The Management of Severe Asthma · 2015-05-14 · Allergy, Asthma and Immunology meeting in...

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w w w . w o r l d a l l e r g y . o r g

“The Management of Severe Asthma”

ProgramChairs:Chairs:Chairs:Chairs:Chairs:G. Walter Canonica, University of Genova DIMIGenova, Italy

Constance H. Katelaris, Westmead Medical CentreWestmead, Australia

1. WWWWWelcome to the Welcome to the Welcome to the Welcome to the Welcome to the World Allergy Forum Symposium and Introduction to “The Management of Severe Asthma”orld Allergy Forum Symposium and Introduction to “The Management of Severe Asthma”orld Allergy Forum Symposium and Introduction to “The Management of Severe Asthma”orld Allergy Forum Symposium and Introduction to “The Management of Severe Asthma”orld Allergy Forum Symposium and Introduction to “The Management of Severe Asthma”G. Walter Canonica, University of Genova DIMIGenova, Italy

Constance H. Katelaris, Westmead Medical CentreWestmead, Australia

2. The Natural HistorThe Natural HistorThe Natural HistorThe Natural HistorThe Natural History of Severe Asthmay of Severe Asthmay of Severe Asthmay of Severe Asthmay of Severe AsthmaMichael Kaliner, Institute for Asthma and AllergyChevy Chase and Wheaton, Maryland

3. TTTTTreatment Options for Severe Asthmareatment Options for Severe Asthmareatment Options for Severe Asthmareatment Options for Severe Asthmareatment Options for Severe AsthmaCarlos E. Baena-Cagnani, Catholic University of CordobaCordoba, Argentina

4. Economic Analysis of the Cost of TEconomic Analysis of the Cost of TEconomic Analysis of the Cost of TEconomic Analysis of the Cost of TEconomic Analysis of the Cost of Treatments for Severe Asthmareatments for Severe Asthmareatments for Severe Asthmareatments for Severe Asthmareatments for Severe AsthmaMichael S. Blaiss, University of Tennessee Health Science CenterMemphis, Tennessee

2003-2005 World Allergy Forum Advisory BoardChairChairChairChairChairCarlos E. Baena-Cagnani, Argentina

MembersMembersMembersMembersMembersG. Walter Canonica, ItalyRonald Dahl, DenmarkStephen Durham, United KingdomMichael Kaliner, USAConnie Katelaris, AustraliaTerumasa Miyamoto, JapanLanny Rosenwasser, USAF. Estelle R. Simons, CanadaPakit Vichyanond, ThailandUlrich Wahn, Germany

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ABOUT THE WORLD ALLERGY ORGANIZATION

World Allergy Organization (WAO)The World Allergy Organization (WAO) is an international umbrella organization of almost 80 regional and nationalallergy and clinical immunology societies. By collaborating with member societies, WAO provides direct educationaloutreach programs, symposia and lectureships to WAO individual members around the globe.

The World Allergy Organization MissionThe World Allergy Organization (WAO) exists to build a global alliance ofallergy societies to advance excellence in clinical care, research, educationand training.

The GLORIA program The GLORIA program The GLORIA program The GLORIA program The GLORIA program promotes good practice inthe management of allergic diseases through programsdeveloped by panels of world experts. GLORIA edu-cates medical professionals worldwide through re-gional and national presentations and local traininginitiatives. GLORIA educational modules promote theWorld Allergy Organization’s (WAO) mission – tooptimize allergy care worldwide.

GLORIA ModulesModule 1: Allergic Rhinitis and Allergic Conjunctivitis

Module 2: Allergic Conjunctivitis (Expanded Version)

Module 3: Allergic Emergencies

Module 4: Immunotherapy

Module 5: Symptoms and Treatment of Asthma

Mobule 6: Food Allergy

World Allergy Forum (WAF)symposia are held at majorinternational allergy meetings.Developed by international expertadvisory panels, the symposia provideup-to-the-minute presentations onscientific and clinical developments inthe field of allergic disease.

PAAA: Prevention of Allergy andAllergic AsthmaPrevention of Allergy and AllergicAsthma (PAAA) is a collaborativeproject with the World HealthOrganization providing guidelinesand recommendations for preventionof the allergen-specific immunologicalsensitization necessary for disease.

