Use Of Biologic Therapies Research Articles

Can Early Aggressive Treatment of Psoriasis Prevent Psoriatic Arthritis? A Debate at the GRAPPA Annual Meeting.

In recent years, a number of studies have examined risk factors for development of psoriatic arthritis (PsA) among patients with PsO. Most recently, 5 studies have examined the effect of biologic therapy on the development of PsA. However, the results have been mixed, with 3 studies suggesting a lower risk for PsA among those using a biologic therapy and 2 suggesting a higher risk for PsA. At the 2022 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) meeting, Drs. Enrique Soriano and Alexis Ogdie conducted a debate to discuss the arguments for and against the use of biologic therapies in PsO for the purpose of preventing PsA.

Extraintestinal Cancers in Inflammatory Bowel Disease: A Literature Review.

Inflammatory bowel disease (IBD) is a group of chronic multifactorial inflammatory disorders including two major entities: Crohn's disease (CD) and ulcerative colitis (UC). Preliminary evidence suggests that patients with IBD may be at increased risk of developing intestinal and extraintestinal cancers (EICs). Actually, little is known about the association between IBD and EICs, and there is ever-growing concern regarding the safety of immunomodulators and biological therapy, which may represent a risk factor for carcinogenesis. The aim of this review is to summarize the evidence regarding the association between IBD and EICs, the safety of immunomodulators and biological therapy and the management of immunomodulators and biologic agents in IBD patients with prior or current EICs. IBD patients have a higher risk of developing different forms of extraintestinal solid organ tumors and hematological malignancies. Immunomodulators and biological therapy may increase the risk of developing some types of EICs and may be consciously used in patients with IBD and current or prior history of malignancy. Decisions regarding the use of immunomodulators or biological therapies should be made on an individual basis, considering a multidisciplinary approach involving oncologists.

Predictive Factors of the Use of Rituximab and Belimumab in Spanish Lupus Patients.

Objectives: To analyze the characteristics and the predictive factors of the use of rituximab and belimumab in daily practice in patients from the inception cohort Registro Español de Lupus (RELES). Material and methods: The study included 518 patients. We considered patients treated with biologics who received at least one dose of rituximab or belimumab, and possible indications of those manifestations registered at the same time or in the previous 2 months of the start of the therapy. Results: In our cohort, 37 (7%) patients received at least one biological treatment. Rituximab was prescribed in 26 patients and belimumab in 11. Rituximab was mainly prescribed for hemolytic anemia or thrombocytopenia (11 patients, 42%), lupus nephritis and neuropsychiatric lupus (5 patients each, 19%). Belimumab was mostly used for arthritis (8 patients, 73%). In the univariate analysis, the predictive factors at diagnosis for the use of biologic therapy were younger age (p = 0.022), a higher SLEDAI (p = 0.001) and the presence of psychosis (p = 0.011), organic mental syndrome (SOCA) (p = 0.006), hemolytic anemia (p = 0.001), or thrombocytopenia (p = 0.01). In the multivariant model, only younger age, psychosis, and hemolytic anemia were independent predictors of the use of biologics. Conclusions: Rituximab is usually given to patients with hematological, neuropsychiatric and renal involvement and belimumab for arthritis. Psychosis, hemolytic anemia and age at the diagnosis of lupus were independent predictive factors of the use of biological agents. Their global effects are beneficial, with a significant reduction in SLE activity and a low rate of side effects.

Trajectories of self-reported pain-related health outcomes and longitudinal effects on medication use in rheumatoid arthritis: a prospective cohort analysis using the Australian Rheumatology Association Database (ARAD)

ObjectiveTo determine distinct trajectories of self-reported pain-related health status in rheumatoid arthritis (RA), their relationship with sociodemographic factors and medication use.Methods988 Australian Rheumatology Association Database participants with RA (71% female,...

