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Asma eosinofílica greu; Comparació indirecta del tractament; Mepolizumab Severe eosinophilic asthma; Indirect treatment comparison; Mepolizumab Asma eosinofílica severa; Comparación de tratamiento indirecto; Mepolizumab Aim To analyse the cost-effectiveness of MEP with standard of care (SoC) versus other anti-IL-5 therapies approved for the treatment of severe eosinophilic asthma (SEA) patients, within the Spanish National Health System (NHS) perspective. Methods A Markov model with a 4-week cycle length was used to compare MEP with BEN and RES as therapies added to SoC in the management of SEA, in terms of cost per QALY gained and incremental cost-effectiveness ratio (ICER). Costs (€2019) were obtained from public sources, while utilities and transition probabilities were retrieved from literature, e.g. network meta-analysis. Continuation criteria for biological treatment and reduction of oral corticosteroids (OCS) was set at 50% minimum reduction of exacerbation rate. Adverse events related to chronic OCS use included diabetes, osteoporosis, cataracts, acute myocardial infarct, and peptic ulcer. The analysis was performed over a 5-year time horizon from the National Healthcare System (NHCS) perspective, with a yearly discount rate of 3% applied to both costs and QALYs. Probabilistic sensitivity analysis and univariate deterministic sensitivity analysis were performed to address uncertainty around the cost-effectiveness results. Results On top of SoC, the model indicates that MEP is dominant (lower cost, higher benefit) compared to BEN and RES: For BEN and RES, respectively, treatment with MEP had a point estimate of 0.076 and 0.075 additional QALYs, and savings of €3,173.47 and €7,772.95 per patient. The findings were robust to variation as estimated using sensitivity analysis. Conclusions MEP is a cost-effective treatment in comparison with BEN and RES added to SoC for patients with SEA in the Spanish setting. This study was funded by GlaxoSmithKline [Study code: HO-19-19968].

Anti-interleukin 5 (IL-5) and anti-IL-5 receptor α monoclonal antibodies markedly decrease airway and peripheral blood eosinophil numbers and are thus highly effective in reducing asthma exacerbations. Nonetheless, these biologics do not completely resolve exacerbations. There is very little information on the cellular nature of exacerbations during treatment with biologics. Using illustrative clinical case scenarios, we highlight the importance of carefully characterizing asthmatics at the time of exacerbation and recognizing neutrophilic causes of exacerbations to ensure optimal management. While an eosinophilic exacerbation may improve with more corticosteroids or by switching to another anti-IL-5 monoclonal antibody, a noneosinophilic exacerbation will likely not. An infective exacerbation needs to be recognized, and the pathogen must be identified and treated with the appropriate antimicrobial agent.

Background Allergic Fungal Rhinosinusitis (AFRS) is a non-invasive fungal disease that results from chronic allergic inflammation of the sinonasal mucosa. Failure to respond to mainstay medical therapies and sinus surgery leaves AFRS patients with limited alternatives and a decreased quality of life. Mepolizumab is a known IL-5 antagonist for patients with severe eosinophilic asthma. Objective To identify the efficacy of mepolizumab on improving Modified Lund-Kennedy (MLK) endoscopic scores in recalcitrant AFRS patients with asthma. Methods Retrospective chart review of 27 recalcitrant AFRS patients with asthma receiving a monthly mepolizumab injection between January 2017 and July 2019. Patients were evaluated endoscopically at baseline and at each follow-up visit every 6–8 weeks until their third visit. Secondary outcomes included SNOT-22 scores, serum eosinophil counts and the rate of prednisone rescues required in patients receiving mepolizumab compared to a retrospective control arm. Results Total median MLK scores improved significantly for all patients over three follow-up visits (6[4,7], 4[2,6], 5[2,6], 3.5[2.25,5]; p = 0.04). Amongst patients with a baseline polyposis score of 1 or more, combined MLK edema and polyposis sub-scores significantly improved (6[5.25,6], 3.5[2.25,5,75], 4[2.75,5.25], 4[3,4]; p = 0.02) versus patients with no polyposis (4[3,4], 3[1,4], 4[2,4], 3[0,4]; p = 0.90). Total SNOT-22 scores (56 vs 43; p = 0.04) and eosinophil counts (0.40 × 109/L vs 0.00 × 109/L; p Conclusion Mepolizumab injections administered once monthly as an adjunctive treatment for recalcitrant AFRS patients with asthma appear to significantly reduce endoscopic signs of inflammation, patient-reported symptomatology and serum eosinophil levels. Patients with evidence of more severe endoscopic inflammation appear to benefit the most. Adjunctive treatment with mepolizumab does not reduce the need for prednisone rescues.