WAO Seminars and ConferencesThe Seminars and Conferences program invites mem-ber societies to apply to host a WAO Invited Lecturer.Complementing WAO’s existing programs, Seminarsand Conferences gives Member Societies the oppor-tunity to bid for an international speaker to give aplenary lecture in the scientific program of the Soci-ety’s annual meeting, on a topic of the Society’s choice.

Emerging Societies MeetingsWAO offers advice on initiating and developing allergy so-cieties throughout the world. This proactive initiative aims toexpand and improve the specialty of allergy by supportingcolleagues working in the field of allergy worldwide. Throughsharing practical experiences and alerting new societies tothe criteria required for WAO membership, ESM creates re-lationships with future World Allergy Organization membersocieties, and educates WAO’s leadership about the chal-lenges and opportunities faced by colleagues in developingcountries.

WAO JournalsACI-International – Journal of the World Allergy Organiza-tion (ACII - JWAO) and International Archives of Allergyand Immunology

Read the latest in global allergy and asthma news andresearch through subscriptions to WAO’s journal partners:ACI International - Journal of the World Allergy Organiza-tion (ACII - JWAO) and International Archives of Allergyand Immunology.

PAAA

Programs of the World Allergy Organization

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WAO MEMBER SOCIETIES

National Member Societies*

Regional Organizations Affiliate Organizations

Associate Member Societies

*As of September 2005

Albanian Society of Allergology and Clinical ImmunologyAmerican Academy of Allergy, Asthma and ImmunologyAmerican College of Allergy, Asthma and ImmunologyArgentine Association of Allergy and ImmunologyArgentine Society of Allergy and ImmunopathologyAustralasian Society of Clinical Immunology and AllergyAustrian Society of Allergology and ImmunologyAzerbaijan Society for Asthma, Allergy and Clinical ImmunologyBangladesh Society of Allergy and ImmunologyBelgian Society of Allergology and ImmunologyBrazilian Society of Allergy and ImmunopathologyBritish Society for Allergy and Clinical ImmunologyBulgarian National Society of AllergologyCanadian Society of Allergy and Clinical ImmunologyChilean Society of Allergy and ImmunologyChina Allergology Society and Chinese Allergists(Chinese) Hong Kong Institute of AllergyColombian Allergy, Asthma and Immunology AssociationCroatian Society of Allergology and Clinical ImmunologyCuban Society of AllergologyDanish Society of AllergologyEcuadorian Society of Allergy and ImmunologyEgyptian Society of Allergy and Clinical ImmunologyFinnish Society of Allergology and Clinical ImmunologyFrench Society of Allergology and Clinical ImmunologyGerman Society for Allergology and Clinical ImmunologyGeorgian Association of Allergology and Clinical ImmunologyHellenic Society of Allergology and Clinical ImmunologyHungarian Society of Allergology and Clinical ImmunologyIcelandic Society of Allergy and Clinical ImmunologyIndian College of Allergy, Asthma and Applied ImmunologyIndonesian Society for Allergy and Immunology

Israel Society of Allergy and Clinical ImmunologyItalian Society for Allergology and Clinical ImmunologyJapanese Society of AllergologyKorean Society of AllergologyLebanese Society of Allergy and ImmunologyMalaysian Society of Allergy and ImmunologyMexican College of Pediatricians Specialized in Allergy and Clinical ImmunologyMexican College of Allergy, Asthma and Clinical ImmunologyMongolian Society of AllergologyNetherlands Society of AllergologyNorwegian Society of Allergology and ImmunopathologyParaguayan Society of Immunology and AllergyPeruvian Society of Allergy and ImmunologyPhilippine Society of Allergy, Asthma and ImmunologyPolish Society of AllergologyPortuguese Society of Allergology and Clinical ImmunologyRomanian Society of Allergology and Clinical ImmunologyRussian Association of Allergology and Clinical ImmunologyAllergy Society of South AfricaSingapore Society of Immunology, Allergy & RheumatologySpanish Society of Allergology and Clinical ImmunologySwedish Association for AllergologySwiss Society for Allergology and ImmunologyAllergy and Immunology Society of ThailandTurkish National Society of Allergy and Clinical ImmunologyUkrainian Association of Allergologists and ImmunologyUruguayan Society of AllergologyVenezuelen Society of Allergy and ImmunologyVietnam Association of Allergy, Asthma and Clinical ImmunologyZimbabwe Allergy Society

