Stakeholder Opinions: Asthma Phenotypes A changing paradigm

Published by: Datamonitor

Published: Mar. 26, 2007 - 178 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Infectious Diseases and Respiratory (ID&R) analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the report

Contributing experts

Datamonitor insight into asthma phenotypes

CHAPTER 2 ASTHMA BACKGROUND AND EPIDEMIOLOGY

Disease definition

Causes of asthma: environment and genes

Etiology

Disease classification and phenotypes

Phenotypes

Prevalence

CHAPTER 3 ASTHMA DIAGNOSIS AND TREATMENT OPTIONS

Presentation and diagnosis

Treatment options and guidelines

Bronchodilators

Beta2-agonists

Anticholinergics

Combination beta2-agonist/anticholinergic

Anti-inflammatories

Inhaled corticosteroids

Systemic corticosteroids

Non-steroidal anti-inflammatory drugs (NSAIDs)

ICS/LABA combinations

Biologicals

Future trends in asthma treatment

Asthma biomarkers

CHAPTER 4 CLINICAL OR PHYSIOLOGICAL PHENOTYPES

Severity-defined asthma

Prevalence

Refractory asthma

Pathobiology

The refractory asthma patient

Prevalence

Treatment

The exacerbation-prone subtype of refractory asthma

Chronic airflow obstruction in asthma

Pathobiology

The asthma patient with chronic airflow obstruction

Prevalence

Treatment

Asthma defined by age of onset

The early- versus late-onset patient

Treatment

Nocturnal asthma

Pathobiology

Prevalence

Treatment

Viral infections during childhood

Asthma and obesity

CHAPTER 5 PHENOTYPES RELATED TO CERTAIN TRIGGERS

Environmental allergens

Pathobiology

The allergic march

The allergic versus non-allergic asthma patient

Prevalence

Treatment

Immunotherapy

Aspirin- and NSAID-sensitive asthma

The aspirin-sensitive asthma patient

Prevalence

Treatment

Occupational allergens or irritants

Prevalence

Treatment

Menses-related asthma

Exercise-induced asthma

Treatment

CHAPTER 6 INFLAMMATORY PHENOTYPES

Eosinophilic inflammatory asthma

Prevalence

Neutrophilic inflammatory asthma

The neutrophilic asthma phenotype

Prevalence

Pauci-granulocytic inflammatory asthma

Prevalence

CHAPTER 7 ASTHMA PHENOTYPES IN THE FUTURE

Why and how could we use phenotypes?

Phenotypes and endpoints

New endpoints

The battle over asthma control

Phenotypes and biomarkers

How can we progress the identification of phenotypes?

Which phenotype should we target first?

Case study 1: Xolair (omalizumab) in severe allergic asthma

Case study 2: Immunotherapy in severe allergic asthma

Case study 3: an anti-inflammatory drug in neutrophilic asthma

REFERENCES

Disclaimer

List of Tables

Table 1: Asthma prevalence and diagnosed population by country and age, 2007

Table 2: Diagnosed asthma by country and severity for children and adults/elderly, 2007

Table 3: Prevalence of severe/refractory asthma by country, 2007

Table 4: Prevalence of exacerbation-prone severe/refractory asthma by country, 2007

Table 5: Prevalence of chronic airflow obstruction in diagnosed adult/elderly and pediatric asthma population by country (000s), 2007

Table 6: Prevalence of diagnosed asthma patients with nocturnal symptoms in the seven major markets (million), 2007

Table 7: The prevalence of allergic and non-allergic asthma in the seven major markets, 2007 ('000)

Table 8: Prevalence of allergic asthma according to severity in the seven major markets, 2007 ('000)

Table 9: Range of prevalence of diagnosed asthma patients with aspirin/NSAID sensitive asthma, 2007

Table 10: Prevalence of occupational asthma in the diagnosed adult asthma population, 2007

Table 11: Prevalence of diagnosed asthma patients with predominantly eosinophilic inflammation, 2007 ('000)

