Showing papers by "Ian D. Pavord published in 2016"

Treatable traits: toward precision medicine of chronic airway diseases.

Abstract: Asthma and chronic obstructive pulmonary disease (COPD) are two prevalent chronic airway diseases that have a high personal and social impact. They likely represent a continuum of different diseases that may share biological mechanisms (i.e. endotypes), and present similar clinical, functional, imaging and/or biological features that can be observed (i.e. phenotypes) which require individualised treatment. Precision medicine is defined as "treatments targeted to the needs of individual patients on the basis of genetic, biomarker, phenotypic, or psychosocial characteristics that distinguish a given patient from other patients with similar clinical presentations". In this Perspective, we propose a precision medicine strategy for chronic airway diseases in general, and asthma and COPD in particular.

Blood eosinophils and inhaled corticosteroid/long-acting β-2 agonist efficacy in COPD

Abstract: Objective We performed a review of studies of fluticasone propionate (FP)/salmeterol (SAL) (combination inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA)) in patients with COPD, which measured baseline (pretreatment) blood eosinophil levels, to test whether blood eosinophil levels ≥2% were associated with a greater reduction in exacerbation rates with ICS therapy. Methods Three studies of ≥1-year duration met the inclusion criteria. Moderate and severe exacerbation rates were analysed according to baseline blood eosinophil levels (<2% vs ≥2%). At baseline, 57–75% of patients had ≥2% blood eosinophils. Changes in FEV1 and St George's Respiratory Questionnaire (SGRQ) scores were compared by eosinophil level. Results For patients with ≥2% eosinophils, FP/SAL was associated with significant reductions in exacerbation rates versus tiotropium (INSPIRE: n=719, rate ratio (RR)=0.75, 95% CI 0.60 to 0.92, p=0.006) and versus placebo (TRISTAN: n=1049, RR=0.63, 95% CI 0.50 to 0.79, p<0.001). No significant difference was seen in the <2% eosinophil subgroup in either study (INSPIRE: n=550, RR=1.18, 95% CI 0.92 to 1.51, p=0.186; TRISTAN: n=354, RR=0.99, 95% CI 0.67 to 1.47, p=0.957, respectively). In SCO30002 (n=373), no significant effects were observed (FP or FP/SAL vs placebo). No relationship was observed in any study between eosinophil subgroup and treatment effect on FEV1 and SGRQ. Discussion Baseline blood eosinophil levels may represent an informative marker for exacerbation reduction with ICS/LABA in patients with COPD and a history of moderate/severe exacerbations.

A phase III randomised controlled trial of single-dose triple therapy in COPD: the IMPACT protocol.

Abstract: Patients with symptomatic advanced chronic obstructive pulmonary disease (COPD) who experience recurrent exacerbations are particularly at risk of poor outcomes and present a significant burden on healthcare systems. The relative merits of treating with different inhaled combination therapies e.g. inhaled corticosteroids (ICS)/long-acting β2-agonist (LABA), LABA/long-acting muscarinic antagonists (LAMA), ICS/LABA/LAMA, in this patient group are poorly understood, as is reflected in current guidelines. The InforMing the PAthway of COPD Treatment (IMPACT) study will evaluate the efficacy and safety of fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) versus FF/VI or UMEC/VI over a 52-week treatment period. The study has been designed with a focus on understanding the comparative merits of each treatment modality in different phenotypes/endotypes.This is a phase III, randomised, double-blind, three-arm, parallel-group, global multicentre study comparing the rate of moderate and severe exacerbations between FF/UMEC/VI and FF/VI or UMEC/VI over a 52-week treatment period. The study aims to recruit 10 000 patients from approximately 1070 centres. Eligible patients are aged ≥40 years, with symptomatic advanced COPD (Global initiative for chronic Obstructive Lung Disease (GOLD) group D) and an exacerbation in the previous 12 months.The first patients were recruited to the IMPACT study (ClinicalTrials.gov: NCT02164513) in June 2014 and the anticipated completion date is July 2017.

Exacerbations of COPD.