For WAO membership information please contact the SecretariatWWWWWorld Allergy Orgnanization (World Allergy Orgnanization (World Allergy Orgnanization (World Allergy Orgnanization (World Allergy Orgnanization (WAO)AO)AO)AO)AO)

555 East Wells Street, Suite 1100 • Milwaukee, WI 53202-3823 USATel: +1 414 276 1791 • Fax: +1 414 276 3349

e-mail: [email protected] site: www.worldallergy.org

The Asian Pacific Association of Allergology and Clinical ImmunologyCIS Society of Immunology and AllergologyEuropean Academy of Allergology and Clinical ImmunologyLatin American Society of Allergy and Immunology

Czech Society of Allergology and Clinical ImmunologyEcuadorian Society of Allergology and Affiliated SciencesEgyptian Society of Pediatric Allergy and ImmunologyItalian Association of Territorial and Hospital Allergists

International Association of Asthmology

Latvian Association of AllergistsPanamanian Association of Allergology and Clinical ImmunologyAssociation of Allergy and Clinical Immunology of Serbia and Montenegro

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Dear Colleagues and Friends,

It is my pleasure to welcome you to the American College of Allergy, Asthma and Immunology Annual Scientific Meeting,and to the 27th World Allergy Forum symposium, “The Management of Severe Asthma”The Management of Severe Asthma”The Management of Severe Asthma”The Management of Severe Asthma”The Management of Severe Asthma”. The World Allergy Forum is thelongest-running educational program of World Allergy Organization (WAO), and we are proud to bring you an excellentinternational faculty for today’s symposium. WAO sincerely recognizes the unrestricted educational grant, provided byNovartis and Genentech, which supports the World Allergy Forum program.

WAO is an alliance of allergy and clinical immunology societies, and currently represents almost 80 Allergy and ClinicalImmunology Societies around the world. Partnership with our member organizations is essential for the success of WAOand the worldwide development of Allergy as a specialty. I would like to warmly thank Dr. Mike Zitt and ACAAI forhosting today’s World Allergy Forum presentation.

In 2005, as an addition to World Allergy Forum and the well-established Global Resources in Allergy - GLORIATM

program, WAO launched the Seminars & Conferences Program. This new program offers member societies the opportu-nity to apply for WAO Lectureships at member society meetings, to provide an international speaker to lecture on a topicof the society’s choice. WAO is very proud of the outstanding educational programs it offers, and in collaboration with theACAAI, WAO is now working to bring GLORIATM to regional and local allergy meetings in the United States. This projectis currently under development, but we urge you to regularly visit the WAO Web site: www www www www www.worldallergy.worldallergy.worldallergy.worldallergy.worldallergy.org.org.org.org.org for updatesabout the program.

To automatically receive updates on WAO activities and membership benefits, register for WAO News and Notes, ourmonthly e-letter. Each e-letter offers a review of the latest allergy papers published in the major journals, news from ourmember societies, information about WAO happenings, and other items, such as new allergy book reviews and educa-tional synopses on all aspects of allergic disease. To subscribe to our e-letter, please visit wwwwwwwwwwwwwww.worldallergy.worldallergy.worldallergy.worldallergy.worldallergy.org.org.org.org.org.

Thank you for attending this World Allergy Forum symposium today and for your valuable contribution to the specialty ofallergy.

With my best regards,

Prof. G. Walter Canonica

World Allergy Organization Secretary General

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Dear Colleagues,

In this era of economic rationalism, physicians like everyone else, must give good account for the money spent onmedications and health care delivery, and they need to be able to justify expenditure in terms of cost benefit analyses. Inorder to do this, physicians have had to learn the language of the accountant and use the tools of the economist.

