Vol 21, No 1 (2024)

BACKGROUND: Severe atopic asthma is a medical and social problem due to its prevalence, the tendency to exacerbations, the impact on the quality of life and on the work ability, and high treatment costs. The appearance biosimilar omalizumab among biologicals makes such therapy more accessible to patients. This article presents the results of an open prospective clinical study of the biosimilar omalizumab in patients with the severe atopic asthma.

AIM: To evaluate the efficacy and tolerability of the domestically produced biosimilar omalizumab in the real clinical practice.

MATERIALS AND METHODS: The study involved 15 adult patients (19–66 years) with a reliable history consistent with moderate to severe atopic asthma who hadn`t have asthma control at the time of inclusion in the study. All patients received the Genolar (omalizumab, Generic JSC, Russia) for 52 weeks at the dose calculated according to the instructions. The efficacy was evaluated taking into account changes in symptom severity, improved asthma control using the Asthma Control Questionnaire (ACQ-5), pulmonary function tests, peak flow measurements, assessment the asthma exacerbations number and the healthcare resources use.

RESULTS: According to our study results, all patients demonstrated a decrease in the night and daytime attacks frequency and the shortness of breath severity due to omalizumab, which made it possible to reduce the basic therapy and refuse systemic glucocorticosteroids using in patients who previously received there. After 6 months we obtained an improvement in the asthma symptoms control: ΔACQ-5=-1.87 (p=0.0002) compared to baseline with a trend towards further improvement in indicators and reached ΔACQ-5=-2.18 (p=0.0001) to the 52nd week. We also obtained a statistically significant improvement in pulmonary function (after a year of treatment, the increase in forced expiratory volume in the first second was +19.85% compared to baseline, p=0.0001). No asthma exacerbation was registered during 12 months omalizumab treatment.

CONCLUSION: Our study showed that the biosimilar treatment in patients with severe atopic asthma allowed to achieve asthma control, decrease the exacerbations number and reduce the basic therapy volume, including oral-corticosteroid elimination.

BACKGROUND: Atopic dermatitis is a chronic inflammatory skin disease, the key pathogenetic mechanisms of which include activation of T2-immune inflammation, IgE-specific sensitization to various allergens, and disruptions of epidermal barrier functions. Allergen-specific immunotherapy is the only pathogenetic treatment method that can prevent the progression of the disease and the development of the atopic march. Currently, clinical experience has been accumulated in using allergen-specific immunotherapy for atopic dermatitis, yet the existing evidence base does not allow for definitive conclusions regarding the indications for conducting allergen-specific immunotherapy, especially in atopic dermatitis associated with pollen allergy.

AIMS: Determination of the clinical significance of sensitization to pollen allergens in atopic dermatitis, determination of indications for allergen-specific immunotherapy with pollen allergens and assessment of the effectiveness and safety of this method in atopic dermatitis patients.

MATERIALS AND METHODS: A comparative controlled study to evaluate the effectiveness of subcutaneous allergen-specific immunotherapy with pollen allergens of birch or cereal grasses in 78 adult atopic dermatitis patients was conducted. A single course of subcutaneous allergen-specific immunotherapy with water-salt solutions of tree pollen allergens was administered to 33 patients, and grass pollen allergens were administered to 21 patients with atopic dermatitis. The comparison group ― patients with atopic dermatitis who received standard therapy for the disease without allergen-specific immunotherapy ― 24 patients. The primary endpoints of the study were to evaluate the effectiveness of therapy based on the reduction in the severity of atopic dermatitis symptoms, based on the absolute and relative number of patients who achieved a reduction in SCORAD score by 75% and IGA 1/0.

RESULTS: In patients receiving one course of subcutaneous allergen-specific immunotherapy with tree pollen allergens, SCORAD 50 achieved 26, 33, 47% and SCORAD 75 achieved 10, 20 and 33% after 16, 32 and 52 weeks, respectively. In patients who received one course of subcutaneous allergen-specific immunotherapy with grass pollen allergens, SCORAD 50 reached 31, 40, 58% and SCORAD 75 ― 14, 28 and 43% after 16, 32 and 52 weeks, respectively. In the comparison group, the number of such patients was significantly smaller: SCORAD 50 reached 24, 32, 37% and SCORAD 75 ― 13, 22 and 26% after 16, 32 and 52 weeks, respectively. Similar results were obtained when studying the IGA. In all study groups, an improvement in the quality of life of patients was noted, which was reflected in a decrease in the DLQI index by 4 or more points in 12, 25 and 37% of patients receiving one course of subcutaneous allergen-specific immunotherapy with tree pollen allergens, in 14, 28 and 43% in patients after 16, 32 and 52 weeks, respectively. However, the number of such patients in the comparison group was significantly lower: 13, 22 and 26%, respectively.

