Статті в журналах: "Benralizumab"

1

Antoniu, S. A. "Benralizumab." Drugs of the Future 39, no. 7 (2014): 463. http://dx.doi.org/10.1358/dof.2014.039.07.2156125.

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Zhuravleva, M. V., S. N. Avdeev, Yu V. Gagarina, and T. V. Marin. "Pharmacoeconomic analysis of using benralizumab for treatment of severe asthma in inpatient and outpatient settings." FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology 15, no. 2 (July 27, 2022): 175–86. http://dx.doi.org/10.17749/2070-4909/farmakoekonomika.2022.143.

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Objective: evaluation of the pharmacoeconomic feasibility of using benralizumab in the form of autoinjector (pen-injector device) in outpatient facilities compared with its use in the form of a syringe in hospital settings for the treatment of severe asthma (SA).Material and methods. The cost minimization and budget impact analysis methods were used. The current practice of treating patients with SA with benralizumab in hospital settings at the expense of compulsory medical insurance funds was compared with the simulated practice. The simulated price was calculated as half patients receiving benralizumab in the hospital transferred to outpatient facilities at the expense of regional funds for 3 years. Direct medical costs included drug cost and outpatient patient monitoring services cost.Results. The direct medical costs associated with benralizumab therapy in outpatient facilities were lower than the costs required for benralizumab therapy in the hospital settings and amounted to 0.99 million rubles versus 1.17 million rubles per one patient per year, respectively. Thus, the use of benralizumab in outpatient facilities leads to savings of 185 thousand rubles (16%). In 2021, 93 patients were prescribed benralizumab in hospital settings. The expansion of the application of benralizumab use in outpatient facilities will lead to a reduction in medical costs in the first year of therapy (when switching 16.7% of patients) by 5.9 million rubles (4,9%). The consistent expansion of the practice of benralizumab use in outpatient facilities over a 3-year horizon (when switching 50% of patients) will lead to a reduction in medical costs by 46.6 million rubles (12.1%).Conclusion. Expansion of benralizumab use in outpatient facilities with a new form of autoinjector (pen-injector device) will lead to savings in medical costs and reduce the burden on the health care system, thus it is economically feasible.

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Bourdin, Arnaud, Don Husereau, Nicolas Molinari, Sarowar Golam, Mohd Kashif Siddiqui, Leandro Lindner, and Xiao Xu. "Matching-adjusted indirect comparison of benralizumab versus interleukin-5 inhibitors for the treatment of severe asthma: a systematic review." European Respiratory Journal 52, no. 5 (October 11, 2018): 1801393. http://dx.doi.org/10.1183/13993003.01393-2018.

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Benralizumab is an interleukin-5 receptor α-directed cytolytic monoclonal antibody that directly depletes eosinophils. Its relative efficacy versus other IL-5-targeted treatments for patients with severe, uncontrolled asthma is not yet fully characterised.We performed a matching-adjusted indirect comparison (MAIC) of benralizumab versus mepolizumab and reslizumab. Trials were selected through systematic review and evaluation of trial methods. Benralizumab patient-level data were weighted to match treatment-effect-modifying patient characteristics of comparator trials before indirect efficacy comparisons.After matching adjustment, benralizumab and mepolizumab reduced exacerbations versus placebo by 52% and 49%, respectively (rate ratio [RR] 0.94, 95% CI 0.78–1.13; n=1524) and reduced the rate of exacerbations requiring hospitalisation/emergency department visit by 52% and 52%, respectively (RR 1.00, 95% CI 0.57–1.75; n=1524). Benralizumab and mepolizumab similarly improved pre-bronchodilator forced expiratory volume in 1 s at 32 weeks (difference 0.03 L, 95% CI −0.06–0.12; n=1443). Benralizumab and reslizumab patient populations were too dissimilar to generate a sufficient effective sample size to produce a reliable estimate for MAIC.MAIC is a robust way to indirectly compare treatment efficacies from trials with heterogeneous patient populations. When baseline patient characteristics were matched across asthma trials, benralizumab and mepolizumab yielded similar efficacy.

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Ando, Koichi, Akihiko Tanaka, and Hironori Sagara. "Comparative Efficacy and Safety of Dupilumab and Benralizumab in Patients with Inadequately Controlled Asthma: A Systematic Review." International Journal of Molecular Sciences 21, no. 3 (January 30, 2020): 889. http://dx.doi.org/10.3390/ijms21030889.

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No head-to-head trials have compared the efficacy and safety between the licensed dosage and administration dosage of dupilumab and benralizumab for inadequately controlled asthma. We conducted an indirect treatment comparison to estimate differences in the efficacy and safety between dupilumab and benralizumab for inadequately controlled asthma using the Bayesian approach. The primary efficacy endpoint was annual exacerbation rate (AER). A subgroup analysis by blood eosinophil count was also performed. The primary safety endpoint was the incidence of any adverse events (AAEs). The results demonstrate that there was no significant difference in the AER between dupilumab and benralizumab in overall patients and the subgroup with the blood eosinophil count of <150. However, the AER was significantly lower in the dupilumab group than in the benralizumab group in the subgroup with a blood eosinophil count of ≥150 but <300, and ≥300 with the rate ratio and 95% credible interval of 0.51 (0.29–0.92) and 0.58 (0.39–0.84), respectively. There was no significant difference in the AAEs between the dupilumab and benralizumab groups. This indirect treatment comparison indicates that dupilumab is superior to benralizumab in patients with inadequately controlled asthma having higher blood eosinophil counts. A direct comparison is required to provide definitive evidence. Systematic Review Registration: UMIN-CTR no. UMIN000036256.

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Bleecker, Eugene R., Michael E. Wechsler, J. Mark FitzGerald, Andrew Menzies-Gow, Yanping Wu, Ian Hirsch, Mitchell Goldman, Paul Newbold, and James G. Zangrilli. "Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma." European Respiratory Journal 52, no. 4 (August 23, 2018): 1800936. http://dx.doi.org/10.1183/13993003.00936-2018.

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Benralizumab is an anti-eosinophilic monoclonal antibody that reduces exacerbations and improves lung function for patients with severe, uncontrolled asthma with eosinophilic inflammation. We evaluated the impact of baseline factors on benralizumab efficacy for patients with severe asthma.This analysis used pooled data from the SIROCCO (ClinicalTrials.gov identifier NCT01928771) and CALIMA (ClinicalTrials.gov identifier NCT01914757) Phase III studies. Patients aged 12–75 years with severe, uncontrolled asthma receiving high-dosage inhaled corticosteroids plus long-acting β2-agonists received benralizumab 30 mg subcutaneously every 8 weeks (Q8W, first three doses every 4 weeks (Q4W)), Q4W or placebo. Baseline factors that influenced benralizumab efficacy were evaluated, including oral corticosteroid (OCS) use, nasal polyposis, pre-bronchodilator forced vital capacity (FVC), prior year exacerbations and age at diagnosis. Efficacy outcomes included annual exacerbation rate and change in pre-bronchodilator forced expiratory volume in 1 s at treatment end relative to placebo.Benralizumab Q8W treatment effect was enhanced with each baseline factor for all patients and those with ≥300 eosinophils·μL−1 relative to the overall population. OCS use, nasal polyposis and FVC <65% of predicted were associated with greater benralizumab Q8W responsiveness for reduced exacerbation rate for patients with <300 eosinophils·μL−1.Baseline clinical factors and blood eosinophil counts can help identify patients potentially responsive to benralizumab.

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Yamada, Hideyasu, Masayuki Nakajima, Masashi Matsuyama, Yuko Morishima, Naoki Arai, Norihito Hida, Taisuke Nakaizumi, et al. "Identification of distinct phenotypes related to benralizumab responsiveness in patients with severe eosinophilic asthma." PLOS ONE 16, no. 3 (March 11, 2021): e0248305. http://dx.doi.org/10.1371/journal.pone.0248305.

