scholarly journals Real-life cost-effectiveness of benralizumab in patients with severe asthma

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
A. Padilla-Galo ◽  
A. J. García-Ruiz ◽  
R. Ch. Levy Abitbol ◽  
C. Olveira ◽  
F. Rivas-Ruiz ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Asthma Control ◽  
Severe Asthma ◽  
Health Economic Evaluation ◽  
Real Life ◽  
Cost Effective ◽  
Total Annual Cost ◽  
Eosinophilic Asthma ◽  
Point Increase ◽  
Act Score

Abstract Background Availability of clinically effective and cost-effective treatments for severe asthma would be beneficial to patients and national healthcare systems. The aim of this study was to evaluate clinical outcomes and healthcare expenditure after incorporating benralizumab into the standard treatment of refractory eosinophilic asthma. Methods This was a cross-sectional multicentre study of consecutive patients with refractory eosinophilic asthma who received treatment with benralizumab during at least 12 months. Patient follow-up was performed in specialised severe asthma units. The main effectiveness parameters measured were: the avoidance of one asthma exacerbation, a 3-point increase in the asthma control test (ACT) score, and the difference in utility scores (health-related quality of life) between a 1-year baseline treatment and 1-year benralizumab treatment. The health economic evaluation included direct costs and incremental cost-effectiveness ratios (ICERs). Results After 1 year of treatment with benralizumab, patients with refractory eosinophilic asthma showed an improvement in all the effectiveness parameters analysed: improvement of asthma control and lung function, and decrease in the number of exacerbations, oral corticosteroid (both as corticosteroid courses and maintenance therapy), and inhaled corticosteroid use. The total annual cost per patient for the baseline and benralizumab treatment periods were €11,544 and €14,043, respectively, reflecting an increase in costs due to the price of the biological agent but a decrease in costs for the remaining parameters. The ICER was €602 per avoided exacerbation and €983.86 for every 3-point increase in the ACT score. Conclusions All the pharmacoeconomic parameters analysed show that treatment with benralizumab is a cost-effective option as an add-on therapy in patients with refractory eosinophilic asthma.

scholarly journals Effectiveness of Benralizumab in Improving the Quality of Life of Severe Eosinophilic Asthmatic Patients: Our Real-Life Experience

2021 ◽  
Vol 12 ◽  
Author(s):  
Giulia Scioscia ◽  
Giovanna Elisiana Carpagnano ◽  
Carla Maria Irene Quarato ◽  
Donato Lacedonia ◽  
Sonia Santamaria ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Function ◽  
Asthma Control ◽  
Severe Asthma ◽  
Life Experience ◽  
Real Life ◽  
Eosinophilic Inflammation ◽  
Eosinophilic Asthma ◽  
Severe Eosinophilic Asthma

Background: Severe eosinophilic asthma decreases lung function and causes worsen symptoms, often forcing recurrent maintenance corticosteroid use. The aim of our real-life study was to evaluate the effectiveness of an add-on treatment with benralizumab in patients with severe eosinophilic asthma, paying particular attention to the impact on their quality of life (QoL).Materials and methods: In this prospective study, 10 outpatients with severe eosinophilic asthma were added-on with benralizumab and followed-up in our severe asthma clinic after 12 and 24 weeks. At each patient visit, pre-bronchodilator FEV1 and inflammatory markers were recorded. Variations in asthma symptoms control and QoL perception was assessed by validated questionnaires.Results: All the subjects experienced a marked reduction of nocturnal and diurnal symptoms over time and were able to stop using OCS, as documented by the improvement in Asthma control test (ACT) and Asthma Control Questionnaire score. Similarly, we recorded a statistically significant increase in patient’s QoL perception in EQ-VAS, EQ-5D-3L and Asthma Quality of Life Questionnaire (AQLQ) assessment (p < 0.05). Simultaneously we recorded a significant reduction in eosinophilic inflammation, an improvement in pre-bronchodilator FEV1. These results appear to be in line with those already obtained in the previous randomized controlled trials (RCTs).Conclusion: Our 24-weeks real life experience supports the effectiveness of an add-on treatment with benralizumab in reducing eosinophilic inflammation and OCS-use, increasing lung function and improving control of nocturnal and diurnal symptoms, as well as restoring severe asthma patients to a better QoL.

