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Allergic rhinitisDisease Coverage

Ref Code: DMKC5942Authors: Nicola Sawalhi-Leckenby

Disease Coverage | Allergic rhinitis 2

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CONTENTS

5 EPIDEMIOLOGY: ALLERGIC RHINITIS (Published on 12 July 2018)

5 OVERVIEW

6 DISEASE BACKGROUND

8 METHODOLOGY

19 FORECAST

24 BIBLIOGRAPHY

26 APPENDIX: ADDITIONAL SOURCES



LIST OF FIGURES

LIST OF TABLES

23 Figure 1: Trends in total prevalent cases of allergic rhinitis in the US, Japan, and five major EU markets, by country, 2017–37

9 Table 1: Sources used for childhood 12-month allergic rhinitis analysis in the US, Japan, and five major EU markets, by

country

14 Table 2: Sources used for adult 12-month allergic rhinitis analysis in the US, Japan, and five major EU markets, by country

18 Table 3: Sources used to estimate diagnosed allergic rhinitis cases, by case type

20 Table 4: Total prevalent cases of allergic rhinitis in the US, Japan, and five major EU markets, by country, 2017–37

Disease Coverage | Epidemiology: Allergic Rhinitis 5


EPIDEMIOLOGY: ALLERGIC RHINITIS OVERVIEW

Description This epidemiologic analysis uses robust, country-specific data sources to estimate and forecast total anddiagnosed prevalent cases of allergic rhinitis (AR) in the US, Japan, and five major EU markets (France,Germany, Italy, Spain, and the UK) between 2017 and 2037.

The accompanying epidemiology datapack includes forecasted total and diagnosed prevalent cases,prevalence proportions, and diagnosed cases segmented by case type (perennial and non-perennial AR) for2017–37.

Diseasebackground

AR is a prevalent yet largely underdiagnosed chronic inflammatory disorder of the nasal mucosa,characterized by the presence of pruritus, sneezing, rhinorrhea, and nasal congestion. AR is mediated by aninappropriate inflammatory response to environmental allergens, which may include pollen and mold, andaffects people of all ages. Although AR is not a serious illness, it is clinically relevant as it may adverselyimpact upon physical and social well-being, and educational performance.

Forecasthighlights

Datamonitor Healthcare estimates that in 2017, there were 137.0 million total prevalent cases of AR in theUS, Japan, and five major EU markets. Although trends vary by country, overall, by 2037, DatamonitorHealthcare forecasts that number will decrease to 135.6 million.

Also, Datamonitor Healthcare estimates that in 2017, there were 78.1 million diagnosed prevalent cases ofAR in the US, Japan, and five major EU markets. Although trends vary by country, overall, by 2037,Datamonitor Healthcare forecasts that number will decrease to 77.3 million.

The drivers of this expected trend in prevalent cases are demographic changes, as there was insufficientevidence available to introduce a trend in prevalence proportions throughout the forecast period.

In 2017, Datamonitor Healthcare estimates that overall, 56.8% of diagnosed prevalent cases were non-perennial AR, including seasonal and occupational AR. This proportion varies from 42.3% in the UK to 81.1%in Germany.

Methodology Proprietary epidemiologic forecasting methodology using robust, population-based studies from the US,Japan, and five major EU markets.



DISEASE BACKGROUND

ALLERGIC RHINITIS IS A HIGHLY PREVALENT YET LARGELY UNDERDIAGNOSED CHRONICINFLAMMATORY DISORDER OF THE NASAL MUCOSA Allergic rhinitis (AR), a chronic inflammation of the inner lining on the nose, is mediated by inappropriate inflammatory responses toenvironmental allergens. In AR sufferers, specific immunoglobulin E (IgE) antibodies are developed in response to otherwise harmlessenvironmental allergens, triggering an immune response. Commonly precipitating allergens vary worldwide, but often include grassand tree pollen, house dust mites, mold, and animal dander. AR due to plant pollens is commonly referred to as hay fever, althoughthe terms are often used interchangeably. Hay fever may also refer to seasonal allergic rhinitis.

