James L. Sublett

International Consensus on Allergen Immunotherapy II: Mechanisms, standardization, and pharmacoeconomics

This article continues the comprehensive international consensus (ICON) statement on allergen immunotherapy (AIT). The initial article also recently appeared in the Journal. The conclusions below focus on key mechanisms of AIT-triggered tolerance, requirements in allergen standardization, AIT cost-effectiveness, and regulatory guidance. Potential barriers to and facilitators of the use of AIT are described in addition to future directions. International allergy specialists representing the European Academy of Allergy and Clinical Immunology; the American Academy of Allergy, Asthma & Immunology; the American College of Allergy, Asthma and Immunology; and the World Allergy Organization critically reviewed the existing literature and prepared this summary of recommendations for best AIT practice. The authors contributed equally and reached consensus on the statements presented herein.

Environmental assessment and exposure control of dust mites: a practice parameter

Jay Portnoy, MD; Jeffrey D. Miller, MD; P. Brock Williams, PhD; Ginger L. Chew, ScD *; J. David Miller, PhD; Fares Zaitoun, MD; Wanda Phipatanakul, MD, MS; Kevin Kennedy, MPH; Charles Barnes, PhD; Carl Grimes, CIEC; Desiree Larenas-Linnemann, MD; James Sublett, MD; David Bernstein, MD; Joann Blessing-Moore, MD; David Khan, MD; David Lang, MD; Richard Nicklas, MD; John Oppenheimer, MD; Christopher Randolph, MD; Diane Schuller, MD; Sheldon Spector, MD; Stephen A. Tilles, MD; and Dana Wallace, MD Chief Editors: Jay Portnoy, MD; Jeffrey D. Miller, MD; P. Brock Williams, PhD; Ginger L. Chew, ScD* Members of the Joint Taskforce on Practice Parameters: David Bernstein, MD; Joann Blessing-Moore, MD; David Khan, MD; David Lang, MD; Richard Nicklas, MD; John Oppenheimer, MD; Jay Portnoy, MD; Christopher Randolph, MD; Diane Schuller, MD; Sheldon Spector, MD; Stephen A. Tilles, MD; Dana Wallace, MD

Environmental assessment and exposure control: a practice parameter—furry animals

