Stephen A. Tilles

Allergy diagnostic testing: an updated practice parameter.

I. Leonard Bernstein, MD; James T. Li, MD, PhD; David I. Bernstein, MD; Robert Hamilton, PhD, DABMLI; Sheldon L. Spector, MD; Ricardo Tan, MD; Scott Sicherer, MD; David B. K. Golden, MD; David A. Khan, MD; Richard A. Nicklas, MD; Jay M. Portnoy, MD; Joann Blessing-Moore, MD; Linda Cox, MD; David M. Lang, MD; John Oppenheimer, MD; Christopher C. Randolph, MD; Diane E. Schuller, MD; Stephen A. Tilles, MD; Dana V. Wallace, MD; Estelle Levetin, PhD; and Richard Weber, MD

Food allergy: a practice parameter

TABLE OF CONTENTS I. Preface S1 II. Glossary S2 III. Executive Summary S3 IV. Summary Statements S6 V. Classification of Major Food Allergens and Clinical Implications S11 VI. Mucosal Immune Responses Induced by Foods S12 VII. The Clinical Spectrum of Food Allergy S15 VIII. Algorithm and Annotations S18 IX. Prevalence and Epidemiology S21 X. Natural History of Food Allergy S22 XI. Risk Factors and Prevention of Food Allergy S23 XII. Cross-reactivity of Food Allergens S24 XIII. Adverse Reactions to Food Additives S30 XIV. Genetically Modified Foods S32 XV. Diagnosis of Food Allergy S33 XVI. Food-Dependent Exercise-Induced Anaphylaxis S39 XVII. Differential Diagnosis of Adverse Reactions to Foods S40 XVIII. General Management of Food Allergy S44 XIX. Management in Special Settings and Circumstances S45 XX. Future Directions S47 XXI. Appendix: Suggested Oral Challenge Methods S48 XXII. Acknowledgments S49 XXIII. References S50

Pathogenesis, prevalence, diagnosis, and management of exercise-induced bronchoconstriction: a practice parameter

Chief Editors: John M. Weiler, MD, MBA, President, CompleWare Corporation, Professor Emeritus, University of Iowa, Iowa City, Iowa; Sandra D. Anderson, PhD, DSc, Clinical Professor, Sydney Medical School, Royal Prince Alfred Hospital, Department of Respiratory and Sleep Medicine, Camperdown NSW 2050, Australia; Christopher Randolph, MD, Clinical Professor of Pediatrics, Yale Affiliated Programs, Waterbury Hospital, Center for Allergy, Asthma and Immunology, Waterbury, Connecticut

Anaphylaxis--a practice parameter update 2015.

Phillip Lieberman, MD; Richard A. Nicklas, MD; Christopher Randolph, MD; John Oppenheimer, MD; David Bernstein, MD; Jonathan Bernstein, MD; Anne Ellis, MD; David B.K. Golden, MD; Paul Greenberger, MD; Steven Kemp, MD; David Khan, MD; Dennis Ledford, MD; Jay Lieberman, MD; Dean Metcalfe, MD; Anna Nowak-Wegrzyn, MD; Scott Sicherer, MD; Dana Wallace, MD; Joann Blessing-Moore, MD; David Lang, MD; Jay M. Portnoy, MD; Diane Schuller, MD; Sheldon Spector, MD; and Stephen A. Tilles, MD Chief Editors: Phillip Lieberman, MD; Richard A. Nicklas, MD; John Oppenheimer, MD; Christopher Randolph, MD Members of the Joint Task Force: David Bernstein, MD; Joann Blessing-Moore, MD; David Khan, MD; David Lang, MD; Richard Nicklas, MD; John Oppenheimer, MD; Jay M. Portnoy, MD; Christopher Randolph, MD; Diane Schuller, MD; Sheldon Spector, MD; Stephen A. Tilles, MD; Dana Wallace, MD Practice ParameterWorkgroup: David Bernstein, MD; Jonathan Bernstein, MD; Anne Ellis, MD; David B.K. Golden, MD; David Khan, MD; Dennis Ledford, MD; Jay Lieberman, MD; Dean Metcalfe, MD; Dana Wallace, MD

Disease management of atopic dermatitis: an updated practice parameter

ratory disease but often is the first manifestation of allergic disease. Most patients with atopic dermatitis will develop allergic rhinitis or asthma. The evaluation and management of atopic dermatitis are, therefore, an integral part of an allergist/immunologist’s training and practice. It is also important for the primary care physician to understand the basis for effective evaluation and management of patients with this condition, since atopic dermatitis affects more than 10% of children and can have a significant impact on the patient’s quality of life. As discussed in this document, it is also important for the primary care physician to know when to appropriately consult a specialist in atopic dermatitis.