SYMPTOMS MOSTLY OCCUR SHORTLY AFTER CONTACT WITH THE ALLERGEN, AND PRESENTSIMILARLY TO THE COMMON COLD AR is characterized by the presence of pruritus (severe itching of the skin, nose, throat, and eyes), sneezing, rhinorrhea (runny nose),and nasal congestion, with symptoms being similar to those of a cold. The defining symptom of AR, however, compared to a cold,tends to be pruritus. These symptoms can have a negative effect on physical, social, and psychological well-being, as well as schoolperformance in children (Greiner et al., 2011; Walker et al., 2007).

THE DEFINITION OF ALLERGIC RHINITIS VARIES WITHIN THE EPIDEMIOLOGICAL LITERATURE Despite AR being a global health problem that causes major illness and disability worldwide, there is currently no AR definition widelyand consistently applied in clinical or epidemiological use. Diagnosis is largely based on presence of symptoms and may beaccompanied by an allergen-specific skin prick or serum antibody test. AR is traditionally classified into perennial and seasonal,although both may exist in one case. The Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines have also led to the definition ofAR as intermittent or persistent, and mild or moderate/severe (ARIA Workshop Group et al., 2001; Bousquet et al., 2008; Brozek et al.,2010).

RISK FACTORS FOR ALLERGIC RHINITIS MAY BE ENVIRONMENTAL OR GENETIC Risk factors for AR include the presence of an atopic disease, ethnic origin other than white European, high socioeconomic status,environmental pollution, birth during a pollen season, no older siblings, late entry into preschool education, heavy maternal smokingduring the first year of life, exposure to indoor allergens, high serum IgE concentrations, and early introduction of foods or formula(Scadding et al., 2008). Genetic risk factors have also been identified through genome-wide association studies, including FLG,S100A7, HDC, IL13, IL6, and TLR7 (Portelli et al., 2015). Also, AR is associated with other inflammatory disorders affecting respiratorymucous membranes. The most common co-morbidity observed with AR cases is asthma, especially in children, although allergicconjunctivitis and rhinosinusitis are also relatively common (Greiner et al., 2011).



PREVENTIVE MEASURES ARE BASED ON ALLERGEN AVOIDANCE, WHILE TREATMENTS MAY BESYMPTOMATIC OR IMMUNO-MODULATORY Preventive measures largely involve allergen avoidance. Treatments either aim to reduce symptoms or alter the immune response,and include oral and nasal antihistamines and decongestants, corticosteroids, leukotriene inhibitors, mast cell stabilizers (chromones),anticholinergics, and nasal saline (Glacy et al., 2013; Greiner et al., 2011; Pharmaprojects, 2018). Mechanisms of action of drugs in thepipeline include immunosuppressants, desensitizers, immunostimulant vaccines, histamine H1 receptor antagonists, andglucocorticoid agonists (Pharmaprojects, 2018).



METHODOLOGY Datamonitor Healthcare conducted an extensive literature review to identify epidemiological studies reporting the total anddiagnosed 12-month prevalence of allergic rhinitis (AR) in the US, Japan, and five major EU markets (France, Germany, Italy, Spain, andthe UK). Searches were conducted in PubMed, Google Scholar, and the Trip Database. Potential data sources were critically appraisedfor their epidemiological quality, including study settings, sampling procedures and sample size, disease definitions, and potentialsources of bias, to provide a robust foundation on which to model and forecast the patient population of allergic rhinitis. Prevalence proportions were extracted, by age and gender, where available, for 12-month total and diagnosed AR. Where only total ordiagnosed prevalence proportions were available, a conversion was made using ratios extracted from appropriate comparisonstudies. This methodology was also followed where lifetime prevalence, rather than 12-month, was available. Total and diagnosed prevalent cases among individuals of all ages were included in the forecast, although sources differed forchildren and adolescents (aged under 20 years), and adults, as described below.

