To see the other types of publications on this topic, follow the link: Profile of Benralizumab.
Journal articles on the topic 'Profile of Benralizumab'
Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles
Consult the top 42 journal articles for your research on the topic 'Profile of Benralizumab.'
Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.
You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.
Browse journal articles on a wide variety of disciplines and organise your bibliography correctly.
1
Miguel Reyes, José Luis, Erika del Carmen López Estrada, Monserrat Arroyo Rojas, et al. "Benralizumab in severe eosinophilic asthma: A real-world, single-center, observational study from Mexico." Allergologia et Immunopathologia 51, no. 6 (2023): 8–15. http://dx.doi.org/10.15586/aei.v51i6.852.
Full textAbstract:
Introduction: Urbanization has increased the prevalence of asthma in lower- and middle-income countries. Severe eosinophilic asthma (SEA), a subtype of asthma, can be refractory to standard therapy. Biologics such as benralizumab target interleukin-5 and have demonstrated effectiveness in managing SEA. There exists no real-world evidence on the effectiveness of benralizumab in Mexico. Therefore, this study presents data on the role of benralizumab in managing SEA in Mexican patients. Objective: The effectiveness of benralizumab on the quality of life (QoL), asthma control, lung function, symptoms of asthma, and benralizumab’s safety profile were assessed. Methods: The study sample comprised 10 patients with SEA treated with a subcutaneous (SC) administration of benralizumab 30 mg once in 4 weeks for the first three doses followed by a dose every 8 weeks for 2 years. Laboratory tests, resting spirometry, and skin prick tests were conducted. Levels of fractional exhaled nitric oxide (FeNO) were evaluated, when possible, with the intent to phenotype asthma, as T2 high or non-T2, before starting benralizumab therapy. The Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ), and Asthma Control Test (ACT) were administered to evaluate the effectiveness of benralizumab on asthma control and QoL. Results: All patients showed significant symptom control, QoL, and lung function over 2 years. Mild adverse effects, such as headache and arthralgia, were observed. Conclusion: Benralizumab appears to be a promising agent in controlling SEA. This study has focused on measuring tangible outcomes, such as a reduction in symptoms, a reduction in exacerbation, and an improvement in QoL. Thus, benralizumab may constitute an important addition to the arsenal of medications against SEA.
2
Dr., M. Govardhan* Shaik Rizwana Alefiya Kotawala. "A Comprehensive Review on Drug Profile of Benralizumab." International Journal of Pharmaceutical Sciences 3, no. 3 (2025): 783–88. https://doi.org/10.5281/zenodo.15000067.
Full textAbstract:
This comprehensive review explain that the drug profile of benralizumab, a monoclonal antibody approved by the FDA for the management of severe eosinophilic asthma and other eosinophilic conditions. Highlighting asthma as a chronic inflammatory disorder characterized by eosinophilic excess, the review classifies treatment options including corticosteroids, leukotriene modifiers, biologics, and bronchodilators. Specifically focusing on benralizumab, the review details its mechanism of action as an IL-5 receptor antagonist, leading to eosinophil depletion via apoptosis and antibody-dependent cell-mediated cytotoxicity. The pharmacokinetic properties reveal a dose-proportional profile with a half-life of 15.5 days and prevalent routes of administration by subcutaneous injection. Compared to mepolizumab, benralizumab demonstrates superior efficacy in reducing exacerbations and improving lung function, particularly in patients with elevated eosinophil counts. Despite its therapeutic advantages, potential adverse effects such as hypersensitivity reactions necessitate careful patient monitoring. This review emphasizes the significance of benralizumab as a targeted therapy in eosinophilic asthma, advocating for its role in clinical practice while recognizing the importance of ongoing assessment for optimal patient outcomes.
3
Menzella, Francesco, Mariarita Marchi, Marco Caminati, et al. "Long-Term Eosinophil Depletion: A Real-World Perspective on the Safety and Durability of Benralizumab Treatment in Severe Eosinophilic Asthma." Journal of Clinical Medicine 14, no. 1 (2024): 191. https://doi.org/10.3390/jcm14010191.
Full textAbstract:
Background/Objectives: Benralizumab is an anti-IL-5 receptor alpha monoclonal antibody that induces the near-complete depletion of eosinophils. This study aimed to evaluate the long-term safety and effectiveness of benralizumab in patients with severe eosinophilic asthma (SEA) over an extended 48-month follow-up period, offering one of the longest real-world perspectives available. Methods: This was a single-arm, retrospective, observational, multicenter study involving 123 SEA patients treated with benralizumab at a dosage of 30 mg every 4 weeks for the first 3 doses and then every 8 weeks. The safety endpoints focused on the frequency and nature of adverse events and the likelihood that they were induced by benralizumab. The efficacy endpoints focused on lung function, asthma exacerbations and control, and oral corticosteroid use. Results: Benralizumab, consistent with its mechanism of action, led to the rapid and nearly complete depletion of eosinophils. In total, 26 adverse events (21.1%) were observed, with 1.6% related to the treatment and 0.8% categorized as serious (vagal hypotension). Bronchitis was the most common unrelated adverse event (15.4%), occurring between months 36 and 38. Importantly, benralizumab effectiveness and safety were maintained consistently across the 48-month duration, resulting in significant improvements in lung function and reductions in oral corticosteroid use and exacerbation frequency. Conclusions: Benralizumab demonstrated a favorable safety profile, comparable to previously published studies, with perdurable effectiveness in controlling SEA and reducing oral corticosteroid use. Finally, this study provides evidence that near-complete eosinophil depletion does not increase long-term safety risks and supports benralizumab as a reliable treatment option for SEA patients.
4
Vantaggiato, Lorenza, Paolo Cameli, Laura Bergantini, et al. "Serum Proteomic Profile of Asthmatic Patients after Six Months of Benralizumab and Mepolizumab Treatment." Biomedicines 10, no. 4 (2022): 761. http://dx.doi.org/10.3390/biomedicines10040761.
Full textAbstract:
Severe eosinophilic asthma is characterized by chronic airway inflammation, oxidative stress, and elevated proinflammatory cytokines, especially IL-5. Mepolizumab and benralizumab are both humanized IgG antibodies directed against IL-5 signaling, directly acting on eosinophils count. Together with the complexity of severe asthma classification and patient selection for the targeted treatment, there is also the urgency to clarify the follow-up of therapy to identify biomarkers, in addition to eosinophils, for the optimal duration of treatment, persistence of effectiveness, and safety. To this purpose, here we performed a follow-up study using differential proteomic analysis on serum samples after 1 and 6 months of both therapies and sera from healthy patients. Statistical analysis by PCA and heatmap analyses were performed, and identified proteins were used for enrichment analysis by MetaCore software. The analysis highlighted 82 differences among all considered conditions. In particular, 30 referred to benralizumab time point (T0, T1B, T6B) and 24 to mepolizumab time point (T0, T1M, T6M) analyses. t-SNE and heatmap analyses evidence that the differential serum protein profile at 6 months of both treatments is more similar to that of the healthy subjects. Among the identified proteins, APOAI, APOC-II, and APOC-III are upregulated principally after 6 months of benralizumab treatment, plasminogen is upregulated after 6 months of both treatments and ceruloplasmin, upregulated already after 1 month of benralizumab, becoming higher after 6 months of mepolizumab. Using enrichment analysis, identified proteins were related to lipid metabolism and transport, blood coagulation, and ECM remodeling.
5
Fomina, D. S., G. L. Ignatova, T. G. Kabanova, et al. "Efficacy of benralizumab in severe eosinophilic asthma: an interim analysis of a real clinical practice prospective study BEST in Russia." PULMONOLOGIYA 33, no. 3 (2023): 374–85. http://dx.doi.org/10.18093/0869-0189-2023-33-3-374-385.
Full textAbstract:
Systematizing clinical experience in the use of biological treatments in patients with severe bronchial asthma in real world settings with assessment of clinical outcomes and quality of life level is of great interest and value in practical pulmonology.The aim of the BEST study (Real World Evidence of Benralizumab in Eosinophilic Severe AsThma in Russia) was to evaluate effectiveness of benralizumab by control and quality of life associated with respiratory status in patients with eosinophilic phenotype of severe asthma in real clinical practice in Russia.Results. The results obtained through 16 weeks of benralizumab therapy in patients with severe eosinophilic asthma (SEA) were analyzed. All 59 enrolled patients showed significant improvement in the asthma control questionnaire (ACQ-5) score, the quality of life associated with respiratory status according to the St. George Respiratory Questionnaire (SGRQ), and subjective assessments of the well-being of patients and the disease severity (PGIC and PGIS). Treatment with benralizumab contributed to a reduction in the oral glucocorticosteroids intake throughout the study period.Conclusion. In real clinical practice, treatment with benralizumab results in significant improvement in disease control and the quality of life in patients with severe eosinophilic asthma and is characterized by a favorable safety profile.
