Targeted Therapy for Severe Asthma: Switching Biological agents in Real Clinical Practice — Causes and Consequences

Naumova, Veronika V.; Beltyukov, Evgeny K.; Kiseleva, Darina V.; Bykova, Galina A.; Smolenskaya, Olga G.; Shtanova, Alexandra A.; Stepina, Daria А.

doi:10.36691/rja15993

Russian Journal of Allergy

2023

DOI: 10.36691/rja15993

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Targeted Therapy for Severe Asthma: Switching Biological agents in Real Clinical Practice — Causes and Consequences

Veronika V. Naumova,

Evgeny K. Beltyukov,

Darina V. Kiseleva

et al.

Abstract: BACKGROUND: complexity of choice a genetically engineered biological drug (GEBD) for severe bronchial asthma (SA) treatment is due to intersection of endotypes and phenotypes of the disease. Mistakes in biologicals choice lead to discontinuation and/or switching of the drug due to insufficient effectiveness of therapy. AIMS: to determine reasons to stop targeted therapy and biologicals switching effectiveness in patients with SA in real clinical practice. MATERIALS AND METHODS: analyz… Show more

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2024

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Cited by 3 publications

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Registry as a tool for monitoring effectiveness of immunobiological therapy for severe asthma in real clinical practice

Naumova,

Kiseleva,

Zykov

et al. 2024

Pulʹmonologiâ (Mosk.)

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Registry is a unique and universal mechanism for group and individual approaches to managing patients, including those with severe asthma (SA) who require targeted therapy.The aim is to evaluate the clinical and organizational potential of the SA patient registry as a tool for group and individual approaches to patient management, as a way to describe and systematize the signs of bronchial asthma, comorbid diseases, and monitoring immunobiological therapy (using anti-IgE therapy as an example) in patients with SA in Sverdlovsk region.Methods. The subject of the study was the Territorial Registry of Patients with SA of the Sverdlovsk region. The registry effectiveness was assessed based on the clinical and organizational indicators, including monitoring the effectiveness of 3-year anti-IgE therapy in patients with SA with an allergic component.Results. From 2016 to 2023, both inclusive, 198 patients with SA were entered into the registry. Analysis of the registry data allowed us to develop a scheme for SA phenotyping and selecting the 1st and 2nd line targeted drugs and a scheme for phenotyping and selecting a targeted drug for T2 inflammatory nasal diseases. Over 3 years of anti-IgE therapy with omalizumab, the ACT test increased from 9.00 to 19.50 points, the proportion of patients with partial and good asthma control increased by 13.89 times, the frequency of exacerbations decreased by 71.43%, FEV1 increased by 17.91%, and the proportion of patients requiring systemic corticosteroids decreased by 83.32%.Conclusion. The registry of SA patients has high clinical and organizational potential to describe and systematize the signs of bronchial asthma, comorbid diseases, and monitor the effectiveness and safety of immunobiological therapy. The 3-year anti-IgE therapy demonstrates statistically significant effectiveness in patients with SA with an allergic component.

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Registry as a tool for monitoring effectiveness of immunobiological therapy for severe asthma in real clinical practice

Naumova,

Kiseleva,

Zykov

et al. 2024

Pulʹmonologiâ (Mosk.)

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show abstract

Clinical and allergological characteristics of patients with severe bronchial asthma in the regional registry and phenotyping principles for the targeted therapy choice

