The Long-Term Omalizumab Therapy in Children with Severe Persistent Uncontrolled Asthma: Evaluation of the Outcomes According to the Data of the Hospital Patient Registry

Вишнёва, Е. А.; Намазова-Баранова, Л. С.; Dobrynina, E. A.; Алексеева, А.А.; Smirnov, Vladimir; Левина, Ю. Г.; Калугина, В. Г.; Эфендиева, К. Е.; Волков, К. С.

doi:10.15690/pf.v15i2.1877

Pediatr. farmakol.

2018

DOI: 10.15690/pf.v15i2.1877

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The Long-Term Omalizumab Therapy in Children with Severe Persistent Uncontrolled Asthma: Evaluation of the Outcomes According to the Data of the Hospital Patient Registry

Е. А. Вишнёва¹,

Л. С. Намазова-Баранова²,

E. A. Dobrynina³

et al.

Abstract: Пациентские регистры помогают получать не только актуальную информацию об особенностях течения заболева-ний, о безопасности и эффективности используемых медицинских технологий, но и позволяют осуществлять дли-тельное наблюдение за исследуемой группой больных. Цель исследования -проанализировать эффективность и безопасность длительной таргетной терапии омализумабом (более 4 лет) у детей с тяжелой персистирующей неконтролируемой бронхиальной астмой по данным электронной информационной базы данных клинических слу… Show more

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Cited by 3 publications

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Safety of omalizumab in the treatment of moderate-to-severe bronchial asthma

Shnaider

Максимов²,

Романов³

2022

Medical Journal of the Russian Federation

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This review aimed to analyze national and international literature on the safety of omalizumab in the treatment of moderate-to-severe bronchial asthma. Omalizumab is one of the longest-standing monoclonal antibodies and the first available treatment option for severe allergic asthma in patients aged 6 years. Several randomized controlled studies have established its efficiency and safety, leading to its final registration more than 15 years ago. In most cases, long-term treatment with omalizumab is safe without increasing the risk of adverse reactions. However, over the years, a growing trend has been observed in several registrations of adverse events associated with the use of omalizumab. A review of the literature revealed a lack of long-term clinical monitoring data (over 2 years) in both patients aged 18 years and children. Long-term adverse reactions during omalizumab therapy are insufficiently examined and require more detailed analysis, despite reports of an association between omalizumab and some adverse events. Moreover, extremely few cases of adverse reactions to omalizumab were reported in the Russian Federation. Thus, further investigations of the safety profile of omalizumab and monitoring of its delayed adverse reactions are required.

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Safety of omalizumab in the treatment of moderate-to-severe bronchial asthma

Shnaider

Максимов²,

Романов³

2022

Medical Journal of the Russian Federation

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Targeted therapy of bronchial asthma in children

Файзуллина

Санникова

Shangareeva

et al. 2022

Med. vestn. Ûga Ross.

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Objective: to evaluate the clinical efficacy of targeted therapy with omalizumab in children with moderate to severe uncontrolled bronchial asthma. Materials and methods: 7 children receiving omalizumab therapy in a hospital and polyclinic of the Ufa City Children’s Clinical Hospital No. 17 were under observation. In accordance with the instructions for use, the monoclonal antibody drug omalizumab was administered subcutaneously every 2-4 weeks. The dosage of the drug was determined based on the child’s body weight and the initial level of serum IgE. The anamnesis of life and disease, the results of instrumental and laboratory research methods, the results of AST and c-AST tests were studied in all the children studied. Results: against the background of therapy with omalizumab in children, there was a significant decrease in the frequency of daytime symptoms (p=0.0179), a decrease in the frequency of night symptoms (p=0.0233), increased physical activity (p=0.0179), a decrease in the need for bronchodilators (p=0.0179), an increase in FEV1 according to spirography (p=0.0431), a decrease in the volume of basic anti-inflammatory therapy with a decrease in the dose of IGCS in 71.43% of patients (p=0.0425), a significant increase in the number of AST and c–AST test scores: before treatment 12 [10; 13] points, against the background of treatment - 23 [20; 25] points, (p=0.0277). During the follow-up period of therapy with omalizumab, no serious adverse reactions were detected. Conclusion: thus, targeted therapy using omalizumab is clinically effective in children with moderate to severe uncontrolled bronchial asthma.

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Safety of omalizumab in children

Shnaider¹,

Максимов²,

Романов³

2023

Chief Medical Officer

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The purpose of the review is to analyze Russian and foreign literature sources on safety of using omalizumab in the treatment of moderate to severe bronchial asthma and chronic idiopathic urticaria in children. Omalizumab is one of the longest used monoclonal antibodies and the first available treatment option for severe atopic asthma in patients aged 6 years and older. Its efficacy and safety have been established in several randomized controlled trials, leading to its final registration over 15 years ago. In most cases, long-term treatment with omalizumab is safe and does not increase the risk of adverse reactions. However, over the years, there has been a trend towards an increase in the number of registrations of adverse reactions associated with the use of omalizumab. Long-term adverse reactions with omalizumab therapy are not sufficiently studied and require more detailed analysis, despite reports of an association between omalizumab and some adverse events. There are very few reports of adverse reactions when taking omalizumab in children in the Russian Federation. Further study of the safety of omalizumab and monitoring of its delayed adverse reactions is required.

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The Long-Term Omalizumab Therapy in Children with Severe Persistent Uncontrolled Asthma: Evaluation of the Outcomes According to the Data of the Hospital Patient Registry

Cited by 3 publications

References 20 publications

Safety of omalizumab in the treatment of moderate-to-severe bronchial asthma

Safety of omalizumab in the treatment of moderate-to-severe bronchial asthma

Targeted therapy of bronchial asthma in children

Safety of omalizumab in children

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