6
Krushna, Darade* Omkar Purnale Vijay Tambade Abhishek Gade Kishor K. Dudhal Ajit Jadhav Amol Supekar. "A Comprehensive Review on Drug Profile of Benralizumab." International Journal of Pharmaceutical Sciences 3, no. 3 (2025): 789–800. https://doi.org/10.5281/zenodo.15000467.
Full textAbstract:
Use of VR Taste Simulator Lollipop thus in pharmaceutical industries:Researchers have developed a groundbreaking lollipop-shaped device that simulates taste in virtual reality, offering users the ability to experience up to nine different flavors through electrically-activated gel pockets. As reported by multiple sources, this innovative interface, created by a team of biomedical engineers and virtual reality researchers, aims to enhance immersion in virtual environments by incorporating the sense of taste please guide me at this topic in detail understanding with basic to all knowledge about this. The VR Taste Simulator Lollipop is an innovative device that combines virtual reality (VR) with taste simulation, offering a new dimension of immersion for users experiencing VR environments. Researchers, mainly biomedical engineers and VR experts, have created this technology to simulate a sense of taste, a critical sensory experience that has often been overlooked in the world of VR. The VR Taste Simulator Lollipop and similar technologies could have a significant impact on the pharmaceutical industry, particularly in areas related to drug development, patient experience, medical treatments, and therapeutic applications. The VR Taste Simulator Lollipop and similar technologies could have a significant impact on the pharmaceutical industry, particularly in areas related to drug development, patient experience, medical treatments, and therapeutic applications.
7
S., Yasotha* Dr. R. Manivannan Dr. D. Kamalakannan Vanmathi. R. L. Gowtham T. Praveen Kumar S. "A Comprehensive Review on Drug Profile of Benralizumab." International Journal of Pharmaceutical Sciences 3, no. 3 (2025): 801–14. https://doi.org/10.5281/zenodo.15003790.
Full textAbstract:
A simple, Précised, Accurate method was developed for the estimation of Lasmiditan by RP-HPLC technique. Chromatographic conditions used are stationary phase Agilent 150mm x 4.6 mm, 5m ,Mobile phase Acetonitrile : Water in the ratio of 50:50 and flow rate was maintained at 1ml/min, detection wave length was 260nm, column temperature was set to 30oC and diluent was mobile phase Conditions were finalized as optimized method. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between 25% to150 % levels, R2 value was found to be as 0.999. Precision was found to be 0.8 for repeatability and 0.9 for intermediate precision.LOD and LOQ are 0.13µg/ml and 0.40µg/ml respectively. By using above method assay of marketed formulation was carried out 99.58% was present. Degradation studies of Lasmiditan were done, in all conditions purity threshold was more than purity angle and within the acceptable range. Full length method was not performed; if it is done this method can be used for routine analysis of Lasmiditan.
8
Menzella, Francesco, Mirco Lusuardi, Carla Galeone, Nicola Facciolongo, and Luigi Zucchi. "The clinical profile of benralizumab in the management of severe eosinophilic asthma." Therapeutic Advances in Respiratory Disease 10, no. 6 (2016): 534–48. http://dx.doi.org/10.1177/1753465816667659.
Full textAbstract:
Despite several therapeutic choices, 10–20% of patients with severe uncontrolled asthma do not respond to maximal best standard treatments, leading to a healthcare expenditure of up to 80% of overall costs for asthma. Today, there are new important therapeutic strategies, both pharmacological and interventional, that can result in improvement of severe asthma management, such as omalizumab, bronchial thermoplasty and other biological drugs, for example, mepolizumab, reslizumab and benralizumab. The availability of these new treatments and the increasing knowledge of the different asthmatic phenotypes and endotypes makes correct patient selection increasingly complex and important. In this article, we discuss the features of benralizumab compared with other anti-interleukin-5 biologics and omalizumab, the identification of appropriate patients, the safety profile and future developments.
9
Harada, Sonoko, Hitoshi Sasano, Shoko Ueda, et al. "Skin Surface Lipid-RNA Profile Obtained from Patients with Severe Asthma After Benralizumab Treatment." Journal of Asthma and Allergy Volume 17 (November 2024): 1103–13. http://dx.doi.org/10.2147/jaa.s490832.
Full text
10
Yılmaz, İnsu. "Biologics for oral corticosteroid-dependent asthma." Allergy and Asthma Proceedings 41, no. 3 (2020): 151–57. http://dx.doi.org/10.2500/aap.2020.41.200015.
Full textAbstract:
Background: Oral corticosteroid (OCS) dependent asthma is one of the severe asthma phenotypes that requires personalized treatment. Objective: To review the role of biologic treatments in OCS-dependent asthma. Methods: A nonsystematic review was performed of emerging multiple novel biologics for potential treatment of OCS-dependent asthma. Results: The serious adverse effects of OCS can be seen as a result of their regular long-term administration. Anti‐interleukin (IL) 5 (mepolizumab), anti‐IL-5R (benralizumab), and anti‐IL-4Rα (dupilumab) are the therapies of choice for OCS-dependent severe asthma. Results of studies showed the efficacy of mepolizumab, benralizumab, and dupilumab, especially in patients with the OCS-dependent severe eosinophilic asthma phenotype and with nasal polyps. Dupilumab may be the therapy of choice of monoclonal antibodies in cases of moderate-severe atopic dermatitis accompanied by OCS-dependent severe asthma. For reslizumab and omalizumab, placebo controlled double-blind studies conducted with OCS-dependent patient populations are needed. Conclusion: Biologics are effective in the “OCS-dependent asthma” phenotype as add-on therapy. It seems that chronic OCS use in OCS-dependent asthma will be replaced by biologic agents that specifically target type 2 inflammation, along with a much better safety profile. However, real-life studies that compare these biologics in OCS-dependent severe asthma are urgently needed.
11
Bagnasco, Diego, Marco Caminati, Matteo Ferrando, et al. "Anti-IL-5 and IL-5Ra: Efficacy and Safety of New Therapeutic Strategies in Severe Uncontrolled Asthma." BioMed Research International 2018 (November 5, 2018): 1–8. http://dx.doi.org/10.1155/2018/5698212.
Full textAbstract:
The current developments of the new biological drugs targeting interleukin 5 (IL-5) and IL-5 receptor allowed to expand the treatment options for severe hypereosinophilic asthma. Clinicians will then be able to choose between antibodies targeting either circulating IL-5 or its receptor expressed on eosinophils and basophils. The available clinical trials consistently reported favorable results about the reduction of exacerbations rate, improvement in quality of life, and sparing of the systemic steroid use, with a favorable safety profile. Two of these new drugs are administered subcutaneously, mepolizumab every 4 weeks and benralizumab every 8 weeks, whereas reslizumab is given intravenously monthly on a weigh-based dose. In the future, the research actions will be involved in the identification of a single biomarker or multiple biomarkers for the optimal choice of biological agents to be properly prescribed.
12
Aalbers, Anna, Maud Hermans, and Pim G. N. J. Mutsaers. "Single Center Experience with Off-Label Benralizumab in Refractory Hypereosinophilic Syndrome Demonstrates a Satisfactory Safety and Efficacy Profile." Blood 140, Supplement 1 (2022): 1401–2. http://dx.doi.org/10.1182/blood-2022-159630.
Full text
13
Rodríguez-Suárez, Eva, Zhi Liu, Mathias Cardner, et al. "Effect Of Treatment With Benralizumab Or Mepolizumab On The Whole Blood Transcriptomic Profile In Eosinophilic Granulomatosis With Polyangiitis." Journal of Allergy and Clinical Immunology 155, no. 2 (2025): AB316. https://doi.org/10.1016/j.jaci.2024.12.973.
Full text
14
Boada-Fernández-del-Campo, Carlos, Marcelino García-Sánchez-Colomer, Eduardo Fernández-Quintana, et al. "Real-World Safety Profile of Biologic Drugs for Severe Uncontrolled Asthma: A Descriptive Analysis from the Spanish Pharmacovigilance Database." Journal of Clinical Medicine 13, no. 14 (2024): 4192. http://dx.doi.org/10.3390/jcm13144192.
Full textAbstract:
Background: The present investigation provides a thorough analysis of adverse drug reactions (ADRs) reported in the Database of the Spanish Pharmacovigilance System (FEDRA) for biologic medications primarily indicated for severe refractory asthma, including omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, and tezepelumab. Our main objective was to identify ADRs not documented in the drugs’ Technical Sheets (summary of product characteristics, SmPC), potentially indicating unrecognized risks meriting pharmacovigilance attention. Methods: Data spanning from each drug’s market introduction until 22 January 2024, were analyzed, sourced from direct submissions to the Spanish Pharmacovigilance System, industry communications, and literature reviews. We evaluated notifications impartially to ensure a comprehensive review of all the ADRs associated with these medications. Results: This investigation underlines the critical role of post-marketing surveillance in enhancing patient safety. It emphasizes the necessity for healthcare professionals to report ADRs comprehensively to foster a robust pharmacovigilance system. Furthermore, the study highlights gaps between the reported ADRs and the information provided in SmPCs, signaling potential areas for improvement in drug safety monitoring and regulatory oversight. Conclusions: Finally, these findings may contribute to informed decision making in clinical practice and regulatory policy, ultimately advancing patient care and safety in the management of severe uncontrolled asthma.