Efficacy and safety of abrocitinib in patients with moderate‐to‐severe atopic dermatitis with prior exposure to oral systemic immunosuppressants or biologic therapies: A post hoc analysis of the JADE clinical trials

AbstractBackgroundPatients with moderate‐to‐severe atopic dermatitis (AD) refractory to topical therapy might require treatment with systemic therapies, including biologics.ObjectivesTo assess the efficacy and safety of abrocitinib monotherapy in patients who previously received systemic therapies.MethodsThis post hoc analysis included patients receiving abrocitinib (200 mg/100 mg) or placebo in the phase 2b and phase 3 JADE MONO‐1 and MONO‐2, REGIMEN (abrocitinib 200 mg; open‐label period) and EXTEND (patients enrolled from MONO‐1 and MONO‐2) trials. Patients who were systemic therapy‐naive or had received prior oral systemic or biologic therapies were assessed for Investigator's Global Assessment (IGA) response of 0 (clear) or 1 (almost clear) and ≥2‐point improvement from baseline, ≥75% or ≥90% improvement in Eczema Area and Severity Index (EASI‐75 or EASI‐90), ≥4‐point improvement in Peak Pruritus Numerical Rating Scale (PP‐NRS4), PP‐NRS score of 0 or 1 and change from baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) and Patient‐Oriented Eczema Measure (POEM) scores. Safety was assessed.ResultsThis analysis included 1579 patients (systemic therapy‐naive, n = 997; prior exposure to oral systemic, n = 429; biologic therapies, n = 153). At Week 12, IGA 0/1 response rates (95% confidence intervals) among patients who were systemic therapy‐naive, had received prior oral systemic therapy or had received biologic therapy were 44.4% (37.5–51.4), 34.5% (22.3–46.7) and 43.5% (23.2–63.7) with abrocitinib 200 mg, 30.9% (24.2–37.5), 16.4% (7.1–25.7) and 24.1% (8.6–39.7) with abrocitinib 100 mg and 9.6% (4.2–14.9), 5.9% (0.0–13.8) and 0.0% (0.0–23.2) with placebo in the pooled monotherapy trials; and 67.0% (62.8–71.2), 62.2% (56.4–68.0) and 53.5% (42.9–64.0) in REGIMEN. Across subgroups, abrocitinib showed greater improvement in EASI‐75, PP‐NRS4, EASI‐90, PP‐NRS 0/1, PSAAD and POEM scores versus placebo. Similar results were seen at Week 48. No new safety signals were observed.ConclusionsPrior use of oral systemic or biologic therapies did not seem to impact the efficacy and safety of abrocitinib in patients with moderate‐to‐severe AD.

Evaluation of impact of new coronavirus infection on clinical course of rheumatic diseases in real clinical practice