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Purpose To characterize the clinical phenotypes of severe eosinophilic asthma based on early responsiveness to benralizumab in terms of forced expiratory volume in 1 second (FEV1) improvement. Patients and methods Sixty-four participants diagnosed with severe eosinophilic asthma and who had completed 4 months of benralizumab treatment were included in this analysis. Pre-treatment clinical factors were compared between responders and non-responders according to improvements in ACT or FEV1. Correlations between the sums of increased Type 2-related inflammatory parameters and changes of ACT or FEV1 were also evaluated before and after the 4-month treatment. A two-step cluster analysis was performed to identify distinct phenotypes related to benralizumab responsiveness in terms of FEV1. Results At the 4-month timepoint, all parameters, except for FeNO, were significantly improved after benralizumab treatment. FEV1 responders were associated with higher levels of Type 2-related inflammatory parameters. An improvement in FEV1 but not in ACT was clearly associated with increases in the sums of increased type 2-related inflammation parameters (p = 0.0001). The cluster analysis identified 5 distinct phenotypes of severe eosinophilic asthma according to the variable FEV1 responsiveness to benralizumab. The greatest response was found in the distinct phenotype of severe eosinophilic asthma, which was characterized by modest increase in total IgE and FeNO relative to blood eosinophils with least exposure to smoking. Conclusion This study, to the best of our knowledge, is the first cluster analysis to report distinct phenotypes related to clinical benralizumab response in a real-world population with severe eosinophilic asthma. These results may help to predict responsiveness to benralizumab in patients with severe eosinophilic asthma.

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Titova, Olga N., Natalia A. Kuzubova, Daria B. Sklyarova, and Maria A. Petrova. "The effectiveness of benralizumab in the treatment of the eosinophilic phenotype of severe asthma in real clinical practice." PULMONOLOGIYA 31, no. 5 (October 20, 2021): 628–34. http://dx.doi.org/10.18093/0869-0189-2021-31-5-628-634.

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To evaluate the effectiveness of benralizumab in patients with the eosinophilic phenotype of severe asthma in real clinical practice after a year of therapy.Methods. During Benralizumab therapy, 13 patients with severe eosinophilic asthma (average age – 55.44 ± 7.18 years old) were examined twice: before the treatment and after 1 year of benralizumab therapy. The assessment included collection of complaints, medical history, current therapy, Asthma Control Questionnaire (ACQ-5) test, absolute blood count of eosinophils, spirometry.Results. All patients initially had pronounced eosinophilia of 577.5 ± 356.4 cells/μl. After 1 year of using benralizumab, the eosinophil count decreased by 96.15%. During therapy, the ACQ-5 index decreased from 1.63 ± 0.62 to 0.73 ± 0.41 in the study patients, which corresponded to the achievement of asthma control. The forced expiratory volume in 1 second (FEV1) increased by 23 %. The number of exacerbations decreased by 58.09%. 12 (92.31%) patients were on oral corticosteroids (OCS) (10 ± 2.17 mg of prednisolone daily) before benralizumab therapy. All subjects noted a decrease in night and day symptoms over time and were able to reduce the use of OCS. 5 (38.46%) patients achieved complete elimination of daily OCS use, 7 (53.84%) patients were able to reduce their daily OCS dose.Conclusion. Benralizumab therapy as an add-on maintenance treatment in patients with eosinophilic phenotype of severe asthma contributes to a significant decrease in peripheral blood eosinophils, which mediates an improvement in asthma control, an increase in FEV1, a reduction in the number of exacerbations, and a decrease in the need for the OCS usage. Careful monitoring of long-term adverse events is necessary during treatment with benralizumab.

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Tsurumaki, Matsuyama, Ezawa, Koga, Yatomi, Aoki-Saito, Chikamatsu, and Hisada. "Rapid Effect of Benralizumab for Hypereosinophilia in a Case of Severe Asthma with Eosinophilic Chronic Rhinosinusitis." Medicina 55, no. 7 (July 3, 2019): 336. http://dx.doi.org/10.3390/medicina55070336.

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A 56-year-old man with severe asthma underwent bronchial thermoplasty (BT). However, his asthma exacerbated and hypereosinophilia developed 2 months later, thus necessitating oral corticosteroid (OCS) therapy. Six months after BT, a diagnosis of severe asthma with eosinophilic chronic rhinosinusitis (ECRS) was made and benralizumab treatment was initiated; the blood eosinophil count subsequently decreased and lung function improved, thereby permitting OCS dose tapering. Surprisingly, benralizumab both reduced nasal polyps and ameliorated ECRS. Thus, benralizumab may be a useful drug for the rapid treatment of severe asthma with ECRS, especially in patients with hypereosinophilia.

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Nedogoda, Sergey Vladimirovich, Alla Sergeevna Salasyuk, Irina Nikolaevna Barykina, Victoria Olegovna Smirnova та Maksim Yurevich Frolov. "Сost of the Biologacal Therapy for Severe Brochcial Asthma Treatment at Inpatient and Day Care Setting". Medical Technologies. Assessment and Choice (Медицинские технологии. Оценка и выбор), № 1 (39) (1 травня 2020): 61–69. http://dx.doi.org/10.31556/2219-0678.2020.39.1.061-069.

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Objective: to assess the cost of the severe bronchial asthma (BA) treatment with various biological agents at inpatient and day care setting from the compulsory medical insurance (CMI) system perspective. Methods. The authors constructed the MS Excel® analytical decision-making model and calculated the CMI system’s costs of severe BA treatment with various biological drugs at inpatient and day care setting. The costs of treatment with benralizumab, dupilumab, omalizumab, reslizumab and mepolizumab were compared. The cost difference between benralizumab and other drugs was identified taking into account the frequency of the drugs’ administration. The first administration was assumed to be inpatient, followed by the administrations in day care ward. Results. The use of benralizumab reduces the expenses of the CMI system by 0.8 million rubles per patient (–39%) compared with omalizumab, mepolizumab, resizumab and by 2.9 million rubles per patient (–69%) versus dupilumab due to the lowest frequency of administration, therefore less hospitalizations for therapy. With a 5-year modeling horizon, benralizumab therapy allows to reduce the CMI system expenses by 4.5 million rubles (–48%) compared with omalizumab, mepolizumab, reslizumab and by 13.9 million rubles (–74%) compared with dupilumab. The use of benralizumab will release 5–7 cases per patient per year compared to omalizumab, resizumab and mepolizumab and 18–20 cases per patient per year compared to dupilumab. Conclusion. Benralizumab therapy in patients with severe BA in inpatient and day care settings will lead to the optimization of CMI expenditures and more rational use of budgets allocated to hospitals.

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Markham, A. "Benralizumab: First Global Approval." Drugs 78, no. 4 (February 20, 2018): 505–11. http://dx.doi.org/10.1007/s40265-018-0876-8.

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Lombardo, Nicola, Corrado Pelaia, Marco Ciriolo, Marcello Della Corte, Giovanna Piazzetta, Nadia Lobello, Pasquale Viola, and Girolamo Pelaia. "Real-life effects of benralizumab on allergic chronic rhinosinusitis and nasal polyposis associated with severe asthma." International Journal of Immunopathology and Pharmacology 34 (January 2020): 205873842095085. http://dx.doi.org/10.1177/2058738420950851.

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The aim of this study has been to evaluate the efficacy of the IL-5 receptor blocker benralizumab on chronic rhinosinusitis with nasal polyposis (CRSwNP), associated with severe eosinophilic allergic asthma. Ten patients with severe eosinophilic allergic asthma and CRSwNP were enrolled. Sino-nasal outcome test (SNOT-22), numerical rating scale (NRS), endoscopic nasal polyp score, Lund Mackey CT (computed tomography) score, and blood eosinophil count were measured at baseline and after 24 weeks of treatment with benralizumab. All the above clinical, endoscopic, imaging, and hematological parameters significantly improved after 24 weeks of treatment with benralizumab. In particular, SNOT-22 decreased from 61.10 ± 17.20 to 26.30 ± 19.74 ( P < 0.001), NRS decreased from 7.20 ± 1.55 to 3.40 ± 2.22 ( P < 0.001), the endoscopic polyp nasal score decreased from 4.20 ± 1.32 to 2.50 ± 1.78 ( P < 0.001), the Lund-Mackay CT score decreased from 16.60 ± 5.50 to 6.90 ± 5.99 ( P < 0.001), and blood eosinophil count decreased from 807.3 ± 271.1 cells/μL to 0 cells/μL ( P < 0.0001). These results strongly suggest that benralizumab exerted a very effective therapeutic action on CRSwNP associated with severe asthma, thus improving nasal symptoms and decreasing polyp size.