15
Orzołek, Izabela, Izabela Stawicka, Jakub Jarmołowicz, Agata Boczar, and Patryk Dryja. "Adverse effects of monoclonal antibodies in the treatment of moderate-to-severe asthma: a narrative review." Journal of Education, Health and Sport 70 (November 6, 2024): 55855. http://dx.doi.org/10.12775/jehs.2024.70.55855.
Full textAbstract:
Introduction and purpose: Over the past two decades, the management of severe asthma shifted from high doses of inhaled and oral corticosteroids to targeted biologic agents. Adverse effects of treatment with monoclonal antibodies are not yet fully characterised. The aim of this paper is to provide a comprehensive review of the adverse effects of the FDA-approved monoclonal antibodies in the treatment of moderate-to-severe asthma, including omalizumab, benralizumab, dupilumab, mepolizumab, reslizumab, tezepelumab. Material and methods of research: A thorough literature review was performed using PubMed Web of Science and Embase, employing key words related to monoclonal antibodies, asthma and adverse effects. Description of the state of knowledge: Omalizumab and mepolizumab have black box warning on the risk of anaphylaxis. Due to scarcity of data, no causal association between the use of monoclonal antibodies and risk of malignancy can be established. The most common adverse effects of biologic agents in severe asthma include upper respiratory tract infections, nasopharyngitis and asthma worsening. Conclusions: Overall, monoclonal antibodies have a favourable safety profile, with certain risk of side effects remains present, and is variable for the different molecules. More studies of asthmatic patients treated with monoclonal antibodies are needed to spot rare adverse events and those developing over longer time.
16
Scioscia, Giulia, Santi Nolasco, Raffaele Campisi, et al. "Switching Biological Therapies in Severe Asthma." International Journal of Molecular Sciences 24, no. 11 (2023): 9563. http://dx.doi.org/10.3390/ijms24119563.
Full textAbstract:
Currently, three classes of monoclonal antibodies targeting type 2 inflammation pathways are available in Italy for the treatment of severe asthma: anti-IgE (Omalizumab), anti-IL-5/anti-IL-5Rα (Mepolizumab and Benralizumab), and anti-IL-4Rα (Dupilumab). Numerous randomized controlled trials (RCTs) and real-life studies have been conducted to define their efficacy and identify baseline patients’ characteristics potentially predictive of favorable outcomes. Switching to another monoclonal antibody is recommended in case of a lack of benefits. The aim of this work is to review the current knowledge on the impact of switching biological therapies in severe asthma as well as on predictors of treatment response or failure. Almost all of the information about switching from a previous monoclonal antibody to another comes from a real-life setting. In the available studies, the most frequent initial biologic was Omalizumab and patients who were switched because of suboptimal control with a previous biologic therapy were more likely to have a higher baseline blood eosinophil count and exacerbation rate despite OCS dependence. The choice of the most suitable treatment may be guided by the patient’s clinical history, biomarkers of endotype (mainly blood eosinophils and FeNO), and comorbidities (especially nasal polyposis). Due to overlapping eligibility, larger investigations characterizing the clinical profile of patients benefiting from switching to different monoclonal antibodies are needed.
17
Sergeeva, Galina R., and Alexander V. Emelyanov. "Effectiveness and safety of biological therapy in patients with severe asthma in a real clinical practice." Terapevticheskii arkhiv 96, no. 3 (2024): 240–45. http://dx.doi.org/10.26442/00403660.2024.03.202626.
Full textAbstract:
Aim. To assess effectiveness and safety of biological therapy in patients with severe asthma during 5 yr follow-up.
 Materials and methods. We recruited 129 adult outpatients (29% males) aged 18–81 yrs with severe asthma were followed up during 5 yrs and were examined for every 3–6 months. Eighty five patients were treated by conventional therapy (ICS/LABA ± tiotropium, montelukast, OCS) only and 44 pts additionally received biologicals (оmalizumab – 9 pts, мepolizumab – 8 pts, benralizumab – 11 pts, dupilumab – 16 pts). Pulmonary function tests were measured by dry spirometer (2120, Vitalograph Ltd., UK). Eosinophil count in blood was assessed by automatic haemoanalyser. Fraction of exhaled nitric oxide was measured by a chemiluminescence analyzer (LR4100; Logan Research, UK). Asthma control and quality of life were assessed by using Russian versions of ACQ-5 and SGRQ.
 Results. The use of biologicals led to a more significant reduction of exacerbations and OCS use, improvement of lung function, asthma control and quality of life, decrease of eosinophil and fraction of exhaled nitric oxide than conventional therapy of severe asthma (p0.05). Systemic side effects were not registered, frequency of local adverse reactions (edema, hyperemia and itching at injection site) was 14%.
 Conclusion. Long-term use of biologicals added to conventional therapy in patients with severe asthma is characterized by high effectiveness and favorable safety profile.
18
Titova, O. N., V. A. Volchkov, N. A. Kuzubova, and D. B. Sklyarova. "Organization of medical care for patients with severe asthma requiring genetically engineered biological therapies in St. Petersburg." Russian Medical Inquiry 7, no. 8 (2023): 493–97. http://dx.doi.org/10.32364/2587-6821-2023-7-8-3.
Full textAbstract:
The proportion of patients with severe asthma among asthma patients is approximately 5–10%. Severe asthma is associated with a heavy economic burden and remains a major public health problem. Patients with severe asthma require significant use of healthcare resources, i.e., the rate of exacerbation-related hospital admissions and unscheduled emergency department visits is two- and three-fold, respectively, higher than that in non-severe asthma. The discovery of the molecular mechanisms of asthma pathogenesis allowed the development of biological genetically engineering therapies that provide an effective therapeutic option for severe asthma by improving the quality of life by reducing the rate of exacerbations, improving lung function, and reducing the need for systemic steroids with a good safety profile. Targets for existing biological agents include IgE, interleukins (IL)-4, 5, and 13, and thymic stromal lymphopoietin. These drugs include omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, and tezepelumab, which were recently registered in Russia. Pharmacoeconomic analysis demonstrates a reduction in the costs of managing patients with severe asthma who receive targeted therapy despite the financial costs of its implementation. The choice of targeted drug is always a complex task that requires careful assessment of clinical, anamnestic, and laboratory parameters. In addition, monoclonal antibodies are an expensive treatment option. Currently, centers for genetically engineering biological therapies are being created to achieve effective routing and continuity in the management of these patients and to minimize financial costs. KEYWORDS: severe asthma, eosinophilic phenotype, genetically engineered biological therapy (GEBT), registry, medical commission, targeted therapy, monoclonal antibodies, type 2 immune response. FOR CITATION: Titova O.N., Volchkov V.A., Kuzubova N.A., Sklyarova D.B. Organization of medical care for patients with severe asthma requiring genetically engineered biological therapies in St. Petersburg. Russian Medical Inquiry. 2023;7(8):493–497 (in Russ.). DOI: 10.32364/2587-6821-2023-7-8-3.
19
Reza, Mohammad Irshad, and Nilesh S. Ambhore. "Inflammation in Asthma: Mechanistic Insights and the Role of Biologics in Therapeutic Frontiers." Biomedicines 13, no. 6 (2025): 1342. https://doi.org/10.3390/biomedicines13061342.
Full textAbstract:
Asthma is a chronic and multifaceted respiratory condition that affects over 300 million individuals across the globe. It is characterized by persistent inflammation of the airways, which leads to episodes of wheezing, breathlessness, chest tightness, and coughing. The most prevalent form of asthma is classified as Type 2 or T2-high asthma. In this variant, the immune response is heavily driven by eosinophils, mast cells, and T-helper 2 (Th2) cells. These components release a cascade of cytokines, including interleukin-4 (IL-4), interleukin-5 (IL-5), and interleukin-13 (IL-13). This release promotes several processes: the production of immunoglobulin E (IgE), which is integral to allergic responses; the recruitment of eosinophils—white blood cells that contribute to inflammation and tissue damage. Conversely, non-Type 2 or T2-low asthma is typically associated with a different inflammatory profile characterized by neutrophilic inflammation. This type of asthma is driven by T-helper 1 (Th1) and T-helper 17 (Th17) immune responses, which are often present in older adults, smokers, and those suffering from more severe manifestations of the disease. Among asthmatic patients, approximately 80–85% of cases are classified as T2-high asthma, while only 15–20% are T2-low asthma. Treatment of asthma focuses heavily on controlling inflammation. Inhaled corticosteroids remain the cornerstone therapy for managing T2-high asthma. For more severe or treatment-resistant cases, biologic therapies targeting specific inflammatory pathways, such as anti-IgE (omalizumab), anti-IL-5 (mepolizumab, benralizumab), and anti-IL-4/IL-13 (dupilumab), have shown great promise. For T2-low asthma, macrolide antibiotics like azithromycin and other novel therapies are being explored. This article reviews the safety, efficacy, and indications of the currently approved biologics and discusses potential novel biologics for asthma.
