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Article ; Online: Fungal sensitization in patients with severe atopic dermatitis as a distinct phenotype

Daria S. Fomina / Marina S. Lebedkina / Anton A. Chernov / Ekaterina A. Nikitina / Olga A. Mukhina / Valeriya I. Mikhaylova

Consilium Medicum, Vol 24, Iss 8, Pp 552-

2022 Volume 557

Abstract: Background. Many factors influence the development of atopic dermatitis (AD): genetic, environmental (including exposure to allergens), skin barrier damage, and activation of the T2-pathway immune response. Patients with AD, including those with severe ... ...

Abstract	Background. Many factors influence the development of atopic dermatitis (AD): genetic, environmental (including exposure to allergens), skin barrier damage, and activation of the T2-pathway immune response. Patients with AD, including those with severe disease, are prone to sensitization to various allergens, including fungal ones. Fungal sensitization (FS) promotes autoreactivity to the body's own structures due to shared epitopes with homologous fungal allergens. It can contribute to the development of allergic diseases, including AD, asthma, and rhinitis, as well as to their exacerbation and uncontrolled course. Since FS can be considered a factor aggravating AD, it is relevant to distinguish patients with FS and AD into a separate phenotype. Aim. To characterize the phenotype of patients with severe AD and FS using retrospective data analysis from a digital analytics platform in a real-world clinical setting. Materials and methods. A retrospective observational single-center study was conducted between 01.06.2017 and 01.07.2022. The study cohort included 88 patients with severe AD who were candidates for therapy or received treatment with either dupilumab or upadacitinib. FS was confirmed in 49 patients from the study group. Part of the cohort without FS (n=39) was used as a comparison group. Inclusion criteria: the age over 18 years old; severe AD (SCORAD40 points at the beginning of therapy); determination of specific immunoglobulin E to a panel of fungal allergens or individual fungi (or by the ImmunoCAP ISAC method to fungal allergen components). A digital analytics platform was used to generate primary data. Results. The phenotype of a patient with severe AD and confirmed FS was described. The patient profile is characterized by an extended sensitization spectrum (at least 34 allergen groups) with the most typical combination of pollen, epidermal, and FS. If there is a food allergy, it is of the classic "big eight" nature. Besides exacerbation of the skin disorder, its manifestations include angioedema ...
Keywords	severe atopic dermatitis ; fungal sensitization ; phenotype ; food sensitization ; Medicine (General) ; R5-920 ; Therapeutics. Pharmacology ; RM1-950
Subject code	610
Language	Russian
Publishing date	2022-11-01T00:00:00Z
Publisher	ZAO "Consilium Medicum"
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Efficacy of dupilumab in real practice in the treatment of severe forms of asthma and atopic dermatitis (comparative retrospective study)

Daria S. Fomina / Sergey V. Fedosenko / Elena N. Bobrikova / Anton A. Chernov / Olga A. Mukhina / Marina S. Lebedkina / Alexander V. Karaulov / Asel Yu. Nurtazina / Mariana A. Lysenko

Терапевтический архив, Vol 95, Iss 7, Pp 568-

2023 Volume 573

Abstract: Background. Dupilumab, a fully human monoclonal antibody directed against the common -subunit of interleukin (IL)-4 receptors and blocking signaling from both IL-4 and IL-13, may be recommended for the treatment of moderate to severe atopic dermatitis ( ... ...