CONCLUSION: Allergen-specific immunotherapy is an effective way to treat atopic dermatitis patients, provided there is proven sensitization to pollen allergens.

BACKGROUND: The effector capabilities of humoral immunity are determined not only by the amount of specific antibodies produced in response to an antigenic effect, but also by their qualitative characteristics, which include avidity ― the total strength of binding to the antigen, which determines the duration and effectiveness of post-infectious immunity to SARS-CoV-2.

AIM: Is a selective study of the quantity and avidity of IgG antibodies to SARS-CoV-2 over time among medical workers of a temporary infectious diseases hospital in Kazan ― convalescents of COVID-19, during the period from July 2020 to July 2021.

MATERIALS AND METHODS: Determination of IgG to the S antigen of SARS-CoV-2 by ELISA was carried out using the test system SARS-CoV-2-IgG quantitative-ELISA-BEST (Vector-Best, Russia) and expressed in BAU/ml (binding antibody units). Antibody avidity was determined using a 4.0 M urea solution and expressed as avidity indices. 1, 4 and 7 months after COVID-19 asymptomatic (n=34); mild severity (n=42); moderate severity (n=29); reinfected (n=34). When statistically processing the data, descriptive statistics methods and the Wilcoxon matched data test were used. Differences were considered significant at p <0.05.

RESULTS: IgG avidity to SARS-CoV-2 depended on the severity of COVID-19. The highest rates of avidity indices were found in the group of those who had a moderate form of COVID-19. If in mild and asymptomatic forms there was a parallel decrease in avidity indices and IgG titer, then in moderate forms an increase in antibody titer was accompanied by a decrease in their avidity 4 months after the infection. 7 months after seroconversion, the IgG level decreased almost twofold, both in mild, asymptomatic and moderate forms. In the group of medical workers who had COVID-19 repeatedly, the initially low levels of avidity indices and antibody titers increased in parallel, while avidity indices after 7 months did not decrease, but remained high. Differences in avidity indices determined the subsequent formation of different trends in the development of the humoral immune response, which were mainly characterized by an uneven decrease in IgG and persistence of IgM antibodies for more than 1 month.

CONCLUSIONS: The research results expand the understanding of the mechanisms of formation of the humoral immune response and the avidity of IgG antibodies against SARS-CoV-2 in the risk group ― medical workers. The level of humoral immunity decreases in the first six months and varies depending on the severity of COVID-19. The data obtained can be used to identify categories of increased risk of SARS-CoV-2 infection among healthcare workers, make decisions about immunorehabilitation and revaccination against COVID-19.

BACKGROUND: An important advance in modern allergology has been made by the introduction of allergenic molecules/components, including their detection by the ImmunoCAP ISAC method. This method is useful in patients with a complex spectrum of sensitization and severe forms of allergic diseases, where various predictors of severe course are actively searched for.

AIM: To evaluate the informativeness of component resolved diagnostic by ISAC ImmunoCAP method in patients with severe bronchial asthma and severe atopic dermatitis.

MATERIALS AND METHODS: A single-center retrospective study was conducted from January to August 2023. 100 patients who were candidates for biologicals for severe bronchial asthma (group 1; 63 patients), severe atopic dermatitis (group 2; 20 patients), or their combination (group 3; 17 patients) were included. Component restlved diagnostic was performed by ImmunoCAP ISAC method.

RESULTS: Polysensitization and high occurrence of food and fungal allergens were more frequently detected in the groups of patients with severe atopic dermatitis. When analyzing the pollen sensitization spectrum in groups 2 and 3, Bet v 1 and PR-10 family cross-linked molecules (Mal d 1, Pru p 1, Ara h 8, Gly m 4, Cor a 1.04), as well as Ole e 9, Cyn d 1, Ph p 1 and Par j 2 were the most common. Epidermal allergens were common in all three groups. Lipocains (Can f 1, Can f 4, Can f 6, Ecu q 1, Mus m 1), kallikreins (Can f 5), and albumin (Fel d 2) dominated among them. The presence of sensitization to household allergens was detected only in group 2 and only to the molecule Der p 23. Among fungal allergens, the allergen Asp f 6 was predominant in the groups with severe atopic dermatitis, and the component Alt a 1 in patients with severe bronchial asthma. Among food allergens, one of the most common allergens was the molecule Gad c 1, Gal d 1, Gal d 2, Gal d 5 and Bos d 6.

CONCLUSION: Component resolved diagnostic is an accurate assay suitable for determining the spectrum of sensitization in patients; its result can serve as a distinct biomarker for severe allergic diseases.

BACKGROUND: Cold urticaria is characterized by hives and/or angioedema and/or systemic reactions in response to a cold stimulus. Typical and atypical forms cold urticariahave distinguished features. Currently there is limited data in the literature on patients with isolated cold urticaria, as well as with typical and atypical forms.

