Systemic Glucocorticosteroids Research Articles

Potential of the domestic biosimile omalizumab in achievement of control in patients with severe asthma: short communication

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.

Clinical observation of the long-term course of COVID- 19 infection in a patient with an immunodeficiency condition

The new coronavirus infection caused by the SARS-CoV-2 virus has become a real challenge for the world’s population. Despite the fact that vaccines have been developed and the effectiveness of antiviral drugs has been demonstrated, COVID-19 continues to be an urgent problem. SARS-CoV-2 is genetically modified due to the accumulation of mutations, new strains with high virulence appear that distort the immune response. In addition, it has been shown that the virus can persist in the body for a long time, which ensures the maintenance of an inflammatory response and causes the persistence and recurrence of symptoms after acute infection, especially in certain groups of patients. The article presents a clinical case of a long-term course of new coronavirus infection with predominant lung damage in the form of interstitial changes and persistent inflammation for 7 months from the moment of diagnosis against the background of an immunodeficiency condition due to the patient’s lymphoma in remission after polychemotherapy, exclusion of pulmonary embolism and progression of lymphoproliferative disease. The article highlights the difficulties of determining the criteria for a post-COVID and the features of its treatment using long-term therapy with systemic glucocorticosteroids, inhalation administration of tauractant (Surfactant-BL) in comparison with the dynamic assessment of total ventilation disorders and dynamic control of MSCT of the chest organs. Thus, the importance of identifying risk factors for the progression of COVID-19-associated conditions in patients with different comorbid backgrounds and identifying criteria for the development of new long-COVID treatment strategies is emphasized.

Metastatic crohn’s disease in a child: rare extraintestinal manifestation

Extraintestinal manifestations occur in every second child with Crohn’s disease, can affect any organ system, and determine the type of therapy and prognosis of the disease. The skin is the most frequent “target organ” of all extraintestinal manifestations, the spectrum of skin lesions is extremely clinically and pathogenically heterogeneous. Metastatic Crohn’s disease (MBC) is a rare extraintestinal manifestation of the disease, approaches to the diagnosis and management of which are not standardized in either adults or children. The most frequent description of MBC in the literature is skin damage, although interstitial lung damage, bone and muscle damage, and ENT organs, could be destructive. MCD lesions vary in morphology and can arise anywhere on the skin, rarely undergo reverse development, require special approaches to therapy. The primary diagnosis of such elements is extremely difficult, often delated, biopsy is required for a definitive diagnosis - the detection of epithelioid granuloma and its elements outside the gastrointestinal tract. Therapeutic approaches to MCD are not standardized now, they are carried out according to the protocols of CD management, and the effect of the use of oral steroids, a-TNFa drugs is shown. A case of metastatic Crohn’s disease in a 16-year-old teenager with an unusual localization - the nasal septum is described. The destructive nature of the lesion with the formation of perforation of the nasal septum determined the difficult path of differential diagnosis with Wegener’s granulomatosis. Morphological examination of the biopsy of the nasal mucosa revealed epithelioid cells of sarcoid-like granuloma. Systemic glucocorticosteroids use (GCS) led to epithelialization of the nasal septum defect and a decrease in the activity of CD in the intestine mucosa.

