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Allergy and Asthma: Improving Outcomes in Primary Care

Allergy and Asthma: Improving Outcomes in Primary Care. El Paso November, 2007. Len Fromer, M.D., FAAFP. The Etiology Challenge. Common symptoms and diseases have many possible etiologies IgE-mediated allergies trigger symptoms from infancy into adulthood

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Allergy and Asthma: Improving Outcomes in Primary Care

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  1. Allergy and Asthma: Improving Outcomes in Primary Care El Paso November, 2007 Len Fromer, M.D., FAAFP

  2. The Etiology Challenge • Common symptoms and diseaseshave many possible etiologies • IgE-mediated allergies triggersymptoms from infancy into adulthood • Identification of true underlying cause is essential for effective management

  3. The Allergic Inflammatory Response

  4. Common Childhood Diseases CHDs • The illnesses of the Allergy March • Atopic dermatitis (eczema) • GI distress • Recurrent otitis media • Allergic rhinitis • Allergic asthma • The symptoms • Inflammatory in nature • Multiple etiologies • Treated empirically CHDs

  5. Food Sensitivity RecurrentOtitisMedia AtopicDermatitis GI Distress AllergicRhinitis AllergicAsthma Genetic Predisposition Inhalant Sensitivity Time (~years) The Allergy March: A Progression of Seemingly Unrelated Diseases CHDs CHDs

  6. Prevalence of Atopic Disease 50 40 Prevalence (%) 30 20 10 0 3 5 10 1 17 Age (years) Symptoms Gastrointestinal Respiratory Skin Allergy March CHDs Saarinen UM, Kajosaari M. Lancet. 1995;346:1065-1069. CHDs

  7. IgE Antibody Level 3 Birch pollen 2 Mean score(Phadebas RAST Class) Peanut 1 Egg white n= 12 29 12 0 0 - 3 4 - 9 10 - 15 Age (years) Allergy March CHDs Sigurs N, et al. J Allergy Clin Immunol. 1994;94:757-763. CHDs

  8. Common Childhood Diseases CHDs • Atopic dermatitis (AD)1 • 17%-20% prevalence in US, other western countries • Not necessarily severe reaction (anaphylaxis) • Driven by early exposure and sensitization • 40% of AD caused by food sensitivity • Empirical treatment: trials of topicals • Leung DYM. In: Pediatric Allergy: Principles and Practice. Mosby-Year Book, Inc; 2003:561-573. CHDs

  9. Common Childhood Diseases CHDs • GI distress1 • Colic, diarrhea, vomiting, constipation, reflux • Multiple etiologies: • atopy, infection, intolerance, malabsorption, inflammatory bowel, anatomic defect • 10%-42% of symptomatic patients are atopic2,3 • 50%-60% of infants with food sensitivities show GI symptoms(not necessarily full-blown food allergy) – Empirical treatment: trials of formulas • Høst A, Halken S. In: Pediatric Allergy: Principles and Practice. Mosby-Year Book, Inc; 2003:488-494. • Australasian Society of Clinical Immunology and Allergy. Adverse reactions to food. Available at: http://www.allergy.org.au/aer/infobulletins/adverse_reactions.htm. • Sicherer SH. Pediatrics. 2003;111:1609-1616. CHDs

  10. Common Childhood Diseases CHDs • Recurrent otitis media (OM) • 26% prevalence in US1 • Key risk factors include attendance in daycare,cigarette smoke exposure2 • 40%-50% involve atopy3,4 • Common underlying cause = eustachian tube dysfunction • Caused by inflammation related to allergy or infection • Recurrence = not treating the underlying cause • Empirical treatment: antibiotics, surgery • Lanphear BP, et al. Pediatrics. 1997;99:1-7. • AAAAI. The Allergy Report. 2000;2:155-161. • Data on file, Pharmacia Diagnostics. • Fireman P. J Allergy Clin Immunol. 1997;99:S787-S797 CHDs

  11. Atopy’s Long-Term Consequences CHDs • Nearly 80% of children with AD go on to develop allergic rhinitis and/or asthma1 • Children with early and long-lasting food sensitization: – 3x more likely to develop allergic rhinitis (AR)than those transiently sensitized2 – 5x more likely to develop asthmathan those transiently sensitized2 • Young wheezers with confirmed atopy are more likely to develop asthma3 1. Leung DYM. In: Pediatric Allergy: Principles and Practice. Mosby-Year Book, Inc; 2003:561-573. 2. Kulig M, et al. Pediatr Allergy Immunol. 1998;9:61-67. 3. Martinez FD, et al. J Allergy Clin Immunol 1999;104:S169-S174. CHDs