The World Allergy Organization is very pleased to present its World Allergy Forum at the 2005 American College ofAllergy, Asthma and Immunology meeting in Anaheim. In the symposium, three experts will address the topic “UnmetNeeds and Economic Burden of Asthma”.

Dr Michael Blaiss will discuss the ways in which health care costs are considered and will discuss direct, indirect andintangible costs as they apply to the management of patients with severe asthma so that we may then consider theeconomic burden of this disease upon the individual and the community.

It will become clear that severe asthma consumes a disproportionate share of health care resources with half the costsoccurring in the most severe 10% of the asthmatic population. According to Cisternas et al (J Allergy Clin Immunol2003;111:1212-8), pharmaceuticals are the largest contributor to total health care costs in asthma, particularly in mildasthma. It is interesting to note that as disease severity increases from mild to severe, the percentages of total costsattributed to medication declines from 47% to 19%. Effective controller medications have been demonstrated to reduceother high-cost components of health care including hospitalizations. The expenses of the treatment failures are magnifiedin both increased need for hospitalization and indirect costs.

Dr Michael Kaliner will present the findings of the TENOR study and discuss insights it has given us into the impact ofsevere and difficult-to-treat asthma on patients and on the health care system. Despite being on multiple standard-of-caremedications, including high dose inhaled CCS, LABA and leukotriene antagonists, the TENOR cohort reports surprisinglyhigh rates of healthcare utilization, most notably patients requiring hospitalization or ER care, as well as a high number ofpatients with a history of intubation.

The reasons why such patients have problems such as concomitant disease and lack of compliance are explored. TheTENOR study highlights the need for every physician caring for patients with severe asthma to optimize management byfocusing on issues such as patient education, minimizing the impact of allergic triggers and managing concomitantdisease such as GERD, sinusitis and sleep apnoea. In this particular population we must continue to strive for newtreatments with the ability to enhance control and decrease asthma exacerbations. In the context of severe asthma,expensive new medications such as omalizumab are potentially cost effective options needing careful consideration. Prof.Carlos Baena-Cagnani will address the treatment of severe asthma and present results of the Investigation of Omalizumabin Severe Asthma Treatment (INNOVATE) study.

Prof. Constance H. Katelaris

World Allergy Organization Treasurer

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Michael A. Kaliner, MDMedical DirectorInstitute for Asthma and AllergyChevy Chase and Wheaton, Maryland

Michael Kaliner is Medical Director of the Institute for Asthma andAllergy in Chevy Chase and Wheaton, MD. Among his achieve-ments, Dr. Kaliner has been Head of Allergic Diseases and theTraining Program Director of Allergy and Immunology at the Na-tional Institutes of Health; President of the American Academy ofAllergy, Asthma and Immunology; Chairman of the American Boardof Allergy and Immunology; a member of the Executive Commit-tee of the Joint Council of Allergy and Immunology, President ofthe Allergy and Immunology Section of the American ThoracicSociety; and currently is President-elect of the World Allergy Or-ganization. In 2004, he co-founded Strategic PharmaceuticalAdvisors, a professional pharmaceutical consulting company.

An avid teacher and researcher, Dr. Kaliner has published morethan 475 articles, reviews, and books relating to allergies, sinusi-tis and asthma. He has edited magazines for patients, such asBreathe Well, which he created, and for physicians, such as TheCurrent Report on Asthma and Allergy, which he also created. Hehas been Editor or on the Editorial Boards of many allergy andasthma journals, including the Journal of Allergy and Clinical Im-munology, E-medicine and the Journal of the World Allergy Or-ganization.

Dr. Kaliner was Head of the Allergy and Asthma Program at theNational Institutes of Health for 18 years before founding theInstitute for Asthma and Allergy, which is a state-of-the-art researchand clinical program designed for difficult-to-manage patients inthe mid-Atlantic area of the United States. Dr. Kaliner is recog-nized on the “Best Doctor” lists of The Best Doctors in America,American Health Magazine, Clinical Guide to Top Doctors, Ameri-ca’s Top Doctors, and The Washingtonian Magazine. In 1995,he received the Gold Key Award from the University of MarylandMedical School as their outstanding alumnus. In 2006 he will behonored to be the recipient of the American Academy of Allergy,Asthma and Immunology’s Distinguished Clinician Award.