Aim. To evaluate the effect of COVID-19 on the clinical course of immunoinflammatory rheumatic diseases (IRD).Material and methods. The clinical course of IRD was analyzed in 324 patients who underwent new coronavirus infection (NCI) from March 2020 to February 2021 and were treated at Clinical Rheumatology Hospital No. 25 (Saint-Petersburg, Russia) for exacerbation of the underlying disease.Results. The risk factors of severe COVID-19 course in IRD were: age older than 60 years, presence of comorbid conditions (IHD, CHD, COLD), use of glucocorticoids in dose more than 12.5 mg per day and erythrocyte sedimentation rate values ≥ 40 mm/h before development of NCI. The use of immunosuppressive therapy and biological therapy had no effect on the worsening of the course of the viral infection in patients with IRD. The development of post-covid syndrome (asthenia, dyspnea, weight loss, memory loss) was noted in ¼ of the patients. Post-covid articular syndrome was characterized by the formation of arthritis associated with viral infection in 3.6% of patients, transformation of undifferentiated arthritis (UDA) into specific nosological forms in 49.0% (more often into early rheumatoid arthritis, RA), and exacerbation of joint syndrome in 83.4% of patients with advanced stage RA. In patients with diffuse connective tissue disease (DCTD), a significant increase in immunological activity due to antinuclear antibodies (maximum 1: 163840) was noted. We present clinical cases of arthritis associated with viral infection and fatal outcome in a patient with systemic sclerosis and interstitial lung damage after COVID-19.Conclusions. In the cohort of patients with IRD observed at Clinical Rheumatology Hospital No. 25 (Saint-Petersburg, Russia) COVID-19 had a moderate to severe course in half of patients, initiated the development of pneumonic complications in 68.6% of patients, arthritis associated with viral infection in 3.6%, transformation of UDA into IRD in 49.0% of cases and exacerbation of the main disease in the great majority of patients. Patients with DCTD with interstitial lung damage have a high risk of adverse outcome of NCI, especially in cases of unstable course of the disease, pronounced immunosuppression and require special monitoring.The authors present their own clinical experience with the use of Alflutop in a comorbid patient with osteoarthritis and increased pain after undergoing CCI, which indicates its effectiveness and cardiovascular safety. An important practical advantage of Alflutop should be considered the absence of its effect on the parameters of hemocoagulation and the reduction in the need for NSAIDs, which reduces the risk of thrombotic complications characteristic of long-term COVID. A short course of Alflutop (ten intramuscular injections of 2.0 ml every other day) contributes to ease of use and increased adherence to therapy in patients with osteoarthritis.

Modern approaches to the treatment of peptic ulcer disease and prospects for the use of biological therapy

Digestive diseases are the sixth leading cause of death in the world and accounted for more than 2.5 million deaths in 2019. In Ukraine, mortality from diseases of the digestive system is recorded as one of the highest in the world, and the leading place in the general structure of diseases of the digestive system is occupied by peptic ulcer disease (РUD).
 The aim of the study. Summarize current information on the etiology and the pathogenesis of РUD and characterize modern approaches to the treatment of patients with РUD and the prospects of biological therapy.
 Materials and methods. Publications were selected based on the PubMed, Clinical Key Elsevier, Cochrane Library, eBook Business Collection, and Google Scholar databases, which covered information on the etiology, pathogenesis, and approaches to the treatment of РUD.
 Results. Standard first-line anti-Helicobacter therapy consists of a proton pump inhibitor and two antibiotics, such as clarithromycin and amoxicillin or metronidazole. A promising direction in the treatment of РUD is the use of biological therapy. According to literature sources, the prophylactic use of cryoextract of the placenta in indomethacin gastric lesions has an anti-ulcer effect at the level of 69.1 % and 92.1 % in diclofenac sodium gastric lesions. In addition, the specified cryoextract is capable of leveling the gastrotoxic effect of acetylsalicylic acid, ibuprofen, stress factor and chemical ulcerogens.
 Conclusions. Today, there is a great need for cell therapy that could be put into practice in clinically relevant volumes. The most promising directions of biological therapy in gastroenterology are considered to be the use of mesenchymal stem cells and agents obtained from the fetoplacental complex.

Improving the Accuracy of Biologic Drug Survival Data: The Increasing Prevalence of Off-Label Dosing Must Be Considered when Reporting Drug Effectiveness and Safety

Improving the Accuracy of Biologic Drug Survival Data: The Increasing Prevalence of Off-Label Dosing Must Be Considered when Reporting Drug Effectiveness and Safety

Safety of Biologic and Small Molecule Therapy for Inflammatory Bowel Disease Among Solid Organ Transplant Recipients: Systematic Review and Meta-Analysis.

