Результаты терапии, включавшей омализумаб, у подростков с хронической крапивницей: ретроспективное когортное исследование

Relevance. Omalizumab is recommended for treatment of severe forms of recurrent urticaria in children since 12 years old. Though the Omalizumab efficiency and safety in children with recurrent urticaria have not been studied specifically.Objective. To estimate results of the therapy including Omalizumab in adolescents with recurrent urticaria.Methods. We have studied clinical records of day hospital patients aged from 12 to 17 with recurrent urticaria uncontrolled with second-generation antihistamines and/or immunosuppressive drugs at least for a month (in standard or higher dose), but receiving Omalizumab (300 mg once in 4 weeks subcutaneously). The main result of this therapy is disease control (urticaria activity score over 7 days, UAS7, equal to zero) at 3 and 6 months of therapy. Additional outcomes of therapy: number of significant recrudescence (use of glucocorticosteroids or emergency hospitalization) at 6th month of therapy and in 6 and 12 months after its end; end of concomitant treatment (antihistamines and/or immunosuppressive drugs) at 3 and 6 months and genetically engineered biological agent (GEBD); remission (UAS7 = 0) after 6 and 12 months after GEBD cessation; adverse effects of Omalizumab therapy (any medical cases connected with GEBD).Results. The disease control at 3 months of treatment was reached in 12 (67%) patients out of 18 children with recurrent urticaria, at 6 months — at 13 (72%) patients. During Omalizumab therapy and at 6 months after therapy cessation there were no significant recrudescence, at 12 months after therapy cessation — at 1 (6%) adolescent. The concomitant treatment was ended after 3 months at 3 (17%) patients, after 6 months — at 10 (56%) patients. Remission was sustained at 11 (61%) out of 18 patients at 6 months and at 9 (60%) out of 15 patients at 12 months after the therapy end. Adverse effects of Omalizumab have not been noted.Conclusion. Addition of Omalizumab to the therapy in adolescents with uncontrolled recurrent urticaria let us reach remission of disease in most cases by 6 months of treatment.Обоснование. Омализумаб рекомендован для лечения хронической спонтанной (идиопатической) крапивницы, резистентной к блокаторам Н1- гистаминовых рецепторов, у детей с 12 лет.Цель исследования — оценить результаты терапии, включавшей омализумаб, у подростков с хронической идиопатической крапивницей.Методы. Изучали истории болезни пациентов дневного стационара в возрасте 12-17 лет с хронической крапивницей, неконтролируемой антигистаминными препаратами 2-го поколения и/или иммунодепрессантами не менее 1 мес (в стандартной или выше стандартной дозировке), получавших омализумаб (300 мг 1 раз в 4 нед подкожно). Основной исход терапии — контроль болезни (индекс активности крапивницы за предыдущие 7 сут, ИАК7, равный нулю) к 3 и 6 мес терапии. Дополнительные исходы: количество значимых обострений (применение глюкокортикостероидов или экстренная госпитализация) к 6 мес терапии и через 6 и 12 мес после ее завершения; отмена сопутствующей терапии (антигистаминные препараты и/или иммунодепрессанты) к 3 и 6 мес и генно-инженерных биологических препаратов (ГИБП); ремиссия (ИАК7=0) через 6 и 12 мес после отмены ГИБП; нежелательные реакции на омализумаб (любые медицинские события, связанные с ГИБП).Результаты. Из 18 детей с хронической крапивницей контроль болезни к 3 мес лечения достигнут у 12 (67%) пациентов, к 6 мес — у 13 (72%). В период терапии омализумабом и через 6 мес после завершения значимых обострений крапивницы не было, через 12 мес после ее завершения — у 1 (6%) подростка. После 3 мес лечения сопутствующая терапия отменена у 3 (17%) пациентов, после 6 мес — у 10 (56%). Ремиссия заболевания сохранялась у 11 (61%) из 18 пациентов через 6 мес и у 9 из 15 оставшихся под наблюдением (60%) через 12 мес после завершения терапии. Нежелательных реакций на омализумаб не отмечено.Заключение. Добавление омализумаба к терапии подростков с неконтролируемой хронической идиопатической крапивницей позволяет достичь контроля болезни к 6 мес лечения у большинства пролеченных больных