Asthma exhibits marked heterogeneity in symptoms with severe or refractory asthma representing a clear area of unmet medical need. These patients require more specifically targeted treatments with monoclonal antibody-based biologics targeted at inhibition of the type 2 cytokines IL-4, IL-5 and IL-13 having considerable potential as effective treatments for severe asthma. For the most part, anti-cytokine-based biologic therapies are more likely to give significant clinical benefit in carefully selected patient populations that take asthma phenotypes and endotypes into account.This review is based on recent English-language original articles in Pub Med or MedLine that reported significant clinical findings on the current status, therapeutic potential and safety of the anti-IL-5 biologics mepolizumab, reslizumab and benralizumab in the treatment of severe refractory asthma.Anti-IL-5 treatment appears effective in patients with eosinophilic asthma through exacerbation prevention with accumulating evidence of glucocorticoid-sparing effects with an acceptable safety profile for these biologics.

Improved knowledge about the pathogenesis of asthma has facilitated the development of novel drugs and provided hope for patients with severe asthma. After the short- and long-term success of omalizumab in severe allergic phenotype, researchers have targeted patients with severe eosinophilic asthma who comprise up to 45% of adult severe asthma. Interleukin (IL)-5 and IL-5 receptor subunit α play crucial roles in the development, maturation, and operation of eosinophils. Currently, patients treated with anti-IL-5 biologicals depleting eosinophils experience the positive efficacy of these drugs, especially with regard to the reduction of exacerbation rate. The aim of this review was to shed light on severe eosinophilic asthma treatment with these new currently available agents selectively targeting IL-5 or its receptor, discussing their usage including pre-treatment concerns, such as selecting the target population and choosing the right agent among them, and subsequent assessment of relevant effect and safety issues.

The interleukin 5 (IL-5) pathway is an important component in the pathophysiology of severe eosinophilic asthma. Mepolizumab is a monoclonal antibody that targets the IL-5 pathway. Clinical trials showed efficacy of Mepolizumab in patients with severe eosinophilic asthma. However, reports on experience with treatment in a real-world cohort are limited.Evaluation of the efficacy and safety of Mepolizumab for treatment of severe eosinophilic asthma in a real-world cohort of patients.A clinical prospective observational trial included all patients18 years treated with Mepolizumab between March 2016 to March 2019 at Rabin Medical Center. The composite primary outcome measures evaluated: increase in FEV1 by≥ 200 ml and/or decrease in exacerbation rate of ≥50% and/or cessation of oral corticosteroids (OCS) treatment or ≥50% decrease in dosage. Also evaluated: blood eosinophil count, adverse events and quality of life.Of 61 patients, 50 (82.0%) achieved the primary outcome. The number of patients who suffered from frequent exacerbations decreased from 52 (85.2%) to 8 (13.1%) (Treatment with mepolizumab was well tolerated and significantly lowered the exacerbation rate and OCS dependence in a real-world cohort of severe eosinophilic asthma patients. Response to therapy was within six months and treatment effect was sustained over time.

Introduction A significant proportion of adult patients with severe eosinophilic asthma (SEA) have evidence of both atopic and eosinophilic airways inflammation and meet eligibility criteria for all 4 NICE-approved biologic therapies. In the absence of randomised head-to-head studies comparing omalizumab and an anti-IL5/5R therapy, physicians lack a robust evidence base for choosing between these two classes of treatment. To date there are no real-world effectiveness data reporting clinical outcomes of mepolizumab and benralizumab in patients also eligible for omalizumab. Methods We retrospectively assessed all SEA patients at our tertiary asthma centre treated with either mepolizumab or benralizumab for a minimum of 24 weeks. Eligibility criteria for omalizumab, including whether patients could be dosed adequately based on weight and IgE levels, were recorded. Clinical outcomes at 24 weeks were compared between patients eligible and ineligible for omalizumab. Results One hundred and fifty-seven patients (46.7% female, mean age 51.7±14.3, 58.9% atopic) treated with either mepolizumab or benralizumab for at least 24 weeks were included in this analysis. 65/157 (41.4%) would have also been eligible for omalizumab at the time of biologic initiation. No baseline differences in blood eosinophils, total IgE, FeNO, FEV1, ACQ6, mAQLQ, or exacerbation rate were observed between eligible and ineligible groups. An atopic phenotype was more common with omalizumab-eligible patients and an adult-onset phenotype was more common in ineligible patients (both p Conclusion In a large cohort of 157 patients with SEA, 41% are eligible for both an anti-IgE and anti-IL-5/5R approach. In a real-world setting, the clinical effectiveness of mepolizumab and benralizumab does not appear to be influenced by eligibility for omalizumab therapy. It remains unclear which SEA patients may respond better to an anti-IgE vs anti-IL5/5R approach when both treatments are an option.