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László, Nimród, Hédy Katalin Sárközy, Cristina Alexandra Man, Edith Simona Ianoși, Botond Mátyás, Bianca Emilia Ciurba, Corina Mărginean, and Gabriela Jimborean. "The Benefit of Benralizumab Monoclonal Antibody Treatment for Severe Eosinophilic Asthma in a Case Series (Pulmonology Clinic Târgu Mureș, Romania)." Journal of Interdisciplinary Medicine 6, no. 3 (September 1, 2021): 157–61. http://dx.doi.org/10.2478/jim-2021-0030.

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Abstract Background: Monoclonal antibody therapy is currently an additional treatment option to reduce exacerbations and improve symptom control in patients with severe eosinophilic asthma (SEA) that is uncontrolled despite treatment with high-dose inhaled corticosteroids and long-acting beta-2 agonists. Benralizumab, a monoclonal antibody that binds to the interleukin-5 receptor (IL-5), significantly reduces symptoms and annual exacerbations, as well as the use of systemic corticosteroids in patients with SEA. However, few studies are available on the effectiveness of this biological treatment in real life. The aim of this case series was to evaluate the efficacy of benralizumab by analyzing changes in clinical parameters and blood eosinophils in patients with SEA. Methods: We analyzed four patients with SEA who started treatment with benralizumab. The history of symptoms and exacerbations, eosinophil counts, data regarding the oral corticosteroid dose, need for rescue treatment, spirometry measurements and asthma control questionnaires (ACT) regarding the level of asthma control were recorded. A positive response to treatment was defined by a significant reduction in eosinophil counts, increased ACT scores, and lower rates of exacerbations. Results and conclusions: Benralizumab monoclonal antibody was effective in all four patients. This was shown by a reduction in exacerbation rates, symptom severity, and lower dose of oral corticosteroids and rescue medication. This novel treatment was well tolerated by the analyzed patients, thus indicating that benralizumab is an attractive choice for patients due to eosinophilic count reduction as well as the less frequent dosing schedule. However, further studies are required, on larger populations.

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Pintea, Irena, Ioana Adriana Muntean, Carmen Teodora Dobrican, Nicolae Miron, and Diana Deleanu. "Off-Label Benralizumab in Severe Non-Necrotizing Eosinophilic Vasculitis following Critical COVID-19 Disease and in DRESS." Journal of Clinical Medicine 11, no. 22 (November 9, 2022): 6642. http://dx.doi.org/10.3390/jcm11226642.

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Benralizumab is a humanized recombinant mAb that binds to the interleukin 5 receptor (IL-5R) expressed on eosinophils and is approved for the treatment of severe eosinophilic asthma. There are a series of severe eosinophilic disorders that may benefit from this treatment, and it could be a life-saving therapy. In this paper, we present two severe patients with eosinophil-induced diseases that had a good resolution after one dose of Benralizumab 30 mg. The first case is a severe non-necrotizing eosinophilic vasculitis following critical COVID-19 disease and the second case is a DRESS (Drug Rash with Eosinophilia and Systemic Symptoms Syndrome) due to allopurinol. Conclusions: The successful administration of Benralizumab in rare or severe eosinophilic disease could be an option for life-saving therapies when conventional treatments fail.

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Pelaia, Corrado, Claudia Crimi, Santi Nolasco, Giovanna Elisiana Carpagnano, Raffaele Brancaccio, Enrico Buonamico, Raffaele Campisi, et al. "Switch from Omalizumab to Benralizumab in Allergic Patients with Severe Eosinophilic Asthma: A Real-Life Experience from Southern Italy." Biomedicines 9, no. 12 (December 3, 2021): 1822. http://dx.doi.org/10.3390/biomedicines9121822.

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Background. The wide availability of monoclonal antibodies for the add-on therapy of severe asthma currently allows for the personalization of biologic treatment by selecting the most appropriate drug for each patient. However, subjects with overlapping allergic and eosinophilic phenotypes can be often eligible to more than one biologic, so that the first pharmacologic choice can be quite challenging for clinicians. Within such a context, the aim of our real-life investigation was to verify whether allergic patients with severe eosinophilic asthma, not adequately controlled by an initial biologic treatment with omalizumab, could experience better therapeutic results from a pharmacologic shift to benralizumab. Patients and methods. Twenty allergic patients with severe eosinophilic asthma, unsuccessfully treated with omalizumab and then switched to benralizumab, were assessed for at least 1 year in order to detect eventual changes in disease exacerbations, symptom control, oral corticosteroid intake, lung function, and blood eosinophils. Results. In comparison to the previous omalizumab therapy, after 1 year of treatment with benralizumab our patients experienced significant improvements in asthma exacerbation rate (p < 0.01), rescue medication need (p < 0.001), asthma control test (ACT) score (p < 0.05), forced expiratory volume in the first second (FEV1) (p < 0.05), and blood eosinophil count (p < 0.0001). Furthermore, with respect to the end of omalizumab treatment, the score of sino-nasal outcome test-22 (SNOT-22) significantly decreased after therapy with benralizumab (p < 0.05). Conclusion. The results of this real-life study suggest that the pharmacologic shift from omalizumab to benralizumab can be a valuable therapeutic approach for allergic patients with severe eosinophilic asthma, not adequately controlled by anti-IgE treatment.

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Cañas, José A., Marcela Valverde-Monge, José M. Rodrigo-Muñoz, Beatriz Sastre, Marta Gil-Martínez, Raquel García-Latorre, Manuel J. Rial, et al. "Serum microRNAs as Tool to Predict Early Response to Benralizumab in Severe Eosinophilic Asthma." Journal of Personalized Medicine 11, no. 2 (January 28, 2021): 76. http://dx.doi.org/10.3390/jpm11020076.

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Severe eosinophilic asthma poses a serious health and economic problem, so new therapy approaches have been developed to control it, including biological drugs such as benralizumab, which is a monoclonal antibody that binds to IL-5 receptor alpha subunit and depletes peripheral blood eosinophils rapidly. Biomarkers that predict the response to this drug are needed so that microRNAs (miRNAs) can be useful tools. This study was performed with fifteen severe eosinophilic asthmatic patients treated with benralizumab, and serum miRNAs were evaluated before and after treatment by semi-quantitative PCR (qPCR). Patients showed a clinical improvement after benralizumab administration. Additionally, deregulation of miR-1246, miR-5100 and miR-338-3p was observed in severe asthmatic patients after eight weeks of therapy, and a correlation was found between miR-1246 and eosinophil counts, including a number of exacerbations per year in these severe asthmatics. In silico pathway analysis revealed that these three miRNAs are regulators of the MAPK signaling pathway, regulating target genes implicated in asthma such as NFKB2, NFATC3, DUSP1, DUSP2, DUSP5 and DUSP16. In this study, we observed an altered expression of miR-1246, miR-5100 and miR-338-3p after eight weeks of benralizumab administration, which could be used as early response markers.

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Vitale, Carolina, Angelantonio Maglio, Corrado Pelaia, Maria D’Amato, Luigi Ciampo, Giulia Pelaia, Antonio Molino, and Alessandro Vatrella. "Effectiveness of Benralizumab in OCS-Dependent Severe Asthma: The Impact of 2 Years of Therapy in a Real-Life Setting." Journal of Clinical Medicine 12, no. 3 (January 27, 2023): 985. http://dx.doi.org/10.3390/jcm12030985.

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Patients with severe OCS-dependent asthma can be considered a subgroup of asthma patients with severe disease and great risk of complications, related to chronic OCS use. The introduction of biological drugs has represented a turning point in the therapeutic strategy for severe asthma, offering a valid alternative to OCS. Benralizumab, like other anti-IL-5 agents, has been shown to reduce exacerbations and OCS intake/dosage and improve symptom control and lung function. While these findings have also been confirmed in real-life studies, data on long-term efficacy are still limited. Methods: In this retrospective study, we evaluated the effects of 2 years of treatment with benralizumab on 44 patients with OCS-dependent severe asthma by analyzing clinical, biological and functional data. Results: After 2 years of benralizumab, 59.4% discontinued OCS and patients who continued to use OCS had their mean dose reduced by approximately 85% from baseline. Meanwhile, 85% of patients had their asthma well-controlled (ACT score > 20) and had no exacerbations, and 41.6% had normal lung function. Conclusions: Our findings support the long-term effectiveness of benralizumab in severe OCS-dependent asthma in a real-life setting, suggesting potential reductive effects on costs and complications such as adverse pharmacological events.