20
Plavsic, Aleksandra, Branka Bonaci Nikolic, Branislava Milenkovic, et al. "Asthma Inflammatory Phenotypes: How Can We Distinguish Them?" Journal of Clinical Medicine 13, no. 2 (2024): 526. http://dx.doi.org/10.3390/jcm13020526.
Full textAbstract:
Background and objectives: induced sputum is used to assess different inflammatory phenotypes in asthma, but is not used routinely. We aimed to determine the proportion of inflammatory asthma phenotypes based on induced sputum, to find biomarkers that can discriminate between phenotypes, and to evaluate biomarkers in patients with and without biological therapy in different inflammatory asthma phenotypes. Materials and Methods: this cross-sectional study investigated clinical characteristics, asthma control tests, skin prick test, impulse oscillometry (IOS), spirometry, induced sputum, biomarkers (IgE, eosinophils, fractional exhaled nitric oxide (FeNO), serum periostin, IL-5, IL-6, IL-8, IL-17A, IL-33) in 80 asthmatics. A total of 17/80 patients were treated with biologics (10 with omalizumab, 7 with benralizumab). Results: a total of 31% of patients had eosinophilic asthma (EA), 30% had mixed granulocytic asthma (MGA), 24% had paucigranulocytic asthma (PGA), and 15% had neutrophilic asthma (NA). The difference was found in blood eosinophils (p = 0.002), the highest observed in EA. The cut-off ≥ 240/μL eosinophils, with 64% sensitivity and 72.7% specificity, identified EA (AUC = 0.743, p = 0.001). A higher IL-8 level was associated with NA (p = 0.025). In 63 non-biologic asthma group, eosinophils were higher in EA than in NA, MGA, and PGA (p = 0.012, p = 0.028, and p = 0.049, respectively). A higher IL-17A was associated with EA without biologics (p = 0.004). A significantly higher IL-5 was found in EA treated with biologics, in comparison with EA without biologics (p = 0.043). The number of leucocytes and neutrophils was higher in MGA without biologics (p = 0.049, p = 0.019), while IL-5, IL-6, and IL-8 levels were higher in MGA treated with biologics (p = 0.012, p = 0.032, p = 0.038, respectively). Conclusions: EA and MGA were the most prevalent asthma phenotypes. Blood eosinophils can identify EA, both in patients with and without biologics. Apart from the clinical profile, a broad spectrum of biomarkers for assessing inflammatory phenotypes is necessary for an adequate therapy approach to patients with asthma.
21
Martin, Maria J., Miguel Estravís, Asunción García-Sánchez, et al. "Effects of Therapeutic Antibodies on Gene and Protein Signatures in Asthma Patients: A Comparative Systematic Review." Biomedicines 10, no. 2 (2022): 293. http://dx.doi.org/10.3390/biomedicines10020293.
Full textAbstract:
Several biologic therapies that target inflammatory modulators are now used for treating patients with uncontrolled, severe asthma. Knowledge about how this type of treatment modifies the molecular milieu is rapidly increasing. Thus, this systematic review aimed to compile the reported effects of therapeutic antibodies on the transcriptome or proteome of asthma patients. Studies of asthmatic patients under biological treatment describing transcriptomic or proteomic changes upon treatment were included. Preclinical or single gene/protein studies were not considered. PubMed and Scopus search was performed in August and September 2021. Following PRISMA guidelines and GRADE recommendations, we selected 12 studies on gene or protein expression changes in patients treated with the antibodies currently approved by EMA and the FDA. All studies were at low risk of bias as per the RoB2 tool. Different gene clusters have been identified to change upon omalizumab treatment, found a reduction in eosinophil-associated gene signatures after benralizumab treatment, and protein profiles were different in patients treated with mepolizumab and in those treated with benralizumab. The main potential biomarkers proposed by the selected studies are shown. These results may contribute to discovering biomarkers of response and selecting the best therapy for each patient.
22
Kavanagh, Joanne E., Andrew P. Hearn, and David J. Jackson. "A pragmatic guide to choosing biologic therapies in severe asthma." Breathe 17, no. 4 (2021): 210144. http://dx.doi.org/10.1183/20734735.0144-2021.
Full textAbstract:
There are now several monoclonal antibody (mAb) therapies (“biologics”) available to treat severe asthma. Omalizumab is an anti-IgE mAb and is licensed in severe allergic asthma. Current evidence suggests it may decrease exacerbations by augmenting deficient antiviral immune responses in asthma. Like all other biologics, clinical efficacy is greatest in those with elevated T2 biomarkers. Three biologics target the interleukin (IL)-5–eosinophil pathway, including mepolizumab and reslizumab that target IL-5 itself, and benralizumab that targets the IL-5 receptor (IL-5R-α). These drugs all reduce the exacerbation rate in those with raised blood eosinophil counts. Mepolizumab and benralizumab have also demonstrated steroid-sparing efficacy. Reslizumab is the only biologic that is given intravenously rather than by the subcutaneous route. Dupilumab targets the IL-4 receptor and like mepolizumab and benralizumab is effective at reducing exacerbation rate as well as oral corticosteroid requirements. It is also effective for the treatment of nasal polyposis and atopic dermatitis. Tezepelumab is an anti-TSLP (thymic stromal lymphopoietin) mAb that has recently completed phase 3 trials demonstrating significant reductions in exacerbation rate even at lower T2 biomarker thresholds.Many patients with severe asthma qualify for more than one biologic. To date, there are no head-to-head trials to aid physicians in this choice. However, post-hoc analyses have identified certain clinical characteristics that are associated with superior responses to some therapies. The presence of allergic and/or eosinophilic comorbidities, such as atopic dermatitis, nasal polyposis or eosinophilic granulomatosis with polyangiitis, that may additionally benefit by the choice of biologic should also be taken into consideration, as should patient preferences which may include dosing frequency. To date, all biologics have been shown to have excellent safety profiles.
23
Landi, C., L. Vantaggiato, E. Shaba, et al. "Differential redox proteomic profiles of serum from severe asthma patients after one month of benralizumab and mepolizumab treatment." Pulmonary Pharmacology & Therapeutics 70 (October 2021): 102060. http://dx.doi.org/10.1016/j.pupt.2021.102060.
Full text
24
Licata, Christine Joy, Sowmya Arja, and Suzanne Teuber. "Steroid resistant hypereosinophilic syndrome found to be Hodgkin’s Lymphoma." Case Reports in Internal Medicine 8, no. 2 (2021): 10. http://dx.doi.org/10.5430/crim.v8n2p10.
Full textAbstract:
Hyperoeosinophilic syndrome (HES) is rare, and clinicians may not recognize its potential association with malignancy. Red flag signs of HES include steroid resistance, older age, and significant lymphadenopathy that can be indicative of malignancy. In this case, an elderly male presenting with right chest wall erythema and axillary lymphadenopathy was initially diagnosed with and treated for cellulitis. Labs were significant for hypereosinophilia. Evidence of end organ damage raised concern for HES. Over the course of three hospitalizations, he was found to have a rising eosinophil count despite high-dose corticosteroid treatment. Further investigation eventually revealed a diagnosis of Hodgkin’s Lymphoma. This case highlights steroid-resistant HES as a presenting sign of malignancy and allows for discussion of potential investigative approaches for HES therapy. Though corticosteroids are first-line treatment for hypereosinophilia and HES, they are well known to have many adverse effects. Biologics, such as mepolizumab and benralizumab, have more acceptable side effect profiles and are effective in treating non-myeloid HES. The use of biologics as first-line treatment for HES has yet to be investigated.
25
Chaverri Repáraz, Claudia María, Esther Lacalle Fabo, María Erroz Ferrer, et al. "Tailoring Biologic Therapies for Pediatric Severe Asthma: A Comprehensive Approach." Children 12, no. 2 (2025): 140. https://doi.org/10.3390/children12020140.