Mepolizumab Is an Effective Option in Severe Eosinophilic Asthma Regardless of Baseline Features: Single-Center Real-Life Data

2021 ◽  
pp. 1-13
Author(s):  
Betül Özdel Öztürk ◽  
Zeynep Yavuz ◽  
Dilek Eraslan ◽  
Dilşad Mungan ◽  
Yavuz Selim Demirel ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Real Life ◽  
Blood Eosinophil ◽  
Life Questionnaire ◽  
Eosinophilic Asthma ◽  
Quality Of Life Questionnaire ◽  
Severe Eosinophilic Asthma ◽  
Median Dosage ◽  
Act Score

<b><i>Background:</i></b> Mepolizumab has been approved as a treatment option for severe eosinophilic asthma (SEA) patients in our country. We aimed to evaluate the clinical and functional efficacy of mepolizumab in this group of patients in real life as well as the response rates to mepolizumab and the possible factors affecting the response. <b><i>Methods:</i></b> The study was a retrospective chart review of patients with SEA treated with mepolizumab. The data were collected at baseline, and at the 6th and 12th month. <b><i>Results:</i></b> A total of 62 patients (41F/21M) with a mean age of 44.41 ± 13.24 years were included in the study. They had poor symptom control with a mean asthma control test (ACT) score of 16.61 ± 5.59, frequent exacerbations with a mean of 3.4 ± 3.7 in the previous 12 months, and 80.6% required daily oral corticosteroid (OCS) with a median dosage of 8 mg/day as methylprednisolone. The ACT score increased to 22.47 ± 3.18 and 22.03 ± 4.31, respectively, and blood eosinophil count decreased from 1,146/μL to 89/μL and 85/μL at the 6th and 12th month, respectively. The mean FEV1 at baseline was 2.102 L there was an increase of 0.373 L at 6th month and 0.596 L at 12th month. The percentage of regular users of OCS decreased to 66.0% at 6th month with a median dosage of 4 mg and 52.6% at 12th month with a median dosage of 2 mg. Mepolizumab reduced the rate of exacerbations compared with the previous year from a mean of 3.40 to 0.15 at 6th month and 0.36 at 12th month. There was a significant improvement in Asthma Quality of Life Questionnaire (AQLQ), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and Sino-nasal Outcome Test (SNOT-22) scores at both of time points. The rate of responders and super-responders at 6th month was 60% and 28%, respectively, and consequently, the overall response rate was 88%. At the 12th month, the super-responder rate increased to 44.7% as well as the overall response to 89.4%. The only difference between the nonresponders, responders, and super-responders at the 6th and 12th month was whether regular daily OCS was used pre-mepolizumab. All nonresponders at both 6th and 12th month were using OCS regularly, whereas most of super-responder used the OCS only during exacerbations. <b><i>Conclusion:</i></b> Mepolizumab effectively reduced asthma exacerbations, steroid requirement, blood eosinophil counts and improved asthma control, pulmonary function, sinonasal symptoms and quality of life. Our data suggest that mepolizumab would be effective in selected patients in real-life settings.

Biologics for oral corticosteroid-dependent asthma

2020 ◽  
Vol 41 (3) ◽  
pp. 151-157
Author(s):  
İnsu Yılmaz
Keyword(s):  
Severe Asthma ◽  
Oral Corticosteroid ◽  
Real Life ◽  
Severe Atopic Dermatitis ◽  
Double Blind ◽  
Eosinophilic Asthma ◽  
Asthma Phenotype ◽  
Severe Eosinophilic Asthma ◽  
Term Administration

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.

scholarly journals Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE Trial

2019 ◽  
Vol 5 (3) ◽  
pp. 00009-2019 ◽  
Author(s):  
Andrew Menzies-Gow ◽  
Jonathan Corren ◽  
Elisabeth H. Bel ◽  
Jorge Maspero ◽  
Liam G. Heaney ◽  
...  
Keyword(s):  
Adrenal Insufficiency ◽  
Asthma Control ◽  
Severe Asthma ◽  
Maintenance Phase ◽  
Phase Iii ◽  
Eosinophilic Asthma ◽  
Interleukin 5 ◽  
Severe Eosinophilic Asthma ◽  
Link Type ◽  
Related Quality