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Bernstein, Jonathan A., Umesh Singh, Marepalli B. Rao, Karen Berendts, Xiang Zhang, and Diya Mutasim. "Benralizumab for Chronic Spontaneous Urticaria." New England Journal of Medicine 383, no. 14 (October 1, 2020): 1389–91. http://dx.doi.org/10.1056/nejmc2016395.

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Cooke, W. Donald, and Abigail Tarr Cooke. "Eosinophilic cystitis treatment with benralizumab." Journal of Allergy and Clinical Immunology 145, no. 2 (February 2020): AB67. http://dx.doi.org/10.1016/j.jaci.2019.12.734.

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Murray, Toby, Ben Haagsma, and Andrew Chetwood. "Non-infective cystitis secondary to benralizumab immunotherapy." BMJ Case Reports 15, no. 1 (January 2022): e244733. http://dx.doi.org/10.1136/bcr-2021-244733.

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This case study discusses a patient who presented with severe lower urinary tract symptoms and pain after commencing immunotherapy for eosinophilic asthma. Initial aetiology was presumed to be infective but cultures were negative. Cross-sectional imaging showed extensive perivesical and periprostatic stranding and inflammation. He was initially treated with antibiotics and anti-inflammatories but a lack of clinical improvement led to a rigid cystoscopy which identified an inflamed, oedematous urothelium which was biopsied. Histology demonstrated extensive, full thickness superficial detrusor inflammation, with marked congestion, oedema and a mixed inflammatory infiltrate in keeping with a severe active chronic non-infectious cystitis, possibly secondary to benralizumab therapy. His benralizumab was stopped and his symptoms completely settled. We believe this is the first described case of severe non-infective cystitis which may be secondary to benralizumab. This case adds to the isolated reports of this rare side effect of some of the newer biological agents in use.

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Sereda, V. P., D. A. Svirido, M. V. Komarov, Zhanna A. Mironova, and M. A. Nyoma. "Experience of using benralizumab in the treatment of patients with severe asthma in the clinical practice of pulmonologists in Saint-Petersburg." PULMONOLOGIYA 32, no. 5 (September 21, 2022): 670–77. http://dx.doi.org/10.18093/0869-0189-2022-32-5-670-677.

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The accumulation of clinical experience in the use of biologic therapy in patients with severe bronchial asthma (SBA) in real-world clinical practice with the possible identification of additional, previously undescribed clinical outcomes is of practical interest.The aim. To present the results of an observational study of using benralizumab in SBA in real clinical practice of pulmonologists in Saint-Petersburg.Methods. We present the results of more than 1 year of follow-up of 18 patients with eosinophilic SBA (12 women, 6 men, age from 28 to 74, average age 55.0 ± 11.9 years). The patients received benralizumab in addition to standard treatment. Clinical, laboratory, and functional examination of the patients were performed, the frequency of exacerbations and additional clinical effects were assessed. Results. It has been shown that the inclusion of benralizumab in complex therapy resulted in a significant improvement in disease control, improved bronchial conduction, a significant decrease in blood eosinophilia, and a reduction in the number of exacerbations. A clinical example is given that indicates a stabilizing effect of this therapy on the course of recurrent nasal polyposis with an initially aggressive course (intracranial polyp growth).Conclusion. The possibility of significant improvement in the control of SBA with the use of biological therapy has been confirmed in real clinical practice. At the same time, data have been obtained that will allow expanding the indications for the use of benralizumab in the future.

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Vantaggiato, Lorenza, Paolo Cameli, Laura Bergantini, Miriana d’Alessandro, Enxhi Shaba, Alfonso Carleo, Fabrizio Di Giuseppe, et al. "Serum Proteomic Profile of Asthmatic Patients after Six Months of Benralizumab and Mepolizumab Treatment." Biomedicines 10, no. 4 (March 24, 2022): 761. http://dx.doi.org/10.3390/biomedicines10040761.

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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.

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Jauhiainen, Alexandra, Lieke E. J. M. Scheepers, Anne L. Fuhlbrigge, Tim Harrison, James Zangrilli, Esther Garcia Gil, Per Gustafson, Malin Fagerås, and Carla A. Da Silva. "Impact of season and geography on CompEx Asthma: a composite end-point for exacerbations." ERJ Open Research 6, no. 4 (October 2020): 00246–2020. http://dx.doi.org/10.1183/23120541.00246-2020.

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BackgroundCompEx Asthma, a novel composite end-point combining severe exacerbations (SevEx) with asthma-worsening events, was recently developed. Further characterisation of CompEx Asthma is needed to illustrate the applicability of this end-point. The objective was to evaluate CompEx Asthma as a rate end-point to determine how seasonal and geographical factors impact this novel outcome.MethodsSeven 24–56-week randomised controlled trials of budesonide/formoterol (BUD/FORM) and benralizumab were analysed. Annualised event rates (AERs) and treatment effects (hazard ratio (HR)) were analysed with Poisson and Andersen–Gill models, respectively. Seasonality was analysed by month and five geographical regions were evaluated.ResultsThe studies included 10 815 patients (63% female, mean age 42–49 years). CompEx Asthma AER mirrored seasonal variations in SevEx AER. CompEx Asthma AERs were higher versus SevEx in BUD/FORM and benralizumab trials (range 2.7–4.5-fold and 1.3–2.0-fold increase, respectively) and were less variable versus SevEx between regions (ratios of greatest:smallest AERs: 1.36 for CompEx versus 2.28 for SevEx (BUD/FORM); 1.81 for CompEx versus 2.22 for SevEx (benralizumab)). Treatment effects for CompEx Asthma and SevEx were generally similar across regions and months. However, in Eastern Europe, where SevEx rates were lowest, treatment effect was greater with CompEx Asthma versus SevEx, reaching statistical significance in the benralizumab studies (HR (95% CI): 0.67 (0.53–0.85) versus 0.87 (0.65–1.15)).ConclusionThis study confirmed the reliability of CompEx Asthma as a rate end-point and allowed detection of variations in seasonal SevEx rates, reduction of variation in rates across regions and potential greater sensitivity to treatment effects.

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Lacouture, Mario E., Alexander Pan, George Dranitsaris, Ucalene Harris, Sarat Chandarlapaty, Chau T. Dang, Devika Gajria, et al. "Interim analysis of a single-center, single-arm, prospective phase 2 study to evaluate the efficacy and safety of benralizumab for alpelisib rash in metastatic PIK3CA-mutant, hormone receptor–positive breast cancer." Journal of Clinical Oncology 40, no. 16_suppl (June 1, 2022): 12100. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.12100.

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12100 Background: Rash associated with increased peripheral eosinophils develops in approximately 50% of metastatic breast cancer patients receiving alpelisib. Antihistamines and corticosteroids have limited benefit. Refractory rash may lead to decreased dose intensity and affect clinical outcome. Benralizumab is an anti-IL-5Rα chimeric monoclonal antibody that depletes peripheral eosinophils and has demonstrated benefit in eosinophilic asthma and hypereosinophilic syndrome. We investigate the efficacy and safety of benralizumab for the treatment of alpelisib rash. Methods: We performed a single-center, single-arm, prospective phase 2 study to evaluate the efficacy and safety of benralizumab in cancer patients who developed CTCAE grade 2/3 skin events resulting from immunotherapy or targeted therapies with absolute blood eosinophil counts of ≥300/mcl. While remaining on culprit drugs, patients were treated with benralizumab 30mg once every 4 weeks for the first 3 doses followed by once every 8 weeks for 3 additional doses (approved dosing for eosinophilic asthma). Primary endpoint was clinical response measured as reduction in CTCAE grade 2/3 skin event to grade ≤1 by week 4. Secondary endpoints were patient quality of life (QoL) measured by skindex16, safety data, need for supportive oral corticosteroids, and changes in cytokines and eosinophil biomarkers. This interim analysis focuses on patients with PIK3CA-mutant metastatic breast cancer receiving alpelisib. Results: Between September 16th 2020 and January 1st 2022, we enrolled 10 metastatic breast cancer patients with grade 2/3 rash attributed to alpelisib (5 pts with G3). All patients had a reduction of rash to grade ≤1 (n = 10, p < 0.0001), and a decrease in peripheral absolute eosinophils (mean 500/mcl to 0, p < 0.0001). Of these, 6 patients had been on prophylactic oral antihistamines and 2 had oral steroid coadministration. QoL significantly improved (Skindex16 mean score 58 to 16, p = 0.0001) and eosinophils in skin histology decreased per HPF (mean 6.25 to 0.25, n = 8, p = 0.2) by week 4. An increase in IL-5 > 600% and reduction IL-6 and TNF-α > 50% were reported by week 4 and 8. Grade 1/2 mucositis in 4 patients were reported as adverse events. Conclusions: Our findings suggest that benralizumab is safe and effective for the treatment of grade 2/3 rash with eosinophilia related to alpelisib in patients with breast cancer. A reduction in rash severity was evidenced in all patients, along with improved QoL. Larger controlled studies are in development to evaluate the efficacy of benralizumab for the prevention of alpelisib rash. Clinical trial information: NCT04552288.