Table 12: Prevalence of diagnosed asthma patients with predominantly neutrophilic inflammation, 2007

Table 13: Prevalence of different inflammatory phenotypes in diagnosed asthmatic children, adults and elderly, 2007 ('000)

Table 14: Marketed and pipeline therapies in eosinophilic and neutrophilic inflammation

List of Figures

Figure 1: Basic etiology of asthma

Figure 2: Levels of asthma control according to the GINA guidelines

Figure 3: Early/childhood onset phenotypes

Figure 4: Late/adult onset phenotypes

Figure 5: Percentage of asthma patients who experience daily or weekly symptoms by age, 2004

Figure 6: Management approach based on asthma control

Figure 7: Novel asthma therapies are moving towards targeted therapy

Figure 8: The role of biomarkers related to asthma therapy

Figure 9: Overview of clinical or physiological phenotypes

Figure 10: Classification of asthma by clinical, pretreatment features

Figure 11: ATS workshop consensus for definition of refractory asthma

Figure 12: A normal airway compared to the process in airway remodeling

Figure 13: Early-onset versus late-onset asthma

Figure 14: Circadian alterations in lung function in healthy subjects and patients with nocturnal asthma

Figure 15: Viral infections have been implicated in at least three ways with asthma pathogenesis

Figure 16: Overview of phenotypes related to certain triggers

Figure 17: The early and late allergic response

Figure 18: Proposed systemic inflammatory mechanisms linking the upper and lower airways

Figure 19: The allergic march

Figure 20: Prevalence of aspirin-sensitive asthma according to studies versus key opinion leaders (KOLs)

Figure 21: Categories and subcategories of occupational asthma

Figure 22: Overview of inflammatory phenotypes

Figure 23: Characteristics of eosinophil-positive (+) and eosinophil-negative (-) severe asthma

Figure 24: The complex relation between various triggers of airway inflammation and the diseases associated with them

Figure 25: Exacerbations in patients following guideline-therapy and sputum-identification therapy

Figure 26: How can we progress the identification of asthma phenotypes?

Figure 27: The reaction of neutrophils to CXC chemokines in the early phase of inflammation

Figure 28: The difference between potential US peak sales and actual US sales of Xolair in allergic asthma

Figure 29: Possible US peak sales of Grazax in allergic asthma

Figure 30: Possible US peak sales of a novel anti-inflammatory in neutrophilic asthma

Abstract

Introduction

An estimated 34 million people are diagnosed with asthma in the major markets. The disease can be broken down into various phenotypes, differentiated by severity, trigger, or predominant inflammatory type. These phenotypes may have important consequences for future approaches to treat asthma in a more targeted fashion, doing away with the one-size-fits-all approach.

Scope

• Analysis of the main asthma phenotypes and their pathobiological characteristics
• Overview of the prevalence of the main phenotypes in asthma
• Assessment of key unmet needs and the opportunities they offer for new product development
• Analysis of the future role of phenotypes and their impact in drug development

Highlights

Refractory asthma seems to be resistant to corticosteroids, and some refractory patients also suffer from chronic airflow obstruction. Resistant disease is thought to afflict about 10% of asthma patients, whose unmet medical needs are for obvious reasons very high. On average, 60% of the adult asthmatic population suffer from allergic asthma. These patients are often well controlled with an early onset of disease and less severe symptoms compared to the non-allergic phenotype. Immunotherapy is suggested to be beneficial for some of the more severe allergic asthmatics. Two inflammatory phenotypes dominate in asthma: eosinophilic and neutrophilic. These types of inflammation can be seen across a variety of phenotypes, although it is thought that eosinophilic inflammation is mostly associated with allergic asthma and neutrophilic inflammation is associated with refractory asthma and chronic airflow obstruction.

Reasons to Purchase

• Evaluate different asthma phenotypes and their prevalence in the seven major markets
• Explore differential treatment and the unmet needs of the most important asthma phenotypes
• Appreciate the impact of various phenotypes on the future of drug development for asthma

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