  12. Knowledge of Etiology Guides Treatment for Today and Tomorrow CHDs • Specific IgE testing in children can help the clinician: – Identify allergen sensitivities – Counsel for avoidance – Eliminate or reduce symptoms – Reduce medication use (including antibiotics) • Targeting atopy can eliminate symptoms and interrupt the Allergy March1-5 – ETAC: Cetirizine and avoidance halved asthma risk in children with AD1 – PAT: Immunotherapy significantly reduced asthma risk in children with AR2 – CCAPPS: Multifaceted avoidance intervention reduced asthma prevalence 56% in high-risk children5 • ETAC® Study Group. Pediatr Allergy Immunol. 1998;9:116-124. • Möller C, et al. J Allergy Clin Immunol. 2002;109:251-256. • Platts-Mills TAE. N Engl J Med. 2003;349:207-208. • Sampson H. Ann Allergy Asthma Immunol. 2004;93:307-308. • Chan-Yeung M, et al. J Allergy Clin Immunol. 2005;116:49-55. CHDs

  13. Etiology Is Elusive URDs URDs

  14. Overlapping Symptoms URDs Allergic Rhinitis • Nasal congestion • Rhinorrhea • Increased secretions • Sneezing • Itchy, watery eyes Non-allergic Rhinitis • Nasal congestion • Rhinorrhea • Increasedsecretions • Postnasal drainage Chronic Sinusitis • Nasal congestion • Rhinorrhea • Increased secretions • Postnasal drainage • Headache • Facial pain URDs

  15. Upper Respiratory Diseases URDs • Allergic rhinitis, non-allergic rhinitis, sinusitis • Symptoms caused by inflammation • Multiple etiologies, including: • Allergic • Hormonal • Anatomic • Vasomotor • Infectious • Usually treated empirically/symptomatically • Depending upon etiology, treatment can/should be different URDs

  16. Productivity Loss $ per 1000 Employees

  17. Comparison of Quality-of-Life in Asthmatic & Chronic Rhinitis Patients

  18. Sinusitis 30% 35M Allergic Rhinitis 35% 40M 40M Non-allergic Rhinitis 35% Distribution of URD in US1-3 URDs • 39% of total population (115M of 295M) have URD • AHRQ. Management of allergic and nonallergic rhinitis. May 2002: AHRQ Pub. No. 02-E023. • Spector SL, ed. Dialogues in Redefining Rhinitis. 1996;1(1,4):1-16. • Allergy Statistics.AAAAI Web site. Available at: http://www.aaaai.org/media/resources/media_kit/allergy_statistics.stm. URDs

  19. 35% AtopicEtiology 65% Non-atopicEtiology Actual Atopy and Antihistamine Use URDs Identification of allergic disease among users of antihistamines1 • Allergic rhinitis, non-allergic rhinitis, sinusitis • Study of managed-care patients repeatedly prescribed oral antihistamines • Convenience sample of 246 evaluated with in vitro allergy testing • Results revealed non-atopicsymptom etiology in 2/3 of patients 1. Szeinbach SL, et al. J Manag Care Pharm. 2004;10(3):234-238. URDs

  20. Non-allergic Rhinitis URDs • Wide array of types and etiologies1,2 • Includes: infectious, vasomotor, hormonal, anatomic, occupational, drug-induced • Not caused by IgE-mediated allergic inflammation • Non-sedating antihistamines and other allergy-targeted therapies will not treat underlying cause • AAAAI. The Allergy Report. 2000;2:1-31. • Dykewicz MS, et al. Ann Allergy Asthma Immunol. 1998;81:478-518. URDs

  21. Allergic Rhinitis URDs • Triggered by seasonal or perennial allergen(s) • Symptoms may include: • nasal congestion, rhinorrhea, increased secretions, sneezing, itchy nose/eyes, watery eyes, coughing, postnasal drip1,2 • Cumulative threshold disease3,4: • Patients are rarely monosensitized • Symptoms emerge after “allergic threshold” has been exceeded • AAAAI. The Allergy Report. 2000;2:1-31. • Dykewicz MS, et al. Ann Allergy Asthma Immunol. 1998;81:478-518. • Pharmacia & Upjohn Diagnostics. The Value of Allergen Identification.1998. Publication 98006.01. • Wickman M. Allergy. 2005;60 (Suppl 79):14-18. URDs