Abstract: Exacerbations of chronic obstructive pulmonary disease (COPD) are defined as sustained worsening of a patient's condition beyond normal day-to-day variations that is acute in onset, and that may also require a change in medication and/or hospitalization. Exacerbations have a significant and prolonged impact on health status and outcomes, and negative effects on pulmonary function. A significant proportion of exacerbations are unreported and therefore left untreated, leading to a poorer prognosis than those treated. COPD exacerbations are heterogeneous, and various phenotypes have been proposed which differ in biologic basis, prognosis, and response to therapy. Identification of biomarkers could enable phenotype-driven approaches for the management and prevention of exacerbations. For example, several biomarkers of inflammation can help to identify exacerbations most likely to respond to oral corticosteroids and antibiotics, and patients with a frequent exacerbator phenotype, for whom preventative treatment is appropriate. Reducing the frequency of exacerbations would have a beneficial impact on patient outcomes and prognosis. Preventative strategies include modification of risk factors, treatment of comorbid conditions, the use of bronchodilator therapy with long-acting β2-agonists or long-acting muscarinic antagonists, and inhaled corticosteroids. A better understanding of the mechanisms underlying COPD exacerbations will help to optimize use of the currently available and new interventions for preventing and treating exacerbations.

Research in progress: Medical Research Council United Kingdom Refractory Asthma Stratification Programme (RASP-UK)

Abstract: The UK Refractory Asthma Stratification Programme (RASP-UK) will explore novel biomarker stratification strategies in severe asthma to improve clinical management and accelerate development of new therapies. Prior asthma mechanistic studies have not stratified on inflammatory phenotype and the understanding of pathophysiological mechanisms in asthma without Type 2 cytokine inflammation is limited. RASP-UK will objectively assess adherence to corticosteroids (CS) and examine a novel composite biomarker strategy to optimise CS dose; this will also address what proportion of patients with severe asthma have persistent symptoms without eosinophilic airways inflammation after progressive CS withdrawal. There will be interactive partnership with the pharmaceutical industry to facilitate access to stratified populations for novel therapeutic studies.

Fractional exhaled nitric oxide for the management of asthma in adults: a systematic review

Abstract: The aim of this review was to evaluate the clinical effectiveness of fractional exhaled nitric oxide (FeNO) measured in a clinical setting for the management of asthma in adults.13 electronic databases were searched and studies were selected against predefined inclusion criteria. Quality assessment was conducted using QUADAS-2. Class effect meta-analyses were performed.Six studies were included. Despite high levels of heterogeneity in multiple study characteristics, exploratory class effect meta-analyses were conducted. Four studies reported a wider definition of exacerbation rates (major or severe exacerbation) with a pooled rate ratio of 0.80 (95% CI 0.63-1.02). Two studies reported rates of severe exacerbations (requiring oral corticosteroid use) with a pooled rate ratio of 0.89 (95% CI 0.43-1.72). Inhaled corticosteroid use was reported by four studies, with a pooled standardised mean difference of -0.24 (95% CI -0.56-0.07). No statistically significant differences for health-related quality of life or asthma control were found.FeNO guided management showed no statistically significant benefit in terms of severe exacerbations or inhaled corticosteroid use, but showed a statistically significant reduction in exacerbations of any severity. However, further research is warranted to clearly define which management protocols (including cut-off points) offer best efficacy and which patient groups would benefit the most.

Cost Effectiveness of Tiotropium in Patients with Asthma Poorly Controlled on Inhaled Glucocorticosteroids and Long-Acting β-Agonists

Abstract: Background A considerable proportion of patients with asthma remain uncontrolled or symptomatic despite treatment with a high dose of inhaled glucocorticosteroids (ICSs) and long-acting β2-agonists (LABAs). Tiotropium Respimat® added to usual care improves lung function, asthma control, and the frequency of non-severe and severe exacerbations, in a population of adult asthma patients who are uncontrolled despite treatment with ICS/LABA.

Scaling up strategies of the chronic respiratory disease programme of the European Innovation Partnership on Active and Healthy Ageing (Action Plan B3: Area 5)