Patients undergoing organ transplantation are often on immunosuppressing medications to prevent rejection of the transplant. The data on use of concomitant immunosuppression for inflammatory bowel disease (IBD) and organ transplant management are limited. This study sought to evaluate the safety of biologic and small molecule therapy for the treatment of IBD among solid organ transplant recipients. Medline, Embase, and Web of Science databases were systematically searched for studies reporting on safety outcomes associated with the use of biologic and small molecule therapy (infliximab, adalimumab, certolizumab, golimumab, vedolizumab, ustekinumab, and tofacitinib) in patients with IBD postsolid organ transplant (eg, liver, kidney, heart, lung, pancreas). The primary outcome was infectious complications. Secondary outcomes included serious infections, colectomy, and discontinuation of biologic therapy. Seven hundred ninety-seven articles were identified for screening, yielding 16 articles for the meta-analyses with information on 163 patients. Antitumor necrosis factor α (Anti-TNFs; infliximab and adalimumab) were used in 8 studies, vedolizumab in 6 studies, and a combination of ustekinumab or vedolizumab and anti-TNFs in 2 studies. Two studies reported outcomes after kidney and cardiac transplant respectively, whereas the rest of the studies included patients with liver transplants. The rates of all infections and serious infections were 20.09 per 100 person-years (100-PY; 95% CI, 12.23-32.99 per 100-PY, I2 = 54%) and 17.39 per 100-PY (95% CI, 11.73-25.78 per 100-PY, I2 = 21%), respectively. The rates of colectomy and biologic medication discontinuation were 12.62 per 100-PY (95% CI, 6.34-25.11 per 100-PY, I2 = 34%) and 19.68 per 100-PY (95% CI, 9.97-38.84 per 100-PY, I2 = 74%), respectively. No cases of venous thromboembolism or death attributable to biologic use were reported. Biologic therapy is overall well tolerated in patients with solid organ transplant. Long-term studies are needed to better define the role of specific agents in this patient population.

Unveiling the power of diet and lifestyle in managing Crohn’s disease

Introduction:
 Crohn's disease (CD) is an inflammatory bowel disease that can affect any part of the digestive tract. Onset, progression, complications and treatment are influenced by many genetic, environmental and dietary factors. Dietary management is very useful in a variety of gastrointestinal diseases, including CD. Some nutrients have been studied in animal models to exacerbate the disease, while others have strong scientific evidence from large studies in human populations, allowing conclusions to be drawn about their impact on the disease. Dietary management is now a well-established and important part of treatment, in addition to the use of systemic corticosteroids, aminosalicylates, immunomodulators (e.g. azathioprine, 6-mercaptopurine, cyclosporine, tacrolimus) or biologic therapies.
 State of knowledge:
 To test the associations between the intake of specific macronutrients and the course of CD, we searched the PubMed database focusing on articles about the effects of consumed food components and stimulants on the onset and progression of CD.
 Conclusion:
 Nutritional treatment plays an important role in the management of CD. An appropriate diet can make a significant contribution to reducing inflammation and attenuating the course and exacerbations of the disease. The intake of proteins, fats, carbohydrates, fiber and certain food additives has been shown in studies to influence the onset and course of CD.

Checkpoint Inhibitor-Induced Colitis: An Update.

Immunotherapy with immune checkpoint inhibitors (ICIs) nowadays has indications for several solid tumors. The current targets for ICIs are CTLA-4, PD-1, and PD-L1 receptors. Despite the clinical advantages derived from ICIs, a variety of side effects are linked to overstimulation of the immune system. Among these, ICI-related colitis is one of the most common, with a disabling impact on the patient. Diarrhea, abdominal pain, abdominal distension, cramping, and hematochezia are the most common ICI enterocolitis presenting symptoms. The most frequently used grading system for assessment of the severity of ICI enterocolitis is called the Common Terminology Criteria for Adverse Events (CTCAE) grading. With regard to the histological picture, there is no specific feature; however, microscopic damage can be classified into five types: (1) acute active colitis, (2) chronic active colitis, (3) microscopic colitis-like, (4) graft-versus-host disease-like, and (5) other types. Supportive therapy (oral hydration, a bland diet without lactose or caffeine, and anti-diarrheal agents) is indicated in mild colitis. Symptomatic treatment alone or with loperamide, a low-fiber diet, and spasmolytics are recommended for low-grade diarrhea. In more severe cases, corticosteroid treatment is mandatory. In refractory cases, off-label use of biological therapies (infliximab or vedolizumab) was proposed.