Full textAbstract:
Introduction: Biologic therapies have revolutionized the management of severe asthma in pediatrics, offering targeted options for specific inflammatory pathways. This study aimed to review the current indications and availability of biologics approved for pediatric use as of January 2025 and to analyze the clinical experience of a tertiary center in managing this condition. Methods: A comprehensive review of the biologics available for treating severe asthma in children was conducted, highlighting their indications and key characteristics. Additionally, a retrospective analysis was conducted on the experience of the Pediatric Severe Asthma Unit at the University Hospital of Navarra in utilizing these therapies between 2015 and 2025, with a focus on treatment distribution and reasons for switching biologics. Results: As of January 2025, the biologics available for pediatric use include omalizumab, mepolizumab, dupilumab, tezepelumab, and benralizumab, each with specific indications and different administration profiles. At the analyzed center, the distribution of biologics was as follows: omalizumab (27%), mepolizumab (27%), dupilumab (37%), and tezepelumab (9%). At the same center, the biologic distribution 10 years earlier was 100% omalizumab. Therapy changes and switches were primarily related to clinical response, posology, and comorbidities. Conclusions: This study emphasizes the importance of individualized management in pediatric severe asthma, based on continuous evaluation and appropriate biologic selection according to the clinical characteristics of each patient. It also highlights the need to develop specific guidelines for adjusting, switching, and discontinuing these therapies.
26
Takabayashi, Tetsuji, Daiya Asaka, Yoshitaka Okamoto, et al. "A Phase II, Multicenter, Randomized, Placebo-Controlled Study of Benralizumab, a Humanized Anti-IL-5R Alpha Monoclonal Antibody, in Patients With Eosinophilic Chronic Rhinosinusitis." American Journal of Rhinology & Allergy, April 11, 2021, 194589242110094. http://dx.doi.org/10.1177/19458924211009429.
Full textAbstract:
Background Strong eosinophil infiltration in chronic rhinosinusitis with nasal polyp (CRSwNP) is highly associated with recalcitrance and higher nasal polyp recurrence rate after surgery. The prevalence of eosinophilic CRSwNP (ECRS) is increasing in Asian countries including Japan. Benralizumab is a humanized anti-IL-5R alpha monoclonal antibody that depletes eosinophils by antibody-dependent cell-mediated cytotoxicity. Objective To assess the efficacy and safety of benralizumab in patients with ECRS. Methods This phase II, randomized, double-blind, placebo-controlled study was conducted in Japan. Patients were randomized 1:2:2 to placebo, a single administration of benralizumab 30 mg, or benralizumab 30 mg every 4 weeks (q4w) for a total of three doses. The primary endpoint was the change in nasal polyp score from baseline at Week 12. Results Overall, 56 patients were enrolled (placebo, n = 11; benralizumab single dose, n = 22; benralizumab q4w, n = 23). Although the mean total nasal polyp score began to decrease after the initiation of benralizumab treatment, there were no statistically significant differences in change in nasal polyp score from baseline at Week 12 between benralizumab and placebo (placebo, −0.5 ± 0.8; benralizumab single, −0.3 ± 0.8; benralizumab q4w, −0.5 ± 1.5). Post-hoc analysis showed that the administration of benralizumab decreased nasal polyp scores ≥2 points in 42.2% of ECRS patients and that patients with high blood eosinophil levels had a greater tendency to respond to benralizumab treatment. The safety profile was similar to that in previous studies and no unexpected adverse events were noted. Conclusion Although benralizumab did not meet the primary efficacy endpoint, reductions of nasal polyp scores were seen in the benralizumab group compared with the placebo group over the whole study period, especially in patients with high levels of blood eosinophils.
27
Guttman-Yassky, Emma, Lila Bahadori, Laura Brooks, et al. "Treating moderate-to-severe atopic dermatitis with benralizumab: results from the HILLIER study, a plain language summary." Immunotherapy, May 2, 2024. http://dx.doi.org/10.2217/imt-2023-0319.
Full textAbstract:
What is this summary about? Atopic dermatitis (AD) is a chronic (long-lasting) skin disease that leads to dry, itchy, and swollen red spots, which can also be painful and flare up at any time. Some people with AD have a high number of eosinophils, a type of white blood cell, which are associated with worse disease. Medicated creams and lotions, prescribed by health care providers, are meant to reduce the symptoms of AD. For some people, these creams and lotions do not work. Benralizumab injection is a medication that reduces and removes eosinophils. A clinical trial called HILLER tested benralizumab to see if there was a difference in symptoms of AD after reducing or removing eosinophils. This article explains how benralizumab reduced eosinophils and the effect it had on AD symptoms in the HILLIER study. What were the main conclusions reported by the researchers? Benralizumab reduced blood eosinophil numbers. However, benralizumab showed no evidence of treatment benefit on signs, symptoms, or severity of AD, as measured by three skin assessments compared with placebo. Benralizumab was well tolerated and had a safety profile that was consistent with previous studies. The five most commonly reported side effects were COVID-19 infection, upper respiratory tract infection, headache, swelling of the lymph nodes, and pink eye (conjunctivitis) in patients who received either benralizumab or placebo What are the key takeaways? Benralizumab lowered the number of blood eosinophils without improving AD symptoms and was well tolerated.
28
Konstantinou, George N., and Vasiliki Voukelatou. "Eosinophilic cystitis refractory to steroids successfully treated with benralizumab: A case report." Frontiers in Allergy 3 (January 10, 2023). http://dx.doi.org/10.3389/falgy.2022.1055129.
Full textAbstract:
We report a case of a 66-year-old male diagnosed with refractory to oral corticosteroids eosinophilic cystitis (EoC). Hematuria was the first and only sign of the disease that was otherwise asymptomatic, and the only abnormal lab finding he had was peripheral eosinophilia (700 cells/μl). Due to cardiovascular issues, an invasive surgical procedure was declined. As an alternative, benralizumab, an anti-IL-5Rα monoclonal antibody with anti-eosinophilic properties, was administered. The patient responded rapidly with clinical and histological complete remission of the EoC four months after benralizumab started. He continued benralizumab 30 mg Q4-weeks for 12 months without experiencing any side effects. Six months after the last dose, he is completely healthy with no peripheral eosinophilia. EoC is a rare condition with no standardized treatment. Those with corticosteroid-refractory EoC are eligible for surgery. Benralizumab has an excellent safety profile; therefore, it should be considered before deciding on invasive surgical procedures in selected, refractory to non-specific treatment cases, especially with EoC of unclear etiology. It is unclear if benralizumab may immunomodulate the unknown underlying mechanisms of EoC, considering that EoC did not relapse after benralizumab was deemed eliminated. Further studies are needed to investigate this possibility.
29
Gschwend, Anna, Arthur Helbling, Laurence Feldmeyer, et al. "Treatment with IL5-/IL-5 receptor antagonists in drug reaction with eosinophilia and systemic symptoms (DRESS)." Allergo Journal International, August 23, 2022. http://dx.doi.org/10.1007/s40629-022-00224-7.
Full textAbstract:
Abstract Purpose Drug reaction with eosinophilia and systemic symptoms (DRESS) is a severe delayed drug hypersensitivity reaction with exanthema, eosinophilia, and organ manifestations. After culprit drug withdrawal, systemic corticosteroids (CS) are the most widely used treatment, often requiring high doses for months. Blocking the IL-5/IL‑5 receptor axis with mepolizumab, reslizumab, and benralizumab is a promising targeted treatment with a good safety profile and no immunosuppressive effect. The aim of this study is to summarize current experience with the anti-IL5/IL-5-receptor therapy in DRESS. Methods A retrospective analysis of all patients diagnosed with DRESS and treated with mepolizumab, reslizumab, or benralizumab in DRESS was performed. In addition, a PubMed–Medline search for publications on DRESS with anti-IL-5/IL‑5 receptor treatment was performed. Results Of the 14 cases identified, 6 patients were treated with mepolizumab, 6 with benralizumab, 1 patient with reslizumab, and 1 patient was switched from benralizumab to mepolizumab. The main indication for an IL‑5 blockade was a therapy-refractory course (7/14 [50.0%]), recurrent relapses (3/14 [21.4%]), and severe organ dysfunction (2/14 [14.3%]). In 13/14 (93%) cases, a rapid clinical improvement with suppression of eosinophilia and reduction of CS could be achieved. In all but two cases under mepolizumab (dose 100–600 mg) or reslizumab (dose according to body weight), two or more doses were necessary until resolution of DRESS. In 4/7 cases under benralizumab, a single 30 mg dose was sufficient. Conclusion Blockade of the IL-5/IL‑5 receptor axis appears to be a promising treatment in DRESS with fast clinical improvement, which may allow more rapid reduction of CS, and a good safety profile. In addition, a summary of recommendations on when to use blockade of the IL-5/IL‑5 receptor axis in DRESS treatment is provided.
30
Pelaia, Corrado, Claudia Crimi, Alida Benfante, et al. "Sustained remission induced by 2 years of treatment with benralizumab in patients with severe eosinophilic asthma and nasal polyposis." Respirology, June 7, 2024. http://dx.doi.org/10.1111/resp.14767.