Members of the Joint Task Force onPractice Parameters:David Bernstein,MD, Joann Blessing-Moore,MD, Linda Cox,MD, David Khan,MD, David Lang,MD, RichardNicklas, MD, John Oppenheimer, MD, Jay Portnoy, MD, Christopher Randolph, MD, Diane Schuller, MD, Sheldon Spector, MD, Stephen A. Tilles, MD, Dana Wallace, MD Practice ParameterWork Group: James Sublett, MD, cochair, Kevin Kennedy, MPH, cochair, Charles Barnes, PhD, David Bernstein, MD, Jonathan Bernstein, MD, Carl Grimes, Elizabeth Matsui, MD, Jeffrey D. Miller, MD, J. David Miller, PhD, Wanda Phipatanakul, MD, MS, James Seltzer, MD, P. Brock Williams, PhD Invited Reviewers: Jack Armstrong, Hans Gr×nlund, PhD, Kraig W. Jacobson, MD, Jill A. Poole, MD, Matthew A Rank, MD, Megan Taylor, MD This parameter was developed by the Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma and Immunology, the American College of Allergy, Asthmaand Immunology, and the Joint Council of Allergy, Asthmaand Immunology. The American Academy of Allergy, Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI) have jointly accepted responsibility for establishing “Environmental Assessment and Remediation: A Practice Parameter.” This is a complete and comprehensive document at the current time. The medical environment is a changingenvironment, andnotall recommendationswillbeappropriate forallpatients.Because thisdocument incorporatedtheeffortsofmanyparticipants,nosingle individual, including thosewhoservedontheJointTaskForce, isauthorizedtoprovideanofficialAAAAIorACAAIinterpretationofthesepracticeparameters.Anyrequestforinformationaboutoraninterpretation of these practice parameters by the AAAAI or ACAAI should be directed to the executive offices of the AAAAI, the ACAAI, and the Joint Council of Allergy, Asthma and Immunology. These parameters are not designed for use bypharmaceutical companies in drugpromotion. Reprints: Joint Council of Allergy, Asthmaand Immunology, 50NBrockway St, #3-3 Palatine, IL 60067. Disclosures: The following is a summaryof interests disclosedonWorkGroupmembers’ Conflict of InterestDisclosure Statements (not including information concerning familymember interests). Completed Conflict of Interest Disclosure Statements are available on request. Dr. Sublett is the owner of AllergyZone. Dr. Portnoy is a speaker and consultant for ThermoFisher (Phadia). Dr. Barnes is a consultant for and has received research funding from Clorox Corporation. Mr. Grimes is the owner of Healthy Habitats LLC. Dr. Matsui is speaker for Indoor BioTechnologies.Dr.Miller is theownerofMission:Allergy Inc.Dr. Seltzer is thePresident of JamesM. Seltzer, Assoc. TheotherWorkGroupmembershaveno conflicts todisclose. The Joint Task Force recognizes that experts in a field are likely to have interests that could come into conflictwith development of a completely unbiased and objective practice parameter. To take advantage of that expertise, a process has beendeveloped to prevent potential conflicts from influencing thefinal document in a negativeway. At theworkgroup level,memberswhohaveapotential conflictof interest eitherdonotparticipate indiscussions concerning topics related to thepotential conflictor, if theywrite a section onthattopic, theworkgroupcompletelyrewritesitwithouttheir involvementtoremovepotentialbias. Inaddition,theentiredocumentisreviewedbytheJointTaskForce,andanyapparent bias is removedat that level. Finally, thepracticeparameter is sent for reviewbothby invited reviewersandbyanyonewithan interest in the topicbyposting thedocumenton thewebsites of theACAAI and theAAAAI. In particular, the 2 owners of companies that produce products discussed in this practice parameter are Jeffrey D. Miller, MD, and James Sublett, MD. DrMiller wrote an initial section on mattress encasings. This section was then completely rewritten by other members of the work groupwithout his participation. Dr Sublett wrote a preliminary draft of the section on air filtration. That sectionwas also subsequently rewritten by othermembers of thework groupwithout his participation. Neither participant provided subsequent input into those sections. The Joint Task Force has made a concerted effort to acknowledge all contributors to this parameter. If any contributors have been excluded inadvertently, the Task Force will ensure that appropriate recognition of such contributions ismade subsequently. Work Group Cochairs: James Sublett,MD, FamilyAllergy andAsthma, Louisville, Kentucky; KevinKennedy,MPH, Center for EnvironmentalHealth, Children’sMercyHospitals C JointTaskForceLiaison:JayM.Portnoy,MD,SectionofAllergy,Asthma& Immunology, TheChildren’sMercyHospitalsC JointTaskForceMembers:David I. Bernstein,MD,DepartmentofClinical,MedicineandEnvironmentalHealth,Division ofAllergy/Immunology,UniversityofCincinnati,CollegeofMedicine,Cincinnati,Ohio; JoannBlessing-Moore,MD,Departmentof Immunology,StanfordUniversityMedicalCenter,PaloAlto, California; Linda Cox, MD, Department of Medicine, Nova Southeastern University College of Osteopathic Medicine, Davie, Florida; David A. Khan, MD, Department of Internal Medicine, University of Texas, Southwestern Medical Center, Dallas, Texas; David M. Lang, MD, Allergy/Immunology Section, Division of Medicine, Allergy and Immunology Fellowship Training Program, Cleveland Clinic Foundation, Cleveland, Ohio; Richard A. Nicklas, MD, Department of Medicine, George Washington Medical Center, Washington, DC; John Oppenheimer, MD, Departmentof InternalMedicine,NewJerseyMedicalSchool,PulmonaryandAllergyAssociates,Morristown,NewJersey; JayM.Portnoy,MD,SectionofAllergy,AsthmaI Christopher C. Randolph, Department of Pediatrics,YaleAffiliatedHospitals,Center forAllergy,Asthma,IDianeE.Schuller,MD,DepartmentofPediatrics,PennsylvaniaStateUniversityMilton S.HersheyMedical College,Hershey, Pennsylvania; SheldonL. Spector,MD,DepartmentofMedicine,UCLASchool ofMedicine, LosAngeles, California; StephenA. Tilles,MD,Departmentof Medicine,UniversityofWashington,SchoolofMedicine,Redmond,Washington;DanaWallaceMD,DepartmentofMedicine,NovaSoutheasternUniversityCollegeofOsteopathicMedicine, Davie, Florida;ParameterWorkGroupMembers:CharlesBarnes,PhD,AllergyResearch,TheChildren’sMercyHospitalsCDavid I.Bernstein,MD,Department of Clinical Medicine, Division of Immunology, University of Cincinnati College of Medicine, Cincinnati, Ohio; Jonathan A. Bernstein, MD, Department of Internal Medicine, Division of Immunology/Allergy Section, University of Cincinnati College of Medicine, Cincinnati, Ohio; Carl Grimes, CIEC, Healthy Habitats LLC, Denver, Colorado; Elizabeth Matsui, MD, MHS, Department of Pediatrics, Johns Hopkins School ofMedicine, Baltimore,Maryland; Jeffrey D.Miller, MD, Department of Pediatrics, NewYorkMedical College, Valhalla, NewYork; J. David Miller,PhD,DepartmentofBiochemistry,CarltonUniversity,Ottawa,Ontario,Canada;WandaPhipatanakul,MD,MS,DepartmentofPediatrics,DivisionofAllergyandImmunology,Harvard Medical School, Children’s Hospital Boston, Boston, Massachusetts; JamesM. Seltzer, MD, RelianceMedical Group, Department of Allergy and Immunology,Worcester, Massachusetts; P. BrockWilliams,PhD,DepartmentofAllergy/Immunology,UniversityofMissouri–KansasCitySchoolofMedicineandTheChildren’sMercyHospitalsC Invited Reviewers: Jack Armstrong, MD, Medical Arts Allergy, P.C., Carlisle, Pennsylvania; Hans Gr×nlund, PhD, Department of Immunology, Clinical Immunology and Allergy Unit Karolinska Institute,Stockholm,Sweden;KraigW.Jacobson,MD,CPI,OregonAllergyAssociates,AllergyandAsthmaResearchGroup,Eugene,Oregon;JillA.Poole,MD,DepartmentofMedicine,Division ofAllergy, Asthma& Immunology,University ofNebraskaMedical Center,Omaha,Nebraska;MatthewARank,MD,DivisionofAllergicDiseases,MayoClinic, Rochester,Minnesota;Megan Taylor,MD, Allergy&AsthmaCare, Jenkintown, Pennsylvania.