Abstract	Background. Dupilumab, a fully human monoclonal antibody directed against the common -subunit of interleukin (IL)-4 receptors and blocking signaling from both IL-4 and IL-13, may be recommended for the treatment of moderate to severe atopic dermatitis (AD) and bronchial asthma (BA). Aim. To perform a comparative assessment of the effectiveness of maintenance therapy with dupilumab in patients with severe BA as the main indication for genetically engineered biological drugs and in patients with severe asthma with concomitant severe AD as the indication for targeted therapy. Materials and methods. A 6-month retrospective comparative study was performed at the specialized reference center for allergology and immunology. The study included 115 adult patients of both sexes treated with dupilumab for uncontrolled severe asthma as the main indication for targeted therapy (BA group; n=65) or for a combination of severe uncontrolled asthma and severe AD (BAAD; n=50). Dupilumab was administered subcutaneously for 6 months. The first dose was 600 mg once and then 300 mg Q2W. Evaluation of the effectiveness of dupilumab therapy at 6 months of treatment in both groups included achieving asthma control (ACT, ACQ5), improving pulmonary function test, reducing the risk of exacerbations and the need for systemic glucocorticosteroids (SGCS), improving quality of life (AQLQ), change of biomarkers (FeNO, eosinophil count) and the course of comorbid diseases, including improvement in the AD (SCORAD, EASI) and rhinosinusitis polyposa (SNOT-22). Results and conclusion. During dupilumab therapy, in a significant proportion of patients, regardless of the presence or absence of other T2-associated diseases (e.g., AD or rhinosinusitis polyposa), an improvement in asthma was demonstrated as early as in the first 6 months of treatment with dupilumab in all recommended domains for assessing the response to targeted therapy: improving asthma control and respiratory function, reducing the frequency of moderate and severe exacerbations ...
Keywords	severe asthma ; t2-asthma ; atopic dermatitis ; dupilumab ; targeted therapy ; biological therapy ; Medicine ; R
Subject code	610
Language	Russian
Publishing date	2023-09-01T00:00:00Z
Publisher	"Consilium Medicum" Publishing house
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Pre-exposure prophylaxis of new COVID-19 coronavirus infection with tixagevimab/cilgavimab in adult Moscow patients with primary immunodeficiencies

Anna A. Roppelt / Marina S. Lebedkina / Anton A. Chernov / Tatiana S. Kruglova / Olga A. Mukhina / Yulia D. Yukhnovskaya / Farida A. Samedova / Ulyana A. Mаrkina / Gerelma V. Andrenova / Alexander V. Karaulov / Mariana A. Lysenko / Daria S. Fomina

Терапевтический архив, Vol 95, Iss 1, Pp 78-

2023 Volume 84

Abstract: Background. Primary immunodeficiencies (PIDs), now known as inborn errors of immunity, are a group of inherited diseases caused by defects in the genes that control the immune response. Patients with PIDs have risks of developing a severe course and/or ... ...

Abstract	Background. Primary immunodeficiencies (PIDs), now known as inborn errors of immunity, are a group of inherited diseases caused by defects in the genes that control the immune response. Patients with PIDs have risks of developing a severe course and/or death in COVID-19. Passive immunization with long-acting monoclonal antibodies (MABs) to SARS-CoV-2 should be considered as pre-exposure prophylaxis in patients with PIDs. Tixagevimab/cilgavimab is a combination of MABs that bind to the SARS-CoV-2 spike protein. Aim. To evaluate the efficacy and safety of pre-exposure prophylaxis of new SARS-CoV-2 infection in PIDs with the combination of tixagevimab/cilgavimab. Materials and methods. Forty eight patients diagnosed with PIDs were included in the study. Median follow-up after drug administration was 174 days. The total number of confirmed coronavirus infections in patients with PIDs as well as 6 months before and after administration of MAT were assessed. Results. In the analyzed cohort, the overall incidence of COVID-19 from pandemic onset to MABs administration was 75% (36/48), with 31% (11/36) of over-infected patients having had the infection more than once. The incidence of COVID-19 immediately 6 months before the introduction of tixagevimab/cilgavimab was 40%. All patients who had COVID-19 after pre-exposure prophylaxis had a mild infection. The incidence of COVID-19 6 months after tixagevimab/cilgavimab administration significantly decreased compared to the incidence 6 months before administration (7 and 40%, respectively; p0.001). Conclusion. The use of tixagevimab/cilgavimab in patients with PIDs is effective as pre-exposure prophylaxis and reduces the risk of severe COVID-19.
Keywords	primary immunodeficiencies ; pre-exposure prophylaxis ; tixagevimab/cilgavimab ; covid-19 ; Medicine ; R
Subject code	610
Language	Russian
Publishing date	2023-02-01T00:00:00Z
Publisher	"Consilium Medicum" Publishing house
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Registry analysis of patients with severe allergic asthma and clinically relevant sensitization to fungal allergens treated with genetically engineered biologics

