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1. Registr biologické/cílené léčby BIOREP – Souhrnná zpráva za rok 2023.

Author

Kojanová, M., Fialová, J., Cetkovská, P., Gkalpakiotis, S., Machovcová, A., Štork, J., Arenberger, P., Doležal, T., Turková, B., and Skupina, Biorep

Abstract

Copyright of Czecho-Slovak Dermatology / Cesko-Slovenska Dermatologie is the property of Czech Medical Association of JE Purkyne and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2024

2. Current treatment goals are achieved by the majority of patients with atopic dermatitis treated with tralokinumab: results from a multicentric, multinational, retrospective, cohort study

Author

Chiricozzi, Andrea, Ferrucci, S. M., Di Nardo, Lucia, Gori, Niccolo', Balato, A., Ortoncelli, M., Maurelli, M., Galluzzo, M., Munera Campos, M., Seremet, T., Caldarola, Giacomo, De Simone, Clara, Ippoliti, Elena, Torres, T., Gkalpakiotis, S., Conrad, C., Carrascosa, J. M., Bianchi, L., Argenziano, G., Ribero, S., Girolomoni, G., Marzano, A. V., Peris, Ketty, Chiricozzi A. (ORCID:0000-0002-6739-0387), Di Nardo L., Gori N., Caldarola G. (ORCID:0000-0002-8837-9232), De Simone C. (ORCID:0000-0002-0898-0045), Ippoliti E., Peris K. (ORCID:0000-0002-5237-0463), Chiricozzi, Andrea, Ferrucci, S. M., Di Nardo, Lucia, Gori, Niccolo', Balato, A., Ortoncelli, M., Maurelli, M., Galluzzo, M., Munera Campos, M., Seremet, T., Caldarola, Giacomo, De Simone, Clara, Ippoliti, Elena, Torres, T., Gkalpakiotis, S., Conrad, C., Carrascosa, J. M., Bianchi, L., Argenziano, G., Ribero, S., Girolomoni, G., Marzano, A. V., Peris, Ketty, Chiricozzi A. (ORCID:0000-0002-6739-0387), Di Nardo L., Gori N., Caldarola G. (ORCID:0000-0002-8837-9232), De Simone C. (ORCID:0000-0002-0898-0045), Ippoliti E., and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Background: Tralokinumab is a human monoclonal antibody targeting interleukin-13 that is approved for the treatment of moderate-severe atopic dermatitis. Studies analyzing the efficacy and safety of tralokinumab in a real-world setting are scarce. Research design and methods: A European, multicentric, real-world, retrospective cohort study was defined to assess the effectiveness and safeness profile of tralokinumab, investigating the achievement of pre-specified treatment goals; and to detect potential differences in terms of effectiveness and safeness across some selected patient subcohorts. Results: A total of 194 adult patients were included in this study. A significant improvement in physician-assessed disease severity was detected at each follow-up visit as compared with baseline and similar trend was observed for patient-reported outcomes and quality of life. No meaningful difference in effectiveness was found when considering patient age (<65 versus ≥65 years), neither dissecting patient cohort in dupilumab-naive vs dupilumab-treated subjects. Among tralokinumab-treated patients, 88% achieved at least one currently identified real-world therapeutic goal at week 16. Conclusions: This retrospective multicenter study confirmed the effectiveness and safeness of tralokinumab throughout 32 weeks of observation, showing the achievement of therapeutic goals identified in both trial and real-world settings in a large proportion of tralokinumab-treated patients.

Published
2023

5. Current treatment goals are achieved by the majority of patients with atopic dermatitis treated with tralokinumab: results from a multicentric, multinational, retrospective, cohort study

Author

Chiricozzi, A, Ferrucci, SM, Di Nardo, L, Gori, N, Balato, A, Ortoncelli, M, Maurelli, M, Galluzzo, M, Munera Campos, M, Seremet, T, Caldarola, G, De Simone, C, Ippoliti, E, Torres, T, Gkalpakiotis, S, Conrad, C, Carrascosa, JM, Bianchi, L, Argenziano, G, Ribero, S, Girolomoni, G, Marzano, AV, and Peris, K