Full textAbstract:
AbstractBackground and ObjectiveSeveral randomized controlled trials (RCTs) have shown that benralizumab is characterized by a good profile of efficacy and safety, thereby being potentially able to elicit clinical remission on‐treatment of severe eosinophilic asthma (SEA). The main goal of this multicentre observational study was to verify the effectiveness of benralizumab in inducing a sustained remission on‐treatment of SEA in patients with or without comorbid chronic rhinosinusitis with nasal polyps (CRSwNP).MethodsThroughout 2 years of treatment with benralizumab, a four‐component evaluation of sustained remission of SEA was performed, including the assessment of SEA exacerbations, use of oral corticosteroids (OCSs), symptom control and lung function.ResultsThe present study recruited 164 patients suffering from SEA. After 24 months of add‐on biological therapy with benralizumab, 69 (42.1%) achieved the important target of sustained remission on‐treatment (exacerbation rate = 0, OCS dose = 0, pre‐bronchodilator FEV1 ≥80% pred., ACT score ≥ 20). During the same period, a persistent improvement of CRSwNP (SNOT‐22 < 30, NP recurrence = 0) was observed in 33 (40.2%) out of 82 subjects with concomitant NP. The latter comorbidity and post‐bronchodilator reversibility of airflow limitation were two independent predictors of sustained remission on‐treatment (OR = 2.32, p < 0.05 and OR = 5.59, p < 0.01, respectively).ConclusionTaken together, the results of this real‐life clinical investigation indicate that benralizumab can induce a sustained remission on‐treatment of SEA, especially in those patients with comorbid CRSwNP and reversible airflow limitation.image
31
Spataro, Federico, Antonio Giovanni Solimando, Attilio Di Girolamo, Angelo Vacca, and Roberto Ria. "Efficacy and safety of benralizumab in eosinophilic granulomatosis with polyangiitis: A meta‐analysis of eight studies." European Journal of Clinical Investigation, October 10, 2024. http://dx.doi.org/10.1111/eci.14333.
Full textAbstract:
AbstractObjectiveEosinophilic granulomatous polyangiitis (EGPA) is a rare autoimmune disease characterized by multisystemic inflammation, with eosinophils playing a central role in its pathogenesis. Traditional management relies heavily on corticosteroids and immunosuppressants, which are associated with significant side effects. The emergence of biologic agents, such as benralizumab, offers targeted therapeutic options by inhibiting the interleukin‐5 receptor α, thereby reducing eosinophilic inflammation.MethodsThis systematic review and meta‐analysis comprehensively evaluate the efficacy and safety of benralizumab in EGPA patients, focusing on its ability to reduce oral corticosteroid (OCS) use, facilitate remission and spare immunosuppressants. We searched MEDLINE, LILACS and ISI Web of Science databases for relevant studies up to July 2024.ResultsEight studies, including both randomized controlled trials (RCTs) and observational studies, were included in the meta‐analysis, involving a total of 396 EGPA patients. The pooled analysis demonstrated a significant reduction in OCS dose, with an overall estimated effect of −8.25 mg/day (95% CI, −9.39 to −7.10). Complete remission was achieved in 56.8% of patients, and immunosuppressants were reduced or discontinued in 28.1% of cases. Adverse events (AEs) were reported in 21.9% of patients, with only one discontinuation due to an AE.ConclusionThese findings provide robust evidence supporting the use of benralizumab as an effective and well‐tolerated treatment option for EGPA, significantly reducing OCS requirements and offering promising remission rates. Future research should focus on larger, multicentre RCTs to confirm these findings and further elucidate the long‐term benefits and safety profile of benralizumab in EGPA.
32
Desaintjean, Charlene, Kaïs Ahmad, Julie Traclet, et al. "Mepolizumab and benralizumab in patients with severe asthma and a history of eosinophilic granulomatosis with polyangiitis." Frontiers in Medicine 11 (March 22, 2024). http://dx.doi.org/10.3389/fmed.2024.1341310.
Full textAbstract:
IntroductionAsthma associated with eosinophilic granulomatosis with polyangiitis (EGPA) is often severe and corticosteroid-dependent, leading to significant morbidity. Mepolizumab and benralizumab are humanized monoclonal antibodies targeting interleukin 5 (IL-5) and its receptor, respectively. They have been shown to be effective in steroid-sparing in patients with severe eosinophilic asthma.ObjectiveOur aim was to evaluate the efficacy and safety of mepolizumab and benralizumab prescribed for severe asthma in patients with EGPA under “real-world” conditions.MethodsThis was a retrospective analysis of patients with EGPA and persistent asthma who received either mepolizumab 100 or 300 mg administered every 4 weeks, or benralizumab 30 mg administered every 4 weeks for the initial 3 injections and followed by an injection every 8 weeks thereafter, whilst combined with oral glucocorticoids. The follow-up every 6 ± 3 months included an assessment of clinical manifestations, pulmonary function tests and eosinophil cell count. The primary outcome was the proportion of patients at 12 months receiving a daily oral dose of prednisone or equivalent of 4 mg or less with a BVAS of 0.ResultsTwenty-six patients were included. After 12 months of treatment with mepolizumab or benralizumab, 32% of patients met the primary outcome and were receiving less than 4 mg of prednisone per day with a BVAS of 0. The median dose of prednisone was 10 mg per day at baseline, 9 mg at 6 months, and 5 mg at 12 months (p ≤ 0.01). At 12 months, 23% of patients were weaned off corticosteroids, while an increase or no change in dose was observed in 27% of patients. The median eosinophil count was significantly reduced from 365 cells/mm3 to 55 cells/mm3 at 6 months and 70 cells/mm3 at 12 months, respectively. No significant change was observed in FEV1. After 12 months of treatment, 14% of patients had had an average of 1 exacerbation of asthma, compared with 52% of patients before baseline. The tolerability profile was favorable.ConclusionIn this real-world study in patients with severe asthma and a history of EGPA asthma, mepolizumab and benralizumab had a significant steroid-sparing effect and reduced asthma exacerbation, but no significant effect on lung function.
33
Martínez-Moragón, Eva, Ismael García-Moguel, Javier Nuevo, et al. "Real-world study in severe eosinophilic asthma patients refractory to anti-IL5 biological agents treated with benralizumab in Spain (ORBE study)." BMC Pulmonary Medicine 21, no. 1 (2021). http://dx.doi.org/10.1186/s12890-021-01785-z.
Full textAbstract:
Abstract Background Benralizumab, a monoclonal antibody targeting the human interleukin-5 (IL-5) receptor (IL-5R), was used before marketing authorisation in Spain in a real world setting as part of an early-access programme (EAP) to treat patients with severe eosinophilic asthma with prior insufficient response or intolerance to anti-IL5 treatment (mepolizumab or reslizumab). The objective of this study is to describe the patient profile candidate for treatment and to assess benralizumab effectiveness. Methods This is an observational, retrospective, multicentre study in severe eosinophilic asthma patients refractory to other biological agents targeting the IL-5 pathway. Baseline characteristics included closest data, from the previous 12 months, to benralizumab treatment onset (index date). Patients were followed until the last treatment dosage while EAP was active (March to December 2018). Effectiveness was evaluated versus baseline, in patients who received at least three doses, with asthma control test (ACT), Mini Asthma Quality of Life Questionnaire (MiniAQLQ), annual severe exacerbation rate, oral corticosteroids treatment (OCS) and asthma-related healthcare resources utilization. Results Twenty-seven patients treated with benralizumab were included in the analysis. Effectiveness was assessed in 19 patients. Both questionnaires showed clinically meaningful differences, i.e. ACT score ≥ 3 and MiniAQLQ score ≥ 0.5, compared with baseline [mean (SD), 3.3 (6.8) and 1.2 (1.9), respectively]. Patients treated with OCS decreased during follow-up from 88.9% (n = 24/27) at baseline to 78.9% (n = 15/19) and 31.6% (n = 6/19) had an OCS dose reduction ≥ 50%. The difference in annual severe exacerbation rate during follow-up showed a significant reduction vs. baseline (2.12 per patient-year, 95% CI 0.99–3.24, p = 0.002). The differences in annual rate of non-scheduled primary care and specialist visits during follow-up indicated a significant decrease [2.28 per patient-year (95% CI 1.55–3.01; p < 0.001) and 1.47 per patient-year (95% CI 0.65–2.30; p = 0.004), respectively], as well as the difference in annual rate of number of emergency department visits [1.18 per patient-year (95% CI 0.51–1.85; p = 0.007)]. Conclusions These results suggest that severe eosinophilic asthma patients receiving benralizumab, presented clinically meaningful improvement in asthma control and asthma-related QoL as well as OCS dose reduction. Results also aim to significant reductions in annual severe exacerbation rates, non-scheduled primary care and specialist visits, and emergency department visits rates.