Practice parameterEnvironmental assessment and exposure control of dust mites: a practice parameter

Jay Portnoy, MD; Jeffrey D. Miller, MD; P. Brock Williams, PhD; Ginger L. Chew, ScD *; J. David Miller, PhD; Fares Zaitoun, MD; Wanda Phipatanakul, MD, MS; Kevin Kennedy, MPH; Charles Barnes, PhD; Carl Grimes, CIEC; Desiree Larenas-Linnemann, MD; James Sublett, MD; David Bernstein, MD; Joann Blessing-Moore, MD; David Khan, MD; David Lang, MD; Richard Nicklas, MD; John Oppenheimer, MD; Christopher Randolph, MD; Diane Schuller, MD; Sheldon Spector, MD; Stephen A. Tilles, MD; and Dana Wallace, MD Chief Editors: Jay Portnoy, MD; Jeffrey D. Miller, MD; P. Brock Williams, PhD; Ginger L. Chew, ScD* Members of the Joint Taskforce on Practice Parameters: David Bernstein, MD; Joann Blessing-Moore, MD; David Khan, MD; David Lang, MD; Richard Nicklas, MD; John Oppenheimer, MD; Jay Portnoy, MD; Christopher Randolph, MD; Diane Schuller, MD; Sheldon Spector, MD; Stephen A. Tilles, MD; Dana Wallace, MD

Effectiveness of Air Filters and Air Cleaners in Allergic Respiratory Diseases: A Review of the Recent Literature

Air filtration is frequently recommended as a component of environmental control measures for patients with allergic respiratory disease. Residential air filtration can be provided by whole house filtration via the home’s heating, ventilation, or air conditioning system, by portable room air cleaners, or a combination of the two. Appliances to filter the sleep breathing zone also have been developed. High-efficiency whole house filtration, high-efficiency particulate air sleep zone air filtration, and high-efficiency particulate air room air cleaners all appear to provide various degrees of benefit. Recent studies of various types of filtration, used alone or as part of more comprehensive environmental control measures, are reviewed.

