Allergen Immunotherapy: A Practice Parameter Third Update
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, MDKey words: Allergy immunotherapy, subcutaneous immunotherapy,sublingual immunotherapy, allergic rhinitis, asthma, Hymenoptera,atopic dermatitis, anaphylaxis, epinephrine, b-blockers, angiotensin-converting enzyme inhibitor, epicutaneous immunotherapy, intralymphatic immunotherapy, nasal immunotherapyDisclosure 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. H. Nelson is a consultant for Merck andPlanet Biopharmaceuticals, is a Data and Safety Monitoring Board member of DBVTechnologies, and has received research support from ALK-Abell o. M. Nelson has received 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 AstraZeneca and Genentech, has received research support from Novartis and GlaxoSmithKline, 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. BlessingMoore 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 AstraZeneca and Merck, has received research support from the Vanberg Family Foundation and the Sellars Family Foundation, is Conjoint Board Review Chair for theACAAI, and is a past president of the Texas Allergy, Asthma and Immunology Society.D. M. Lang is a speaker and consultant for GlaxoSmithKline; is a speaker for AstraZeneca, Merck, TEVA, Sanofi-Aventis, and Genentech/Novartis; and has received research support from Genentech/Novartis. R. A. Nicklas is a fellow for the ACAAI. J.Oppenheimer is a consultant and has provided lectures for AstraZeneca, Merck, andGlaxoSmithKline; and has received research support from AstraZeneca, Merck, GlaxoSmithKline, and Genentech. J. M. Portnoy is a speaker for Phadia, Merck, and CSLBehring; 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 & Johnson, 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, Roxane, and Sepracor; is Associate Editor of Allergy Watch and Annals of Allergy; and is atask force member for the Joint Task Force for Practice Parameters. 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 interest.Received for publication September 18, 2010; accepted for publication September 23,2010.Available online December 3, 2010.Reprint requests: Joint Council of Allergy, Asthma & Immunology, 50 N Brockway St,#3-3, Palatine, IL 60067. E-mail: lindaswolfcox@msn.com.0091-6749/ 36.00Ó 2010 American Academy of Allergy, Asthma & Immunologydoi:10.1016/j.jaci.2010.09.034These parameters were developed by the Joint Task Force onPractice Parameters, representing the American Academy ofAllergy, Asthma & Immunology (AAAAI); the American College of Allergy, Asthma & Immunology (ACAAI); and the JointCouncil of Allergy, Asthma & Immunology. 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 comprehensive document at the current time. The medical environment is a changing environment, and not all recommendationswill be appropriate for all patients. Because this documentincorporated the efforts of many participants, no single individual, 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. 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 at www.jacionline.org.CONTRIBUTORSThe Joint Task Force has made a concerted effort to acknowledge all contributors to this parameter. If any contributors havebeen excluded inadvertently, the Task Force will ensure thatappropriate recognition of such contributions is made subsequently. The Joint Task Force gratefully acknowledges theAAAAI Board of Directors and the ACAAI Board of Regentsfor their review and support of this document.The authors and editors gratefully acknowledge Susan Grupeand Jessica Karle for their administrative assistance.CHIEF EDITORSLinda Cox, MDDepartment of Medicine Nova Southeastern UniversityCollege of Osteopathic MedicineDavie, FloridaRichard Lockey, MDDivision of Allergy and ImmunologyDepartment of Internal MedicineS1
S2 COX ET ALUniversity of South Florida College of Medicine and James A.Haley Veterans’ HospitalTampa, FloridaHarold Nelson, MDDepartment of MedicineNational Jewish HealthDenver, ColoradoWORK GROUP MEMBERSChristopher Calabria, MDGlen Burnie, MarylandThomas Chacko, MDRoswell, GeorgiaIra Finegold, MDNew York, New YorkMichael Nelson, MD, PhDWashington, DCRichard Weber, MDDenver, ColoradoJOINT TASK FORCE REVIEWERSDavid Bernstein, MDDepartment of Medicine and Environmental HealthUniversity of Cincinnati College of MedicineCincinnati, OhioJ ALLERGY CLIN IMMUNOLJANUARY 2011University 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, MPHChicago, IllinoisDavid A. Khan, MDDepartment of Internal MedicineUniversity of Texas Southwestern Medical CenterDallas, TexasDesiree Larenas-Linnemann, MDMexico city, MexicoJoann Blessing-Moore, MDDepartments of Medicine and