  22. Ragweed Dust mites Cat dander Cumulative Threshold Disease1 URDs Symptoms Situation A2 No avoidance measures Situation B3 No avoidance measures Third allergen Situation C3 Avoidance measures employed Third allergen 1. Pharmacia & Upjohn Diagnostics. The Value of Allergen Identification. 1998. Publication 98006.01. 2. Ciprandi G, et al. J Allergy Clin Immunol. 1995;96:971-979. 3. Boner AL, et al. Clin Exp Allergy. 1993;23:1021-1026. URDs

  23. Support for Avoidance in the Management of Allergies and Asthma URDs URDs • …It has become clear that early intervention may modulate the natural course of atopic disease…the reduction in exposure of high-risk infants to food and house-dust mite allergens substantially lowers the frequency of allergic manifestations in infancy.”1 – Halmerbauer, et al. • “Extensive experience suggests that both drug treatment and immunotherapy are more effective if patients also decrease exposure. The approach is to identify the allergen source (or sources) to which the patient is allergic and to educate patients extensively.”2 – Platts-Mills, et al. • The NIH, AAAAI, and AAFP urge trigger avoidance as a cornerstone of asthma management3-5 1. Halmerbauer G, et al Pediatr Allergy Immunol. 2003;14:10-17. 2. Platts-Mills TAE, et al. J Allergy Clin Immunol. 2000;106(5)787-804 .3. NIH. Guidelines for the Diagnosis and Management of Asthma.1997. NIH publication 97-4051. 4. AAAAI. The Allergy Report. 2000;2:33-109. 5. AAFP. Asthma & Allergy Resource Guide. 2004:11-13 Return to >> Cumulative Threshold

  24. Sinusitis URDs • Multiple etiologies • Caused by inflammation from infection, allergy, structural abnormalities,other causes1 • ENT experts use term “rhinosinusitis” due to epithelial continuum of sinus/nasal passages1,2 • Common comorbidity–often with atopy • Rarely occurs without concurrent rhinitis2 • >50% of moderate to severe asthmatics have chronic rhinosinusitis3 • Brook I, et al. Ann Otol Rhinol Laryngol. 2000;109:2-20. • AAO-HNS. Fact sheet. ENT Link Web site. Available at: http://www.entnet.org/healthinfo/sinus/allergic_rhinitis.cfm. • AAAAI. The Allergy Report. 2000;2:7,137-153. URDs

  25. Why Should You Test? URDs • History and physical alone yield a correct diagnosis only 50% of the time1 • Different etiologies demand different treatment approaches • Testing for specific IgE levels can rule in/out atopy • If atopic: – NSAs probably drug of choice – Testing can help clinician pinpoint offending allergens • If non-atopic: – Results will allow you to focus on other etiologies – Drugs of choice may include decongestants/steroids – Patient can avoid unnecessary/ineffective treatment 1. Homburger HA. Arch Pathol Lab Med. 2004;128:1028-1031.

  26. Specific IgE-Positive/Abnormal Atopic Etiology Specific IgE-Negative/Normal Non-Atopic Etiology Specific Allergen Avoidance Inadequate Response Allergy-TargetedPharmacotherapy(eg, NSAs, LTRAs) Pharmacotherapy (allergy-targeted Rx not helpful) AdequateResponse AdequateResponse Inadequate Response Inadequate Response Referral? Stop Referral? Stop URD Management Options URDs

  27. The Experts on Differential Diagnosis of Rhinitis URDs “A positive diagnosis (or diagnoses) should be made before formulating management.”1 • Middleton E, et al, eds. Allergy: Principles & Practice. Vol II, 5th ed. St. Louis, Mo: Mosley-Year Book, Inc; 1998:1007. URDs

  28. The Experts on Differential Diagnosis of Rhinitis URDs • An expert panel in the area of allergy diagnosis recommended selective use of in vitro allergy testing by primary care physicians. • According to these experts, in vitro tests1: • Offer a well standardized alternative to skin testing • Are easily used by generalist physicians • Are effective in the diagnosis of allergy 1. Selner JC, et al. Ann Allergy Asthma Immunol. 1999;82:407-412.