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Lacouture, Mario E., Alexander Pan, George Dranitsaris, Ucalene Harris, Sarat Chandarlapaty, Chau T. Dang, Devika Gajria, et al. "Interim analysis of a single-center, single-arm, prospective phase 2 study to evaluate the efficacy and safety of benralizumab for alpelisib rash in metastatic PIK3CA-mutant, hormone receptor–positive breast cancer." Journal of Clinical Oncology 40, no. 16_suppl (June 1, 2022): 12100. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.12100.

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12100 Background: Rash associated with increased peripheral eosinophils develops in approximately 50% of metastatic breast cancer patients receiving alpelisib. Antihistamines and corticosteroids have limited benefit. Refractory rash may lead to decreased dose intensity and affect clinical outcome. Benralizumab is an anti-IL-5Rα chimeric monoclonal antibody that depletes peripheral eosinophils and has demonstrated benefit in eosinophilic asthma and hypereosinophilic syndrome. We investigate the efficacy and safety of benralizumab for the treatment of alpelisib rash. Methods: We performed a single-center, single-arm, prospective phase 2 study to evaluate the efficacy and safety of benralizumab in cancer patients who developed CTCAE grade 2/3 skin events resulting from immunotherapy or targeted therapies with absolute blood eosinophil counts of ≥300/mcl. While remaining on culprit drugs, patients were treated with benralizumab 30mg once every 4 weeks for the first 3 doses followed by once every 8 weeks for 3 additional doses (approved dosing for eosinophilic asthma). Primary endpoint was clinical response measured as reduction in CTCAE grade 2/3 skin event to grade ≤1 by week 4. Secondary endpoints were patient quality of life (QoL) measured by skindex16, safety data, need for supportive oral corticosteroids, and changes in cytokines and eosinophil biomarkers. This interim analysis focuses on patients with PIK3CA-mutant metastatic breast cancer receiving alpelisib. Results: Between September 16th 2020 and January 1st 2022, we enrolled 10 metastatic breast cancer patients with grade 2/3 rash attributed to alpelisib (5 pts with G3). All patients had a reduction of rash to grade ≤1 (n = 10, p < 0.0001), and a decrease in peripheral absolute eosinophils (mean 500/mcl to 0, p < 0.0001). Of these, 6 patients had been on prophylactic oral antihistamines and 2 had oral steroid coadministration. QoL significantly improved (Skindex16 mean score 58 to 16, p = 0.0001) and eosinophils in skin histology decreased per HPF (mean 6.25 to 0.25, n = 8, p = 0.2) by week 4. An increase in IL-5 > 600% and reduction IL-6 and TNF-α > 50% were reported by week 4 and 8. Grade 1/2 mucositis in 4 patients were reported as adverse events. Conclusions: Our findings suggest that benralizumab is safe and effective for the treatment of grade 2/3 rash with eosinophilia related to alpelisib in patients with breast cancer. A reduction in rash severity was evidenced in all patients, along with improved QoL. Larger controlled studies are in development to evaluate the efficacy of benralizumab for the prevention of alpelisib rash. Clinical trial information: NCT04552288.

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Krysanov, I. S., V. S. Krysanova, and V. Yu Ermakova. "Th e clinical-economic analysis of Dupilumab in severe asthma." Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice, no. 5 (February 14, 2021): 15–26. http://dx.doi.org/10.37489/2588-0519-2020-5-15-26.

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Background. Severe Asthma is a most social important chronic illness due to highest expenditures of Health Care System for control and treatment of exacerbations and decreasing of GDP. Situation with modern treatment is better now because biologic drugs have introduced into real practice. Biologic drugs — dupilumab, mepolizumab, reslizumab and benralizumab — decrease annual exacerbation rate of severe asthma as well as improve a lung function. Comparison of clinical-economic analyses of biologic drugs usage can help choose an optimal treatment technology of severe asthma. Materials and methods. Calculation of direct and indirect costs of treatment based of indirect treatment comparison of biologic drugs in severe asthma has been performed. Weighted average annual number of exacerbations prevention was chosen as efficacy criteria and their were for dupilumab 200 mg — 0,41, 0,26 for mepolizumab, 0,22 for reslizumab, 0,16 — for benralizumab. Cost-effective ratios were calculated, and sensitivity analysis has been performed for results confirmation. Results. Direct annual costs were less for dupilumab treatment — 834 970 RUR/ patient/year. Same costs for others biologicals were: for mepolizumab — 935 931 RUR, for reslizumab — 1 582 577 RUR/patient/ year, for benralizumab — 1 224 786 RUR/patient/year. Dupilumab has demonstrated less indirect costs in severe asthma patients. Disability is a major contributor of GDP loss. Total expenditures were higher in mepolizumab (on 11,3 %), in reslizumab (on 82,9 %), in benralizumab (on 43,4 %) in compare with the same parameter for dupilumab. Sensitivity analysis has confirmed a stability results calculated in different scenariois. Conclusion. Dupilumab 200 mg in severe asthma is an preference alternative in the treatment compare with other biologics because it has better efficacy and less annual costs.

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Miralles-López, Juan Carlos, Rubén Andújar-Espinosa, Francisco Javier Bravo-Gutiérrez, Manuel Castilla-Martínez, Isabel Flores-Martín, María Loreto Alemany-Francés, Manuel José Pajarón-Fernández, et al. "Analysis of response of severe eosinophilic asthmatic patients to benralizumab." Allergologia et Immunopathologia 50, no. 6 (November 1, 2022): 163–68. http://dx.doi.org/10.15586/aei.v50i6.704.

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Introduction: Clinical trials and real-life studies have been published showing effectiveness of benralizumab in severe eosinophilic asthmatic patients. The aim of the present study is to describe super-responders to benralizumab in a series of 79 patients who completed at least 1 year of treatment, and to compare super-responders with non super-responders. Methods: This is a multicenter study of the Register of Severe Asthma of the Region of Murcia (RE-ASGRAMUR) Group performed in eight hospitals under the conditions of routine clinical practice. Patients with zero exacerbations and no oral corticosteroid therapy for asthma were considered super-responders. We analyzed clinical, functional, and inflammatory parameters of selected patients.Results: In all, 50 of the 79 patients (63%) met the super-responder criteria. In addition, 36% of the patients (26/71) were considered as complete responders to treatment (superresponder + Asthma Control Test [ACT] ≥ 20 + forced expiratory volume in 1 s [FEV1] ≥ 80%). The super-responders were significantly older in age (P = 0.0029), had higher eosinophils count (P = 0.0423), higher proportion of nasal polyps (P = 0.036), and they had less severe disease at baseline. After 1 year of treatment, the super-responders had higher levels of ACT questionnaire (23 vs 19, P = 0.0007) and better percentage of FEV1 (83 vs 75, P = 0.0359). Conclusion: Almost two of the three patients treated with benralizumab were super-responders after 1 year of treatment and 36% had a complete response. Super-responders were associated with older age, higher eosinophils count, had nasal polyposis as comorbidity, and had less severe disease at baseline. This data illustrated the good real-life response of patients with severe eosinophilic asthma to the treatment with benralizumab.