Abstract

ABSTRACTBackgroundTralokinumab is a human monoclonal antibody targeting interleukin-13 that is approved for the treatment of moderate-severe atopic dermatitis. Studies analyzing the efficacy and safety of tralokinumab in a real-world setting are scarce.Research design and methodsA European, multicentric, real-world, retrospective cohort study was defined to assess the effectiveness and safeness profile of tralokinumab, investigating the achievement of pre-specified treatment goals; and to detect potential differences in terms of effectiveness and safeness across some selected patient subcohorts.ResultsA total of 194 adult patients were included in this study. A significant improvement in physician-assessed disease severity was detected at each follow-up visit as compared with baseline and similar trend was observed for patient-reported outcomes and quality of life. No meaningful difference in effectiveness was found when considering patient age (<65 versus ≥65 years), neither dissecting patient cohort in dupilumab-naive vs dupilumab-treated subjects. Among tralokinumab-treated patients, 88% achieved at least one currently identified real-world therapeutic goal at week 16.ConclusionsThis retrospective multicenter study confirmed the effectiveness and safeness of tralokinumab throughout 32 weeks of observation, showing the achievement of therapeutic goals identified in both trial and real-world settings in a large proportion of tralokinumab-treated patients.

Published
2023
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9. BIOREP – registr biologické/cílené léčby: Souhrnná zpráva za rok 2022.

Author

Kojanová, M., Cetkovská, P., Gkalpakiotis, S., Fialová, J., Machovcová, A., Štork, J., Arenberger, P., Doležal, T., Turková, B., and Skupina, Biorep

Abstract

Copyright of Czecho-Slovak Dermatology / Cesko-Slovenska Dermatologie is the property of Czech Medical Association of JE Purkyne and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2023

10. Atopická dermatitida: současná doporučení pro diagnostiku a léčbu. Část I.

Author

Machovcová, A., Cetkovská, P., Kojanová, M., Fialová, J., Karlová, I., Březinová, E., Litvik, R., Salavec, M., and Gkalpakiotis, S.

Abstract

Copyright of Czecho-Slovak Dermatology / Cesko-Slovenska Dermatologie is the property of Czech Medical Association of JE Purkyne and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2023

14. Drug Survival of IL-12/23, IL-17 and IL-23 Inhibitors for Psoriasis Treatment: A Retrospective Multi-Country, Multicentric Cohort Study

Author

Torres, T, Puig, L, Vender, R, Lynde, C, Piaserico, S, Carrascosa, JM, Gisondi, P, Dauden, E, Conrad, C, Mendes-Bastos, P, Ferreira, P, Leite, L, Lu, JSD, Valerio, J, Bruni, M, Messina, F, Nidegger, A, Llamas-Velasco, M, del Alcazar, E, Mufti, A, White, K, Caldarola, G, Teixeira, L, Romanelli, P, Desai, K, Gkalpakiotis, S, Romanelli, M, Yeung, JN, Nogueira, M, and Chiricozzi, A

Abstract

Background Drug survival analysis of biologic agents in psoriasis is of extreme importance, as it allows not only the evaluation of objective clinical outcomes (such as effectiveness and safety) but also of factors that are associated with patients' adherence to treatment. The aim of this study was to evaluate and compare the drug survival of the most recent biologic agents approved for the treatment of moderate-to-severe psoriasis-ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab, and risankizumab-and to identify clinical predictors that can influence the drug survival of these drugs. Methods This retrospective multicentric cohort study from 16 dermatology centers in Portugal, Spain, Italy, Switzerland, Czech Republic, Canada, and the United States included patients that started IL-12/23, IL-17 (IL-17A and IL-17R) and IL-23 inhibitors for the treatment of psoriasis between January 1, 2012 and December 31, 2019. Survival analysis was performed using a Kaplan-Meier estimator, to obtain descriptive survival curves, and proportional hazard Cox regression models. Results A total of 3312 treatment courses (total patients: 3145) were included in the study; 1118 (33.8%) with an IL-12/23 inhibitor (ustekinumab), 1678 (50.7%) with an IL-17 inhibitor [911 (27.5%) on secukinumab, 651 (19.7%) on ixekizumab, 116 (3.5%) on brodalumab], and 516 (15.5%) with an IL-23 inhibitor [398 (12.0%) on guselkumab, 118 (3.5%) on risankizumab]. At 18 months, the cumulative probability of survival was 96.4% for risankizumab, 91.1% for guselkumab, 86.3% for brodalumab, 86.1% for ustekinumab, 82.0% for ixekizumab, and 79.9% for secukinumab. Using ustekinumab as reference, drug survival of guselkumab was higher (HR 0.609; 95% CI 0.418-0.887) and that of secukinumab was lower (HR 1.490; 95% CI 1.257-1.766). In the final multivariable model, secukinumab, female sex, higher BMI, and prior exposure to biologic agents significantly increased the risk of drug discontinuation, whereas risankizumab was protective. Conclusion In this multinational cohort with 8439 patient-years of follow-up, the cumulative probability of drug survival for all drugs was >79% at 18 months. Prescribed biologic, female sex, higher BMI, and previous exposure to biologic agents were predictors of drug discontinuation. Drug survival of guselkumab and risankizumab was higher than that of ustekinumab, and secukinumab was lower.