Daria S. Fomina / Olga A. Mukhina / Marina S. Lebedkina / Elena N. Bobrikova / Dmitry O. Sinyavkin / Anton A. Chernov / Valeriya I. Mikhailova

Consilium Medicum, Vol 24, Iss 3, Pp 170-

2022 Volume 176

Abstract: Background. Fungal sensitization (FS) often escapes the attention of clinicians when assessing the spectrum of sensitization in patients with atopic diseases. According to cohort studies is found in 310% of the general population and in 720% of ... ...

Abstract	Background. Fungal sensitization (FS) often escapes the attention of clinicians when assessing the spectrum of sensitization in patients with atopic diseases. According to cohort studies is found in 310% of the general population and in 720% of asthmatics; the proportion of patients with severe bronchial asthma (SBA) with HS ranges from 35 to 75%. Fungal conidia have a 1000-fold higher exposure and are among the most important clinically relevant allergens in asthma. Exposure to fungal allergens is capable of generating a sustained T2 response with production of proinflammatory cytokines such as IL-5 and 13, which is indirectly related to the severity of airway eosinophilia. The identification of specific serum IgE is considered the benchmark diagnostic sign of FS, and the encapsulated hydrophobic carrier polymer system is considered preferable to skin prick tests. The process of reclassifying diseases with fungal lung lesions is confusing treatment strategies, leaving the FS problem underestimated. A series of publications have shown that omalizumab and other biologics targeting IL-5 or IL-5 receptor (IL5R) alpha are effective in treating SBA with FS. However, there remains an unmet need in real clinical practice for standardized approaches to genetically engineered biological therapies (BT) for different phenotypes of SBA, especially those associated with impaired microbiological homeostasis and this type of sensitization. Aim. Using retrospective analysis of clinical-dynamic observational data from patients on BT treatment in a real clinical setting to determine phenotypic features of severe allergic bronchial asthma with FS and to perform additional detailed analysis of a cohort of patients on anti-IgE therapy. Materials and methods. A retrospective observational single-center registry study was conducted between June 2017 and August 2021 at the City Reference Center for Allergology and Immunology. The baseline cohort consisted of 198 patients with severe allergic AD who were in the initial phase of BT. ...
Keywords	severe bronchial asthma ; fungal sensitization ; phenotype ; genetically engineered biological therapy ; biological agents ; Medicine (General) ; R5-920 ; Therapeutics. Pharmacology ; RM1-950
Subject code	610
Language	Russian
Publishing date	2022-05-01T00:00:00Z
Publisher	ZAO "Consilium Medicum"
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Analysis of predictors of response to anti-IgE therapy in patients with severe atopic bronchial asthma in real clinical practice

Daria S. Fomina / Olga A. Mukhina / Marina S. Lebedkina / Mirada K. Gadzhieva / Elena N. Bobrikova / Dmitry O. Sinyavkin / Vasiliy V. Parshin / Anton A. Chernov / Andrey S. Belevskiy

Терапевтический архив, Vol 94, Iss 3, Pp 413-

2022 Volume 419

Abstract: Introduction. Guidelines on Biological Therapy for Bronchial Asthma of the European Academy of Allergy and Clinical Immunology (EAACI) identified a number of controversial issues for additional outcome analysis using randomized clinical trials and data ... ...

