Allergen immunotherapy: A practice parameter third update

1 Task force reportAllergen immunotherapy: A practice parameter third updateChief Editors: Linda Cox, MD, Harold Nelson, MD, and Richard Lockey, MDWorkgroup Contributors: Christopher Calabria, MD, Thomas Chacko, MD, Ira Finegold, MD, Michael Nelson, MD, PhD,and Richard Weber, MDTask Force Reviewers: David I. Bernstein, MD, Joann Blessing-Moore, MD, David A. Khan, MD, David M. Lang, MD,Richard A. Nicklas, MD, John Oppenheimer, MD, Jay M. Portnoy, MD, Christopher Randolph, MD, Diane E. Schuller, MD,Sheldon L. Spector, MD, Stephen Tilles, MD, and Dana Wallace, MDKeywords:Allergy immunotherapy, subcutaneous immunotherapy,sublingual immunotherapy, allergic rhinitis, asthma, Hymenoptera,atopic dermatitis, anaphylaxis, epinephrine,b-blockers, angioten-sin-converting enzyme inhibitor, epicutaneous immunotherapy, in-tralymphatic immunotherapy, nasal immunotherapyThese parameters were developed by the Joint Task Force onPractice Parameters, representing the American Academy ofAllergy, Asthma & Immunology (AAAAI); the American Col-lege of Allergy, Asthma & Immunology (ACAAI); and the JointCouncil of Allergy, Asthma & Immunology.

2 The AmericanAcademy of Allergy, Asthma & Immunology and the AmericanCollege of Allergy, Asthma & Immunology have jointly acceptedresponsibility for establishing Allergen immunotherapy: Apractice parameter third update . This is a complete and com-prehensive document at the current time. The medical environ-ment is a changing environment, and not all recommendationswill be appropriate for all patients. Because this documentincorporated the efforts of many participants, no single individ-ual, including those who served on the Joint Task Force, isauthorized to provide an official AAAAI or ACAAI interpretationof these practice parameters. Any request for information about oran interpretation of these practice parameters by the AAAAI orthe ACAAI should be directed to the Executive Offices of theAAAAI, the ACAAI, and the Joint Council of Allergy, Asthma &Immunology. These parameters are not designed for use bypharmaceutical companies in drug promotion.

3 A current list ofpublished practice parameters of the Joint Task Force on PracticeParameters for Allergy and Immunology can be found in Table E1in this article s Online Repository Joint Task Force has made a concerted effort to acknowl-edge all contributors to this parameter . If any contributors havebeen excluded inadvertently, the Task Force will ensure thatappropriate recognition of such contributions is made subse-quently. The Joint Task Force gratefully acknowledges theAAAAI board of Directors and the ACAAI board of Regentsfor their review and support of this authors and editors gratefully acknowledge Susan Grupeand Jessica Karle for their administrative EDITORSL inda Cox, MDDepartment of Medicine Nova Southeastern UniversityCollege of Osteopathic MedicineDavie, FloridaRichard Lockey, MDDivision of Allergy and ImmunologyDepartment of Internal MedicineDisclosure of potential conflict of interest: L. Cox is a consultant for Genentech/Novartis,Hollister-Stier, and Stallergenes; is a speaker for Novartis; has received researchsupport from Stallergenes; is on the board of Directors for the American board ofAllergy and Immunology; and is on the US Food and Drug Administration (FDA) sAllergenic Product Advisory Committee.

4 H. Nelson is a consultant for Merck andPlanet Biopharmaceuticals, is a Data and Safety Monitoring board member of DBVT echnologies, and has received research support from ALK-Abell o. M. Nelson has re-ceived research support from the Department of Defense, is a speaker for the AmericanCollege of Allergy, Asthma & Immunology (ACAAI), and is a member of the FDA sAdvisory Committee on Allergic Products. R. Weber is on the speakers bureau for As-traZeneca and Genentech, has received research support from Novartis and Glaxo-SmithKline, and is Committee Chair of the ACAAI. D. I. Bernstein is a consultantand on the advisory board for ALK America, is on the advisory board for Merck,and has received research support from Merck and Schering-Plough. J. Blessing-Moore is a speaker for Merck-Schering/AstraZeneca, Novartis, TEVA, and MedaAlcon and has received research support from Meda. D. A. Khan is a speaker for As-traZeneca and Merck, has received research support from the Vanberg Family Foun-dation and the Sellars Family Foundation, is Conjoint board Review Chair for theACAAI, and is a past president of the Texas Allergy, Asthma and Immunology M.