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Shimizu, Hideyasu, Masamichi Hayashi, Hisayuki Kato, Mitsuru Nakagawa, Kazuyoshi Imaizumi, and Mitsushi Okazawa. "IL13 May Play an Important Role in Developing Eosinophilic Chronic Rhinosinusitis and Eosinophilic Otitis Media with Severe Asthma." International Journal of Molecular Sciences 22, no. 20 (October 18, 2021): 11209. http://dx.doi.org/10.3390/ijms222011209.

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A woman in her 50s was a super responder to benralizumab administered for the treatment of severe bronchial asthma (BA) with eosinophilic chronic rhinosinusitis with nasal polyp (ECRS) and eosinophilic otitis media (EOM). She exhibited the gradual exacerbation of ECRS/EOM despite good control of BA approximately 1 year after benralizumab initiation. Therefore, the treatment was switched to dupilumab, and the condition of the paranasal sinuses and middle ear greatly improved with the best control of her asthma. The patient reported that her physical condition was the best of her life. However, she developed a pulmonary opacity on chest computed tomography after 6 months. Histological examination of the lung parenchyma and cell differentiation of the bronchoalveolar lavage fluid indicated atypical chronic eosinophilic pneumonia, and treatment was switched to mepolizumab. Similarly to the period of benralizumab treatment, exacerbation of ECRS/EOM reduced her quality of life approximately 10 months after the administration of mepolizumab. Dupilumab was again introduced as a replacement for mepolizumab. The clinical course and consideration of the interaction between inflammatory cells led us to speculate that interleukin-13 could play a key role in the development of ECRS/EOM with severe BA.

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Laorden, Daniel, David Romero, and Javier Domínguez-Ortega. "Benralizumab in eosinophilic granulomatosis with polyangiitis." Medicina Clínica (English Edition) 158, no. 9 (May 2022): 441–42. http://dx.doi.org/10.1016/j.medcle.2021.07.018.

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Sugino, Keishi, Hirotaka Ono, Akira Hebisawa, and Eiyasu Tsuboi. "Eosinophilic bronchiolitis successfully treated with benralizumab." BMJ Case Reports 14, no. 10 (October 2021): e246058. http://dx.doi.org/10.1136/bcr-2021-246058.

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A 53-year-old non-smoking Japanese woman was admitted to our hospital with a 20-year history of wet cough and dyspnoea on exertion. Bronchial asthma (BA) had been diagnosed 20 years earlier. Although she has been treated with high-dose inhaled corticosteroid, she had experienced frequent exacerbation of BA, and short-term oral corticosteroid bursts were occasionally administered. High-resolution CT of the chest revealed diffuse centrilobular nodules with bronchial wall thickening and patchy ground-glass opacities in both lungs. Lung biopsy specimens showed widespread cellular bronchiolitis with follicle formations in the membranous and respiratory bronchioles, accompanied by marked infiltration of plasma cells and eosinophils. In addition, immunohistochemical immunoglobulin G4 (IgG4) staining revealed many IgG4-positive plasma cells, and the ratio of IgG4-positive cells to IgG-positive cells exceeded 40%. The final diagnosis was eosinophilic bronchiolitis with marked IgG4-positive plasma cell infiltration in association with BA. With benralizumab therapy, her clinical condition dramatically improved.

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Matera, M. G., P. Rogliani, L. Calzetta, G. W. Canonica, and M. Cazzola. "Benralizumab for the treatment of asthma." Drugs of Today 53, no. 12 (2017): 633. http://dx.doi.org/10.1358/dot.2017.53.12.2736670.

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Kuang, Fei Li, Fanny Legrand, Michelle Makiya, JeanAnne Ware, Lauren Wetzler, Thomas Brown, Tamika Magee, et al. "Benralizumab for PDGFRA-Negative Hypereosinophilic Syndrome." New England Journal of Medicine 380, no. 14 (April 4, 2019): 1336–46. http://dx.doi.org/10.1056/nejmoa1812185.

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Saco, Tara Vinyette, Amber N. Pepper, and Richard F. Lockey. "Benralizumab for the treatment of asthma." Expert Review of Clinical Immunology 13, no. 5 (April 19, 2017): 405–13. http://dx.doi.org/10.1080/1744666x.2017.1316194.

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Hussar, Daniel A., and Justin George. "Erenumab-aooe, Benralizumab, and Tezacaftor/ivacaftor." Journal of the American Pharmacists Association 58, no. 5 (September 2018): 579–82. http://dx.doi.org/10.1016/j.japh.2018.07.006.

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Griscti Soler, Daniel, Alessandra Bennici, Silvia Brunetto, Sebastiano Gangemi, and Luisa Ricciardi. "Benralizumab in the management of rare primary eosinophilic lung diseases." Allergy and Asthma Proceedings 43, no. 6 (November 1, 2022): 494–500. http://dx.doi.org/10.2500/aap.2022.43.220056.

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Background: Eosinophils have a double-edged role in the human body, being essential in important physiologic functions but whose presence is conspicuous in a variety of diseases characterized by a T2 inflammation phenotype. Eosinophils are exquisitely sensitive to corticosteroids, and the latter have, until recently, represented the cornerstone of treatment of eosinophilic diseases. However, most patients remain dependent on oral corticosteroids, with a notable adverse effect burden and experience a chronic relapsing disease that leads to high morbidity and mortality. Treatment prospects have changed with the advent of biologic drugs that target the eosinotropic cytokine interleukin (IL) 5 or its receptor. The success of the latter drugs in severe eosinophilic asthma has paved the way for their use in other, rarer, eosinophilic lung diseases. Recently, mepolizumab, a humanized monoclonal antibody that works against IL-5, was approved for the add-on treatment of relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA) in patients ages ≥ 6 years. Benralizumab, a humanized antibody that binds to the α portion of the IL-5 receptor, is also being tested for its efficacy in EGPA in two clinical trials, after a growing number of case reports and case series supported its use as a steroid-sparing agent in the treatment of EGPA. Methods: In this review, we summarized the scientific literature evaluating the efficacy of benralizumab treatment in patients afflicted with rare primary eosinophilic lung diseases. Results: The literature we found, largely case reports, reported that the use of benralizumab in EGPA, chronic eosinophilic pneumonia (CEP) and allergic bronchopulmonary aspergillosis (ABPA) often led to a depletion of eosinophils, less exacerbations and a decreased systemic corticosteroid burden. No adverse effects were reported. Conclusion: Benralizumab has a prospective role in the treatment of rare eosinophilic lung diseases, which needs to be further elucidated in randomized controlled trials.

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Wechsler, M., P. A. Merkel, S. Necander, L. Börjesson Sjö, E. A. Duncan, N. Makulova, G. D’angelo та ін. "AB0619 Rationale and Design of the 52-week, Randomized, Phase 3, Head-to-Head MANDARA Study to Evaluate the Efficacy and Safety of Benralizumab, a Humanized, Anti-interleukin–5 Receptor α Monoclonal Antibody in Refractory or Relapsing Eosinophilic Granulomatosis with Polyangiitis". Annals of the Rheumatic Diseases 81, Suppl 1 (23 травня 2022): 1435.2–1436. http://dx.doi.org/10.1136/annrheumdis-2022-eular.2075.