Deverji's disease after COVID-19: Case report

Deverji's disease is a rare idiopathic skin disease characterized by keratinization disorder and manifested in follicular hyperkeratosis, orange-red peeling plaques, palmar-plantar keratodermia with the possible development of erythroderma. The etiopathogenesis of this dermatosis is still unknown. There are such possible trigger factors as traumatization, ultraviolet radiation, taking certain medications, autoimmune and oncological diseases, bacterial or viral infection, vaccination. The presence of familial cases is due to a mutation in the CARD14 gene. Diagnosis of the disease is based on characteristic clinical symptoms. The histological picture has no pathognomonic features; however, a biopsy is necessary for differential diagnosis with other papulosquamous dermatoses. Treatment of Deverji's disease remains a difficult task, since the disease pathogenesis has not been fully studied.
 The article describes a clinical case of Deverji's disease manifestation in a 64-year-old woman who had suffered COVID-19 infection twice. She was admitted to the Department of Dermatology and Venerology (Sechenov University) with complaints of skin rashes on her face, trunk, upper and lower extremities, accompanied by severe itching. The absence of any distinctive clinical and histological changes, the torpidity of the skin process and resistance to the therapy made it difficult to make a diagnosis. After the emergence of characteristic clinical symptoms (palmar-plantar keratodermia, salmon-tinged rashes with islands of healthy skin), as well as the results of repeated histological examination (alternating areas of ortho- and parakeratosis; uneven granular layer; vacuolization of basal cells; uneven broad acantholytic strands; loosened dermo-epidermal junction; small perivascular lymph-macrophage infiltrates) Deverji's disease was diagnosed.
 The use of standard therapies (systemic glucocorticosteroid therapy, methotrexate, topical therapy) did not give any results, and therefore it was decided to initiate the netakimab. After 5 injections, the first positive results were obtained in the form of the color paling and a decrease in the number of rashes, palmar-plantar keratodermia regression and improvement of the patient psychoemotional state. After 11 injections, almost complete remission was achieved, and treatment was continued until all symptoms disappeared completely.
 The article provides a literature review of the etiopathogenesis, clinical manifestations and treatment methods of Deverji's disease. The described clinical case is the fifth example in the world of the Deverji's disease manifestation after a COVID-19 infection, and is also the first case of the IL-17 inhibitor netakimab successful use for the disease treatment.

S2k guideline: Diagnosis and therapy of localized scleroderma.

The updated S2k guideline deals with the diagnosis and therapy of localized scleroderma (LoS). LoSrepresents a spectrum of sclerotic skin diseases in which, depending on the subtype and localisation, structures such as adipose tissue, muscles, joints, and bones may also be affected. Involvement of internal organs or progression to systemic sclerosis does not occur. LoScan be classified into four main forms: limited, generalized, linear, and mixed forms, with some additional subtypes. For cases of limited skin involvement, the guideline primarily recommends therapy with topical corticosteroids. UV therapy can also be recommended. In subtypes with severe skin or musculoskeletal involvement, systemic therapy with methotrexate is recommended. During the active phase of the disease, systemic glucocorticosteroids can be used additionally. In cases of methotrexate and steroid refractory courses, contraindications, or intolerance, mycophenolate mofetil, mycophenolic acid, or abatacept can be considered as second-line systemic therapies. In the case of linear LoS, autologous adipose-derived stem cell transplantation can also be performed for correcting soft tissue defects.

Evaluation of ongoing mepolizumab treatment in chronic rhinosinusitis with nasal polyps

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disease of the mucous membranes of the nose and paranasal sinuses. Eosinophilic inflammation is described as a common endotype. The anti-interleukin-5 (IL-5) antibody mepolizumab was approved in November 2021 as an add-on therapy to intranasal glucocorticosteroids for the treatment of adults with severe CRSwNP when systemic glucocorticosteroids or surgery do not provide adequate disease control. While national and international recommendations exist for the use of mepolizumab in CRSwNP, therapy monitoring and follow-up documentation are required, and therapy discontinuation has not been adequately established yet. In this paper, recommendations for monitoring the course and efficacy of therapy as well as for reviewing the duration and possible termination of therapy are provided. For this purpose, a literature search was performed to analyze previous data on the treatment of CRSwNP with mepolizumab and to determine the available evidence by searching MEDLINE, PubMed, and the national and international trial and guideline registries and the Cochrane Library. Human studies published in the period up to and including October 2022 were considered. Based on the international literature and previous experience, recommendations for follow-up, adherence to therapy intervals and possible therapy breaks, as well as termination of therapy when using mepolizumab for the indication CRSwNP in the German health care system are given by an expert panel on the basis of a documentation sheet.