Abstract	Introduction. Guidelines on Biological Therapy for Bronchial Asthma of the European Academy of Allergy and Clinical Immunology (EAACI) identified a number of controversial issues for additional outcome analysis using randomized clinical trials and data from routine clinical practice. In particular, there is unmet need to clarify algorithms for prescribing biologicals using predictors of response and its timing, taking into account risk factors and multimorbidity. Omalizumab is a recombinant humanized monoclonal anti-IgE antibody of IgG1 class used for the treatment of severe refractory atopic bronchial asthma (BA) and a variety of IgE-mediated diseases. Among biological agents, this "pioneer molecule" has the greatest experience in the "allergology and immunology" profile. Detailed description of the "nonresponders" portraits will allow to perform the therapy response assessment on time and facilitate rational planning of individual therapy, which is a prerequisite for biologicals era. Using only routine methods, it is possible to perform initial and dynamic screening to phenotype a heterogeneous cohort of patients with severe asthma and chose the optimal strategy. Aim. To identify predictors of nonresponse to omalizumab anti-IgE therapy in patients with severe atopic BA and to establish optimal timing of efficacy assessment using retrospective analysis of data from the Biologic Therapy Registry of Allergology and Immunology in routine clinical practice. Materials and methods. A retrospective single-center registry study was conducted at the Allergy and Immunology Reference Center from June 2017 to August 2021. 135 patients with severe BA, with confirmed perennial sensitization, who received omalizumab according to the recommendations of the current version of GINA, were selected from the clinical and dynamic observational system (registry). Dosing regimen and administration frequency of omalizumab were determined in accordance with the instructions for the drug. Assessment of therapy efficacy was performed at ...
Keywords	anti-ige therapy ; omalizumab ; predictors of non-response ; severe atopic asthma ; Medicine ; R
Subject code	610
Language	Russian
Publishing date	2022-03-01T00:00:00Z
Publisher	"Consilium Medicum" Publishing house
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Optimization of approaches to the management of adult patients with severe atopic dermatitis

Daria S. Fomina / Sofya A. Serdotetskova / Anton A. Chernov / Marina S. Lebedkina / Asel Iu. Nurtazina / Mirada K. Gadzhieva / Olga A. Mukhina / Elena N. Bobrikova

Consilium Medicum, Vol 23, Iss 8, Pp 654-

analysis of real clinical practice outcomes

2021 Volume 661

Abstract: Atopic dermatitis (AD) is a multifactorial genetically determined immune-mediated skin disease. It is difficult to treat and significantly affects patients quality of life. The development of an integrated approach focusing on atopic multimorbidity, ... ...

Abstract	Atopic dermatitis (AD) is a multifactorial genetically determined immune-mediated skin disease. It is difficult to treat and significantly affects patients quality of life. The development of an integrated approach focusing on atopic multimorbidity, implementation of validated control tools and distinction of clinical parameters specific for different phenotypes of severe forms of disease is especially relevant to patients resistant to standard therapy techniques. Dupilumab, a biologic, is approved for the treatment of the resistant group of patients with moderate to severe AD in the Russian Federation. Dupilumab inhibits the functions of two key cytokines of T2-mediated inflammation IL-4 and IL-13. The article presents personal experience of the authors concerning individual approach to the choice of therapy for the management of this cohort of patients in routine clinical practice. The disease aggravating criteria were determined, which are fundamental for the formation of individual patient portrait for the biologic (dupilumab) treatment for severe AD.
Keywords	atopic dermatitis ; targeted biologic therapy ; dupilumab ; multimorbidity ; bronchial asthma ; phenotypes ; Medicine (General) ; R5-920 ; Therapeutics. Pharmacology ; RM1-950
Subject code	610
Language	Russian
Publishing date	2021-08-01T00:00:00Z
Publisher	ZAO "Consilium Medicum"
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Temporal Clinical and Laboratory Response to Interleukin-6 Receptor Blockade With Tocilizumab in 89 Hospitalized Patients With COVID-19 Pneumonia

Daria Fomina / Mar’yana A. Lysenko / Irina P. Beloglazova / Zinaida Yu. Mutovina / Nataliya G. Poteshkina / Inna V. Samsonova / Tat’yana S. Kruglova / Anton A. Chernov / Alexander V. Karaulov

Pathogens and Immunity, Vol 5, Iss 1, Pp 327-

2020 Volume 341

Abstract: Background: Pandemic COVID-19 pneumonia due to SARS-2 is an important cause of morbidity and mortality. Emerging evidence links poor outcomes to an inflammatory cytokine storm. Methods: We treated 89 hospitalized patients with COVID-19 pneumonia and ... ...