Published
2021

16. Drug Survival of IL-12/23, IL-17 and IL-23 Inhibitors for Psoriasis Treatment: A Retrospective Multi-Country, Multicentric Cohort Study

Author

Torres, T., Puig, L., Vender, R., Lynde, C., Piaserico, S., Carrascosa, J. M., Gisondi, P., Dauden, E., Conrad, C., Mendes-Bastos, P., Ferreira, P., Leite, L., Lu, J. D., Valerio, J., Bruni, M., Messina, Federica, Nidegger, A., Llamas-Velasco, M., del Alcazar, E., Mufti, A., White, K., Caldarola, Giacomo, Teixeira, L., Romanelli, P., Desai, K., Gkalpakiotis, S., Romanelli, Margherita, Yeung, J., Nogueira, M., Chiricozzi, Andrea, Messina F., Caldarola G. (ORCID:0000-0002-8837-9232), Romanelli M., Chiricozzi A. (ORCID:0000-0002-6739-0387), Torres, T., Puig, L., Vender, R., Lynde, C., Piaserico, S., Carrascosa, J. M., Gisondi, P., Dauden, E., Conrad, C., Mendes-Bastos, P., Ferreira, P., Leite, L., Lu, J. D., Valerio, J., Bruni, M., Messina, Federica, Nidegger, A., Llamas-Velasco, M., del Alcazar, E., Mufti, A., White, K., Caldarola, Giacomo, Teixeira, L., Romanelli, P., Desai, K., Gkalpakiotis, S., Romanelli, Margherita, Yeung, J., Nogueira, M., Chiricozzi, Andrea, Messina F., Caldarola G. (ORCID:0000-0002-8837-9232), Romanelli M., and Chiricozzi A. (ORCID:0000-0002-6739-0387)

Abstract

Background: Drug survival analysis of biologic agents in psoriasis is of extreme importance, as it allows not only the evaluation of objective clinical outcomes (such as effectiveness and safety) but also of factors that are associated with patients’ adherence to treatment. The aim of this study was to evaluate and compare the drug survival of the most recent biologic agents approved for the treatment of moderate-to-severe psoriasis—ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab, and risankizumab—and to identify clinical predictors that can influence the drug survival of these drugs. Methods: This retrospective multicentric cohort study from 16 dermatology centers in Portugal, Spain, Italy, Switzerland, Czech Republic, Canada, and the United States included patients that started IL-12/23, IL-17 (IL-17A and IL-17R) and IL-23 inhibitors for the treatment of psoriasis between January 1, 2012 and December 31, 2019. Survival analysis was performed using a Kaplan-Meier estimator, to obtain descriptive survival curves, and proportional hazard Cox regression models. Results: A total of 3312 treatment courses (total patients: 3145) were included in the study; 1118 (33.8%) with an IL-12/23 inhibitor (ustekinumab), 1678 (50.7%) with an IL-17 inhibitor [911 (27.5%) on secukinumab, 651 (19.7%) on ixekizumab, 116 (3.5%) on brodalumab], and 516 (15.5%) with an IL-23 inhibitor [398 (12.0%) on guselkumab, 118 (3.5%) on risankizumab]. At 18 months, the cumulative probability of survival was 96.4% for risankizumab, 91.1% for guselkumab, 86.3% for brodalumab, 86.1% for ustekinumab, 82.0% for ixekizumab, and 79.9% for secukinumab. Using ustekinumab as reference, drug survival of guselkumab was higher (HR 0.609; 95% CI 0.418–0.887) and that of secukinumab was lower (HR 1.490; 95% CI 1.257–1.766). In the final multivariable model, secukinumab, female sex, higher BMI, and prior exposure to biologic agents significantly increased the risk of drug discontinuation, whereas risan