Surveying the new Allergic and hypersensitivity conditions chapter of the International Classification of Diseases (ICD)-11.

Over the last 4 years, a strategic action plan has been put in practice for a better classification of the allergic and hypersensitivity conditions in the ongoing International Classification of Diseases (ICD)-11 revision. The actions so far have been unwaveringly acknowledged by the Joint Allergy Academies and documented by peer-reviewed publications (1–7). Meanwhile, we started a bilateral collaboration with the World Health Organization (WHO) ICD revision governance. The main outcome of the process was the construction of the ‘Allergic and hypersensitivity conditions’ sections under the ‘Immune system disorders’ chapter of the ICD-11 beta draft (8) upon the WHO ICD representatives’ guidance and as a result of collaboration with all the specialties with whom we have overlapping conditions, represented by ICD Topic Advisory Groups (TAGs). By consolidating all allergic conditions into one ICD-11 single section, as opposed to spreading them out over many ICD-10 chapters, and by allowing all the relevant codes to be used to represent mortality and morbidity outcomes, our aim was to facilitate the use of such classification and codes by all relevant personnel. To further inform these deliberations and to follow the ICD-11 revision agenda to ensure accuracy, usability, and feasibility of the new structure, we proposed to evaluate the adequacy of the new ‘Allergic and hypersensitivity conditions’ section by surveying the allergy community. For that, a web-based survey, in English (Annex S1), was launched via Internet together with two attachments: the frozen version of the ‘Allergic and hypersensitivity conditions’ section of the ICD-11 beta draft (May 2015 version) (8) and the published classification proposal previously validated by crowdsourcing the allergy community (4). The frozen version of the ‘Allergic and hypersensitivity conditions’ section of the ICD-11 beta draft (May 2015 version) consists of a document of 30 pages including 306 entities following the WHO ICD content model, scattered under six main headings (Fig. 1). The audience of this process included top experts in different fields of allergy selected on the basis of their publications over the past 5 years in the major peerreviewed journals as first/last authors, terminology specialists, and end users. It had anonymous and voluntary nature, and only one response was allowed per person. The respondents were asked to review the attachments and access the questionnaire to evaluate the accuracy and ease of use of the new classification and/or send us their impressions and suggestions by free text space or e-mail. A reminder was sent out after 2 weeks. Responses were categorized according to the intent as ‘full approval’, ‘not able to help’ or ‘suggestions’. For all the responses classified as ‘suggestions’, we categorized as ‘typo’, ‘terminology changes’, ‘structural changes’, ‘content changes’, and ‘blended changes’. In the second step of the process, we evaluated the replies regarding the accuracy and ease of use of each of the groups of entities listed into the questionnaire. For it, the analysis covered just the responses for the online questionnaire. A total of 773 e-mails were sent out, and 54 (7.4%) were bounced by the server. A total of 90 (13.3%) responses were received on behalf of 98 professionals, 63 (70%) through the online survey, and 27 (30%) by e-mail. The attachments have been discussed in face-to-face meetings when requested (25 persons) during the period of the survey.

Revisiting Desensitization and Allergen Immunotherapy Concepts for the International Classification of Diseases (ICD)-11

Allergy and hypersensitivity intervention management procedures, such as desensitization and/or tolerance induction and immunotherapy, have not been pondered up to now in the content of International Classification of Diseases (ICD) context because the focus has been on prioritizing the condition implementations. Tremendous efforts have been devoted to implementing allergic and hypersensitivity conditions in the forthcoming ICD-11. However, we consider that it is crucial now to have nomenclature and classification universally accepted for these procedures to be able to provide scientifically consistent proposals into the new ICD-11 platform for the best practice parameters of our specialty. With the aim of promoting a harmonized comprehension and aligning it with the ICD-11 revision, we have reviewed the definitions and concepts currently used for desensitization and/or tolerance induction and immunotherapy. We strongly believe that this review is a key instrument to support the allergy specialty identity into the ICD-11 framework and serves as a platform to perform positive quality improvement in clinical practice.