Abstract	Background: Pandemic COVID-19 pneumonia due to SARS-2 is an important cause of morbidity and mortality. Emerging evidence links poor outcomes to an inflammatory cytokine storm. Methods: We treated 89 hospitalized patients with COVID-19 pneumonia and heightened systemic inflammation (elevated serum C reactive protein and interleukin-6 levels) with an infusion of tocilizumab (TCZ), a human monoclonal IgG1 antibody to the interleukin-6 receptor. Results: Clinical and laboratory evidence of improvement was evident when baseline and 1-2-day post-infusion indices were compared. Among the 72 patients receiving supplemental oxygen without mechanical ventilation, severity of condition on the NEWS2 scale scores fell from 5 to 2 (P<0.001), C reactive protein levels fell from 95 to 14 mg/L (P<0.001), and lymphocyte counts rose from 900 to 1000/uL (P=0.036). Sixty-three of 72 patients were discharged from the hospital, one patient died, and eight patients remained in the hospital at the time of this writing. Among the 17 patients receiving mechanical ventilation, despite a rapid decrease in CRP levels from 89 to 35 mg/L (P=0.014) and early improvements in NEWS2 scores in 10 of 17 patients, 10 patients ultimately died and the other seven remain in the hospital at the time of this writing. Overall, mortality was only seen in patients who had markedly elevated CRP levels (>30 mg/L) and low lymphocyte counts (<1000/uL) before TCZ administration. Conclusions: Inflammation and lymphocytopenia are linked to mortality in COVID-19. Inhibition of IL-6 activity by administration of tocilizumab, an anti-IL-6 receptor antibody, is associated with rapid improvement in both CRP and lymphocyte counts and in clinical indices. Controlled clinical trials are needed to confirm the utility of IL-6 blockade in this setting. Additional interventions will be needed for patients requiring mechanical ventilation.
Keywords	covid-19 ; sars-cov-2 ; pneumonia ; cytokine storm ; il-6 ; tocilizumab ; Pathology ; RB1-214 ; Immunologic diseases. Allergy ; RC581-607 ; covid19
Subject code	610 ; 616
Language	English
Publishing date	2020-10-01T00:00:00Z
Publisher	Case Western Reserve University
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Criteria for the optimal use of interleukin-6 receptor blockers in patients with COVID-19

Tatyana S. Kruglova / Darya S. Fomina / Nataliya G. Poteshkina / Nadija F. Frolova / Irina P. Beloglazova / Zinaida Yu. Mutovina / Inna V. Samsonova / Elena A. Kovalevskaja / Alena I. Zagrebneva / Sofya A. Serdotetckova / Anton A. Chernov / Maryana A. Lysenko

Терапевтический архив, Vol 93, Iss 11, Pp 1316-

2021 Volume 1324

Abstract: Aim. To determine the criteria for the optimal use of IL-6 receptor blockers in patients with COVID-19 community-acquired pneumonia based on predictors of adverse outcomes. Materials and methods. The single-center, non-randomized prospective study ... ...