Dr. Kaliner earned his MD from the University of Maryland anddid his post-graduate training at the Hospital of the University ofMaryland, the University of California in San Francisco, andHarvard University School of Medicine.

The Natural History of Severe Asthma

AbstractThe Unmet Needs in Asthma will cover some epidemiologicand experimental observations that indicate that asthma continuesto be a difficult disease to manage, that many patients are notadequately controlled and that even when under excellent care,asthmatics continue to have exacerbations requiring urgent care,emergency room visits, and hospitalizations. While the currentmedications we employ are excellent, there is a significant portionof patients who do not respond adequately to them or fail to usethem properly. Thus, there remains a large segment of theasthmatic population which is under treated and remains at risk.Identifying these unmet needs is the first step towards creatingapproaches and identifying strategies that work for this largesegment of the diseased population

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Carlos E. Baena-Cagnani, MDCatholic University of CordobaCordoba, Argentina

Treatment of Options for Severe Asthma

Professor Carlos E. Baena-Cagnani, a specialist in allergology,immunology and respiratory medicine, is the President of theWorld Allergy Organisation (WAO). He is a professor in thePostgraduate Department of the Faculty of Medicine at the Catho-lic University, Cordoba, Argentina. He is past President of theLatin American Society of Allergy and Immunology and theArgentinean Association of Allergy and Clinical Immunology.He is a member of the Global Initiative for Asthma (GINA) As-sembly, and currently Prof. Baena-Cagnani is a member of theExecutive Committee and Latin America Chairman for the ARIA–WHO committee. He trained in allergy and respiratory medi-cine at the University Clinic of the University of Navarra,Pamplona, Spain, and completed his speciality training in clini-cal research at the South Florida University in Tampa, USA. Hismain research interests focus on the epidemiology of asthmaand allergy, with a particular emphasis on risk factors includingallergen exposure. Professor Baena-Cagnani is also involved inclinical trials for the treatment of asthma and rhinitis and their co-morbidities, and sublingual immunotherapy in children. He haspresented at more than 250 meetings and seminars throughoutthe world on such topics as asthma, rhinitis and immunotherapy,and has implemented educational asthma plans in different LatinAmerican countries. Additionally, he has coordinated the phaseIII International Study of Asthma and Allergies in Childhood(ISAAC) in Argentina. Professor Baena-Cagnani is a member ofthe editorial board and contributing editor of several interna-tional scientific journals, and has published numerous manuscriptsin peer-reviewed journals.

AbstractSevere Asthma

The prevalence of asthma is rising all over the world and there isevidence that the number of patients suffering from severe asthmahas increased. This is a very important issue since patients withsevere asthma incur 50 percent of the public health expenditureon asthma. Severe asthma induces a dramatic deterioration inquality of life, with social and economic implications, as well asthe anxiety associated with near fatal asthma or the potential ofan asthma death.

Options evauated for the treatment of severe asthma includecyclosporin, methrotrexate, gold salts, IVIG, among others, how-ever, the outcomes are variable and unpredictable, and there-fore, these medications are not adequate treatment options forsevere asthma. Recently, omalizumab, a humanized monoclonalantibody against IgE, has been launched in some countries in-cluding the U.S., and it has also recently been approved in theEuropean Union. IgE is pathologically associated with allergicasthma, and omalizumab is recommended for administration inpatients with severe allergic asthma.

Clinical studies have clearly demonstrated that omalizumab iseffective and safe in patients suffering from severe asthma.Omalizumab significantly reduced emergency room visits as wellas unscheduled doctor visits, and also asthma-relatedhospitalizations in both children and adults. In addition,omalizumab was shown to significantly increase the quality oflife of patients suffering from severe asthma. Clinical efficacywas demonstrated by patients being able to reduce corticoster-oid doses, and lung function was improved. An anti-inflamma-tory effect of omalizumab has also been demonstrated. It has anexcellent safety profile, with adverse events similar to those foundin the placebo group. Omalizumab is an important new optionfor the treatment of patients with severe allergic asthma.

