2017 until August 2018 (year I) as well as one year after the document came into force, i.e. the period from September 2018 until August 2019 (year II). Comparative analyses were based on the statistical data of monthly expenditures and the number of packages reimbursed by the National Health Fund (NHF). Fixed base and chain dynamics indices were used in the analysis. Findings: An increase in the expenditure and the number of packages sold in year II was observed for biosimilars. Research limitations/implications: It should be stressed, however, that the article pertains to a single example – the infliximab market, and that numerous other important factors may affect the sales of biosimilars. Originality/value: The analysis may be used to help evaluate the Ministry of Health’s work on biosimilars. JEL: H51, H75, I15, I18 Acknowledgements This research received no funds. Suggested Citation: Barszczewska, O., Piechota, A., & Suchecka, J. (2020). Management of the National Drug Administration Through the Use of Biosimilar Medicines. Expenditures, Numbers of Reimbursed Packages and Shares of Biosimilar Products in the Infliximab Market a Year Prior to and a Year After the Introduction of the National Drug Policy 2018–2022. Problemy Zarządzania (Management Issues), 18(3), 121–138.
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