Benralizumab is an interleukin-5 receptor α-directed cytolytic monoclonal antibody approved in several countries for the add-on maintenance treatment of patients with severe eosinophilic asthma aged 12 years and older. In the 28-week Phase III ZONDA trial (ClinicalTrials.gov identifier: NCT02075255), benralizumab produced a median 75% reduction from baseline in oral corticosteroid (OCS) dosage (versus 25% for placebo) while maintaining asthma control for patients with OCS-dependent severe asthma. This manuscript presents the detailed protocol for the Phase IIIb PONENTE (ClinicalTrials.gov identifier: NCT03557307), a study that will build on the findings from ZONDA.As the largest steroid-sparing study undertaken in severe asthma, PONENTE has a faster steroid tapering schedule for prednisone dosages ≥7.5 mg·day−1 than previous studies, and it includes an evaluation of adrenal insufficiency and an algorithm to taper OCS dosage when prednisone dosage is ≤5 mg·day−1. It also has a longer maintenance phase to assess asthma control for up to 6 months after completion of OCS tapering.The two primary endpoints are whether patients achieve 100% reduction in daily OCS use and whether patients achieve 100% reduction in daily OCS or achieve OCS dosage ≤5 mg·day−1, if adrenal insufficiency prevented further reduction, both sustained over ≥4 weeks without worsening of asthma. Safety and change from baseline in health-related quality of life will also be assessed.PONENTE should provide valuable guidance for clinicians on tapering OCS dosage, including the management of adrenal insufficiency, following benralizumab initiation for the treatment of patients who are OCS-dependent with severe, uncontrolled eosinophilic asthma.

scholarly journals The Cost-Effectiveness of Continuous Erythropoiesis Receptor Activator Once Monthly versus Epoetin Thrice Weekly for Anaemia Management in Chronic Haemodialysis Patients

Anemia ◽  
2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Omar Maoujoud ◽  
Samir Ahid ◽  
Hocein Dkhissi ◽  
Zouhair Oualim ◽  
Yahia Cherrah
Keyword(s):  
Cost Effectiveness ◽  
Health Economic Evaluation ◽  
Cost Effective ◽  
Erythropoietin Receptor ◽  
Chronic Haemodialysis ◽  
Period 2 ◽  
Receptor Activator ◽  
Anaemia Management ◽  
One Year ◽  
The Cost

Introduction. The aim of this study was to compare the cost-effectiveness of continuous erythropoietin receptor activator (CERA) once monthly to epoetin beta (EpoB) thrice weekly to maintain haemoglobin (Hb) within the range 10.5–12 g/dL.Methods. Prospective cohort study and cost-effectiveness analysis. Chronic haemodialysis patients (CHP), being treated with EpoB, were selected for two periods of follow-up: period 1, maintaining prior treatment with EpoB, and period 2, conversion to CERA once monthly. Hb concentrations and costs were measured monthly. Health care payer perspective for one year was adopted.Results. 75 CHP completed the study, with a mean age of52.9±14.3years. Baseline Hb was11.14±1.18 g/dL in EpoB phase and11.46±0.79 g/dL in CERA phase; we observed a significant increase in the proportion of patients successfully treated (Hb within the recommended range), 65.3% versus 70.7%,p: 0.008, and in the average effectiveness by 4% (0.55 versus 0.59). Average cost-effectiveness ratios were 6013.86 and 5173.64$, with an ICER CERA to EpoB at −6457.5$.Conclusion. Our health economic evaluation of ESA use in haemodialysis patients suggests that the use of CERA is cost-effective compared with EpoB.

scholarly journals Duration of the efficacy of omalizumab after treatment discontinuation in ‘real life’ severe asthma

Thorax ◽  
2017 ◽  
Vol 73 (8) ◽  
pp. 782-784 ◽  
Author(s):  
Maria del Carmen Vennera ◽  
Carlos Sabadell ◽  
Cesar Picado
Keyword(s):  
Prospective Study ◽  
Asthma Control ◽  
Severe Asthma ◽  
Asthma Exacerbation ◽  
Real Life ◽  
First Year ◽  
Severe Asthma Exacerbation ◽  
Optimal Duration ◽  
Open Prospective Study