DISEASE DEFINITION There are numerous ways of defining AR for clinical use, and there is currently no universally accepted standard definition of AR inepidemiological studies. The difficulties associated with this include low diagnosis rates and the impracticality of using subjectivemeasures in large-scale population studies. As a result, studies of AR rely heavily on self-report symptom data, and thus may bemeasuring perceived allergic status instead of rhinitis due to a true immune-mediated response. The definitions of AR applied in thisanalysis, which were all validated for use in comparable samples, were:

METHODS Datamonitor Healthcare forecasts the prevalence of 12-month diagnosed and 12-month total AR across the US, Japan, and five majorEU markets. This allows comparisons to be made across markets. Where prevalence is presented in this way, proportions areextracted directly from the source. When prevalence proportions are presented in an alternative format, such as lifetime diagnosedor lifetime total prevalence, Datamonitor Healthcare converted the proportions into 12-month diagnosed and 12-month totalprevalence using ratios extracted from sources presenting both. An overview of the sources used and methodology applied for children and adolescents, and adults, is provided in the tables below.

self-awareness of hay fever, allergic rhinitis, or allergic rhinoconjunctivitis•

doctor diagnosis of hay fever or allergic rhinitis, or allergic rhinoconjunctivitis•

symptomatic description of hay fever or allergic rhinitis (hay fever or sneezing/runny nose/blocked nose when not suffering fromcold, and current symptoms of rhinitis or use of medication for rhinitis in the last 12 months, symptoms for at least two years,and no sinusitis or nasal polyps) (de Marco et al., 2010).

•


Table 1: Sources used for childhood 12-month allergic rhinitis analysis in the US, Japan, and five major EU markets, by country

Market Region Sample size (n) Time period Age (years) Method of datacollection

Source Measurepresented

Processing to12-month totalprevalence

Processing to12-monthdiagnosedprevalence

US National 11,107 2016 0–17 National cross-sectional survey

CDC, 2018; USDepartment ofHealth andHuman Serviceset al., 2017

12-month total Not required Total prevalenceconverted todiagnosedprevalence usingratios calculatedfrom Nathan etal. (1997)

Japan National Not stated 2008 0–19 Nationallyproducedestimates

Okubo et al.,2014

Lifetime total Lifetime totalprevalenceconverted to 12-month totalprevalence usingratio calculatedfrom Patil et al.(2015)

Calculated 12-month totalprevalenceconverted to 12-monthdiagnosedprevalence usingratios calculatedfrom Nathan etal. (1997)



France Germany resultsapplied toFrance

1,240 2001–02 6–7, 13–14 Population-based, cluster-randomized,cross-sectionalsurvey

ISAAC SteeringCommittee,2013



Germany National 12,128 2012 0–17 German HealthInterview andExaminationSurvey forChildren andAdolescents(KiGGS); anational cross-sectional survey

Schmitz et al.,2012

Lifetimediagnosed, 12-monthdiagnosed

12-monthdiagnosedprevalenceconverted tototal prevalenceusing ratioscalculated fromNathan et al.(1997)

Not required



Italy 13 centers 5,302 2001–02 6–7, 13–14 Population-based, cluster-randomized,cross-sectionalsurvey




Spain 12 centers 4,579 2001–02 6–7, 13–14 Population-based, cluster-randomized,cross-sectionalsurvey






UK Six centers 7,315 2001–02 6–7, 13–14 Population-based, cluster-randomized,cross-sectionalsurvey




ISAAC = International Study of Asthma and Allergies in Childhood

Source: various (see above)


Table 2: Sources used for adult 12-month allergic rhinitis analysis in the US, Japan, and five major EU markets, by country

Market Region Sample size (n) Time period Age (years) Method of datacollection

Source Measurepresented

Processing to12-month totalprevalence

Processing to12-monthdiagnosedprevalence

US National 33,028 2016 18+ National cross-sectional survey

CDC, 2018; USDepartment ofHealth andHuman Serviceset al., 2017

12-monthdiagnosed

Diagnosedprevalenceconverted tototal prevalenceusing ratioscalculated fromNathan et al.(1997)

Not required

Japan National Not stated 2008 20+ Nationallyproducedestimates

Okubo et al.,2014





France MetropolitanFrance(excludingCorsica)

10,038 2006 18+ Population-based, cross-sectional survey

Klossek et al.,2009

12-month total Not required 12-month totalprevalenceconverted to 12-monthdiagnosedprevalence usingratios calculatedfrom Nathan etal. (1997)