PediatricsStanford University Medical CenterDepartment of ImmunologyPalo Alto, CaliforniaSandra Y. Lin, MDJohns Hopkins Department of Otolaryngology–Head & NeckSurgeryBaltimore, MarylandOral and sublingual immunotherapy for food hypersensitivityDavid M. Lang, MDAllergy/Immunology SectionDivision of Medicine Allergy and Immunology FellowshipTraining ProgramCleveland Clinic FoundationCleveland, OhioWesley Burkes, MDDuke UniversityRaleigh, North CarolinaVenom hypersensitivityRichard 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 PediatricsBryan Leatherman, MDGulfport, MississippiDavid Golden, MDBaltimore, MarylandTheodore M. Freeman, MDHelotes, TexasAllergen extract sectionDerek Constable, PhDSpokane, WashingtonRobert Esch, PhDLenoir, North CarolinaLarry Garner, CPT, BASpokane, WashingtonRichard Lankow, PhDRound Rock, Texas
J ALLERGY CLIN IMMUNOLVOLUME 127, NUMBER 1Greg 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 College of Allergy, Asthma & Immunology (ACAAI); and the JointCouncil of Allergy, Asthma & Immunology (JCAAI).The objective of ‘‘Allergen immunotherapy: a practice parameter third update’’ is to optimize the practice of allergen immunotherapy 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 development and use of practice parameters for medical qualitydecision-making.’’1This document builds on the previous Joint Task Forcedocument ‘‘Allergen immunotherapy: a practice parametersecond update’’ published in the Journal of Allergy and ClinicalImmunology in 2007.2 The 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, MD.In 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. 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 Laboratorybased studies were not rated.The 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 included those with known expertise in specific areas (eg, oralimmunotherapy or immunotherapy mechanisms), the US Foodand Drug Administration’s (FDA) Center for Biologics Evaluation and Research, and the American Academy of OtolaryngicAllergy, who formally endorsed the previous practice parameterupdate.4 The scientific representatives of the US AllergenCOX ET AL S3Extract Manufacturers were invited through their organization,the Allergenic Products Manufacturing Association, to reviewand comment on the allergen extract section. All of these invited reviewers who contributed to the document are acknowledged for their efforts within the particular section that theyreviewed.In addition, the draft was posted on the ACAAI and AAAAIWeb sites with an invitation for members to review and comment.The authors carefully considered all of these comments inpreparing the final version.An annotated algorithm in this document summarizes the keydecision points for the appropriate use of allergen immunotherapy(Fig 1). The section on efficacy summarizes the evidence demonstrating that allergen immunotherapy is effective in the management of properly selected patients with aeroallergen andstinging insect hypersensitivity. This document also contains recommendations for optimizing the efficacy and safety of allergenimmunotherapy, including specific recommendations on prevention and management of adverse reactions and a uniform classification system for grading systemic reactions.Specific recommendations guide the physician in selectingthose patients for whom allergen immunotherapy is appropriate. Aeroallergen immunotherapy should be considered forpatients who have symptoms of allergic rhinitis/conjunctivitisor asthma with natural exposure to allergens and who demonstrate specific IgE antibodies to the relevant allergen orallergens. There is also some evidence that patients with atopicdermatitis with aeroallergen sensitivity might benefit fromimmunotherapy.Candidates for immunotherapy are patients whose symptomsare not controlled adequately by medications and avoidancemeasures or those experiencing unacceptable adverse effects ofmedications or who wish to reduce the long-term use of medications. Immunotherapy is recommended for patients with ahistory of a systemic reaction to Hymenoptera stings whodemonstrate Hymenoptera-specific IgE antibodies. There is evidence that venom immunotherapy (VIT) might be effective inreducing large local reactions (LLRs) that might cause significantmorbidity and impair quality of life.The focus of this parameter is on allergen immunotherapypractice in the United States. Although several studies havedemonstrat
Allergy, Asthma & Immunology (AAAAI); the American Col-lege of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy, Asthma & Immunology (JCAAI). 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.
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