In a real-world setting, the clinical response to the anti-IL-5/5R mAbs mepolizumab and benralizumab in patients with severe eosinophilic asthma is independent of co-eligibility with the anti-IgE mAb omalizumabhttps://bit.ly/2NfAitP

The original version of this article unfortunately contained a mistake in the fifth paragraph of the "Conclusion" section.

Background: Therapeutic mAbs targeting the IL-5 or IL-5Rα have been developed for treatment of severe eosinophilic asthma. However, prevalence of severe asthma and proportion of asthmatics who might benefit from such treatments remain unknown. Aims and Objectives: To evaluate the prevalence and characteristics of patients (pts) eligible for anti-IL-5/Rα treatment in an unselected cohort of adult-onset asthma. Methods: Seinajoki Adult Asthma Study (SAAS) is a 12-year follow-up study of pts with new-onset adult asthma (n=203). Prevalence was estimated based on information collected at the 12-year follow-up visit. Details of health care use were collected from the entire follow-up period. Pts eligible for anti‒IL-5/Rα treatment were defined as: daily use of medium-to-high ICS dosages/LABA, ≥2 exacerbations/previous year, and blood eosinophil count ≥300 cells/µl (or FeNO ≥50 ppb). Results: Prevalence of anti-IL-5/Rα-treatable pts was 2%, while prevalence of severe asthma (ERS/ATS criteria), was 5.9%. Only one patient met criteria for both groups. Compared with pts eligible for anti‒IL-5/Rα therapy, severe asthmatics were more often current smokers at diagnosis and obese, used higher ICS dose and had higher blood neutrophils 12 years after diagnosis. Both groups differed from non-severe asthma by higher numbers of all planned and unplanned respiratory-related visits to healthcare. Severe asthmatics had the highest number of hospitalizations. Conclusions: Of pts with adult-onset asthma, 5.9% had severe asthma and 2% might have benefitted from anti-IL-5/anti-IL-5Rα treatment. Both groups represent a high burden to society, and targeted treatment could lead to lower long-term health care utilization.

Immunoglobulin (Ig) E-mediated food allergy and eosinophilic esophagitis (EoE) are chronic, allergen-mediated disorders characterized by an aberrant TH2 immune response. The development and investigation of biologics for the treatment of IgE-mediated food allergy and eosinophilic esophagitis have provided further insight into the pathophysiology and management of these disorders. This article provides an overview of biologic therapies that are being investigated or have potential as treatments for IgE-mediated food allergy and eosinophilic esophagitis. Identification of EoE phenotypes that are responsive to biologics and investigation of biologics combined with other therapies may help elucidate a role for biologics in EoE.

Several biologics are currently FDA approved for asthma that target Th2 high patients. Unfortunately, 50% of patients with severe asthma do not fit this phenotype of disease and have fewer effective therapeutic options. In the clinical setting, total IgE, FeNO and peripheral blood eosinophils are important tools in defining Th2 high patients with asthma. However, precise biomarkers to predict better response to one specific Th2 high asthma therapy versus another is lacking. It is important to recognize that none of the current medications targeting the Th2 pathway induces persistent immunomodulation or remission.

Asthma is an important chronic disease affecting a lot of people worldwide. Treatment options for asthma like biological agents are being developed more frequently nowadays. Despite a lot of treatment options, some patients still remain symptomatic. As more and more practitioners choose treatment with biologic agents as a convenient way of therapy, biologic agents and other valuable methods must be discovered in order to cope with a growing number of treatment agents. This manuscript emphasizes on new generation monoclonal human(ized) antibodies in asthmatics and off-label use . The first developed biologic agent is the anti-immunoglobulin E monoclonal antibody called omalizumab. Currently it is an approved treatment option for asthma.

Eosinophils are suppressed by a new class of drugs targeting Interleukin-5 (IL-5), an eosinophil growth, activation, and survival factor. Humanized anti-IL-5 antibodies are effective in treating asthma patients with the severe eosinophilic form of the disease and are the first new class of asthma drugs approved in 12 years.

Recent advances in our understanding of the immune-mediated inflammatory pathways in asthma and other allergic diseases have resulted in the development of novel biological compounds for the treatment of these conditions. These compounds offer an advantage over glucocorticosteroid therapy by specifically targeting components of the immunologic cascade, thereby allowing patients to reduce or discontinue their glucocorticosteroid treatment. Another potential advantage of biological compounds is that they may provide additional anti-inflammatory benefits, over and above those provided by glucocorticosteroid therapy, for patients who continue to have evidence of refractory asthma. The anti-IgE monoclonal antibody omalizumab is already being used for the treatment of allergic asthma and a number of other biological therapies are currently in various stages of clinical development. The purpose of this review is to summarize the data from these studies and to provide a rationale for the use of these compounds in asthma and related allergic airway diseases.