Germany National 7,998 2012 18–79 German HealthInterview andExaminationSurvey forAdults (DEGS1);a national cross-sectional survey

Langen et al.,2013

Lifetimediagnosed, 12-monthdiagnosed

12-monthdiagnosedprevalenceconverted tototal prevalenceusing ratioscalculated fromNathan et al.(1997)

Not required



Italy Three studycenters

8,130 2009 20–80 Population-based, case-control studywith casesextracted fromwell-definedcohorts orcross-sectionalsurveys

de Marco et al.,2010

12-month total Not required 12-month totalprevalenceconverted to 12-monthdiagnosedprevalence usingratios calculatedfrom Nathan etal. (1997)

Spain Four/five studyareas

1,600 2001 18+ Europeanpopulation-based, cross-sectional survey

Bauchau andDurham, 2004;Izquierdo-Domínguez etal., 2013

Lifetimediagnosed

Lifetimediagnosedprevalenceconverted to 12-monthdiagnosedprevalence usingLangen et al.(2013), then to12-month totalprevalence usingNathan et al.(1997)




UK Four/five studyareas

1,625 2001 18+ Europeanpopulation-based, cross-sectional survey

Bauchau andDurham, 2004

Lifetimediagnosed

Lifetimediagnosedprevalenceconverted to 12-monthdiagnosedprevalence usingLangen et al.(2013), then to12-month totalprevalence usingNathan et al.(1997)





Where available, age- and gender-specific prevalence proportions were extracted for the US, Japan, and five major EU markets. Wherenot available, age- and gender-specific distributions from a comparable country were applied to the overall prevalence proportion forthe country of interest. This was the case for the prevalence of AR in adults in France, Italy, Spain, and the UK. Here, the age- andgender-specific distributions were applied from information available for Germany.

FORECASTING To calculate the number of prevalent cases of AR in the 2017–37 forecast period, Datamonitor Healthcare multiplied prevalenceproportions by the corresponding country-, age-, and gender-specific population estimates from the UN World Population Prospectsdatabase (United Nations, 2017). The UN database was chosen as a reliable population denominator; the data include standard setsof demographic indicators and populations by five-year age group and gender. This was done for both 12-month total and 12-monthdiagnosed prevalence, to provide 20-year forecasts for both.

DIAGNOSED PREVALENT CASES BY CASE TYPE Datamonitor Healthcare identified sources describing the split between perennial AR and non-perennial AR in the diagnosed patientpopulation. Perennial AR occurs year-round and is not restricted to a particular season or time of year. Cases of non-perennial ARinclude those with seasonal AR (such as hay fever), both seasonal and perennial AR, and occupational AR. The perennial ARsegmentation is of particular interest when considering that those suffering from AR year-round may seek treatment on a morefrequent basis, or may be more likely to try novel therapies, as existing treatments may have previously proved ineffective for them. The sources utilized to estimate the proportion of AR cases classified as perennial and non-perennial are given in the table below. Nosuitable source for Japan could be found; therefore, cases in Japan were excluded from this segmentation.



Table 3: Sources used to estimate diagnosed allergic rhinitis cases, by case type

Country Data source description Estimated proportion ofperennial AR

Reference

US Cross-sectional study of arepresentative sample of theUS population of diagnosed ARpatients recruited in 2006through either their familyphysician or an allergyspecialist

46.3% Schatz, 2007

France, Germany, Italy, and theUK

Two-step, cross-sectional,population-based survey invarious European countries,with AR patients identified in2001 through symptomsand/or self-awareness of thecondition, followed byconfirmation by studyinvestigators

France; 54.3%Germany; 18.9%Italy; 35.1%UK; 57.7%

Bauchau and Durham, 2004

Spain Cross-sectional, multicenterstudy with AR patientsidentified in 2006 based onpositive skin prick tests orspecific serum IgE to clinicallyrelevant allergens