Naumova,

Beltyukov,

Kovtun

et al. 2024

Medicinskij sovet

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Introduction. Severe asthma targeted therapy effectiveness depends on precise targeting of the selected drug to the key link in pathogenesis. Therefore, severe asthma phenotyping in real clinical practice is relevant.Aim. To determine main clinical and allergological characteristics of patients with severe asthma and to establish important phenotyping signs determined choice of a targeted drug for severe asthma treatment.Materials and methods. The prospective and retrospective study involved patients (n = 198) of the Sverdlovsk region registry receiving targeted therapy of severe asthma. Considering clinical and allergological picture, allergic, non-allergic eosinophilic and mixed severe asthma phenotypes were identified. Clinical and laboratory characteristics of phenotypes were described. A phenotyping algorithm was developed.Results. In the register of patients (n = 198) with severe asthma, non-allergic eosinophilic asthma was 46.5%, allergic – 34.8%, mixed – 18.7%. Significant signs for phenotyping were identified: age of asthma onset, proven allergy, Phadiatop ImmunoCAP level and blood eosinophils on baseline, concomitant allergic rhinitis, chronic rhinosinusitis with nasal polyps and hyper-sensitivity to NSAIDs. The main signs of allergic severe asthma determined: early onset, proven allergy and a positive result of Phadiatop ImmunoCAP (the probability of allergic phenotype increases with Phadiatop ≥ 1.53 PAU/l). Signs of non-allergic eosinophilic asthma were eosinophilia ≥ 150 cells/µl, absence of allergy, concomitant chronic rhinosinusitis with nasal polyps and hypersensitivity to NSAIDs, late onset (after 30 years). Signs were identified for mixed asthma: presence of proven allergy or latent sensitization in combination with high level of Phadiatop ImmunoCAP, late onset, eosinophilia ≥ 300 cells/µl, chronic rhinosinusitis with nasal polyps, hypersensitivity NSAIDs.Conclusions. The algorithm for severe asthma phenotyping based on the isolation of eosinophilia of allergic and non-allergic origin is proposed. Severe asthma phenotyping, which can be carried out in real clinical practice, should facilitate the selection of an initial targeted drug.

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Targeted therapy for severe bronchial asthma: Phenotyping of patients and algorithm for selecting a genetically engineered biological drug

Naumova,

Zykov,

Valenta

et al. 2024

Medicinskij sovet

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Introduction. The “spot” effect of immunobiological drugs necessitates patients' selection based on pathogenetic mechanisms of the disease to ensure therapy effectiveness.Aim. To determine characteristics of T2-asthma main phenotypes and develop an algorithm for selecting a first- and second-line biologics.Materials and methods. Being retrospective and prospective in nature the research was directed at adult patients with severe asthma who received target therapy and were included in the registry of Sverdlovsk region. Cluster analysis made it possible to identify the most distinctive features of allergic, nonallergic eosinophilic and mixed SA. Pathogenetic mechanisms of T2 inflammation determined the choice of first-and-second-line biologics.Results. Allergic phenotype is characterized by existence of allergy and first appearance of asthma before the age of 18, satellite allergic rhinitis and the Phadiatop test result ≥ 1,53 PAU/L. The features of non-allergic eosinophilic asthma are as follows: asthma first appearance at the age of 32 and older, eosinophilia ≥ 150 cells/gl, absence of allergy, satellite chronic rhinosinusitis polyposa (CRSP) and NSAIDs intolerance. The features of the mixed asthma are as follows: first appearance at the age of ≥ 18 and < 32 years old, allergy in combination with eosinophilia ≥ 300 cells/gl, AR and a positive Phadiatop allergy test result, CRSP and NSAIDs intolerance. It is the allergic phenotype of SA when preference should be given to anti-IgE drug. Dealing with non-allergic phenotype of SA one should consider anti-IL5 biologics more preferable. Taking into consideration Th2 and ILC2 ways in action mechanism it is possible to affirm that anti-IL4R therapy is effective in mixed asthma.Conclusions. In real clinical practice the initial phenotyping of SA facilitates the correct choice of a first- and second-line targeted drug.

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Targeted Therapy for Severe Asthma: Switching Biological agents in Real Clinical Practice — Causes and Consequences

Cited by 3 publications

References 21 publications

Registry as a tool for monitoring effectiveness of immunobiological therapy for severe asthma in real clinical practice

Registry as a tool for monitoring effectiveness of immunobiological therapy for severe asthma in real clinical practice

Clinical and allergological characteristics of patients with severe bronchial asthma in the regional registry and phenotyping principles for the targeted therapy choice

Targeted therapy for severe bronchial asthma: Phenotyping of patients and algorithm for selecting a genetically engineered biological drug

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