Novel coronavirus infection (COVID-19) — clinical recommendations

The treatment of patients with a new coronavirus infection (COVID-19) is the cornerstone of practical healthcare. This is due to the widespread and unjustified use of antimicrobial drugs, the use of irrational antiviral therapy schemes. Also, the discussion regarding the use of systemic glucocorticosteroids and monoclonal antibodies continues to this day. In this publication, based on research data and own clinical observations, clinical recommendations for COVID-19 pharmacotherapy are presented.

Localized scleroderma

Localized scleroderma (LS), also called circumscribed scleroderma or morphea, comprises aheterogeneous group of diseases that can be classified into four subtypes: limited, linear, generalized, and mixed LS. All manifestations are primarily due to chronic progressive fibrosis of the skin or structures close to the skin. Involvement of internal organs or the transition to systemic sclerosis is excluded by definition. Adistinction is made between forms that primarily affect the skin (up to the dermis) or that severely involve subcutaneous fat tissue, muscle fascia or muscles. Adetailed examination is required for clinical diagnosis. In order to improve comparability of findings, photo documentation and the use of clinical scores should be carried out. For superficial subtypes the use of topical glucocorticosteroids, calcineurin inhibitors or phototherapy is initially recommended, whereas for severe forms with deep involvement or overall therapy refractoriness, the diagnosis should first be expanded and systemic therapy initiated at an early stage. Especially, in cross joint or extremity-dominant forms of linear LS or in cases with head and neck involvement, such as en coup de sabre, Parry-Romberg syndrome and other subtypes with aprominent musculoskeletal affection, an MRI examination should be arranged. Depending on location, an ophthalmological, neurological, orthodontic, rheumatological or orthopedic consultation may be necessary. For systemic therapy, methotrexate alone or in combination with systemic glucocorticosteroids as pulse therapy is recommended as first-line treatment.

Scleromyxedema

Scleromyxedema or generalized diffuse lichen myxoedematosus is arare mucinosis that is associated with monoclonal gammopathy and which frequently affects multiple extracutaneous organ systems. The pathogenesis of scleromyxedema has not been fully elucidated, but includes stimulation of glycosaminoglycan synthesis. The clinical course of scleromyxedema is chronic and often progressive, leading to severe morbidity and even death. The characteristic skin findings encompass multiple waxy papules often on indurated plaques, while thickening of skin leads to conspicuous folds on glabella and dorsal aspects of finger joints. Microscopical manifestations are dermal deposits of glycosaminoglycans between collagen bundles in reticular dermis, increased numbers of fibroblasts and fibrosis as well as loss of elastic fibers. Progressive skin involvement results in decreased mobility of the mouth and joints and even contractures. Extracutaneous manifestations occur in the musculoskeletal or cardiovascular system, in the gastrointestinal or respiratory tract, in the kidneys or in the central and peripheral nervous system. There are no in-label or evidence-based treatments available for scleromyxedema, but by expert consensus high-dose immunoglobulins are considered as treatment of choice, followed in case of insufficient efficacy by systemic glucocorticosteroids and then lenalidomide or thalidomide. In severe and refractory cases, autologous hematopoietic stem cell transplantation has been performed. Long-term maintenance treatment is usually required to prevent recurrences. Close interdisciplinary follow-up is recommended.

MAIN METHODS OF QUALITY CONTROL OF BЕТА-BLOCKER DRUGS AND APPLICATION OF SPECTROPHOTOMETRY IN THE ANALYSIS OF ANTIANGIOGENIC OINTMENTS ON TIZOL GEL (REVIEW)