38.8% del Cuvillo et al., 2010

Note: perennial AR occurs year-round and is not restricted to a particular season or time of year. Cases of non-perennial AR include thosewith seasonal AR, both seasonal and perennial AR, and occupational AR.AR = allergic rhinitis; IgE = immunoglobulin E




FORECAST This chapter contains the topline 20-year forecast of total prevalent allergic rhinitis (AR) cases for 2017–37. For a further detailedbreakdown of case numbers, please consult the accompanying datapack, which includes a 20-year diagnosed prevalent case forecast,and segmentation of prevalent cases by case type. The datapack provides the following:

TOTAL PREVALENT CASES OF ALLERGIC RHINITIS

total prevalent cases of AR, by country, gender, and age, 2017–37•

diagnosed prevalent cases of AR, by country, gender, and age, 2017–37•

prevalence proportions of AR, by country, gender, and age, 2017–37•

diagnosed prevalent cases of AR, by country and case type, 2017–37.•

Datamonitor Healthcare estimates that in 2017, there were 137.0 million total prevalent cases of AR in the US, Japan, and fivemajor EU markets (France, Germany, Italy, Spain, and the UK).

•

Although trends vary by country, overall, by 2037, Datamonitor Healthcare forecasts that the number of total prevalent cases ofAR in the US, Japan, and five major EU markets will decrease to 135.6 million (1.0% decrease). This trend is driven by populationchange, where the population aged under 20 years, where prevalence is highest, is forecasted to decrease slightly overall(United Nations, 2017).

•

Compared to the previous Datamonitor Healthcare update, the total prevalent cases estimates for the US are higher. This is dueto the publication of updated prevalence estimates for adults and children in 2016 by the Centers for Disease Control andPrevention, which were not available at the time of writing of the previous report, and which were higher than previousestimates (Blackwell et al., 2014; Bloom et al., 2013; CDC, 2018).

•

The reverse is true for France, where the total prevalent cases estimates are lower than the previous ones. This is due to theinclusion of a different source of estimates for prevalence in adults, which was not available in full text at the time of theprevious update. This source was identified for this update to provide France-specific prevalence estimates (Bauchau andDurham, 2004; Klossek et al., 2009).

•


Table 4: Total prevalent cases of allergic rhinitis in the US, Japan, and five major EU markets, by country, 2017–37

Year US Japan France Germany Italy Spain UK 5EU Total

2017 35,083,000 41,717,000 16,960,000 15,904,000 7,923,000 6,733,000 12,710,000 60,230,000 137,030,000

2018 35,331,000 41,449,000 17,011,000 15,896,000 7,881,000 6,703,000 12,761,000 60,251,000 137,031,000

2019 35,574,000 41,181,000 17,063,000 15,882,000 7,838,000 6,674,000 12,814,000 60,271,000 137,025,000

2020 35,818,000 40,917,000 17,114,000 15,862,000 7,793,000 6,643,000 12,868,000 60,281,000 137,016,000

2021 36,032,000 40,682,000 17,165,000 15,825,000 7,748,000 6,609,000 12,925,000 60,273,000 136,986,000

2022 36,259,000 40,452,000 17,218,000 15,780,000 7,703,000 6,576,000 12,984,000 60,261,000 136,971,000

2023 36,493,000 40,222,000 17,270,000 15,730,000 7,657,000 6,543,000 13,042,000 60,242,000 136,957,000

2024 36,729,000 39,983,000 17,321,000 15,676,000 7,611,000 6,511,000 13,095,000 60,214,000 136,926,000

2025 36,962,000 39,730,000 17,370,000 15,621,000 7,566,000 6,479,000 13,142,000 60,176,000 136,868,000

2026 37,194,000 39,486,000 17,417,000 15,566,000 7,524,000 6,449,000 13,188,000 60,145,000 136,826,000

2027 37,424,000 39,235,000 17,463,000 15,511,000 7,484,000 6,420,000 13,230,000 60,109,000 136,768,000



2028 37,654,000 38,972,000 17,508,000 15,456,000 7,444,000 6,392,000 13,266,000 60,066,000 136,691,000

2029 37,885,000 38,694,000 17,551,000 15,399,000 7,404,000 6,363,000 13,298,000 60,016,000 136,594,000