Современные стратегии терапии персистирующей бронхиальной астмы у подростков

Bronchial asthma remains one of the most common non-infectious diseases. In children, the highest prevalence and incidence of asthma is observed in adolescence. Difficulties in achieving and maintaining control over the disease in adolescents are due to the peculiarities of their socio-psychological adaptation, low adherence to therapy, and poor doctor-patient interaction. To achieve maximum control over the disease in children and adolescents suffering from moderate bronchial asthma, according to current guidelines, combined drugs should be used. A number of conciliation documents on asthma adopted the concept of using a single inhaler from the third stage of treatment, which is used both as a basic therapy and for relieving exacerbations. A large number of studies have demonstrated successful experience with the use of such tactics, including in adolescents in real clinical practice. It is proved that this approach increases adherence to therapy, reduces the risk of exacerbations, and improves the control over the disease. However, further research is needed, because therapy with a single inhaler has age limits. Бронхиальная астма остается одним из самых распространенных неинфекционных заболеваний. У детей наибольшая распространенность и заболеваемость астмой отмечается в подростковом возрасте. Трудности достижения и подержания контроля над болезнью у подростков обусловлены особенностями их социально-психологической адаптации, низкой приверженностью к терапии и плохим взаимодействием между врачом и пациентом. Для достижения максимального контроля над болезнью у детей и подростков, страдающих среднетяжелой бронхиальной астмой, согласно современным руководствам, следует использовать комбинированные препараты. В ряде согласительных документов по астме с 3-й ступени лечения принята концепция использования единого ингалятора, который применяется и в качестве базисной терапии, и для купирования обострений. В большом количестве исследований продемонстрирован успешный опыт применения подобной тактики, в том числе у подростков в условиях реальной клинической практики Доказано, что данный подход повышает приверженность к терапии, снижает риск обострений и улучшает контроль над заболеванием. Однако, необходимы дальнейшие исследования, т.к. терапия в режиме единого ингалятора имеет возрастные ограничения. 

Современные возможности терапии хронической крапивницы у детей

Chronic urticaria in children is one of the diseases that are underestimated in their severity and impact on the quality of life. The world academic literature data gives very little information on epidemiology, etiology of chronic urticaria, and researches on application of various therapies in children with the studied disease. Second-generation antihistamines are the leading medications in the therapy of chronic urticarial; however, there are not enough studies on the use of other treatment options in children with this pathology. Resistance to standard therapy and to high doses of antihistamines is one of the problems of managing both adult patients and children. Omalizumab is the first generation of biologicals drug for treating chronic urticaria resistant to standard therapy; the pharmaceutical can be administered in children over 12 years. Further research on the drug efficacy in chronic urticaria is required including safety rate evaluation in the pediatric group of patients.Хроническая крапивница у детей — одно из недооцененных по своей тяжести и влиянию на качество жизни заболеваний. В мировой научной литературе крайне мало информации об эпидемиологии, и этиологии хронической крапивницы. Антигистаминные препараты 2-го поколения являются ведущими в терапии хронической крапивницы, однако исследований по применению других видов лечения у детей при данной патологии недостаточно. Резистентность к стандартной терапии и высоким дозам антигистаминных препаратов — одна из проблем ведения как взрослых пациентов, так и детей. Омализумаб — первый генно-инженерный биологический препарат для лечения резистентной к стандартной терапии хронической крапивницы, разрешен к применению у детей с 12 лет. Необходимы дальнейшие исследования по эффективности его применения при хронической крапивнице, в том числе с оценкой безопасности у педиатрической группы пациентов.КОНФЛИКТ ИНТЕРЕСОВЛ.С. Намазова-Баранова — получение исследовательских грантов от фармацевтических компаний Пьер Фабр, Genzyme Europe B. V., ООО «Астра зенека Фармасьютикалз», Gilead / PRA «Фармасьютикал Рисерч Ассошиэйтс СиАйЭс», «Bionorica», Teva Branded Pharmaceutical products R&D, Inc / ООО «ППД Девелопмент (Смоленск)», «Сталлержен С. А.» / «Квинтайлс ГезмбХ» (Австрия).Остальные авторы данной статьи подтверждают отсутствие конфликта интересов, о котором необходимо сообщить