34
Chaia, Genny, Ubaldo Martín, Arturo Cortés-Telles, et al. "Benralizumab: eficacia y seguridad en pacientes con asma grave eosinofílica." Revista Alergia México 67 (December 18, 2020). http://dx.doi.org/10.29262/ram.v67i7.807.
Full textAbstract:
ResumenEl asma grave conlleva una carga de salud desproporcionadamente alta y cerca de la mitad de los adultos con esta patología tiene un fenotipo eosinofílico. En estos pacientes aunado a la producción de eosinófilos en médula ósea, se activan mecanismos de eosinopoyesis local en tejido pulmonar. Benralizumab es un anticuerpo monoclonal humanizado, que se une con alta afinidad y especificidad a la subunidad alfa del receptor de IL-5 (IL-5Rα) sobre la superficie de eosinófilos y otras células. El principal diferenciador de su mecanismo de acción se relaciona con la remoción de un residuo de fucosa en la Fc, lo cual incrementa hasta 50 veces la afinidad a células NK con apoptosis de eosinófilos mediante citotoxicidad celular dependiente de anticuerpos (CCDA), resultando en una reducción rápida y cercana al 100% tanto en suero como en médula ósea. Adicionalmente, benralizumab reduce >90% de los eosinófilos en tejido pulmonar y esputo. En diversos estudios clínicos controlados y en vida real se ha demostrado que esto se traduce en incremento actual del control del asma y disminución del riesgo futuro. El perfil de seguridad es adecuado sin haberse documentado infestaciones parasitarias ni efectos adversos a largo plazo relacionados con la reducción de los eosinófilos. Abstract Severe asthma carries a disproportionately high health burden and about half of adults with this pathology have an eosinophilic phenotype. In these patients, in addition to the production of eosinophils in bone marrow, local eosinopoiesis mechanisms are activated in lung tissue. Benralizumab is a humanized monoclonal antibody, which joins with high affinity and specificity to the alpha subunit of the IL-5 receptor (IL-5Rα) on the surface of eosinophils and other cells. The main differentiator of its mechanism of action is related to the removal of a fucose residue in Fc, which increases up to 50 times the affinity to NK cells with eosinophil apoptosis by antibody-dependent cell cytotoxicity (CCDA), that leads to a direct, rapid and nearly complete depletion in both peripheral blood and bone marrow. Additionally, benralizumab reduces >90% of eosinophils in lung tissue and sputum. Several controlled and real-life clinical studies have shown that this action over eosinophils is related to increased asthma control and decreased future risk. The safety profile is adequate without documenting parasitic infestations or long-term adverse effects related to the reduction of eosinophils.
35
Upadhyay, Henil, Stefano Aliberti, Andrew Husband, James D. Chalmers, Katy Hester, and Anthony De Soyza. "Safety profile of drugs used in non-cystic fibrosis bronchiectasis: a narrative review." Therapeutic Advances in Drug Safety 15 (January 2024). http://dx.doi.org/10.1177/20420986241279213.
Full textAbstract:
Non-cystic fibrosis bronchiectasis is a long-term lung disease characterised by abnormal dilatation of the bronchi, with patients experiencing chronic productive cough and recurrent exacerbations. Currently, there are no licensed drugs for use in bronchiectasis while clinical trials have been conducted to either test new drugs or repurpose existing ones. These drugs target the underlying pathophysiology of bronchiectasis which is known to include infection, inflammation, mucus hypersecretion and retention. Most of the drugs used in daily clinical practice for bronchiectasis are off-label with no randomised trials exploring their safety. This review aims at exploring the safety profile of drugs frequently used in clinical practice to manage bronchiectasis, including antibiotics (e.g. macrolides, aminoglycosides, polymyxins, fluoroquinolones, aztreonam), mucoactive therapy (e.g. hypertonic saline, mannitol, DNase and carbocisteine), anti-inflammatory therapy (inhaled corticosteroids) and drugs currently in development for use in bronchiectasis (e.g. brensocatib, benralizumab and itepekimab).
36
Tondo, Pasquale, and Francesco Fanfulla. "Resolution of daytime and night-time respiratory symptoms but persistent sleep apnea in severe asthma with the add-on of benralizumab." Multidisciplinary Respiratory Medicine 17 (October 4, 2022). http://dx.doi.org/10.4081/mrm.2022.853.
Full textAbstract:
Introduction: The relationship between asthma and obstructive sleep apnea (OSA) is a widely debated topic in the scientific literature with the controversy surrounding the bi-directional nature of the correlation.Case presentation: We report the case of a 59-year-old male being affected by severe allergic eosinophilic asthma and severe OSA (apnea-hypopnea index [AHI] 32 ev·hr-1). Due to a clinical worsening of asthma (aggravation of dyspnea, chest constriction and night-time respiratory symptoms), despite the optimal therapy for asthma and recurrent administration of systemic corticosteroids, we have added-on treatment with benralizumab (monoclonal anti-interleukin 5 antibody). After eight months, the patient reported an improvement in asthma control (asthma control test [ACT]= 25 points), in pulmonary function and a good control of nocturnal symptoms of both diseases (i.e., wheezing, snoring, etc.). Then, the follow-up polysomnography (PSG) was performed resulting in a high reduction of OSA severity (~18% AHI) even if obstructive events persisted and almost resolution of nocturnal hypoxemia. So, a trial with positive airway pressure (PAP) was proposed to the patient, who declined.Conclusions: In consideration of our experience, we suggest that the nocturnal profile of patients with severe asthma should be always studied by a sleep investigation to prevent the negative effects of interaction with OSA. However, further studies on larger samples are needed to better understand the pathophysiological mechanisms underlying the beneficial effects of benralizumab on obstructive events during sleep.
37
Berti, Alvise, Fabiola Atzeni, Lorenzo Dagna, et al. "Targeting the interleukin-5 pathway in EGPA: evidence, uncertainties and opportunities." Annals of the Rheumatic Diseases, November 10, 2022, ard—2022–223044. http://dx.doi.org/10.1136/ard-2022-223044.
Full textAbstract:
Only a minority of patients with eosinophilic granulomatosis with polyangiitis (EGPA) can be weaned-off glucocorticoids (GC) using conventional treatment strategies. The development of biological agents specifically inhibiting the IL-5 pathway provided the opportunity to treat EGPA by targeting one of the crucial regulators of eosinophils, reducing the GC dose required to control the disease.The anti-IL-5 antibody mepolizumab at the dose of 300 mg/4 weeks has proven to be safe and effective in EGPA. While relapsing patients—who often experience recurrent respiratory manifestations—benefit from this treatment, data are not enough to support its use combined with GC alone in remission induction of severe active forms, or in remission maintenance without conventional immunosuppressants in patients with vasculitic manifestations. Ultimately, the profile of the best candidate for mepolizumab is still unclear.Several real-life reports suggest that mepolizumab at the dose of 100 mg/4 weeks, approved for eosinophilic asthma/chronic rhinosinusitis with nasal polyposis (CRSwNP), effectively maintains remission of EGPA-related asthma and, to a lesser extent, CRSwNP. Preliminary data on the IL-5 pathway-inhibitors benralizumab and reslizumab in EGPA as steroid-sparing agents are also accumulating.Overall, it remains to be proven whether targeting the IL-5 pathway could block progression of organ damage in EGPA, on top of reducing relapses and sparing GC. Other disease-related factors further complicate the understanding of the real anti-IL-5 agent efficacy, such as the lack of a clear definition of remission, of an effective tool to measure disease activity, and of well-defined treat-to-target approaches or goals of treatment.
38
Pyne, Ashley L., Amiko M. Uchida, Mark W. Hazel, et al. "Effect of benralizumab on histopathology and inflammatory signatures in a clinical cohort of eosinophilic esophagitis." Diseases of the Esophagus, July 11, 2024. http://dx.doi.org/10.1093/dote/doae031.
Full textAbstract:
Summary A preliminary report from the recent phase 3 trial of benralizumab, a monoclonal antibody that binds to interleukin-5 receptor alpha (IL5Rα), in patients with EoE revealed that medication use led to tissue eosinophil eradication but did not meet the clinical endpoint of symptom resolution. Here, we characterized the clinical, endoscopic, histologic, and transcriptional changes in patients with active EoE following benralizumab treatment. We retrospectively examined patients with EoE treated with benralizumab at the University of Utah (n = 11) and reviewed reported clinical symptoms, circulating and tissue eosinophilia, and endoscopic and histologic scores. Gene expression profiles from available esophageal tissue from benralizumab-treated patients were compared to those from patients with remission EoE (n = 5), active EoE (n = 10), and controls (n = 22). Benralizumab treatment resulted in partial symptom improvement and significant reduction in tissue eosinophilia, and endoscopic and histologic disease scoring (P &lt; 0.01). Histologic score reductions were driven by eosinophil feature scores, while scores for epithelial features (basal cell hyperplasia and dilated intercellular spaces) were similar to those in active EoE. The gene signatures in benralizumab-treated patients mimicked those of active EoE (e.g. upregulation of POSTN, CDH26, CCL26, and downregulation of DSG1). RNA profiles and pathways support histologic findings of impaired epithelial function that persists despite benralizumab treatment. In conclusion, despite eosinophil eradication, patients treated with benralizumab had persistent epithelial injury at the histologic and transcriptional level. In this cohort, benralizumab therapy failed to eradicate inflammation and epithelial dysfunction showing that interleukin-5 receptor alpha blockade monotherapy is insufficient to control EoE.