Platelet-rich plasma injections as a treatment for Achilles tendinopathy and plantar fasciitis in athletes.

Platelet-rich plasma (PRP) injections represent a growing interest in the use of biologic therapies for treatment of musculoskeletal injuries. One possible application of PRP is in the management of overuse injuries commonly experienced by athletes. The aim of this review is to evaluate and summarize existing evidence regarding the efficacy of PRP in the treatment of Achilles tendinopathy and plantar fasciitis in athletes. Although many lower quality single-armed studies have demonstrated clinical improvement in athletes treated for Achilles tendinopathy with PRP, higher quality randomized controlled trials (RCTs) have shown no clear benefit in athletes. Existing data suggest PRP significantly improves clinical outcomes for plantar fasciitis in the general population, but very few studies and no RCTs are available that specifically analyze outcomes in athletic populations. More research is needed to evaluate how platelet concentration, leukocyte and erythrocyte presence, and sport type may interact to affect clinical outcomes in athletes.

Systemic Juvenile Idiopathic Arthritis and Secondary Macrophage Activation Syndrome in Latvia from 2009 to 2020: A Nationwide Retrospective Study.

Background and Objectives: Systemic juvenile idiopathic arthritis (sJIA) is a distinctive JIA subtype with mostly nonspecific systemic clinical features, which can be a diagnostic challenge. This study aimed to analyze our experience with sJIA in Latvia for twelve years: assessing clinical and epidemiological characteristics, the efficacy of therapy, and disease outcomes, including the development of macrophage activation syndrome (MAS). Materials and methods: This is a descriptive study in which we conducted a retrospective case review of all patients with sJIA diagnosis admitted to the only pediatric tertiary centre in Latvia during the period 2009-2020. Results: sJIA was diagnosed in 35 patients with a mean annual incidence rate of 0.85 patients per 100,000 children. Major clinical signs at the first visit were: fever, rash, arthritis, and lymphadenopathy. Almost half of the patients, 48.5%, had a monocyclic disease course, and only 20% of patients had persistent disease. MAS developed in 28.6% of patients. Biological therapy was administered to 48.6% of patients, mostly by tocilizumab, which induced remission in 75% after one year, and in 81.2% after two years without any serious therapy-related complications. In our study, none of the patients had interstitial lung disease, drug reaction with eosinophilia and systemic symptoms (DRESS)-like syndrome, or fatal disease. Conclusions: The incidence and clinical characteristics of sJIA correlate with the literature findings, although MAS was more common than described in other studies. There is a tendency for the persistent disease to decrease with the use of biological therapy. Tocilizumab is an efficient choice of treatment with a good safety profile.

Analysis of the course and outcomes of COVID-19 in HIV infected patients according to the infectious diseases’ hospital of Moscow