Abstract: Action Plan B3 of the European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) focuses on the integrated care of chronic diseases. Area 5 (Care Pathways) was initiated using chronic respiratory diseases as a model. The chronic respiratory disease action plan includes (1) AIRWAYS integrated care pathways (ICPs), (2) the joint initiative between the Reference site MACVIA-LR (Contre les MAladies Chroniques pour un VIeillissement Actif) and ARIA (Allergic Rhinitis and its Impact on Asthma), (3) Commitments for Action to the European Innovation Partnership on Active and Healthy Ageing and the AIRWAYS ICPs network. It is deployed in collaboration with the World Health Organization Global Alliance against Chronic Respiratory Diseases (GARD). The European Innovation Partnership on Active and Healthy Ageing has proposed a 5-step framework for developing an individual scaling up strategy: (1) what to scale up: (1-a) databases of good practices, (1-b) assessment of viability of the scaling up of good practices, (1-c) classification of good practices for local replication and (2) how to scale up: (2-a) facilitating partnerships for scaling up, (2-b) implementation of key success factors and lessons learnt, including emerging technologies for individualised and predictive medicine. This strategy has already been applied to the chronic respiratory disease action plan of the European Innovation Partnership on Active and Healthy Ageing.

Blood eosinophil count: a biomarker of an important treatable trait in patients with airway disease

Abstract: Blood eosinophil count can identify eosinophilic airway inflammation, a “treatable trait” of COPD http://ow.ly/Xn098

Predictors of objective cough frequency in pulmonary sarcoidosis.

Abstract: Cough is a common symptom of pulmonary sarcoidosis. This study aimed to quantify cough frequency, and investigate its relationship with cough reflex sensitivity, pulmonary function and health status.32 patients with pulmonary sarcoidosis were compared with 40 healthy controls. Cough reflex sensitivity to capsaicin, objective 24-h cough counts, cough-specific health status, cough severity and cough triggers were measured. The predictors of cough frequency in sarcoidosis were determined in a multivariate analysis.Objective cough frequency was significantly raised in patients with sarcoidosis compared with healthy controls (p<0.001) and patients with cough had an impaired health status. Patients with pulmonary sarcoidosis had a heightened cough reflex sensitivity compared with healthy controls (p<0.001). Only cough reflex sensitivity was significantly associated with objective cough frequency in multivariate analysis, explaining 42% of the variance (p<0.001). There was no association between cough frequency, lung function, number of organs involved, chest radiograph stage or serum angiotensin-converting enzyme levels.Cough is a common and significant symptom in patients with sarcoidosis. Ambulatory objective cough monitoring provides novel insights into the determinants of cough in sarcoidosis, suggesting that cough reflex sensitivity may be more important than lung function and other measures of disease severity, and this should be investigated further.

A systematic review of fractional exhaled nitric oxide in the routine management of childhood asthma

Abstract: Background Fractional exhaled nitric oxide (FeNO) is a non-invasive biomarker of eosinophilic inflammation which may be used to guide the management of asthma in childhood. Objectives To synthesise the available evidence on the efficacy of FeNO-guided management of childhood asthma. Methods Databases including MEDLINE and the Cochrane Library were searched, and randomised controlled trials (RCTs) comparing FeNO-guided management with any other monitoring strategy were included. Study quality was assessed using the Cochrane risk of bias tool for RCTs, and a number of outcomes were examined, including: exacerbations, medication use, quality of life, adverse events, and other markers of asthma control. Meta-analyses were planned if multiple studies with suitable heterogeneity were available. However, due to wide variations in study characteristics, meta-analysis was not possible. Results Seven RCTs were identified. There was some evidence that FeNO-guided monitoring results in improved asthma control during the first year of management, although few results attained statistical significance. The impact on severe exacerbations was unclear. Similarly, the impact on use of anti-asthmatic drugs was unclear, and appears to depend on the step up/down protocols, and the clinical characteristics of patients. Conclusions The potential benefit of FeNO monitoring is equivocal. Trends toward reduced exacerbation and increased medication use were seen, but typically failed to reach statistical significance. There are a number of issues that complicate data interpretation, including differences in the likely severity of included cohorts and variations in treatment algorithms. Further work is needed to systematically explore the impact of these parameters. Pediatr Pulmonol. 2016;51:316–328. © 2016 Wiley Periodicals, Inc.

First maintenance therapy for COPD in the UK between 2009 and 2012: a retrospective database analysis.