5 Lang is a speaker and consultant for GlaxoSmithKline; is a speaker for Astra-Zeneca, Merck, TEVA, Sanofi-Aventis, and Genentech/Novartis; and has received re-search support from Genentech/Novartis. R. A. Nicklas is a fellow for the ACAAI. is a consultant and has provided lectures for AstraZeneca, Merck, andGlaxoSmithKline; and has received research support from AstraZeneca, Merck, Glax-oSmithKline, and Genentech. J. M. Portnoy is a speaker for Phadia, Merck, and CSLB ehring; has received research support from the US Department of Housing and UrbanDevelopment; and is a board member of the ACAAI board of regents. S. L. Spector hasreceived research support from Genentech, GlaxoSmithKline, Schering-Plough,Aventis, Novartis, Pharmaxis, Boehringer Ingelheim, AstraZeneca, Johnson & John-son, Xyzal, Alcon, Centocor, Sepracor, UCB, Amgen, Capnia, and IVAX. S. Tillesis a speaker for Alcon; is on the advisory board for ALK, Ista, Merck, and Stallergenes;has received research support from Alcon, Amgen, Amphastar, Astellas, BoehringerIngelheim, Ception, Genentech, Icagen, MAP Pharma, MEDA, Merck, Novartis, Rox-ane, and Sepracor; is Associate Editor ofAllergy WatchandAnnals of Allergy; and is atask force member for the Joint Task Force for practice Parameters.

6 D. Wallace is aspeaker and advisor for Alcon, is a speaker for Merck and Sanofi-Aventis, and isPresident-Elect of the ACAAI. The rest of the authors have declared that they haveno conflict of for publication September 18, 2010; accepted for publication September 23, online December 3, requests: Joint Council of Allergy, Asthma & Immunology, 50 N Brockway St,#3-3, Palatine, IL 60067. 2010 American Academy of Allergy, Asthma & of South Florida College of Medicine and James Veterans HospitalTampa, FloridaHarold Nelson, MDDepartment of MedicineNational Jewish HealthDenver, ColoradoWORK GROUP MEMBERSC hristopher Calabria, MDGlen Burnie, MarylandThomas Chacko, MDRoswell, GeorgiaIra Finegold, MDNew York, New YorkMichael Nelson, MD, PhDWashington, DCRichard Weber, MDDenver, ColoradoJOINT TASK FORCE REVIEWERSD avid Bernstein, MDDepartment of Medicine and Environmental HealthUniversity of Cincinnati College of MedicineCincinnati, OhioDavid A. Khan, MDDepartment of Internal MedicineUniversity of Texas Southwestern Medical CenterDallas, TexasJoann Blessing-Moore, MDDepartments of Medicine and PediatricsStanford University Medical CenterDepartment of ImmunologyPalo Alto, CaliforniaDavid M.

7 Lang, MDAllergy/Immunology SectionDivision of Medicine Allergy and Immunology FellowshipTraining ProgramCleveland Clinic FoundationCleveland, OhioRichard A. Nicklas, MDDepartment of MedicineGeorge Washington Medical CenterWashington, DCJohn Oppenheimer, MDDepartment of Internal MedicineNew Jersey Medical SchoolPulmonary and Allergy AssociatesMorristown, New JerseyJay M. Portnoy, MDSection of Allergy, Asthma & ImmunologyThe Children s Mercy HospitalDepartment of PediatricsUniversity of Missouri Kansas City School of MedicineKansas City, MissouriChristopher Randolph, MDYale UniversityNew Haven, ConnecticutDiane E. Schuller, MDDepartment of PediatricsPennsylvania State UniversityMilton S. Hershey Medical CollegeHershey, PennsylvaniaSheldon L. Spector, MDDepartment of MedicineUCLA School of MedicineLos Angeles, CaliforniaStephen A. Tilles, MDDepartment of MedicineUniversity of Washington School of MedicineRedmond, WashingtonDana V. Wallace, MDDepartment of MedicineNova Southeastern UniversityDavie, FloridaINVITED REVIEWERSDon Aaronson, MD, JD, MPHC hicago, IllinoisDesiree Larenas-Linnemann, MDMexico city, MexicoBryan Leatherman, MDGulfport, MississippiSandra Y.