The course of two pandemics (syndemic) — HIV & COVID-19, demonstrated the synergistic eff ect of SARS-CoV-2 & HIV on the human body.The aim of the study was to identify the features of diagnosis, course, treatment and outcomes of coronavirus infection (COVID-19) in HIV infected patients admitted to an infectious hospital.Materials and methods: the retrospective data of 1,250 patients with COVID-19/HIV coinfection admitted to ICH No. 2 in Moscow in 2021 have been analyzed. Laboratory and instrumental diagnostics were carried out to clarify the diagnosis and severity of the condition. Statistical processing was performed using Excel (Microsoft) and StatTech v. 1.2.0 software. The diff erences were considered statistically signifi cant at p <0.05.The results of the conducted studies of 1,250 patients with coinfection have shown that HIV infection does not aff ect the risk of contracting SARS-CoV-2, and at the same time, the key predictors that cause high mortality in COVID-19 against the background of HIV infection are age over 55, avoidance of regular checkups and antiretroviral therapy (ART), severe immunodefi ciency (CD4+ < 200 μl–1), concomitant pathology (HCV, liver cirrhosis, damage to the cardiovascular system) and a combination of SARS-CoV-2 with various opportunistic pathogens. Late diagnosis of HIV infection contributes to a more severe course and unfavorable outcome of COVID-19 in HIV infected patients in the future. Counting the potential cost and benefi ts for each individual patient has proved that the use of biological therapy in patients with coinfection is recommended only after monitoring the immunological status indicators. Benefi cial eff ect factors in relation to HIV/SARS-CoV-2 coinfection include vaccination of HIV infected patients against COVID-19, which shows the greatest eff ectiveness in people receiving ART, with the amount of CD4+ ≥ 350 μl–1, thus preventing infection, reducing the risk of severe disease and the frequency of hospitalization and mortality rate.

Experience with the use of immunobiological drugs in the treatment of patients with severe bronchial asthma and comorbidities

Introduction. The accumulation of clinical experience in the use of biological therapy in patients with severe bronchial asthma (SBA) in real-world clinical practice with the possible identification of additional, previously undescribed clinical results is of practical interest.Aim. The goal of the study is to present results of observational study that reflects experience of using benralizumab in SBA in real-world clinical practice in city of Saint Petersburg.Materials and methods. We presents results of more than 1 year observation of 18 patients with eosinophilic SBA (12 females, 6 males, age from 28 to 74, average age 55 ± 11.9 years). Patients received benralizumab in addition to standard medical management. Conducted clinical, laboratory, functional examination of patients, assessment of the frequency of exacerbations and additional clinical effects.Results. It was shown that the inclusion of benralizumab in complex therapy led to a significant improvement in disease control, improved bronchial conduction, a significant decrease in blood eosinophilia and a reduction in the number of exacerbations. Clinical examples are given that evidence to the stabilizing effect of this therapy on the course of recurrent nasal polyposis and the positive effects on the course of eosinophilic granulomatous polyangiitis, manifested by SBA.Conclusions. In real clinical practice, the possibility of a significant improvement in control in patients with SBA with the use of biological therapy has been confirmed. At the same time, data have been obtained that will allow expanding the indications for the use of benralizumab in the future.

ИСПОЛЬЗОВАНИЕ ГУМАНИЗИРОВАННЫХ МОНОКЛОНАЛЬНЫХ АНТИТЕЛ OFF-LABEL В ПЕДИАТРИЧЕСКОЙ ПРАКТИКЕ

In recent years, the use of off-label drugs (the use of drugs for indications not approved by state regulatory bodies, and also not mentioned in the instructions for use) has become widespread in the pediatric population. For a long time, clinical trials in the pediatric population were considered difficult to conduct due to ethical issues, leading to frequent off-label drug use. Off-label drug use remains an important public health problem, especially in children with rare diseases or diseases not responding to standard treatment. The purpose of the review is to analyze foreign literature sources on the use of biological preparations outside the instructions. The use of drugs outside the instructions (off-label) is a topical issue in the clinical practice of doctors of various specialties, and this is especially in demand in pediatric practice. This is due to the fact that a registered drug may have a successful experience in adults, but at the same time not have official approval for use in children. The need to use drugs outside the instructions for use, as a rule, occurs in patients with severe, chronic, life-threatening pathology. Further studies analyzing their efficacy, safety, and cost-benefit ratio are needed to expand the use of biological therapy in the pediatric population.

Biologicals in IgE-mediated food allergy.