39
Schoepfer, Alain M., and Ekaterina Safroneeva. "Pharmacologic treatment of eosinophilic esophagitis: efficacious, likely efficacious, and failed drugs." Inflammatory Intestinal Diseases, July 26, 2024. http://dx.doi.org/10.1159/000540275.
Full textAbstract:
Background: Treatment options for Eosinophilic esophagitis (EoE) evolve rapidly. This review focuses on pharmacologic options to treat EoE. Summary: Orodisopersible budenoside tablets (Jorveza®) have been approved by regulatory authorities for EoE treatment of adults in Europe, Canada and Australia, but not the United States. Jorveza®, as compared to placebo, is effective in inducing and maintaining histologic and clinical remission over time. Before the approval of Jorveza®, several investigator-initiated randomized controlled clinical studies evaluated esophagus-targeted formulations of either budesonide or fluticasone to treat pediatric and adult EoE patients. These drugs were generally efficacious in inducing and maintaining histological and clinical remission. Proton-pump inhibitors (PPI) are used off-label for EoE treatment of pediatric and adult EoE patients given that they are able to induce histologic and clinical remission. Dupilumab (Dupixent®), a monoclonal antibody targeted against IL-4 and IL-13, was approved by regulatory authorities in the United States, Europe, Canada, but not yet Australia. In Europe, including Switzerland, Dupixent® is approved to treat EoE patients of at least 12 years of age with at least 40 kg body weight if they are either unresponsive or intolerant to or not candidates for conventional EoE therapies. Due to lack of efficacy or unfavorable safety profile, the following drugs are not recommended for EoE treatment: systemic steroids, sodium cromoglycate, montelukast, azathioprine, TNF-antagonists (eg. infliximab), vedolizumab (mAb against α4β7), benralizumab (mAb against IL-5 receptor), mepolizumab (mAb against IL-5), reslizumab (mAb against IL-5), omalizumab (mAb against IgE), and lirentelimab (mAb against siglec-8). Key messages: Long-term effectiveness and safety data on different drugs are currently sparse. Concerted efforts of different stakeholders will be necessary to continue the endeavour of providing our patients with much-needed therapies.
40
Melchers, Susanne, and Jan P. Nicolay. "Chronic spontaneous urticaria—status quo and future." Allergo Journal International, October 11, 2023. http://dx.doi.org/10.1007/s40629-023-00272-7.
Full textAbstract:
AbstractChronic spontaneous urticaria (CsU) is a chronic inflammatory dermatosis whose etiology is not yet fully understood. In affected patients, it is often associated with a high limitation of health-related quality of life, which necessitates effective therapeutic management. Different immune cell populations such as mast cells, eosinophilic and basophilic granulocytes, and T cells are involved in the pathogenesis of CsU, whereby mast cells playing a key role. In addition, type I autoallergic reactions with auto IgE antibodies or type IIb autoimmune reactions with auto IgG antibodies have been identified in a proportion of patients. The current international guideline initially recommends the use of second-generation H1 antihistamines, first in standard, then in off-label quadruple dosing. Subsequently, the anti-IgE antibody omalizumab should be added. However, this therapy algorithm does not lead to freedom from manifestations in all patients. Therefore, various targeted therapies are currently being evaluated for their efficacy in CsU, such as off-label use of the anti-interleukin receptor alpha (IL4Rα) antibody dupilumab, the anti-IL-17A antibody secukinumab, or interleukin‑5 blockade using mepolizumab, reslizumab, or benralizumab. In addition, new promising compounds such as the Bruton tyrosine kinase (BTK) inhibitors remibrutinib and fenebrutinib, the anti-cKIT antibody barzolvolimab, the anti-SIGLEC8 antibody lirentelimab, the anti-TSLP antibody tezepelumab, the anti-C5aR1 antibody advoralimab, or the topical application of Syk kinase inhibitors are being tested, which were developed according to new insights into the pathogenesis of CsU. The BTK inhibitor fenebrutinib is currently not being pursued due to a less favorable side effect profile compared to remibrutinib, as well as the anti-IgE antibody ligelizumab, which was inferior to omalizumab therapy in a phase 3 study. Overall, there is a high need for new therapeutic strategies to better treat CsU both symptomatically and curatively. This requires a more comprehensive understanding of pathogenesis of the disease in order to develop new targeted therapies.
41
Haldar, Koirobi, Vijay Mistry, Mathew Richardson, et al. "Effect of Benralizumab treatment on the airway microbiome in COPD." ERJ Open Research, November 7, 2024, 00802–2024. http://dx.doi.org/10.1183/23120541.00802-2024.
Full textAbstract:
BackgroundOne-third of patients with Chronic obstructive pulmonary disease (COPD) have an eosinophilic inflammatory phenotype. Benralizumab is an afucosylated humanised monoclonal antibody that targets the IL-5 receptor α subunit, leading to rapid and near-complete eosinophil depletionviaantibody-dependent cellular cytotoxicity. We hypothesized that benralizumab targeted immune modulation could have an impact on the airway microbiome in COPD.ObjectiveTo investigate the effect of Benralizumab treatment on inflammation and the sputum microbiome in COPD.MethodsSputum samples from 94 COPD patients enrolled to the GALATHEA trial (NCT02138916) and randomized to receive placebo (33), benralizumab at 100 mg (29) or 30 mg (32) over 52 weeks, were analysed at baseline, week 24 and at end-of-treatment (week 56). Sputum microbiota taxonomic profiles and diversity indices, generated from paired-end Illumina sequencing targeting the 16sRNA gene, were used for comparative analyses. Linear mixed model analyses were applied on blood and sputum cell count and eosinophil mediators for within and between treatment group analysis.ResultsParticipants treated with 100 and 30 mg benralizumab respectively, showed a significant reduction from baseline in blood and sputum eosinophil counts (Blood p=1.2E-10 & p=8.8E-10; Sputum p=0.03 & p=0.004) and eosinophil-derived serum mediators (ECP p<3E-09 & p<2E-08; EDN p<8E- 12 & p<2E-09). No significant changes in the composition or diversity of the sputum microbiome were observed.ConclusionsIn this study, the airway microbiome measured in sputum was unaffected by targeted reduction of eosinophilic inflammation with benralizumab treatment.
42
Ho, Calvin N., Harald Fjällbrant, Evan S. Dellon, et al. "Patient experience with eosinophilic esophagitis symptoms and impacts on daily life based on in-trial qualitative interviews." Journal of Patient-Reported Outcomes 9, no. 1 (2025). https://doi.org/10.1186/s41687-025-00836-x.
Full textAbstract:
Abstract Purpose Eosinophilic esophagitis (EoE), a chronic immune-mediated progressive disease, causes dysphagia, food impaction, abdominal pain, vomiting, and heartburn. EoE requires long-term monitoring and can affect quality of life owing to its symptoms and associated emotional and social burden. This study aimed to understand patients’ experiences with EoE. Methods Semi-structured longitudinal interviews were conducted with patients from MESSINA, a phase 3 placebo-controlled trial evaluating benralizumab for EoE. Interviews were held at two different times to assess the impact of EoE on patients’ lives before and during trial participation. Data were analyzed qualitatively to develop detailed patient profiles. Results The MESSINA trial was terminated prematurely. Of the 34 patients recruited for the first interview, 15 (44%) completed the second interview and 11 patient profiles were developed. Patients were a demographically diverse group with varying experiences. The primary reported symptom was difficulty swallowing (n = 11), leading to serious consequences like choking and hospitalization (n = 2). Other symptoms included pain when swallowing (n = 7), reflux (n = 6), and stomachache (n = 6). In the second interview, most (n = 9) patients reported moderate improvements in symptoms, while others experienced symptom recurrence or worsening. EoE had a significant negative impact on social and emotional well-being, and professional lives. Trial participation improved emotional well-being for some; however, concerns about the need for ongoing treatment were noted. Conclusion This study highlighted emotional and social burdens of EoE. The encouraging feedback on study participation underscores the importance of patient insights in developing holistic management strategies for EoE.