Современные подходы к ведению детей с крапивницей

The authors presented the main provisions of the current clinical guidelines for the treatment of children with urticaria. The specifics of disease epidemiolog y, etiolog y and pathogenesis are described. The steps of dif ferential diagnosis are highlighted. For pediatric patients, treatment recommendations are provided based on the principles of evidence and a step-by-step therapy is suggested. A clear explanation is given on how to conduct an analysis of the ef fectiveness of therapy and assess the degree of disease activity.Авторами представлены  основные положения  акт уальных к линических рекомендаций по оказанию медицинской помощи детям с крапивницей.  Рассматриваются особенности  эпидемиологии,  этиологии  и патогенеза. Подробно  освещаются этапы дифференциально-диагностического поиска. Для  пациентов  детского  возраста приведены основанные на доказательной  базе рекомендации  по лечению и предложена  ст упенчатая схема терапии.  Дано четкое разъяснение к проведению анализа  эффективности  терапии  и оценки степени  активности заболевания

Efficiency of Adding Omalizumab to Standard Therapy for Children with Recurrent Spontaneous Urticaria: Comparative Observational Study

Background. Recurrent spontaneous urticaria (RSU) is rare in children, thus, it is debilitating condition that always requires treatment. There are several limitations on the drugs use in children with RSU. Omalizumab is the effective medication for achieving the control of RSU, used in adolescents over 12 years of age.The aim of the study is to compare the efficiency of various approaches for RSU management in children.Methods. The three-year comparative study of patients with RSU aged from 1 to 17 years managed only with 2nd generation antihistamines in standard or increased doses for at least 3 months and patients managed in addition to standard treatment with omalizumab (300 mg once in 4 weeks subcutaneously) was conducted. The essential treatment outcomes are achieving control of the disease (UAS7 = 0) in 6 months and remission maintaining after 36 months of observation. Additional outcomes are decrease in the number of aggravations that required the use of glucocorticosteroids (GCS) during 3 years of followup; analysis of treatment outcomes of patients with severe urticaria in subgroups (including UAS7 levels).Results. The frequency of disease control (UAS7 = 0) by 6 months of therapy was significantly higher in patients of the omalizumab group — 76%, in the second group — 0%. The UAS7 in the omalizumab group was 0 (0; 1) points, in the group of patients on standard therapy — 13 (10; 16) points (p < 0.05). Remission was observed in 53% of patients (9 people) in the omalizumab group in 36 months, in the comparison group — in 32% (13 people), p = 0.129; UAS7 in the omalizumab group was 0 (0; 8.5) points, in the comparison group — 8 (0; 13) points, p = 0.076. The use of systemic GCS for acute treatment decreased during 3 years of follow-up: in the omalizumab group — from 41 to 5.9%, in the group on 2nd generation antihistamines — from 46 to 19% (p = 0.258). The result of subgroup analysis was similar.Conclusion. Adding omalizumab to standard RSU therapy makes it possible to achieve control of the disease reliably faster in most cases. There was gradual decrease in RSU activity in the group on standard therapy during the 3-year follow-up: spontaneous remission was mentioned in 32% of children within 3 years

Results of Therapy Including Omalizumab in Adolescents With Recurrent Urticaria: Retrospective Cohort Study