Over th past decade, beta-blockers have shown their promise in the therapy of skin hemangiomas. Infantile hemangiomas are the most common soft tissue tumors occurring in 4-10% of children under the age of 1 year. Various methods are used to treat the disease: laser therapy, surgical exci-sion, cryodestruction, sclerosing, as well as conservative treatment with systemic glucocorticosteroids and beta-blockers administered enterally, topi-cally, and externally. Pharmacotherapy with the use of application dosage forms of beta-receptor antagonists is considered to be the most effective and safe method. This approach to treatment has several advantages over the oral method of administration: first, the convenience and painlessness of use, and secondly, the local effect on the pathological process, hence reducing the risk of systemic side effects (bradycardia, hypotension, bron-chospasm, insomnia). All these advantages emphasize the relevance of the development of soft dosage forms of beta-blockers. The patent RU 2471500 C2 “Use of beta-blocker for preparing drug for treating hemangiomas” proposes atenolol, betaxolol, bisoprolol, carvediol, metoprolol, nebivolol, propranolol and sotalol as antiangiogenic agents. The creation of soft dosage forms of beta-blockers with domestic transcutaneous enhancer Tizol gel is a solution to the problem of targeted delivery of active substances to the lesion site. For the development of new drugs, one of the most fundamen-tal areas of pharmaceutical science, pharmaceutical analysis, is of fundamental importance. The main objectives of pharmaceutical analysis are to determine the qualitative and quantitative characteristics of medicines. This article provides a review of the main methods for the analysis of beta-blockers used for the effective quality control of medicines, as well as methods for identifying, quantifying, and biopharmaceutically analyzing new ointments based on Tizol gel.

Topical issues of therapy for patients with ulcerative colitis

Ulcerative colitis is an autoimmune disease characterized by ulcerative destructive processes in the mucous membrane of the colon. Despite advances in the pharmaceutical industry, its prevalence in the world is increasing every year. The etiology of UC is currently unknown to the end. According to modern concepts, ulcerative colitis is considered as a multifactorial disease, in the pathogenesis of which genetic determinism, disorders of the intestinal microbiota with a decrease in populations of anaerobic bacteria in combination with the trigger action of environmental factors are discussed. With high probability, the leading pathogenetic mechanisms of the disease are associated with the polarization of the Th2-type immune response, which is characterized by the synthesis of IL-4, IL-5, IL-9 and IL-13, which is regulated by STAT-5 and Gata-3. During the development of the disease, Th17, a type of immune response, is also involved in the immunopathological process, but with the participation of transcription factors STAT-3 and ROR-yt and the synthesis of IL-17, IL-2, IL-6, IL-26 and IL-22, as well as chemokine CCL20. Diet and lifestyle are part of the global guidelines for the treatment of patients with ulcerative colitis. Derivatives of 5-aminosalicylic acid are used as basic therapy preparations: combined preparations and preparations of pure 5-aminosalicylic acid. Nevertheless, the administration of systemic glucocorticosteroids is indicated to control the activity of the disease. However, as our practice shows, they are effective, but only at the first attack and subsequent 2-3 relapses of the disease, followed by a high incidence of hormone resistance. To date, there are modern medicines with a different mechanism of action, allowing achieving stable remission and improving the quality of life of patients. Among them, JAK -tofacitinib inhibitors are of particular interest in the treatment of ulcerative colitis. This is the first oral drug capable of inducing and maintaining steroidal remission. The choice of a particular drug is determined by the experience of use, cost and national recommendations.

Monitoring mepolizumab treatment in chronic rhinosinusitis with nasal polyps (CRSwNP): Discontinue, change, continue therapy?

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disease of the mucous membranes of the nose and sinuses. Eosinophilic inflammation is described as a common endotype. The anti-IL-5 antibody mepolizumab was approved in November 2021 as an add-on therapy to intranasal glucocorticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyps when systemic glucocorticosteroids or surgery do not provide adequate disease control. While national and international recommendations exist for the use of mepolizumab in CRSwNP, it has not yet been adequately specified how this therapy should be monitored, what follow-up documentation is necessary, and when it should be discontinued if necessary. A literature search was performed to analyze previous data on the treatment of CRSwNP with mepolizumab and to determine the available evidence by searching Medline, Pubmed, the national and international trial and guideline registries, and the Cochrane Library. Human studies published in the period up to and including 10/2022 were considered. Based on the international literature and previous experience by an expert panel, recommendations for follow-up, adherence to therapy intervals, and possible therapy breaks as well as discontinuation of therapy when using mepolizumab for the indication CRSwNP in the German healthcare system are given on the basis of a documentation sheet. Understanding the immunological basis of CRSwNP opens up new non-surgical therapeutic approaches with biologics for patients with severe, uncontrolled courses. Here, we provide recommendations for follow-up, adherence to therapy intervals, possible therapy pauses, or discontinuation of therapy when mepolizumab is used as add-on therapy with intranasal glucocorticosteroids to treat adult patients with severe CRSwNP that cannot be adequately controlled with systemic glucocorticosteroids and/or surgical intervention.