Efficacy of omalizumab in severe asthma is well documented; however, the optimal duration of the treatment remains unclear. In an open prospective study, we sought to assess the persistence of response in subjects withdrawing from omalizumab treatment. We evaluated 49 patients who voluntarily accepted to discontinue omalizumab treatment after 6 years of therapy. Asthma relapse was defined as any severe asthma exacerbation associated with loss of asthma control. Twelve patients relapsed in the first year of follow-up, and 7 within 13 and 48 months. These results suggest that the effects of 6 years of omalizumab may persist after discontinuation of therapy in 60% of patients for at least 4 years.

scholarly journals The Benefit of Benralizumab Monoclonal Antibody Treatment for Severe Eosinophilic Asthma in a Case Series (Pulmonology Clinic Târgu Mureș, Romania)

2021 ◽  
Vol 6 (3) ◽  
pp. 157-161
Author(s):  
Nimród László ◽  
Hédy Katalin Sárközy ◽  
Cristina Alexandra Man ◽  
Edith Simona Ianoși ◽  
Botond Mátyás ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Asthma Control ◽  
Symptom Control ◽  
Real Life ◽  
Case Series ◽  
High Dose ◽  
Antibody Treatment ◽  
Eosinophilic Asthma ◽  
Severe Eosinophilic Asthma ◽  
Eosinophil Counts

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.

scholarly journals Asthma Control during COVID-19 Lockdown in Patients with Severe Asthma under Biological Drug Treatment

2021 ◽  
Vol 11 (24) ◽  
pp. 12089
Author(s):  
Corrado Pelaia ◽  
Alessandro Casarella ◽  
Gianmarco Marcianò ◽  
Lucia Muraca ◽  
Vincenzo Rania ◽  
...  
Keyword(s):  
Asthma Control ◽  
Severe Asthma ◽  
Health Facilities ◽  
Biological Therapies ◽  
Biological Drugs ◽  
Exacerbation Rate ◽  
Severe Asthmatic ◽  
Access To Health ◽  
The Mean ◽  
Act Score

Introduction: Coronavirus disease 2019 (COVID-19) has deeply affected the management of patients with severe asthma, treated with add-on biological therapies. Objective: In this study, severe asthmatic patients on treatment with one of three different biologics (omalizumab, mepolizumab, benralizumab) underwent a survey to evaluate the effects of COVID-19 on the management of their clinical condition, with regard to the changes caused by the limited access to health facilities during the pandemic period. Methods: In this prospective observational study, 28 severe asthmatic outpatients referring to the Respiratory Unit of Magna Graecia University Hospital, Catanzaro (Italy), were asked to answer a telephone survey from May to July 2021. This survey included the evaluation of demographic and clinical data, as well as the number of lung function tests performed, exacerbations, biologic doses administered at hospital, or at general practitioner office, or through self-administration. Adherence to biological therapies before and during the pandemic period was also assessed. Moreover, the most recent asthma control test (ACT) score and the last forced expiratory volume in the first second (FEV1) measurement, recorded during the pandemic phase, were compared to the pre-pandemic (baseline) period. Results: When comparing the pre-pandemic data with the pandemic observations, the mean ACT score and the exacerbation rate did not significantly change [ACT, 21.5 ± 2.8 to 23.0 ± 3.9 (p = 0.1); exacerbation rate, 0.3 ± 0.6 and 0.5 ± 1.5 (p = 0.3)]. When considering some variables related to disease management in the same periods, a statistically significant difference was detected with regard to the mean number of outpatient visits (5.2 ± 3.8 vs. 0.9 ± 2.5, p < 0.0001), as well as to the mean number of accesses to health facilities for the administration of biological drugs (from 7.0 ± 3.4 to 2.5 ± 3.9, p < 0.0001). None of the patients reported to have been infected with the SARS-CoV-2 virus and no adverse drug reactions (ADR) occurred during the study. Conclusions: The above results suggest that COVID-19 pandemic did not induce any significant change related to severe asthma control. Indeed, add-on treatment with biological drugs was regularly continued, despite the obvious limited access to health facilities.

scholarly journals Switching from omalizumab to mepolizumab: real-life experience from Southern Italy

2020 ◽  
Vol 14 ◽  
pp. 175346662092923 ◽  
Author(s):  
Giovanna Elisiana Carpagnano ◽  
Corrado Pelaia ◽  
Maria D’Amato ◽  
Nunzio Crimi ◽  
Nicola Scichilone ◽  
...  
Keyword(s):  
Allergic Asthma ◽  
Severe Asthma ◽  
Southern Italy ◽  
Life Experience ◽  
Real Life ◽  
Forced Expiratory Volume ◽  
Asthma Control Test ◽  
Eosinophilic Asthma ◽  
Life Study ◽  
First Choice