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BackgroundEosinophilic granulomatosis with polyangiitis (EGPA, formerly Churg-Strauss syndrome) is a rare, potentially organ- and life-threatening disease characterized by systemic eosinophilia, airway disease, and multi-system small-vessel vasculitis. Management of EGPA generally focuses on reducing active inflammation using corticosteroids and immunosuppressants, both of which are associated with serious adverse effects and incomplete disease control. High blood eosinophil (bEOS) levels are a central component of the pathophysiology of EGPA, and studies have shown that bEOS-reducing therapies, such as mepolizumab, are effective in some patients with EGPA. Benralizumab is a humanized, afucosylated, anti-interleukin-5 receptor α monoclonal antibody that induces direct, rapid, and near complete depletion of eosinophils through antibody-dependent cell-mediated cytotoxicity. Eosinophil depletion by benralizumab is effective in eosinophilic asthma, corticosteroid-dependent asthma, and has shown promise in a small phase 2 trial in hypereosinophilic syndrome, which has overlapping organ systems involvement and similar clinical features to EGPA. Collectively, the evidence from these indications supports examination of the efficacy of benralizumab as an eosinophil-depleting therapy in patients with EGPA.ObjectivesThe phase 3, head-to-head MANDARA (NCT04157348) study will evaluate the efficacy and safety of benralizumab versus mepolizumab in adults with relapsing or refractory EGPA.MethodsThis randomized (1:1), multicentre, double-blind (DB), active-controlled study is enrolling adults with a diagnosis of EGPA, defined as a history of asthma and eosinophilia together with ≥2 additional clinical features, a history of relapsing or refractory disease, and maintained on a stable prednisolone/prednisone dose ≥7.5 mg/day for ≥4 weeks prior to baseline. Patients will receive either benralizumab 30 mg or mepolizumab 300 mg every 4 weeks over the 52-week DB study period. Patients who complete the DB treatment period will be eligible to continue into an optional open-label extension, during which all patients will receive benralizumab (Figure 1). The primary endpoint is the proportion of patients who achieve EGPA remission, defined as a Birmingham Vasculitis Activity Score (BVAS)=0 and prednisolone dose of ≤4 mg/day, at both Week 36 and 48 of the DB period, and it will assess non-inferiority (NI) between benralizumab and mepolizumab. Secondary endpoints include duration of remission, time to first EGPA relapse, annualized relapse rate, average daily prednisolone dose between Weeks 48 to 52, and the proportion of patients who achieve and maintain remission from Week 24 through the end of the DB period. Other endpoints include safety, symptoms, health-related quality of life, healthcare utilization due to EGPA, and tolerability. The trial also includes a non-interventional patient interview sub-study, which will collect data related to patients’ EGPA personal experience and perceived impact on study treatment, and a mechanistic sub-study, which will explore the pharmacodynamic response and mechanism of action of benralizumab compared to mepolizumab.Figure 1.MANDARA Study DesignResultsThe study aims to enrol 140 patients which will provide ~90% power to demonstrate NI with a NI margin of -25% at the 2.5% one-sided significance level, assuming each treatment group has a remission rate of 32%. Screening started in Oct 2019 and the trial is ongoing.ConclusionMANDARA is one of few multicentre randomized trials conducted to date in EGPA. Results from this phase 3, head-to-head study will characterize the efficacy and safety of benralizumab compared with mepolizumab in adults with relapsing or refractory EGPA. The trial’s active comparator design will also provide critical evidence of efficacy and safety in a disease with considerable unmet needs.Disclosure of InterestsMichael Wechsler Speakers bureau: GlaxoSmithKline, AstraZeneca, Amgen, Sanofi, Regeneron, Novartis, Genentech, and Teva Pharmaceuticals, Grant/research support from: GlaxoSmithKline, AstraZeneca, Amgen, Sanofi, Regeneron, Novartis, Genentech, and Teva Pharmaceuticals, Peter A. Merkel Consultant of: AbbVie, AstraZeneca, Boeringher-Ingelheim, Bristol-Myers Squibb, ChemoCentryx, CSL Behring, Dynacure, EMDSerono, Forbius, Genentech/Roche, Genzyme/Sanofi, GlaxoSmithKline, InflaRx, Janssen, Kiniksa, Kyverna, Magenta, MiroBio, Neutrolis, Novartis, Pfizer, Sparrow, Takeda, Talaris, Grant/research support from: AbbVie, AstraZeneca, Boeringher-Ingelheim, Bristol-Myers Squibb, ChemoCentryx, Eicos, Forbius, Genentech/Roche, Genzyme/Sanofi, GlaxoSmithKline, InflaRx, Sanofi, Sofia Necander Shareholder of: AstraZeneca, Employee of: AstraZeneca, Lena Börjesson Sjö Shareholder of: AstraZeneca, Employee of: AstraZeneca, Elizabeth A. Duncan Shareholder of: AstraZeneca, Employee of: AstraZeneca, Natalya Makulova Shareholder of: AstraZeneca, Employee of: AstraZeneca, Gina D’Angelo Shareholder of: AstraZeneca, Employee of: AstraZeneca, Ron A. Chen Shareholder of: AstraZeneca, Employee of: AstraZeneca, Vivian H. Shih Shareholder of: AstraZeneca, Employee of: AstraZeneca, Rohit Katial Shareholder of: AstraZeneca, Employee of: AstraZeneca, Ubaldo J. Martin Shareholder of: AstraZeneca, Employee of: AstraZeneca

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Ignatova, G. L., V. N. Antonov, E. V. Blinova, I. V. Grebneva, and E. V. Sheklanova. "New therapy options for patients with eosinophilic type of severe bronchial asthma." Medical Council, no. 21 (January 28, 2020): 111–16. http://dx.doi.org/10.21518/2079-701x-2019-21-111-116.

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The article provides data on the epidemiology of severe asthma. It defines the phenotype and endotype of bronchial asthma and classifies BA according to phenotype/endotype. The features of the eosinophilic phenotype of severe bronchial asthma are considered. Clinical characteristics of the patient corresponding to the prescription of benralizumab are presented. The algorithm of decision making by a doctor-therapist about patients’ referral to a pulmonologist for consideration of the biological therapy issue is given. The results of the main clinical studies to assess the efficacy and safety of benralizumab in patients with severe eosinophilic bronchial asthma: SIROCCO, CALIMA, ZONDA, BORA are described. The experience of using various biological preparations for the treatment of severe asthma in Chelyabinsk and the Chelyabinsk Region has also been summarized.

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Leuppi, Jörg D., Peter Schmid-Grendelmeier, Thomas Rothe, Christophe von Garnier, Hans-Uwe Simon, Claudio Schuoler, Gunther Pendl, and Markus Solèr. "Benralizumab: Der IL-5-Rezeptor als Ziel bei schwerem eosinophilem Asthma." Praxis 108, no. 7 (May 2019): 469–76. http://dx.doi.org/10.1024/1661-8157/a003222.

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Zusammenfassung. Für Patienten mit schwierig kontrollierbarem, schwerem Asthma bronchiale stehen heute neben der inhalativen Medikation hochwirksame, gezielte Behandlungsmöglichkeiten zur Verfügung. Bei Vorliegen einer deutlichen Eosinophilie verspricht die Hemmung der Interleukin-5-Achse (IL‑5) mit spezifischen, monoklonalen Antikörpern eine wirksame und nebenwirkungsarme Alternative zur dauerhaften systemischen Steroidtherapie. In diesem Übersichtsartikel werden die Daten zu Benralizumab, einem spezifischen Antikörper gegen den IL-5-Rezeptor Alpha, zusammengefasst. Dieser Angriffspunkt verhindert die Rezeptorstimulation durch IL-5 und aktiviert eine NK-zellvermittelte zytotoxische Reaktion, die zur Apoptose der eosinophilen Granulozyten führt. Die s.c.-Applikation von Benralizumab führt innerhalb von Tagen zur nahezu vollständigen Depletion der Eosinophilen im Blut mit konsekutiver Verbesserung der Lungenfunktion und Stabilisierung des Asthmas. Für ausgewählte Patienten mit schwerem Asthma eröffnet sich hier eine vielversprechende Therapie-Option.

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Leuppi, Jörg D., Peter Schmid-Grendelmeier, Thomas Rothe, Christophe von Garnier, Hans-Uwe Simon, Claudio Schuoler, Gunther Pendl, and Markus Solèr. "Benralizumab: Cibler le récepteur de l’IL-5 dans l’asthme sévère éosinophile." Praxis 108, no. 7 (May 2019): 1–8. http://dx.doi.org/10.1024/1661-8157/a003250.

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Zusammenfassung. Für Patienten mit schwierig kontrollierbarem, schwerem Asthma bronchiale stehen heute neben der inhalativen Medikation hochwirksame, gezielte Behandlungsmöglichkeiten zur Verfügung. Bei Vorliegen einer deutlichen Eosinophilie verspricht die Hemmung der Interleukin-5-Achse (IL-5) mit spezifischen, monoklonalen Antikörpern eine wirksame und nebenwirkungsarme Alternative zur dauerhaften systemischen Steroidtherapie. In diesem Übersichtsartikel werden die Daten zu Benralizumab, einem spezifischen Antikörper gegen den IL-5-Rezeptor Alpha, zusammengefasst. Dieser Angriffspunkt verhindert die Rezeptorstimulation durch IL-5 und aktiviert eine NK-zellvermittelte zytotoxische Reaktion, die zur Apoptose der eosinophilen Granulozyten führt. Die s.c.-Applikation von Benralizumab führt innerhalb von Tagen zur nahezu vollständigen Depletion der Eosinophilen im Blut mit konsekutiver Verbesserung der Lungenfunktion und Stabilisierung des Asthmas. Für ausgewählte Patienten mit schwerem Asthma eröffnet sich hier eine vielversprechende Therapie-Option.