S3 guideline Atopic dermatitis: Part 2 - Systemic treatment.

The present S3 guideline was created based on the European English-language S3 guideline, with special consideration given to the medical conditions in the German-speaking region, and with additions from the previous German-language version, in accordance with the criteria of the AWMF. This second part of the guideline addresses the systemic therapy of atopic dermatitis (AD). It covers topics such as the indication for systemic therapy in children, adolescents, and adult patients with AD. Furthermore, it addresses all medications approved for AD, such as the biologics dupilumab and tralokinumab, the Janus kinase inhibitors abrocitinib, baricitinib, and upadacitinib, as well as conventional immunosuppressive therapies with systemic glucocorticosteroids and ciclosporin. Additionally, it discusses systemic off-label therapies. The first part of the guideline, published separately, includes the definition and diagnostic aspects of AD, describes topical therapy, non-drug therapy approaches, and addresses aspects related to special patient groups.

Non-antimicrobial therapy of community-acquired pneumonia

This publication deals with the issue of adjuvant (non-antimicrobial) therapy for community-acquired pneumonia. A critical analysis is provided on the appropriateness of using various drugs (mucolytics, non-steroidal anti-infl ammatory drugs, immunoglobulins, etc.) and physical methods of chest impact for community-acquired pneumonia, and recommendations are given for their clinical use. Special attention is paid to the use of systemic glucocorticosteroids and inhaled nitric oxide.

Omalizumab: a quarter of a century in the fight against T2-inflammatory diseases of upper and lower respiratory tract

T2 inflammation underlies diseases such as bronchial asthma, allergic rhinitis and chronic rhinosinusitis with nasal polyps. These diseases often have a severe course and often accompany each other, which leads to a significant decrease in the quality of life of patients. Studying the mechanisms of inflammation at the molecular level has made it possible to develop immunobiological drugs aimed at different stages of pathogenesis. One of the targets of immunobiological therapy for T2 inflammation, which can be affected by monoclonal antibodies, is immunoglobulin E. The purpose of the scientific review is to summarize the data accumulated over the past 25 years from randomized clinical trials and studies of real clinical practice on the effectiveness and safety of the original anti-IgE drug – “omalizumab”, including in comorbid patients. Clinical trials have shown that the use of omalizumab in patients with severe bronchial asthma reduces the frequency of exacerbations and severe exacerbations of asthma, reduces the number of hospitalizations and emergency room visits due to asthma exacerbations, reduces oral and inhaled glucocorticosteroids doses, improves respiratory function and improves quality of life. Omalizumab reduces the severity of nasal and ocular symptoms and reduces the need for antihistamines in patients with severe allergic rhinitis. Omalizumab effectiveness in patients with chronic rhinosinusitis with nasal polyps is manifested by decrease in nasal symptoms (nasal congestion, rhinorrhea), improvement in the sense of smell, decrease in polyps size, and the need for systemic glucocorticosteroids and surgical interventions. Omalizumab showed good tolerability and safety profile comparable to placebo in both clinical trials and routine practice.

Direct comparative study of the effectiveness of mepolizumab and dupilumab in patients with severe non-allergic eosinophilic asthma