Abstract: Clinical guidelines recommend long-acting bronchodilators as first maintenance therapy for chronic obstructive pulmonary disease (COPD), with inhaled corticosteroids (ICS) reserved for patients with more severe disease and exacerbations. The aim of this analysis was to examine real-life prescribing of first maintenance therapy for COPD in the UK. Data were extracted from the UK Optimum Patient Care Research Database for patients with a first prescription for COPD maintenance therapy between 2009 and 2012 and a diagnosis of COPD at or before the date of the first prescription for COPD maintenance therapy. Routine clinical data including demographics, disease history and symptoms, comorbidities, therapy, hospitalisation rate and exacerbation rate were collected and used to characterise patients stratified by disease severity and Global Initiative for Chronic Obstructive Lung Disease (GOLD) group (A-D). The analysis population included 2,217 individuals (55.4% male, 45.2% smokers). Long-acting muscarinic antagonists (LAMA) as monotherapy were prescribed as first maintenance therapy for 40.2% of patients. ICS were prescribed as ICS/long-acting beta-agonists combination for 29.1% of patients or as monotherapy for 15.5%. ICS (alone or in combination) were prescribed to >40% of patients in each GOLD group. ICS-containing regimens were prescribed to patients with a history of pneumonia and comorbid conditions for whom the risks of ICS therapy may outweigh the benefits. The clinical reality of prescribing indicates that ICS are often prescribed outside current guideline recommendations for many patients newly diagnosed with COPD in the UK. Encouragingly, LAMAs are increasingly being prescribed as first maintenance therapy for these patients.

Description of a randomised controlled trial of inhaled corticosteroid/fast-onset LABA reliever therapy in mild asthma.

Abstract: This paper describes the rationale and design of the Novel START (Symbicort Turbuhaler Asthma Reliever Therapy) randomised controlled trial of inhaled corticosteroid (ICS)/fast-onset long-acting β-agonist (LABA) reliever therapy in mild asthma. Description of a real world study of the novel ICS/fast-onset LABA reliever therapy regimen in mild asthma

Morbidity associated with oral corticosteroids in patients with severe asthma

Abstract: Cross-sectional primary care record studies show that 0.9% of the adult population receive regular oral corticosteroids (OCS). Prescriptions have increased steadily over the past 20 years, presumably reflecting an increasingly elderly and infirm population.1 Respiratory conditions (mainly airway diseases) are responsible for 25–40% of these OCS prescriptions,1 ,2 by some way the largest proportion of any specialty. Against this background, it is surprising and disappointing that little is known about morbidity due to OCS usage in patients with airway disease and we remain in the unsatisfactory position of having to extrapolate from studies carried out in non-respiratory conditions. Better information in an airway disease population is important as we are approaching the biological treatment era and have within our sights treatments that offer a realistic potential to be alternatives to OCS and to allow patients already taking them to withdraw therapy safely.3–9 High quality data will be key to inform cost-effectiveness analyses for these new asthma therapies. The paper by Sweeney et al 10 in this issue of the journal is therefore timely. The authors present data from two large severe asthma populations derived from the Optimum Patient Care Research Database (OPCRD) and British Thoracic Society (BTS) Difficult Asthma Registry on the occurrence of corticosteroid associated comorbidities. OPCRD is a respiratory database that contains anonymous longitudinal medical records supplemented by information from patient-completed questionnaires from over 525 general practices across UK. This data set was used to examine potentially OCS-related morbidity in a severe asthma cohort requiring regular OCS and two age and gender-matched control cohorts: one with mild/moderate asthma requiring minimal OCS use and the other without asthma. The BTS Difficult Asthma Registry consists of anonymised data collected from Specialist UK Difficult Asthma Services. Potentially OCS-related morbidity was compared in patients with severe asthma requiring daily …

What can we learn from blood granulocyte patterns in patients with asthma

Abstract: Blood eosinophil counts are a potentially informative biomarker in airway diseasehttp://ow.ly/aOHt3032iz0

FourFold Asthma Study (FAST): a study protocol for a randomised controlled trial evaluating the clinical cost-effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations

Abstract: Asthma is one of the commonest chronic diseases in the UK. Acute exacerbations of asthma are unpredictable, disruptive and frightening. They cause considerable morbidity and account for a large component of the health service costs of asthma. The widespread use of an asthma self-management plan, designed to encourage disease monitoring and timely intervention, can reduce exacerbations and is, therefore, recommended for all patients with asthma. Unfortunately, the majority of patients are not provided with such a plan. There are a variety of reasons for this but uncertainty about what to include in the plan when asthma control is deteriorating, but before the need for orally administered corticosteroids, is a contributing factor. The aim of this trial is to determine whether an asthma self-management plan, which includes a temporary quadrupling of the dose of inhaled corticosteroid when asthma control starts to deteriorate, reduces asthma exacerbations requiring orally administered corticosteroids or unscheduled health care consultation for asthma. A multicentre, pragmatic, randomised trial in adults aged over 16 years with a clinical diagnosis of asthma, treated with a licensed dose of inhaled corticosteroid and at least one exacerbation in the previous 12 months requiring treatment with systemic corticosteroids. Participants will be randomised to either a self-management plan, which includes a temporary (maximum of 14 days) fourfold increase in inhaled corticosteroid or the same plan without an increase in inhaled corticosteroid. Participants will be followed up at 6 and 12 months and will attend the clinic for an additional visit if their asthma control deteriorates. The primary outcome is time to first asthma exacerbation, defined as the need for systemic corticosteroids and/or unscheduled health care consultation for asthma. The estimated sample size is 1800 participants. The FAST trial is an independent study that has been prioritised and commissioned by the National Institute for Health Research (NIHR) in the United Kingdom. It will provide high-quality evidence to inform clinical decision-making on the role of an asthma self-management plan, which includes a temporary fourfold increase of inhaled corticosteroid, when asthma control starts to deteriorate. The first participant was randomised on 17th May 2013 and recruitment will close on 31 January 2016 with the last patient last visit taking place in January 2017. ISRCTN: 15441965 , registered on 25 April 2013.

Step 4: stick or twist? A review of asthma therapy.

Abstract: Many people with asthma do not achieve disease control, despite bronchodilators and inhaled corticosteroid therapy. People with uncontrolled asthma are at higher risk of an asthma attack and death, with mortality rates estimated at 1000 deaths/year in England and Wales. The recent National Review of Asthma Deaths (NRAD) report, ‘Why asthma still kills’, recommended that patients at step 4 or 5 of the British Thoracic Society/Scottish Intercollegiate Guidelines Network (BTS/SIGN) guidance must be referred to a specialist asthma service. This article reviews the 2014 evidence base for therapy of asthma patients at BTS/SIGN step 4 of the treatment cascade, in response to key findings of the NRAD report and lack of preferred treatment option at this step.

Practising Personalized Medicine in Asthma

Abstract: Asthma is a common and, in many cases, serious condition. After rapid improvement in outcomes following the introduction of the first guidelines in 1990, progress in this area has stalled. Current treatments follow a “one size fits all” approach without acknowledgement of the many different underlying disease mechanisms that drive the morbidity of asthma. Personalized medicine allows us to instead direct treatments at these specific causal mechanisms, targeting the exact pathology present in each patient. We believe that with this approach not only will we improve patient outcomes, we will also open the door to novel areas of research and drug discovery. In this article we describe where we are presently with the move towards personalized medicine in asthma, firstly explaining why we believe our current approach is insufficient, and secondly outlining in practical terms how physicians can adopt this novel approach when treating patients with asthma in clinics today. (BRN Rev. 2016;2:229-38) Corresponding author: Ian Pavord, Ian.pavord@ndm.ox.ac.uk

LATE-BREAKING ABSTRACT: Blood eosinophils (EOS) are a biomarker of COPD exacerbation reduction with inhaled corticosteroids (ICS): An across-trials model-based approach

Abstract: Retrospective analyses of COPD trials have demonstrated that blood EOS level at baseline (BL) may predict response to ICS; however, comparisons between published data have limitations due to different study designs/analyses. We examined exacerbation risk according to BL blood EOS absolute count (cells/µL; continuous scale) in studies with similar designs that compared long-acting β2-agonists (LABA) with ICS/LABA. NCT01009463/NCT01017952: vilanterol (VI) vs fluticasone furoate [FF]/VI; NCT00929851: formoterol [FOR] vs beclomethasone dipropionate (BDP)/FOR. Studies covered a 48–52wk period . Moderate/severe exacerbation rate was the primary outcome; patients had COPD and a history of exacerbations in the past year. In NCT00929851, exploratory predictive modelling showed that with increasing BL blood EOS count there was an association with increased exacerbation risk in the absence of ICS; stable rates were seen with ICS/LABA. Using similar methodology, a similar trend was seen in a post-hoc analysis of NCT01009463/NCT01017952. These data from comparable trials strengthen the evidence for blood EOS being a useful biomarker of ICS responsiveness. Sponsors: GSK (NCT01009463/NCT01017952)/Chiesi Farmaceutici S.p.A (NCT00929851).