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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 (September 19, 2016): 534–48. http://dx.doi.org/10.1177/1753465816667659.

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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.

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Nolasco, Santi, Raffaele Campisi, Rossella Intravaia, Morena Porto, Corrado Pelaia, Nunzio Crimi, and Claudia Crimi. "Case Report: Acute effect of benralizumab on asthma exacerbation without concomitant corticosteroid use." F1000Research 9 (June 23, 2020): 637. http://dx.doi.org/10.12688/f1000research.24603.1.

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Background: Monoclonal antibodies are a relatively new therapeutic option for patients with severe refractory asthma, which can be used as an add-on to maintenance therapy, reducing the need for systemic corticosteroid usage, improving asthma symptom control and reducing exacerbations. We report a case of a patient with severe refractory eosinophilic asthma, reluctant to take systemic steroids, who was successfully treated with benralizumab alone during an acute asthma attack. Case presentation: A 59-year-old Caucasian woman with a history of allergic asthma since childhood showed a progressive decline in lung function with difficult to control symptoms and an increased number of hospitalizations despite maximal maintenance treatment, and was diagnosed with severe refractory asthma. She was reluctant to take systemic corticosteroids during exacerbations due to severe urinary retention; therefore, she started omalizumab with a partial reduction of symptoms and exacerbations over time. During a follow-up visit, she showed signs of acute exacerbation and she was switched to benralizumab during her acute phase with a rapid, dramatic amelioration of respiratory symptoms and pulmonary function, without concomitant systemic corticosteroid administration. During the treatment and at follow-up after one month, good tolerance and no side effects were observed. Conclusions: The use of benralizumab seems to be feasible, rapid, and safe in treating acute exacerbation of severe eosinophilic asthma without the use of systemic corticosteroids.

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Nolasco, Santi, Raffaele Campisi, Rossella Intravaia, Morena Porto, Corrado Pelaia, Nunzio Crimi, and Claudia Crimi. "Case Report: Acute effect of benralizumab on asthma exacerbation without concomitant corticosteroid use." F1000Research 9 (July 23, 2020): 637. http://dx.doi.org/10.12688/f1000research.24603.2.

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Background: Monoclonal antibodies are a relatively new therapeutic option for patients with severe refractory asthma, which can be used as an add-on to maintenance therapy, reducing the need for systemic corticosteroid usage, improving asthma symptom control and reducing exacerbations. We report a case of a patient with severe refractory eosinophilic asthma, reluctant to take systemic steroids, who was successfully treated with benralizumab alone during an acute asthma attack. Case presentation: A 59-year-old Caucasian woman with a history of allergic asthma since childhood showed a progressive decline in lung function with difficult to control symptoms and an increased number of hospitalizations despite maximal maintenance treatment, and was diagnosed with severe refractory asthma. She was reluctant to take systemic corticosteroids during exacerbations due to severe urinary retention; therefore, she started omalizumab with a partial reduction of symptoms and exacerbations over time. During a follow-up visit, she showed signs of acute exacerbation and she was switched to benralizumab during her acute phase with a rapid, dramatic amelioration of respiratory symptoms and pulmonary function, without concomitant systemic corticosteroid administration. During the treatment and at follow-up after one month, good tolerance and no side effects were observed. Conclusions: The use of benralizumab seems to be feasible, rapid, and safe in treating acute exacerbation of severe eosinophilic asthma without the use of systemic corticosteroids.

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Morimoto, Hiroki, Kensuke Fukuchi, Yasuaki Ogura, Masaki Ohtsuka, and Yoshiki Tokura. "Development of lichen planus following benralizumab treatment." European Journal of Dermatology 31, no. 2 (April 2021): 261–62. http://dx.doi.org/10.1684/ejd.2021.3995.

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Engler, D. "M271 SEVERE EOSINOPHILIC CYSTITIS CONTROLLED WITH BENRALIZUMAB." Annals of Allergy, Asthma & Immunology 127, no. 5 (November 2021): S122. http://dx.doi.org/10.1016/j.anai.2021.08.388.

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Cushen, Breda, and Andrew Menzies-Gow. "Benralizumab: an updated treatment of eosinophilic asthma." Expert Review of Respiratory Medicine 14, no. 5 (March 17, 2020): 435–44. http://dx.doi.org/10.1080/17476348.2020.1739526.

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Mishra, Ajay Kumar, Kamal Kant Sahu, and Atem James. "Disseminated herpes zoster following treatment with benralizumab." Clinical Respiratory Journal 13, no. 3 (February 17, 2019): 189–91. http://dx.doi.org/10.1111/crj.12998.

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Criner, Gerard J., Bartolome R. Celli, Christopher E. Brightling, Alvar Agusti, Alberto Papi, Dave Singh, Don D. Sin, et al. "Benralizumab for the Prevention of COPD Exacerbations." New England Journal of Medicine 381, no. 11 (September 12, 2019): 1023–34. http://dx.doi.org/10.1056/nejmoa1905248.

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Fabbri, Leonardo M. "Benralizumab: for asthma, not yet for COPD." Lancet Respiratory Medicine 2, no. 11 (November 2014): 862–63. http://dx.doi.org/10.1016/s2213-2600(14)70225-5.

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Dagher, Rania, Varsha Kumar, Alan M. Copenhaver, Sandra Gallagher, Mahboobe Ghaedi, Jonathan Boyd, Paul Newbold, Alison A. Humbles, and Roland Kolbeck. "Novel mechanisms of action contributing to Benralizumab's potent anti-eosinophilic activity." European Respiratory Journal, July 21, 2021, 2004306. http://dx.doi.org/10.1183/13993003.04306-2020.

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Benralizumab is a humanised, anti-IL-5Rα monoclonal antibody with anti-eosinophilic activity. Lack of fucose (afucosylation) increases its affinity to CD16a and significantly enhances antibody-dependent cell-mediated cytotoxicity (ADCC) by NK cells. Although benralizumab proved clinically efficacious in clinical trials for patients with severe asthma and hypereosinophilic syndrome, in-depth characterisation of its anti-eosinophilic mechanisms of action remain elusive. Here, we further investigated the mechanisms involved in benralizumab's anti-eosinophilic activities. In the presence of NK cells benralizumab induced potent eosinophil apoptosis as demonstrated by the upstream induction of caspase 3/7 and upregulation of cytochrome C. In addition, we uncovered a previously unrecognised mechanism whereby benralizumab can induce eosinophil phagocytosis/efferocytosis by macrophages, a process called antibody-dependent cell phagocytosis (ADCP). Using live cell imaging we unravel the stepwise processes leading to eosinophil apoptosis and uptake by activated macrophages. Through careful observations of cellular co-culture assays we identified a novel role for macrophage derived TNF to further enhance benralizumab-mediated eosinophil apoptosis through activation of TNF-receptor 1 on eosinophils. TNF-induced eosinophil apoptosis was associated with Cytochrome C upregulation, mitochondrial membrane depolarisation, and increased caspase 3/7 activity. Moreover, activated NK cells were found to amplify this axis through the secretion of IFNγ, subsequently driving TNF expression by macrophages. Our data provide insights into the timely appearance of events leading to benralizumab-induced eosinophil apoptosis and suggest that additional mechanisms may contribute to the potent anti-eosinophilic activity of benralizumab in vivo. Importantly, afucosylation of benralizumab strongly enhanced its potency for all mechanisms investigated.

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"Benralizumab." Reactions Weekly 1914, no. 1 (July 2022): 126. http://dx.doi.org/10.1007/s40278-022-18712-0.

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"Benralizumab." Reactions Weekly 1895, no. 1 (February 2022): 95. http://dx.doi.org/10.1007/s40278-022-10520-1.

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