Adverse reactions to vaccines practice parameter 2012 update

Mild local reactions and fever after vaccinations are common and do not contraindicate future doses. Anaphylactic reactions to vaccines are rare and should be evaluated with skin tests to the vaccine and its components. If the skin test results are negative, subsequent doses can be administered in the usual manner but under observation. If the skin test results are positive and the patient requires subsequent doses, the vaccine can be administered in graded doses under observation. Some nonanaphylactic reactions to vaccines might also require evaluation, but only a few are contraindications to future doses. Pregnant women and persons who are immune compromised should generally not receive live vaccines. Purported long-term sequelae of vaccination, such as autism, are not supported by epidemiologic studies. Patients with egg allergy of any severity should receive annual influenza vaccinations because studies have demonstrated a very low rate of reactions. Studies to date have evaluated the injectable trivalent influenza vaccine (TIV), and thus TIV, rather than the live attenuated influenza vaccine (LAIV), should be used for recipients with egg allergy. All influenza vaccines available in the United States contain low amounts of ovalbumin. Neither skin testing with the vaccine nor dividing the dose is required; however, the vaccine should be administered in a setting in which anaphylaxis can be recognized and treated. EXECUTIVE SUMMARY Mild local reactions and constitutional symptoms, such as fever, after vaccinations are common and do not contraindicate future doses. Rarely, delayed-type hypersensitivity to a vaccine constituent can cause an injection-site nodule, but this is not a contraindication to subsequent vaccination. Anaphylactic reactions to vaccines are estimated to occur at a rate of approximately 1 per million doses. There are approximately 220million doses of vaccines distributed in the United States each year. All serious events occurring after vaccine administration should be reported to the Vaccine Adverse Event Reporting System (VAERS), even if it is not certain that the vaccine was the causal agent. Measuring levels of IgG antibodies to the immunizing agents in a vaccine suspected of causing a serious adverse reaction to determine whether they are at protective levels can help determine whether subsequent doses are required. All suspected anaphylactic reactions to vaccines should ideally be evaluated in an attempt to determine the culprit allergen. IgE-mediated reactions to vaccines are more often caused by additive or residual vaccine components, such as gelatin, rather than the microbial immunizing agent itself. Patients who have had an apparent anaphylactic reaction after immunization should undergo immediate-type allergy skin testing to help confirm that the reaction was IgE mediated and to determine the responsible component of the vaccine. If the intradermal skin test result is negative, the chance that the patient has IgE antibodies to any vaccine constituent is negligible, and the vaccine can be administered in the usual manner. Nonetheless, it is prudent in a patient with a history suggestive of an anaphylactic reaction to administer the vaccine under observation with epinephrine and other treatment available. In a patient with a history and skin test results consistent with an IgE-mediated reaction to a vaccine who requires additional doses of the suspect vaccine or other vaccines with common ingredients, consideration can be given to administering the vaccine in graded doses under observation. Some nonanaphylactic reactions to vaccines might also require evaluation, but only a few are absolute contraindications to future doses. Pregnant women should not be vaccinated with live vaccines. However, pregnant women should be given inactivated influenza vaccine, as well as tetanus and hepatitis B vaccine, if otherwise indicated. In general, live vaccines should not be given to persons who are immune compromised because of a risk of generalized infection with the immunizing agent. Specific vaccines or vaccination in general have been purported to have long-term consequences, including atopy, autism, and multiple sclerosis. Epidemiologic studies have not supported such associations. Patients with egg allergy should receive influenza vaccinations (TIV) because the risks of vaccinating are outweighed by the risks of not vaccinating. Persons with a history of suspected egg allergy should be evaluated by an allergist to determine the status of their egg allergy, but this should not delay their influenza vaccination. A growing number of studies suggest that influenza vaccines can be safely administered even to patients with a history of anaphylaxis to egg ingestion. Skin testing (prick, intradermal, or both) with the influenza vaccine itself in subjects with egg allergy (but without a history of reacting to the vaccine itself) does not reliably identify patients who are at increased risk of reacting to the vaccine and is not recommended. Influenza vaccine can be administered as a single dose to patients with egg allergy. Patients with egg allergy should receive influenza vaccines in a setting in which clinicians experienced in recognizing and treating anaphylaxis and equipment to manage anaphylaxis are immediately available and should be observed for 30minutes after vaccination. Patients with egg allergy with a history of only hives after egg ingestion can receive influenza vaccine in a primary care provider’s office provided the appropriate personnel and equipment are available, whereas those with a history of more severe reactions to egg ingestion should receive their vaccine in an allergist’s office. All influenza vaccines available in the United States contain low amounts of ovalbumin. Although the intranasally administered LAIV contains a low amount of ovalbumin, all published studies to date have evaluated the injectable TIV, and thus TIV rather than LAIV should be used for recipients with egg Category of evidence: Ia Evidence from meta-analysis of randomized controlled trials Ib Evidence from at least 1 randomized controlled trial IIa Evidence from at least 1 controlled study without randomization IIb Evidence from at least 1 other type of quasiexperimental study III Evidence from nonexperimental descriptive studies, such as comparative studies IV Evidence from expert committee reports or opinions or clinical experience of respected authorities or both Strength of recommendation: A Directly based on category I evidence B Directly based on category II evidence or extrapolated from category I evidence C Directly based on category III evidence or extrapolated from category I or II evidence D Directly based on category IV evidence or extrapolated from category I, II, or III evidence E Based on consensus of the Joint Task Force on Practice Parameters J ALLERGY CLIN IMMUNOL VOLUME nnn, NUMBER nn KELSO ET AL 3