P138 An innovative approach to study design: using electronic medical records to inform the feasibility and design of the novelty study (a novel observational longitudinal study on patients with asthma and/or COPD)

Abstract: Introduction Asthma and COPD have traditionally been viewed as distinct diseases. While they have overlapping biological mechanisms, past studies often focused on specific aspects of each disease based on a single diagnostic label, and many clinical trial populations were defined by strict enrolment criteria with limited generalisability. NOVELTY is a prospective, multinational, observational, longitudinal cohort study aiming to enrol 14,800 patients aged ≥12 years with a diagnosis or suspected diagnosis of asthma and/or COPD. In this population, the objectives of NOVELTY are to: (i) describe patient characteristics, treatment patterns and burden of illness over time in clinical practice; and (ii) use biomarkers and clinical parameters to identify phenotypes and endotypes associated with differential outcomes for symptom burden, clinical evolution and healthcare utilisation. Aim This feasibility analysis of electronic medical records (EMRs) aimed to understand the potential study population, assess patient numbers across disease severities and evaluate EMRs as a data source for NOVELTY. Methods EMRs from patients with asthma and/or COPD were identified from national databases covering primary and specialist care in 11 countries (Table). Disease severity was classified using treatment- and/or lung function-based algorithms for asthma and COPD. EMR variable coverage and completeness were assessed for standardised clinical, laboratory and physiological data and patient-reported outcomes (PROs). Results EMRs for 921,888 patients with asthma, 958,945 with COPD and 117,893 with both diagnoses were identified. EMRs routinely documented patient demographics and characteristics, but many disease- and treatment-related data, and PROs/symptoms required for evaluation of disease severity and clinical outcomes were frequently missing (not collected or not documented; Table). Disease severity could not be classified in 561,837 patients (asthma) and 355,743 patients (COPD), representing 22−100% and 7−85% of patients across countries. Conclusions EMR analysis revealed numbers of patients per country potentially eligible for NOVELTY. Many variables required to meet NOVELTY objectives were missing in EMRs (e.g. lung function and PRO/symptoms); therefore, variables in NOVELTY will primarily be documented in electronic case report forms, not EMRs. The lack of lung function data in many countries suggested divergences in diagnosis of asthma/COPD between clinical guidelines (which include lung function tests) and clinical practice.

Glutamine supplementation in cystic fibrosis: A randomized placebo-controlled trial.

Abstract: RATIONALE Pulmonary infection and malnutrition in cystic fibrosis are associated with decreased survival. Glutamine has a possible anti-microbial effect, with a specific impact against Pseudomonas aeruginosa. We aimed to test the hypothesis that oral glutamine supplementation (21 g/day) for 8 weeks in adults with cystic fibrosis would decrease pulmonary inflammation and improve clinical status. METHODS The study design was a randomized double-blind placebo-controlled study design with an iso-nitrogenous placebo. The primary analysis was intention to treat, and the primary outcome was change in induced sputum neutrophils. RESULTS Thirty-nine individuals were recruited and thirty-six completed the study. Glutamine supplementation had no impact on any of the outcome measures in the intention-to-treat analysis. In the per protocol analysis, glutamine supplementation was associated with an increase in induced sputum neutrophils (P = 0.046), total cells (P = 0.03), and in Pseudomonas isolation agar colony forming units (P = 0.04) compared to placebo. CONCLUSIONS There was no effect of glutamine supplementation on markers of pulmonary inflammation in the intention-to-treat analysis.

Biologicals to Treat Allergy and Asthma

Abstract: In 2003, anti-immunoglobulin E (omalizumab) was registered for the treatment of mild to moderate allergic asthma In 2015, anti-interleukin-5 (mepolizumab) followed with registration for the treatment of severe eosinophilic asthma These biologicals are medicinal products made partially or totally of naturally occurring molecules, such as antibodies, cytokines, or receptors and have a favorable safety profile and low incidence in adverse events compared to conventional asthma treatments Therefore, anti-IgE and anti-IL-5 treatment fulfills an unmet need of specific subgroups of patients that do not respond to the classical inhaled steroid-based treatment many of whom need on systemic glucocorticoid treatment The severe long-term effects of systemic glucocorticoid use in these patients make biologicals a promising alternative