A better understanding of the most recent scientific literature in the use of biological therapy in the treatment of patients with IgE-mediated food allergy. A systematic review and meta-analysis demonstrated safety and effectiveness of omalizumab in the treatment of food allergy. The findings support the potential use of omalizumab as a monotherapy or as an adjunct to oral immunotherapy in IgE-mediated cow's milk allergy. The potential use of other biologics in the management of food allergy is subject of speculation. Different biological therapies are under evaluation for food allergic patients. The advance in literature will guide for a personalized treatment in the near future. However, additional research is needed to better understand the best candidate for each treatment, the optimal dose and timing.

Can we treat anti‐PD1 induced psoriasis in patients with active cancer with biologic therapy? Report of three cases

Can we treat anti‐PD1 induced psoriasis in patients with active cancer with biologic therapy? Report of three cases

The impact of psoriasis biologic therapy on HIV viral load andCD4+ cell counts in HIV-positive individuals: A real-world cohort study.

Psoriasis is a chronic immune-mediated inflammatory disorder that also occurs in the setting of human immunodeficiency virus (HIV). Biological therapy has transformed the treatment landscape for psoriasis; however, individuals with HIV are excluded from clinical trials. The impact of biological therapy on blood parameters in HIV is unclear and is only observed in small case series. The aim of this study was to assess the effect of biological therapy in psoriasis vulgaris in individuals with well-controlled HIV on CD4+ cell counts, CD4+ proportion and HIV viral load over 12 months. This retrospective cohort study was conducted at a tertiary referral centre in Sydney, Australia and included 36 HIV-positive individuals with psoriasis treated with biological therapy, compared with 144 age-, gender- and HAART-matched individuals without psoriasis seen between 2010 and 2022. Outcomes of interest included HIV viral load, CD4+ cell count and incidence of infections. No statistically significant difference was seen in baseline HIV viral load and CD4+ count between individuals with and without psoriasis. No significant change in CD4+ count or HIV viral load was seen over the 12-month period of analysis in the HIV cohort without psoriasis. The HIV cohort treated with biological therapy for psoriasis also did not demonstrate any significant change in HIV viral load and CD4+ counts over the 12-month period examined. Stratification by type of biological therapy used did not identify any significant changes in these parameters. Rates of infections and adverse events were also not significantly different between cohorts. It is possible that minor blips seen in the biologics cohort may be a risk factor for future virological failure, and future prospective longitudinal studies are required. In individuals with well-controlled HIV, the use of biological therapy for psoriasis does not significantly impact HIV viral load, CD4+ cell count, CD4+ proportion and rates of infection over the first 12 months of therapy.

Treatment of patients with atopic dermatitis and extremely high immunoglobulin E: world experience and own clinical observation

Atopic dermatitis is a chronic inflammatory skin disease characterized by a recurrent course, difficulty in individual selection of therapy, especially in patients with severe course. When examining and treating such patients, one of the routine diagnostic methods is to determine the level of total immunoglobulin E in the blood serum. The article is devoted to the analysis of available world practice data on published clinical cases of the use of biological therapy with dupilumab in real clinical practice in patients with severe atopic dermatitis, in whom high and very high levels of immunoglobulin E. The appointment of biological therapy for this cohort of patients often raises significant concerns. However, the use of a monoclonal antibody against IL-4/IL-13 proved effective, did not lead to serious adverse reactions in such patients and was accompanied by a decrease in the level of immunoglobulin E during treatment. It was noted that immunosuppressive treatment prior to biological therapy led to the development of adverse events in these patients. A separate group of patients with genetically determined hyper-IgE syndrome and severe atopic dermatitis is described, in which the positive experience of using dupilumab is also noted. The author presents his own clinical case of a patient with severe atopic dermatitis and a high level of immunoglobulin E receiving successful targeted therapy after a preliminary thorough examination except for lymphoproliferative and autoimmune diseases. Against the background of dupilumab therapy, there was a pronounced clinical regression of skin symptoms, a decrease in the level of immunoglobulin E, an increase in the patient’s quality of life, and the absence of side effects.