Introduction. Biologics for severe asthma (SA) treatment are widely used in real clinical practice. But there are very few direct comparative studies at the moment.Aim. To compare mepolizumab and dupilumab effectiveness in patients with non-allergic eosinophilic SA in real clinical practice using regional register of Sverdlovsk region.Materials and methods. The data of patients with non-allergic eosinophilic SA treated with dupilumab (n = 23) and mepolizumab (n = 19) were analyzed. Therapy effectiveness was determined according to BARS and patients’ proportion who achieved asthma remission, dynamics of ACT, AQLQ, FEV1, blood eosinophils, frequency of short-acting bronchodilators use and systemic glucocorticosteroids (SGCS) demand, frequency of asthma exacerbations and hospitalizations.Results. Within 12 months of targeted therapy a good response to biologics according to BARS in 77.8% of patients on dupilumab and in 82.4% of patients on mepolizumab (p = 1.000) was revealed. Remission of SA (without FEV1) was achieved in 62.5% of patients in dupilumab group and in 68.8% of patients in mepolizumab group (p = 1.000). Remission of SA (with FEV1) was achieved in 43.8% of patients on dupilumab and in 56.2% of patients on mepolizumab (p = 0.724). There were statistically significant improvements for all separately analyzed indicators in each observation group. Statistically significant differences after a year of therapy between groups were recorded in terms of eosinophil levels (p < 0.001) and nasal symptoms assessed using the SNOT-22 questionnaire (p = 0.048) in favour of mepolizumab.Conclusions. Patients with non-allergic eosinophilic SA have good response to both dupilumab and mepolizumab. The drugs equally improve disease control, life quality, reduce the need for relievers and SGCS, show a similar safety level.

Case of newly diagnosed primary immunodeficiency at age 65

Low awareness of doctors of various specialties about such an initial defect in immunity as hereditary angioedema leads to poor detection of this disease, as a result of which patients often receive ineffective drugs for a long time and are at risk of developing life-threatening complications.
 A clinical case was presented of a patient whose diagnosis of hereditary angioedema was first established at the age of 65 despite a long history of edema. There were no urticarial rashes. For edema for 3 years, the patient took Loratadine, systemic glucocorticosteroids were repeatedly administered. In addition, for many years she was worried about abdominal syndrome with an episode rate of up to several times a week, for the purpose of stopping which she used Tempalgin. There is a burdened family history of angioedema. This hospitalization was due to the development of edema of the lower lip and left cheek, the appearance of which is associated with a bite of the inner side of the cheek in sleep, there was no effect from the use of systemic glucocorticosteroids and antihistamines. The examination revealed a decrease in both the amount and functional activity of the C1-inhibitor, thus, hereditary angioedema of type I was diagnosed. Genetic examination revealed a previously undescribed variant of mutations in the SERPING1 gene.
 The pathogenesis of edema in hereditary angioedema is due to the accumulation of bradykinin, therefore, the use of glucocorticosteroids and antihistamines is ineffective. Currently, there are modern highly effective and safe means, both for stopping and for the prevention of such edema.
 It is important to inform specialists of various profiles about this disease and the principles of its therapy.

A clinical case of pyoderma gangrenosum as a severe extraintestinal manifestation of Crohn’s disease

Pyoderma gangrenosum is a rare neutrophilic dermatosis associated with a number of immune-mediated disorders, most frequently with inflammatory bowel disease and rheumatoid arthritis. Despite significant success in the treatment in inflammatory bowel disease, the problem of multidisciplinary management of patients with extraintestinal manifestations in routine medical practice remains unsolved. The paper presents a clinical case of a 32-year old female patient with a life-threatening extraintestinal manifestation of Crohn's disease, i. e. pyoderma gangrenosum. Late diagnosis of Crohn's disease, underestimation of the inflammation activity in the gut and respective lack of disease-modifying treatment were the reasons for the occurrence of pyoderma gangrenosum and its uncontrolled course. The untimely diagnosis of the skin purulent wound as an extraintestinal manifestation of Crohn's disease has led to delay in the immunosuppressive therapy required. The patient needed an intensive course of systemic glucocorticosteroids, prompt addition of a tumor necrosis factor-alpha inhibitor and surgery as a circulatory autodermoplasty.

Осложнения бесконтрольного применения топических и системных глюкокортикостероидов: клинические случаи

Осложнения бесконтрольного применения топических и системных глюкокортикостероидов: клинические случаи

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

Dupilumab, a fully human monoclonal antibody directed against the common α-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). 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. 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). 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 associated with the use of SGCS and/or hospitalization, a positive effect on the quality of life and the comorbid diseases, as well as a cumulative reduction in the need for SGCS.