Published
2021

20. Registr biologické/cílené léčby BIOREP - Souhrnná zpráva za rok 2021.

Author

Kojanová, M., Cetkovská, P., Gkalpakiotis, S., Fialová, J., Machovcová, A., Štork, J., Arenberger, P., Doležal, T., Velacková, B., and Skupina, Biorep

Abstract

Copyright of Czecho-Slovak Dermatology / Cesko-Slovenska Dermatologie is the property of Czech Medical Association of JE Purkyne and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2022

28. Hypertrofická ložiska v axilách.

Author

Chmelíková, M., Marešová, T., Kujal, P., and Gkalpakiotis, S.

Abstract

Copyright of Czecho-Slovak Dermatology / Cesko-Slovenska Dermatologie is the property of Czech Medical Association of JE Purkyne and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2022

30. Vliv dlouhodobé terapie adalimumabu na biomarkery systémového zánětu u psoriázy.

Author

Gkalpakiotis, S., Arenberger, P., Tivadar, S., Gkalpakioti, P., Potočková, J., and Kraml, P.

Abstract

Patients with psoriasis are at increased risk of atherosclerosis, which is characterized by endothelial dysfunction associated with systemic inflammation. It appears that anti-tumor necrosis alpha treatment may reduce this risk. The purpose of this study was to measure serum marker levels associated with systemic inflammation in patients with psoriasis compared to healthy subjects and to further evaluate the change in their levels after 3 months and 2 years of treatment with adalimumab. We investigated four biomarkers: highly sensitive C-reactive protein (hsCRP), oxidized low density lipoproteins (OxLDL), E-selectin and Interleukin 22 (IL-22). These markers were determined in healthy volunteers and in 28 patients with moderate to severe psoriasis before and after 3 and 24 months of adalimumab treatment. Patients with psoriasis had elevated markers levels compared to controls. After 3 months of treatment, E-selectin decreased significantly (p < 0.001), same as IL-22 (p < 0.001). HsCRP also decreased, but statistically insignificantly, OxLDLs were slightly higher than originally. After 24 months, 17 patients were still treated with adalimumab. In these patients, HsCRP (p < 0.05), E-selectin (p < 0.001) and IL-22 (p < 0.001) were significantly reduced. The OxLDL value remained elevated. A steady decrease in E-selectin, hsCRP and IL-22 after 24 months confirms that adalimumab suppresses systemic inflammation. [ABSTRACT FROM AUTHOR]

Published
2021

31. Atopická dermatitida v registru BIOREP.

Author

Kojanová, M., Fialová, J., Cetkovská, P., Gkalpakiotis, S., Štork, J., Machovcová, A., Doležal, T., Štrosová, D., and Biorep-Ad, Skupina

Abstract

Copyright of Czecho-Slovak Dermatology / Cesko-Slovenska Dermatologie is the property of Czech Medical Association of JE Purkyne and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2021

32. Hyperkeratotické kuželovité útvary na zádech.

Author

Procházková, A., Sticová, E., Mardešičová, L., Arenbergerová, M., and Gkalpakiotis, S.

Abstract

Copyright of Czecho-Slovak Dermatology / Cesko-Slovenska Dermatologie is the property of Czech Medical Association of JE Purkyne and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2022

33. Péče o reprodukční zdraví žen s revmatoidní artritidou, psoriázou a psoriatickou artritidou ve fertilním věku v běžné klinické praxi.

Author

Olejárová, M., Macejová, Ž., Gkalpakiotis, S., Procházková, L., Tóth, Z., and Prágr, P.

Subjects
MEDICAL personnel, MEDICAL specialties & specialists, RHEUMATISM, RHEUMATOID arthritis, CHILDBEARING age, PSORIATIC arthritis
Abstract

Copyright of Czech Rheumatology / Česká Revmatologie is the property of Czech Medical Association of JE Purkyne and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2021

34. Účinnost biologické léčby středně těžké až těžké psoriázy - analýza z registru BIOREP.

Author

Kojanová, M., Fialová, J., Cetkovská, P., Gkalpakiotis, S., Štork, J., Arenberger, P., Machovcová, A., Doležal, T., Štrosová, D., and Velacková, B.