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Michael Steven Blaiss, MDClinical Professor of Pediatrics and MedicineUniversity of Tennessee Health Sciences Center College of MedicineMemphis, Tennessee

Economic Analysis of the Cost of Treatments for Severe Asthma

Dr. Michael S. Blaiss is Clinical Professor of Pediatrics andMedicine at the University of Tennessee Health Sciences Centerin Memphis and in private practice in Memphis at Allergy &Asthma Care. He has presented at more than 250 meetingsand seminars throughout the world on such topics as allergicrhinitis, asthma, socioeconomic subjects in allergy and asthmaand issues in compliance and adherence. Dr. Blaiss has writtenfor several peer-reviewed journals, including Journal of Pediatrics,Journal of Allergy and Clinical Immunology, and JAMA and severalallergy textbooks. He has co-edited one text, Atlas of AllergicDiseases. In addition, he is a member of the editorial board forthe Journal of Asthma, The World Allergy Organization Journal,Allergy and Asthma Proceedings, and the Annals of Allergy,Asthma and Immunology. Dr. Blaiss is a fellow of the AmericanCollege of Allergy, Asthma and Immunology and the AmericanAcademy of Allergy, Asthma and Immunology. He served on theBoard of Directors for the American Board of Allergy and ClinicalImmunology and is Immediate Past-President of the AmericanCollege of Allergy, Asthma, and Immunology. Dr. Blaiss receivedhis medical degree from the University of Tennessee Center forHealth Sciences. After completing his residency at Le BonheurChildren’s Medical Center, he completed a fellowship in allergy/immunology at Ochsner Medical Foundation in New Orleans,Louisiana.

AbstractEconomic Analysis of the Cost of Treatments for Severe Asthma

Severe asthma consumes a disproportionate share of asthmahealth care resources. We need treatment strategies that mini-mize exacerbations which may decrease the need for unsched-uled medical services, reduced ED visits, and minimizehospitalizations should be cost-effective in asthma care.

Direct Medical Costs-Direct Medical Costs-Direct Medical Costs-Direct Medical Costs-Direct Medical Costs-1) The amount of money spent on medical services directly dueto an illness. This includes hospital care, pharmaceutical prod-ucts, physician care, nursing services, etc.2) The amount of resources consumed directly to produce acertain outcome such as personnel time, equipment, supplies,etc.

Direct Non-medical Costs-Direct Non-medical Costs-Direct Non-medical Costs-Direct Non-medical Costs-Direct Non-medical Costs-1) Expenditures outside the medical market such as costs borneby patients seeking care. This includes costs such as transporta-tion, child care, and lodging, etc.

Indirect Costs-Indirect Costs-Indirect Costs-Indirect Costs-Indirect Costs-1) Costs resulting from a patient being unable to perform normalactivities due to illness and therefore borne by the patient, thepatient’s family, or an employer.2) Expenditures or losses as an indirect consequence of illness orconsumption of medical care. Examples include lost earnings,decreased productivity.3) Economic value of changes in health status as measured bylost wages, willingness to pay, or human capital theory.

Intangible Costs-Intangible Costs-Intangible Costs-Intangible Costs-Intangible Costs-1) Include humanistic measures of changes in health status suchas quality of life and satisfaction.

Costs disproportionately affects those with most severedisease:severe asthma 50% costs (10% population)mild asthma 20% costs (70% population)

Medical management can lead to cost savings in severe asthma.Combination therapy with inhaled corticosteroids and long-act-ing beta agonist has been documented to decrease ED visitsand hospitalizations. In severe and difficult-to-treat asthmatics,omalizumab prevented the development of exacerbations in 17additional patients for every 100 treated. This corresponds to aprevented fraction of 50% in the incidence of exacerbations inpatients randomized to omalizumab. In the INNOVATE study(Humbert M, Beasley R, Ayres J et al. Allergy 2005; 60:309-16), omalizumab decreased hospital admission rate to 1 admis-sion for every 8 treated patients per year compared to 1 admis-sion for every 4 placebo patients per year. Further studies areneeded to measure economic outcomes in the treatment of se-vere asthma.

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