Comparative study of extended release albuterol sulfate and long-acting inhaled salmeterol xinafoate in the treatment of nocturnal asthma

BACKGROUND Nocturnal worsening of asthma is a common problem in asthma and is associated with increased morbidity and mortality. Long acting beta-2 agonists are considered long-term symptom control medications, especially for nocturnal symptoms. OBJECTIVE To compare efficacy of an extended release oral beta-2 agonist, albuterol sulfate (Volmax), to a long-acting inhaled agent, salmeterol (Serevent) in the treatment of nocturnal asthma. METHODS This was a multicenter double-blind, double-dummy, randomized, crossover design with a 1-week baseline period and two 3-week treatment periods separated by a 7 to 9-day washout. An optional 2-week, open-label phase was conducted to evaluate patient preference. RESULTS A total of 46 patients were included in the efficacy analysis. For the primary outcome variable of morning peak expiratory flow, there were similar and significant improvements over the 3-week treatment period for both medications compared with baseline (P < .001). Similar improvements were seen in the overnight change in PEF values (P < .001). The morning and overnight changes in FEV1 were not significantly different between treatment arms (P > .05). There were significant improvements in both treatment periods in regard to the percentage of nights without awakenings (baseline 53.6+/-5.3%), extended release albuterol 83.3+/-3.0% (P < .001), and salmeterol 88.8+/-2.4%. The percentage of patients who had no awakenings during treatment did not differ significantly for the two medications. Both treatments also resulted in a decrease in the use of rescue albuterol (extended release 2.66+/-0.35 puffs per day, salmeterol 1.85+/-0.29) from baseline (4.57+/-0.41, P < .001). There was a significant difference between groups (P = .001). The reasons why patients preferred one medication over the other varied. CONCLUSION Both extended release albuterol tablets and inhaled salmeterol resulted in similar bronchodilation and good control of nocturnal asthma symptoms.

Smoothing the transition from International Classification of Diseases, Tenth Revision, Clinical Modification to International Classification of Diseases, Eleventh Revision

Although the International Classification of Diseases, Tenth Revision, Clinical Modification has only recently been introduced in the United States, the present study is the first attempt to contribute for a softer transition of the International Classification of Diseases, Tenth Revision, Clinical Modification allergic and hypersensitivity conditions to the International Classification of Diseases, Eleventh Revision, whenever it will happen.

Comparison of systemic reactions in rush, cluster, and standard-build aeroallergen immunotherapy

BACKGROUND Given the choice of standard, cluster, and rush build-up for aeroallergen immunotherapy, standard-build immunotherapy has generally been preferred because of a perceived high rate of systemic reactions (SRs) associated with cluster and rush immunotherapy. OBJECTIVE To characterize the incidence of SRs during standard, cluster, and rush build-up immunotherapy in an allergy practice during a 5-year period. METHODS A retrospective review was conducted among patients receiving standard-build, 8- to 10-step cluster, or 2-day rush immunotherapy from January 1, 2010, through December 31, 2014, at Family Allergy & Asthma clinics in Louisville, Kentucky. Investigators excluded reactions that occurred during skin prick testing, venom immunotherapy, and not-true SRs, and identified the build-up method, age, sex, date of reaction, vial concentration, and presence of asthma. Per-shot and per-patient incidence of SRs was computed from these data. RESULTS During our review period, 2,549,643 injections were administered to 11,982 patients. Per-shot incidence of SR was 0.01%, 0.06%, and 0.33% for standard, cluster, and rush immunotherapy, respectively; per-patient incidence of SR was 2.84%, 2.52%, and 11.86% for standard, cluster, and rush immunotherapy, respectively. A total of 42% of SRs were grade 1, 43% were grade 2, 12% were grade 3, and 3% were grade 4. No fatalities were reported. A total of 70% of total SRs, 75% of cluster SR, and 55% of rush SR occurred in females, with an emergent peak in SR from May to October. CONCLUSION Compared with previously published rates, we observed a decrease in the incidence of SR for standard, cluster, and rush immunotherapy, with peak seasonality from May to October and a female predominance.