  29. The Experts on Differential Diagnosis of Rhinitis URDs “Allergy [IgE] testing should be considered in all patientswith a suspected diagnosis of allergic rhinitis.”1 • Bierman CW, et al, eds. Allergy, Asthma, and Immunology From Infancy to Adulthood. 3rd ed. Philadelphia, Pa: WB Sanders Company; 1995:403-404. URDs

  30. Etiology Linked to Triggers LRDs LRDs

  31. Overlapping Symptoms LRDs “All that wheezes is not asthma.” – Chevalier Jackson [1865-1958] Allergic Asthma • Wheezing • Cough • Dyspnea • Chest tightness • Rhinitis • Conjunctivitis Non-allergic Asthma • Wheezing • Cough • Dyspnea • Chest tightness “Bronchitis” • Wheezing • Cough • Dyspnea LRDs

  32. Lower Respiratory Diseases LRDs • Course and severity affected by inflammation (often caused by allergy) • Underlying atopy shown to increase symptoms and precipitate exacerbations • A wide range of possible triggers include: • Allergy • Occupational exposures • Infection • GERD • Tobacco smoke • Emotional stress • Exercise • Cold weather LRDs

  33. Asthma LRDs • Widespread • 7% prevalence (>20 million1) and rising • 73% managed by PCPs2 • Allergic vs. non-allergic asthma • 60% of asthmatics have allergic asthma3 • 90% of children with asthma also have allergies4 NCHS. Asthma prevalence, health care use and mortality 2002. Available at: http://www.cdc.gov/nchs/Default.htm. NCHS. Ambulatory care visits 1999–2000. Available at: http://www.cdc.gov/nchs/Default.htm. Milgrom H. Understanding allergic asthma [AAAAI News Release]. June 18, 2003. HØst A, Halken S. Allergy. 2000;55:600-608. LRDs

  34. The “One Airway” Concept LRDs • Common inflammatory process links upper and lower airways1 • Asthma and allergic rhinitis commonly co-exist2,3 • In concomitant disease, experts recommend evaluation and treatment of one condition to aid management of the other4 • Asthma management guidelines from ARIA,4 the NIH,5 AAFP,6 and AAAAI7encourage treatment of AR (and other URDs) to help control asthma Bachert C, et al. Immunol Allergy Clin N Am. 2004;24:19-43. Nayak AS. Allergy Asthma Proc. 2003;24:395-402. Halpern MT, et al. J Asthma. 2004;41:117-126. Bousquet J, et al. Allergic Rhinitis and its Impact on Asthma (ARIA). Allergy. 2002;57:841-855. NIH. Guidelines for the Diagnosis and Management of Asthma.1997. NIH publication 97-4051. AAFP. Asthma & Allergy Resource Guide. 2004:18. AAAAI. The Allergy Report. 2000;2:33,54.

  35. NIH Asthma Guidelines1 LRDs Trigger identification/control is primary management step • “For at least those patients with persistent asthma on daily medications,the clinician should: • Identify allergen exposures • Use the patient’s history to assess sensitivity to seasonal allergens • Use skin testing orin vitro [blood] testing to assess sensitivity to perennial indoor allergens • Assess the significance of positive tests in contextof the patient’s medical history” • NIH. Guidelines for the Diagnosis and Management of Asthma.1997. NIH publication 97-4051. LRDs

  36. NIH Asthma Guidelines1 (cont’d) LRDs • “Use skin testing orin vitro testing to determine the presence of specific IgE antibodies to the indoor allergens to which the patient is exposed year round.” • Allergy testing is the only reliable way to determine sensitivity to perennial indoor allergens.” • For selected patients with asthma at any level of severity, detection of specific IgE sensitivity to seasonal or perennial allergens may be indicated as a basis for avoidance, or immunotherapy, or to characterize the patient’s atopic status.” Return to >> Third-party Perspectives • NIH. Guidelines for the Diagnosis and Management of Asthma. 1997. NIH publication 97-4051. LRDs