Abstract	Aim. To determine the criteria for the optimal use of IL-6 receptor blockers in patients with COVID-19 community-acquired pneumonia based on predictors of adverse outcomes. Materials and methods. The single-center, non-randomized prospective study included 190 patients with community-acquired pneumonia caused by coronavirus 2 between the beginning of March and the end of May 2020. Of these, 89 patients received tocilizumab and 101 patients received sarilumab. The study inclusion criterion for the patient was indications for initiating therapy with one of the inhibitors of IL-6 receptors (anti-IL-6R) according to the Interim guidelines (versions 4 and 5). The exclusion criterion was the need to re-prescribe genetically engineered biological therapy (GEBT). The severity of the patient's condition was assessed according to the early warning score (NEWS2), the volume of lung tissue lesions was assessed according to computed tomography (CT). Laboratory monitoring included counting the absolute (abs) number of lymphocytes, serum levels of C-reactive protein (CRP), interleukin 6 (IL-6), D-dimer, lactate dehydrogenase, fibrinogen. Statistical data processing was conducted by nonparametric methods using the IBM SPSS Statistics V-22 software. Results. The phenotype of a patient with a negative outcome prognosis was described: a male patient over 50 years of age with aggravated premorbid background (with cardiovascular diseases, obesity and/or chronic renal disease), lung lesion CT 34, saturation less than 93% upon inhalation of atmospheric air, persisting for 2448 hours after GEBT. According to the blood test, lymphopenia was below 1000 U/L and CRP levels were above 50 mg/L. The laboratory parameters and clinical picture of the patient progressively worsened after 911 days of illness, regardless of the use of Anti-IL-6R. The features of patients monitoring when administering IL-6 receptor blockers have been determined. Conclusion. IL-6 receptor blockers should be administered to patients hospitalized with severe COVID-19 ...
Keywords	covid-19 ; interleukin-6 ; interleukin-6 receptor blockers ; tocilizumab ; sarilumab ; Medicine ; R
Subject code	616
Language	Russian
Publishing date	2021-11-01T00:00:00Z
Publisher	"Consilium Medicum" Publishing house
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Levilimab and baricitinib prescribing experience in outpatient COVID-19 patients’ treatment

Alexey I. Khripun / Andrey V. Starshinin / Yulia O. Antipova / Mariana A. Lysenko / Yulia V. Urozhaeva / Olga F. Gavrilenko / Natalya A. Rusantsova / Andrei A. Tyazhelnikov / Elena Yu. Tikhonovskaya / Natalia V. Okolot / Maria V. Sokolova / Daria S. Fomina / Elena N. Simonova / Tatiana S. Kruglova / Anton A. Chernov / Alena I. Zagrebneva

Терапевтический архив, Vol 94, Iss 5, Pp 668-

2022 Volume 674

Abstract: Aim. To study the effect of levilimab or baricitinib in combination with standard therapy (ST) on the incidence of severe viral pneumonia associated with a new coronavirus infection COVID-19. Materials and methods. A multicenter, open-label observational ...

Abstract	Aim. To study the effect of levilimab or baricitinib in combination with standard therapy (ST) on the incidence of severe viral pneumonia associated with a new coronavirus infection COVID-19. Materials and methods. A multicenter, open-label observational study of the efficacy and safety of levilimab in combination with ST (group 1, n=100), baricitinib in combination with ST (group 2, n=139), or in comparison with ST (group 3, n=200) in outpatients with verified CT-1 pneumonia. Results. According to the results of laboratory tests, patients treated with levilimab in combination with ST had the best dynamics of changes in CRP from reliably the highest level (mg/L) to the lowest in comparison with other groups. In the group of patients with ST, in contrast to the other groups, no dynamics of CRP was observed by day 5 of therapy. In group of hospitalized patients initially receiving levilimab in addition to ST, the rate of transfer to the intensive care unit (2 patients, 9.52%) and length of stay (4 days) was significantly lower compared to the values in patients in both the baricitinib group in combination with ST (7 patients, 15.56%; 5 days [interquartile range 36.5]) and in patients receiving ST alone (7 patients, 15.56%; 5 days [interquartile range 36.5]). Also in hospitalized patients we observed no statistically significant intergroup differences in the incidence of infectious complications and thromboembolic events, which confirms the safety of including levilimab or baricitinib in COVID-19 pathogenetic therapy regimens. Observational results support the hypothesis that the initial inclusion of levilimab or baricitinib in addition to ST is accompanied by a reduced risk of viral pneumonia progression. Conclusion. The addition of levilimab or baricitinib to the therapy regimen for coronavirus infection during the outpatient phase has demonstrated a preemptive anti-inflammatory effect and reduced the probability of lung tissue damage progression.
Keywords	levilimab ; baricitinib ; cytokine storm ; viral pneumonia ; covid-19 ; outpatient ; Medicine ; R
Subject code	610
Language	Russian
Publishing date	2022-06-01T00:00:00Z
Publisher	"Consilium Medicum" Publishing house
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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