8 Lin, MDJohns Hopkins Department of Otolaryngology Head & NeckSurgeryBaltimore, MarylandOral and sublingual immunotherapy for food hypersensitivityWesley Burkes, MDDuke UniversityRaleigh, North CarolinaVenom hypersensitivityDavid Golden, MDBaltimore, MarylandTheodore M. Freeman, MDHelotes, TexasAllergen extract sectionDerek Constable, PhDSpokane, WashingtonRobert Esch, PhDLenoir, North CarolinaLarry Garner, CPT, BASpokane, WashingtonRichard Lankow, PhDRound Rock, TexasJ ALLERGY CLIN IMMUNOLJANUARY 2011S2 COXETALGreg Plunkett, PhDRound Rock, TexasRonald Rabin, MDRockville, MarylandASSIGNED REVIEWERSPaul Greenberger, MDNorthwestern University Feinberg School of MedicineChicago, IllinoisBryan Martin, DOOhio State UniversityColumbus, OhioPREFACEThis document was developed by the Joint Task Force onPractice Parameters, which represents the American Academy ofAllergy, Asthma & Immunology (AAAAI); the American Col-lege of Allergy, Asthma & Immunology (ACAAI); and the JointCouncil of Allergy, Asthma & Immunology (JCAAI).

9 The objective of Allergen immunotherapy: a practice param-eter third update is to optimize the practice of Allergen immu-notherapy for patients with allergic diseases. This parameter isintended to establish guidelines for the safe and effective use ofallergen immunotherapy while reducing unnecessary variation inimmunotherapy practice . These guidelines have undergone anextensive peer-review process consistent with recommendationsof the American College of Medical Quality Policy on devel-opment and use of practice parameters for medical qualitydecision-making. 1 This document builds on the previous Joint Task Forcedocument Allergen immunotherapy: a practice parametersecond update published in theJournal of Allergy and ClinicalImmunologyin updated practice parameter draftwas prepared by a work group that included 3 of the editorsfrom the second update , Linda Cox, MD; Hal Nelson, MD; andRichard Lockey, MD, and other workgroup members as follows:Christopher Calabria, MD; Thomas Chacko, MD; Ira Finegold,MD; Michael Nelson, MD, PhD; and Richard Weber, preparation for the third update , the workgroup performed acomprehensive search of the medical literature, which wasconducted with various search engines, including PubMed;immunotherapy, allergic rhinitis, asthma, stinging insect allergy,and related search terms were used.

10 In addition to the publishedliterature from the comprehensive search, information fromarticles known to the authors was considered. Published clinicalstudies were rated by category of evidence and used to establishthe strength of a clinical recommendation (Table I).3 Laboratory-based studies were not working draft of Allergen immunotherapy: a practiceparameter third update was reviewed by a large number ofindividuals. Reviewers include persons appointed by theAAAAI, ACAAI, and invited experts. Invited reviewers in-cluded those with known expertise in specific areas (eg, oralimmunotherapy or immunotherapy mechanisms), the US Foodand Drug Administration s (FDA) Center for Biologics Evalu-ation and Research, and the American Academy of OtolaryngicAllergy, who formally endorsed the previous practice scientific representatives of the US AllergenExtract Manufacturers were invited through their organization,the Allergenic Products Manufacturing Association, to reviewand comment on the Allergen extract section.