Abstract

Copyright of Czecho-Slovak Dermatology / Cesko-Slovenska Dermatologie is the property of Czech Medical Association of JE Purkyne and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2021

35. Registr biologické/cílené léčby BIOREP - Souhrnná zpráva za rok 2020.

Author

Kojanová, M., Fialová, J., Gkalpakiotis, S., Cetkovská, P., Štork, J., Arenberger, P., Machovcová, A., Doležal, T., Velacková, B., and Skupina, Biorep

Abstract

Copyright of Czecho-Slovak Dermatology / Cesko-Slovenska Dermatologie is the property of Czech Medical Association of JE Purkyne and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2021

37. Biologics combined with conventional systemic agents or phototherapy for the treatment of psoriasis: real-life data from PSONET registries

Author

Busard, C.I., primary, Cohen, A.D., additional, Wolf, P., additional, Gkalpakiotis, S., additional, Cazzaniga, S., additional, Stern, R.S., additional, Hutten, B.A., additional, Feldhamer, I., additional, Quehenberger, F., additional, Lichem, R., additional, Kojanova, M., additional, Adenubiova, E., additional, Addis, A., additional, Naldi, L., additional, and Spuls, P.I., additional

Published
2017
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39. Registr biologické/cílené léčby BIOREP - Souhrnná zpráva za rok 2019.

Author

Kojanová, M., Cetkovská, P., Fialová, J., Štork, J., Gkalpakiotis, S., Arenberger, P., Machovcová, A., Doležal, T., and A, Biorep Skupina

Abstract

Copyright of Czecho-Slovak Dermatology / Cesko-Slovenska Dermatologie is the property of Czech Medical Association of JE Purkyne and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2020

40. Palladium causes bizarre skin hyperpigmentation in long‐term dihydrocodeinone 'Braun' abusers.

Author

Arenbergerova, M., Arenberger, P., Gkalpakiotis, S., Sticova, E., Hulkova, H., Trhlikova, O., and Sikora, J.

Subjects
HYDROCODONE, VASCULAR endothelial cells, PALLADIUM, HYPERPIGMENTATION, GRANULAR materials
Abstract

Background: 'Braun' is an illegal injectable dihydrocodeinone‐enriched drug mixture of semi‐synthetic opioids. It is prepared by palladium‐catalysed hydrogenation from codeine‐containing tablets. Objective: We aimed to characterize the dermatologic consequences of long‐term abuse of 'Braun'. Methods: Skin biopsies of two long‐term 'Braun' abusers were evaluated histopathologically, immunohistochemically and ultrastructurally. Palladium skin content was assessed by X‐ray fluorescence (XRF) spectrometry. Results: Both patients showed generalized diffuse dark blue–grey hyperpigmentation of the skin. In both, an abnormal population of cells containing intracytoplasmic brownish granular material was identified in the papillary dermis by light microscopy. Electron microscopy revealed a dense and minimally structured material that predominantly accumulated in macrophages, fibroblasts and vascular endothelial cells. XRF analysis confirmed elevated levels of palladium in the patient's skin in comparison to healthy controls. Conclusion: Long‐term abuse of palladium‐contaminated dihydrocodeinone ('Braun') results in excessive accumulation of granular material in various dermal cell types and causes generalized diffuse skin hyperpigmentation. [ABSTRACT FROM AUTHOR]

Published
2020
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42. Krvácející nodul v pupku.

Author

Smetanová, A., Marinenko, E., Arenbergerová, M., Dolná, Z., Prouzová, Z., and Gkalpakiotis, S.

Abstract

Copyright of Czecho-Slovak Dermatology / Cesko-Slovenska Dermatologie is the property of Czech Medical Association of JE Purkyne and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2020

43. Kerion Celsi u dítěte - možnosti diagnostiky a léčby.

Author

Pereira Forjaz, D., Arenberger, P., Arenbergerová, M., and Gkalpakiotis, S.

Abstract

Copyright of Czecho-Slovak Dermatology / Cesko-Slovenska Dermatologie is the property of Czech Medical Association of JE Purkyne and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2019

49. COVID-19 in 3 patients treated with immune checkpoint inhibitors for advanced melanoma.

Author

Arenbergerova, M., Gkalpakiotis, S., Arenberger, P., Fialova, A., and Pasek, M.