Onset and duration of protection against exercise-induced bronchoconstriction by a single oral dose of montelukast

BACKGROUND Leukotriene modifiers have been shown to protect against exercise-induced bronchoconstriction (EIB) with repeated, chronic dosing. OBJECTIVE To study the onset and duration of protection against EIB after a single dose of montelukast, a leukotriene receptor antagonist. METHODS In this randomized, crossover, double-blind study, 51 adult asthma patients with EIB (> or = 20% postexercise decrease in forced expiratory volume in 1 second [FEV1]) received a single oral dose of montelukast (10 mg), or placebo followed by exercise challenge 2, 12, and 24 hours after dosing. The primary end point was maximum percentage decrease in FEV1 from preexercise baseline during 60 minutes after the 2-hour challenge. RESULTS At 2, 12, and 24 hours after dosing, the maximum decrease in FEV1 was 10.8% +/- 7.9%, 8.4% +/- 7.5%, and 8.3% +/- 7.3% for montelukast and 22.3% +/- 13.1%, 16.1% +/- 10.2%, and 16.9% +/- 11.7% for placebo, respectively (P < or = .001 at each time point). Postexercise recovery was quicker with montelukast than with placebo (P < or = .001); mean (95% confidence interval) differences were -26.8 minutes (-35.1 to -18.4 minutes), -16.0 minutes (-22.9 to -9.2 minutes), and -17.4 minutes (-24.9 to -9.9 minutes) at the 3 time points, respectively. At all time points, area under the curve for percentage decrease in FEV1 during 60 minutes after exercise was smaller after montelukast (P < or = .001); montelukast protected more patients against EIB (P < or = .001). Fewer patients required postexercise beta-agonist rescue at 2 hours after dosing with montelukast (P = .03). CONCLUSION Montelukast provided significant protection against EIB as soon as 2 hours after a single oral dose, with persistent benefit up to 24 hours.

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

Baseline characteristics of patients enrolled in EXCELS: a cohort study.

BACKGROUND The Epidemiologic Study of Xolair (omalizumab): Evaluating Clinical Effectiveness and Long-term Safety in Patients with Moderate-to-Severe Asthma (EXCELS) is a unique opportunity to evaluate the prospective, long-term clinical safety and effectiveness of the anti-IgE antibody omalizumab (Xolair) in real-world clinical practice. OBJECTIVES To describe the study design and study cohorts of EXCELS at baseline and to compare the characteristics of this population with other large asthma cohorts. METHODS Patients with moderate-to-severe persistent asthma and a positive skin test result or in vitro reactivity to a perennial aeroallergen were eligible for EXCELS. Two cohorts of patients with asthma were enrolled: those treated with omalizumab and those not treated with omalizumab. We analyzed baseline demographic and clinical characteristics, including asthma history and control and allergy history. RESULTS Large proportions of patients enrolled in EXCELS had historically severe and poorly or not well-controlled asthma at the time of enrollment, objective evidence of airway obstruction, a history of long-term oral corticosteroid use, and/or other allergic disorders. Minor differences were observed between the omalizumab and nonomalizumab cohorts. Our total patient cohort was generally similar to other large cohorts. In a subgroup analysis, patients who had received omalizumab within 7 days before enrollment had more severe asthma and greater degrees of impairment at baseline than nonomalizumab patients. CONCLUSIONS This study of baseline characteristics in EXCELS offers a unique opportunity to better understand the history of allergic patients with moderate-to-severe asthma in a real-world treatment setting. This analysis of EXCELS baseline data sets the foundation for long-term assessment of the safety and effectiveness of omalizumab.

Adverse reactions to vaccines.

TABLE OF CONTENTS I. Preface S2 II. Classification of Recommendations and Evidence S3 III. Summary Statements S3 IV. Acknowledgments S11 V. References S12