Background: Current availability of several biologic treatments for severe asthma makes it possible to choose the most appropriate for each patient. Sometimes a good percentage of patients with severe asthma may be eligible for biologics that target either the allergic phenotype or the eosinophilic one, but not all respond to that selected as first choice. The aim of our real-life study was to assess whether, for patients with severe eosinophilic allergic asthma, not previously controlled by the anti-IgE omalizumab, the shift to another biologic targeting interleukin-5, such as mepolizumab, may represent a good therapeutic choice. Methods: A total of 41 consecutive patients with severe, persistent allergic, eosinophilic asthma, uncontrolled despite treatment with omalizumab, were enrolled in seven certified Clinical Respiratory Units of Southern Italy (Catania, Catanzaro, Foggia, Bari, Palermo, and two University Respiratory Units of Naples) and shifted to mepolizumab without a wash-out period. Data at baseline, after at least 12 months of therapy with omalizumab, and after at least 12 months of treatment with mepolizumab were collected. Results: After at least 12 months of therapy with mepolizumab, patients experienced a significant decrease in the number of exacerbations/year (5.8 ± 1.8 versus 0.7 ± 0.9, p < 0.0001), an increment of asthma control test score (12 ± 2.7 versus 21.9 ± 2.7, p < 0.0001), an increase in pre-bronchodilator forced expiratory volume in 1 s (1.56 ± 0.45 l versus 1.86 ± 0.52 l, p < 0.0001), and a reduction of blood eosinophils (584 ± 196 cells/µl versus 82 ± 56 cells/µl, p < 0.0001). The percentage of patients who were dependent on corticosteroids significantly decreased from 46% at baseline to 5% during treatment with mepolizumab. Conclusion: Results of our real-life multicentric experience confirms that the shift to mepolizumab could be a good therapeutic strategy in severe eosinophilic allergic asthma not previously controlled by omalizumab. The reviews of this paper are available via the supplemental material section.

Cost-effectiveness of a health care provider-directed intervention to promote colorectal cancer screening

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6583-6583
Author(s):  
V. Shankaran ◽  
T. H. Luu ◽  
N. Nonzee ◽  
J. M. McKoy ◽  
J. G. Zivin ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Academic Detailing ◽  
Intervention Delivery ◽  
Crc Screening ◽  
Percentage Point Increase ◽  
Delivery Costs ◽  
Point Increase ◽  
The Cost

6583 Background: Colorectal cancer (CRC) screening remains underutilized. Prior studies reported the cost-effectiveness of interventions to improve CRC screening, but none have been replicated in the setting of small medical practices. We recently conducted a randomized trial of an academic detailing strategy within 264 small physician offices in New York City. The objective of this analysis is to assess the cost-effectiveness of this intervention. Methods: 264 physician offices were randomized to usual care or to a series of ‘academic detailing’ visits from health educators trained in evidence-based CRC screening guidelines. CRC screening rates were measured at baseline and 12 months. Intervention-related costs were categorized as fixed or intervention delivery costs. The incremental cost effectiveness ratio (ICER) was expressed as cost per percentage point increase in CRC screening. Each practice contained an average of 4 physicians. Sensitivity analyses were estimated by varying the number of physicians per practice and accordingly, intervention delivery costs. Results: Academic detailing resulted in a 7% increase in CRC screening with colonoscopy. The cost of the intervention was $147,865. The ICER was $21,124 per percentage point increase in CRC screening. Sensitivity analyses that varied the intervention delivery costs by the average medical practice size were associated with ICERs ranging from $13,361 (8 physicians/office) to $36,109 (2 physicians/office) per percentage point increase in CRC screening rates. Conclusions: A multi-component academic detailing intervention conducted in small urban practices was clinically effective, but was not cost-effective when compared to other reported low-intensity patient-directed and infrastructural interventions ($131-$1,161 per percentage increase in CRC screening). (Table) While academic detailing may be more cost-effective in physician practices of larger size, new cost-effective approaches in small community practices are needed. [Table: see text] No significant financial relationships to disclose.

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