Relevance. Omalizumab is recommended for treatment of severe forms of recurrent urticaria in children since 12 years old. Though the Omalizumab efficiency and safety in children with recurrent urticaria have not been studied specifically.Objective. To estimate results of the therapy including Omalizumab in adolescents with recurrent urticaria.Methods. We have studied clinical records of day hospital patients aged from 12 to 17 with recurrent urticaria uncontrolled with second-generation antihistamines and/or immunosuppressive drugs at least for a month (in standard or higher dose), but receiving Omalizumab (300 mg once in 4 weeks subcutaneously). The main result of this therapy is disease control (urticaria activity score over 7 days, UAS7, equal to zero) at 3 and 6 months of therapy. Additional outcomes of therapy: number of significant recrudescence (use of glucocorticosteroids or emergency hospitalization) at 6th month of therapy and in 6 and 12 months after its end; end of concomitant treatment (antihistamines and/or immunosuppressive drugs) at 3 and 6 months and genetically engineered biological agent (GEBD); remission (UAS7 = 0) after 6 and 12 months after GEBD cessation; adverse effects of Omalizumab therapy (any medical cases connected with GEBD).Results. The disease control at 3 months of treatment was reached in 12 (67%) patients out of 18 children with recurrent urticaria, at 6 months — at 13 (72%) patients. During Omalizumab therapy and at 6 months after therapy cessation there were no significant recrudescence, at 12 months after therapy cessation — at 1 (6%) adolescent. The concomitant treatment was ended after 3 months at 3 (17%) patients, after 6 months — at 10 (56%) patients. Remission was sustained at 11 (61%) out of 18 patients at 6 months and at 9 (60%) out of 15 patients at 12 months after the therapy end. Adverse effects of Omalizumab have not been noted.Conclusion. Addition of Omalizumab to the therapy in adolescents with uncontrolled recurrent urticaria let us reach remission of disease in most cases by 6 months of treatment

Modern Strategies for the Therapy of Persistent Bronchial Asthma in Adolescents

Bronchial asthma remains one of the most common non-infectious diseases. In children, the highest prevalence and incidence of asthma is observed in adolescence. Difficulties in achieving and maintaining control over the disease in adolescents are due to the peculiarities of their socio-psychological adaptation, low adherence to therapy, and poor doctor-patient interaction. To achieve maximum control over the disease in children and adolescents suffering from moderate bronchial asthma, according to current guidelines, combined drugs should be used. A number of conciliation documents on asthma adopted the concept of using a single inhaler from the third stage of treatment, which is used both as a basic therapy and for relieving exacerbations. A large number of studies have demonstrated successful experience with the use of such tactics, including in adolescents in real clinical practice. It is proved that this approach increases adherence to therapy, reduces the risk of exacerbations, and improves the control over the disease. However, further research is needed, because therapy with a single inhaler has age limits

Successful Treatment of Chronic Spontaneous Urticaria Associated with Autoimmune Thyroiditis: Clinical Case

Chronic spontaneous urticaria (CSU) can be associated with some autoimmune diseases which may affect the CSU course. Autoimmune thyroiditis can cause severe CSC. 2nd generation antihistamines are the golden standard of CSY therapy. However, even dose-escalation in some cases will not lead significant improvement. Nowadays there are not enough studies about other medications administration in children with CSU. Omalizumab is the only genetically engineered biologic drug for treatment of resistant (to standard therapy) forms of CSU, it can be used in children over 12 years old. We would like to present our data on one adolescent girl with CSU and comorbid autoimmune thyroiditis with thyroid function abnormality. The multidisciplinary approach to diagnostics and management of this patient as well as Omalizumab administration let us achieve total disease control and, finally, its remission

Local Glucocorticoids in Treatment of Children with Dermatitis

Local glucocorticoids (GCs) are the gold standard of anti-inflammatory topical therapy. The description of the main pharmaceutics properties and classification of local GCs, as well as its indications and contradictions are presented in the article. This article also provides fundamentals for application of local GCs which should be implemented for effective and safe use of these drugs in children. The problems of steroid-phobia (one of the reasons of the wrong and untimely administration of local GCs) are discussed. Advantages of 0.1% methylprednisolone aceponate (new generation GCs) use are discussed. This medication has optimal efficiency/safety ratio and unique bioactivation pathway that enables its effective administration in management of various dermatitis in children from 4 months of age. Results of different comparative and double blind placebo-controlled clinical trials of 0.1% methylprednisolone aceponate administration are discussed in this article. High efficiency and safety of this medication are noted. The use of modern local GCs at the first signs of skin inflammatory changes allows to relieve aggravation quickly and achieve remission of the disease