2030 38,121,000 38,398,000 17,594,000 15,340,000 7,363,000 6,335,000 13,324,000 59,957,000 136,476,000

2031 38,355,000 38,112,000 17,638,000 15,281,000 7,325,000 6,307,000 13,355,000 59,906,000 136,374,000

2032 38,590,000 37,815,000 17,681,000 15,222,000 7,287,000 6,279,000 13,382,000 59,851,000 136,256,000

2033 38,825,000 37,509,000 17,723,000 15,163,000 7,250,000 6,250,000 13,405,000 59,790,000 136,125,000

2034 39,061,000 37,203,000 17,762,000 15,101,000 7,212,000 6,222,000 13,425,000 59,723,000 135,987,000

2035 39,298,000 36,900,000 17,799,000 15,036,000 7,175,000 6,195,000 13,443,000 59,648,000 135,845,000

2036 39,530,000 36,626,000 17,835,000 14,972,000 7,142,000 6,170,000 13,467,000 59,585,000 135,741,000

2037 39,761,000 36,363,000 17,869,000 14,906,000 7,110,000 6,145,000 13,490,000 59,520,000 135,643,000

Absolutechange

13.3% -12.8% 5.4% -6.3% -10.3% -8.7% 6.1% -1.2% -1.0%

Note: totals may not sum due to rounding.



5EU = five major EU markets (France, Germany, Italy, Spain, and the UK)

Source: Datamonitor Healthcare; Bauchau and Durham, 2004; CDC, 2018; de Marco et al., 2010; del Cuvillo et al., 2010; ISAAC Steering Committee, 2013; Izquierdo-Domínguez et al., 2013; Klossek et al., 2009; Langen et al., 2013; Nathan et al., 1997; Okubo et al., 2014; Patil et al., 2015; Schmitz et al., 2012;United Nations, 2017



Figure 1: Trends in total prevalent cases of allergic rhinitis in the US, Japan, and five major EU markets, by country,

2017–37

Source: Datamonitor Healthcare; Bauchau and Durham, 2004; CDC, 2018; de Marco et al., 2010; del Cuvillo et al., 2010; ISAAC Steering Committee, 2013; Izquierdo-Domínguez et al., 2013; Klossek et al., 2009;Langen et al., 2013; Nathan et al., 1997; Okubo et al., 2014; Patil et al., 2015; Schmitz et al., 2012; United Nations, 2017



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ftp://ftp.cdc.gov/pub/Health_Statistics/NCHS/Dataset_Documentation/NHIS/2016/srvydesc.pdf



APPENDIX: ADDITIONAL SOURCES For further information regarding the general etiology, pathology, treatment, and epidemiology of allergic rhinitis (AR), DatamonitorHealthcare recommends consulting the following sources:

A World Health Organization fact sheet on AR can be found at: http://www.who.int/respiratory/other/Rhinitis_sinusitis/en/•

A high-quality review on AR entitled “Allergic rhinitis” was published in The Lancet in 2011, and is available at:http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60130-X/fulltext?rss%3Dyes

•

A review of the treatment options for AR was published in 2013, and is available at:http://www.ncbi.nlm.nih.gov/books/NBK153714/

•

A commentary on the co-existence of AR and asthma can be found in an article published in 2013, entitled “Allergic rhinitis,chronic rhinosinusitis and asthma: unravelling a complex relationship,” available at: http://journals.lww.com/co-otolaryngology/Abstract/2013/02000/Allergic_rhinitis,_chronic_rhinosinusitis_and.15.aspx.

•

http://www.who.int/respiratory/other/Rhinitis_sinusitis/en/

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60130-X/fulltext?rss%3Dyes

http://www.ncbi.nlm.nih.gov/books/NBK153714/

http://journals.lww.com/co-otolaryngology/Abstract/2013/02000/Allergic_rhinitis,_chronic_rhinosinusitis_and.15.aspx

http://journals.lww.com/co-otolaryngology/Abstract/2013/02000/Allergic_rhinitis,_chronic_rhinosinusitis_and.15.aspx

www.datamonitorhealthcare.com

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