AIM: To analyze a cohort of patients with isolated cold urticaria and the characteristics of patients with typical and atypical cold urticaria.

MATERIALS AND METHODS: We conducted a study of 89 patients with a verified diagnosis of cold urticaria, who underwent provocative testing (ice cube, TempTest). In case of a positive result, typical cold urticaria was diagnosed (n=38), negative ― atypical (n=51). The typical cold urticaria group was divided into 2 subgroups ― low threshold (17 degrees or less), high threshold (above 17 degrees). Correlations between characteristics in the subgroups were analyzed. Mathematical and statistical processing of the data was performed using the SPSS software package (version 22). Kraskell–Wallis and Dunn's criteria were used. For quantitative and categorical variables, dependence was assessed using Spearman correlation.

RESULTS: The predominance of female gender, young age of disease onset, high prevalence of angioedema, high incidence of cold anaphylaxis, and atopy are noted in patients with cold urticaria. Most patients are on therapy with standard doses of antihistamines. Patients with atypical cold urticaria were younger (p=0.012), had earlier cold urticaria onset (p=0.003), lower basophil (p <0.001) and higher eosinophil counts (p=0.007). In the high temperature group, atypical cold urticaria was found to correlate with bronchial asthma (r=0.69; p <0.001) and the need to escalate the dose of antihistamines (r=0.4; p=0.03). It was also revealed that patients with cold anaphylaxis had lower scores on the Urticaria Control Test questionnaire (r=-0.46; p=0.03). At the same time, higher scores correlated in this group with the duration of the disease (r=0.66; p=0.001). In the low temperature threshold group, threshold correlates with female gender (r=-0.68; p=0.003), autoimmune diseases (r=0.51; p=0.043). Cold anaphylaxis correlates with angioedema (r=0.65; p=0.006) and autoimmune diseases (r=0.75; p=0.001).

CONCLUSION: Cold anaphylaxis is a significant problem, especially in countries with cold climates. There are a number of factors that distinguish typical cold urticaria from atypical cold urticaria. Further research is needed on cold urticaria and the associated factors.

The relevance of the disease is due to its prevalence ― for acute urticaria up to 20% with predominance in the paediatric population, for chronic spontaneous urticaria up to 0.5–5% of the population. The course of the disease is characterised by unpredictability of prognosis of duration, effectiveness of standard therapy, serious impact on the quality of life of the patient, his relatives, the burden on health authorities. The lack of accurate understanding of the mechanisms of disease development, a wide range of pathogenetic treatment complicates the possibility of rapid achievement of drug remission. The clinical Recommendations contain up-to-date information on epidemiology, pathogenesis, clinical picture, differential diagnosis, possibilities of examination and stage treatment, including immunobiological therapy. The procedure of medical care, prophylaxis and dispensary observation, criteria for assessing the quality of patient management and supporting material, including questionnaires to assess the severity of the condition and the effectiveness of treatment are outlined. Clinical recommendations on urticaria are intended for practicing physicians of all specialities, students, teachers of medical schools, residents, postgraduates and researchers.

Psoriasis is a common chronic immune-mediated inflammatory inflammatory skin disease. The systemic nature of the inflammatory process, as well as the association with other diseases (psoriatic arthritis, inflammatory bowel disease, cardiovascular disease, depression, metabolic syndrome) significantly worsen the patient's quality of life, increasing the mortality curve.

Different groups of drugs are used in the treatment of psoriasis, but according to the latest scientific data, the most effective is genetically engineered biological therapy, which targets key cytokines of psoriasis immunopathogenesis. Although there are numerous and effective biologics therapy used for the treatment of psoriasis, primary and secondary non-responders are becoming increasingly common, and not all patients achieve remission in the long term, which has a negative impact on quality of life. Identification of genetic markers associated with response to therapy using pharmacogenetic studies is a high current issue, as this presents new opportunities for personalized medicine and will identify genetic markers for each drug group.

The review analyzes the available data from pharmacogenetic studies that have identified genes and their polymorphisms associated with response to biologics therapy.

Atopic dermatitis is the most common chronic inflammatory skin disease, characterized by itching, chronic recurrent course, and in most cases is associated with respiratory allergies ― allergic rhinitis and asthma. The incidence of atopic dermatitis varies from 15 to 30% or more among children and from 2 to 14% among adults in different countries. The pathophysiological mechanisms of atopic dermatitis are based on a genetic predisposition to allergies, immune dysregulation, and the influence of environmental factors. Recent studies have shown that a key feature of atopic dermatitis is a barrier defects in compromised skin which leads to increased permeability and penetration of environmental factors (e.g., microbes, allergens) and finally to allergen sensitization and to the development of specific allergic inflammation in the target organ ― the skin.

The article presents a series of clinical cases of moderate and severe atopic dermatitis, demonstrated an integrated approach to the treatment and selection of emollients, considering the phenotypic features of atopic dermatitis.