Subjects
*IPILIMUMAB, *IMMUNE checkpoint inhibitors, *IMMUNOGLOBULIN M, *COVID-19, *COUGH, *MELANOMA
Abstract

Dear Editor, The COVID-19 pandemic has changed the therapeutic algorithm for many dermatological diseases, particularly those where drugs are influencing the immune system. In 76 patients the therapy was ongoing, while in 28 patients the treatment was initiated during the pandemic. [Extracted from the article]

Published
2022
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50. Clinical results of the application of a hemoglobin spray to promote healing of chronic wounds

Author

Arenberger, P, Engels, P, Arenbergerova, M, Gkalpakiotis, S, García Luna Martínez, FJ, Villarreal Anaya, A, Jimenez Fernandez, L, Arenberger, P, Engels, P, Arenbergerova, M, Gkalpakiotis, S, García Luna Martínez, FJ, Villarreal Anaya, A, and Jimenez Fernandez, L

Abstract

A new technological approach for supplying hypoxic chronic wounds with oxygen is a moist wound treatment with aqueous solutions containing tissue compatible oxygen binders. This facilitates diffusion of oxygen, necessary for the healing process, from the surroundings (room air through an open-porous wound padding) into the ulcerous tissue. A product that is still in development is a spray which contains hemoglobin obtained from domestic pigs. Clinical investigations (a clinical trial, treatment observations and single patient uses) are presented, which were performed to create clinical data regarding efficiency and safety of this product. All data have shown that the application of the hemoglobin spray promoted wound healing in all analyzed cases.Data from a clinical study in Mexico and subsequent therapy observations revealed that in 39 out of 42 patients (93%) the treated wounds were healed. 9 patients from a series of therapy observations in Monterrey (Mexico) showed similar observations. All treated wounds were closed. Single patient uses carried out in Witten (Germany; 6 wounds from 8 (75%)) and Prague (Czech Republic; 5 wounds from 5 (100%) were healed) further support these results: The application of hemoglobin spray can promote healing of chronic wounds. Within the framework of the clinical investigation, the treatment observations, and the individual healing experiments the hemoglobin spray was applied more than 2,000 times onto chronic wounds of 82 patients. In all cases, the spray was well tolerated and there were no adverse event that might have been an adverse reaction to the hemoglobin spray., Ein neuer technologischer Ansatz zur Versorgung hypoxischer chronischer Wunden mit dem zur Heilung benötigten Sauerstoff ist eine feuchte Wundbehandlung mit wässrigen Lösungen, in denen gut gewebeverträgliche Sauerstoff-Binder eine erleichterte Diffusion von Sauerstoff aus der Umgebung (Raumluft aus einer offenporigen Wundauflage) zum Ulcus-Gewebe ermöglichen. Ein Produkt in Entwicklung enthält als Sauerstoff-Binder Hämoglobin vom Hausschwein (Hämoglobin-Spray).Klinische Untersuchungen (eine klinische Studie, Therapiebeobachtungen und individuelle Heilversuche) werden präsentiert, aus denen sich klinische Daten zur Wirksamkeit und Unbedenklichkeit ergeben.Alle durchgeführten Anwendungen des Hämoglobin-Spray ergaben, dass die Wundheilung gefördert wurde. In einer klinischen Studie und einer unmittelbar nachfolgenden Serie von Therapiebeobachtungen konnten bei 39 von 42 Patienten (93%) die behandelten Wunden komplett geheilt werden. In gleicher Weise wurden die Wunden von 9 Patienten einer weiteren Serie von Therapiebeobachtungen in Monterrey (Mexiko) bis zur Abheilung behandelt. Individuelle Heilversuche in Witten (Deutschland; 6 von 8 Wunden (75%) abgeheilt) und in Prag (Tschechische Republik; 5 von 5 Wunden (100%) geheilt) bestätigen diese Ergebnisse: Anwendungen des Hämoglobin-Sprays können die Heilung chronischer Wunden fördern.Dabei wurden die Anwendungen des Hämoglobin-Spray ausnahmslos gut vertragen, sämtliche beobachteten unerwünschten Ereignisse während der Anwendungen hatten andere Ursachen. Im Rahmen der klinischen Studie, der Therapiebeobachtungen und der individuellen Heilversuche wurde das Hämoglobin-Spray über 2.000-mal in den chronischen Wunden von 82 Patienten angewendet. Es wurde durchgehend gut vertragen, und es gab keine unerwünschten Ereignisse, die verdächtig waren, möglicherweise unerwünschte Reaktionen auf das Hämoglobin-Spray zu sein.

Published
2011

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