  37. Knowledge of Symptom Triggers Guides Management LRDs • Allergy testing may be conducted along with pulmonary function testsand other diagnostic evaluations1 • In allergic asthma: • Confirm atopy and identify specific allergic triggers for avoidance counseling, symptom reduction, and control of severity and comorbid AR • In non-allergic asthma: • Rule out atopy to focus on possible non-allergic triggers • Prevent needless control measures • NIH. Practical Guide for the Diagnosis and Management of Asthma. 1997. NIH publication 97-4053. LRDs

  38. Specific IgE-Positive/Abnormal Atopic Etiology Specific IgE-Negative/NormalNon-Atopic Etiology Specific Allergen Avoidance Focus on Non-allergic Triggers • Pharmacotherapy • Allergy Rx not helpful • Controller(s) • Rescue Rx Inadequate Response • Pharmacotherapy • Treat AR (eg, NSAs) • LTRAs • Controller(s) • Rescue Rx AdequateResponse InadequateResponse AdequateResponse Inadequate Response Referral? Stop Referral? Stop Asthma Management Options LRDs

  39. What Is Happening to Treatment? Treatment • Mechanism of disease is better understood • Means that treatments are nearer the root cause • Therapeutic specificity is increasing • Diseases are different and differentiation is key • The mechanism of action of drugs is more specific than ever • Diagnostic precision by PCP is necessary • New diagnostic technology must be employed Treatment

  40. TreatmentProgression 1st GenerationAntihistamines(1970s) Non-sedatingAntihistamines(1990s) Montelukast(2002) Anti-IgE Vaccine(2003) Mode(s) of Action Antihistamine effect + Anticholinergic effect Antihistamine effect with very little anticholinergic effect Leukotriene antagonist Binds to IgE;Suppression of IgEresponse Treatment Results Non-specific resolution of symptoms regardless of etiology More specific resolution of symptoms primarily due to atopic etiology — necessitates more specific diagnosis Specific resolution of symptoms of atopy by blocking another mediator pathway Highly specific resolution of symptoms due to IgE response only — necessitates perfect diagnosis Therapeutic Approach Broad (shotgun) Introduction of “D” formula creates less specific treatment Very specific to atopy — necessitates even more accurate diagnosis (Doctors report marginal response for AR with Singulair — could be 65% are not allergic) Highly specifictreatment Cost $ $$ $$$ $$$$$$ Market Review: The Role of Diagnostics in Pharmacotherapy Treatment Medications for Respiratory Allergy Treatment Treatment

  41. Diabetes Mellitus Type 2 Hx & PE lab tests diet & exercise pharmacotherapy Hypercholesterolemia Hx & PE lipid profile diet & exercise pharmacotherapy CHDs, URDs, LRDs ? IgE profile avoidance Hx & PE pharmacotherapy Disease Paradigms Treatment Treatment

  42. CAP RAST: Gain Knowledge to Guide Treatment CAP RAST® • FDA-cleared quantitative measure of specific IgE • Only a single blood draw required • Covered under most insurance plans • Accuracy superior to RASTTM*1 • Next-generation assay offers consistently improved sensitivity,2 • De facto standard, documented in >2,700 peer-reviewed publications3 • In vitro blood testing and skin prick testing (SPT) viewed as interchangeable4 • CAP RAST is available throughout the nation from all major reference and clinical laboratories, including Quest Diagnostics, NS-LIJ & BioReference • * RAST is a trademark of Pharmacia Diagnostics. • Williams PB, et al. J Allergy Clin Immunol. 2000;105:1221-1230. • Szeinbach SL, et al. Ann Allergy Asthma Immunol. 2001;86:373-381. • 3. Johansson SGO. Expert Rev Mol Diagn. 2004;4:273-279. • 4. Hamilton RG. In: Pediatric Allergy: Principles and Practice. Mosby-Year Book, Inc; 2003:233-242. CAP RAST®

  43. Solid-phase Protein Binding Capacity Comparison • CAP RAST cellulose polymer binds almost 150 times more protein than a passively coated tube, well or bead, and about 250 percent more protein than a paper disc. Solid Phase H. Drevin, 1989A. Kober, 2004

  44. Line represents minimum acceptable R2performance values Ideal Test (Correlation Coefficient) Newest generation: CAP RAST RAST/ Modified RAST Alastat/ 3gAllergyTM** Accuracy of Immunoassays for Specific IgE CAP RAST® 1.0 .96 - .98 .82 .65 *The authors noted that regression values below 0.80 reflect poor performance in the ability to correctly detect levels of specific IgE antibodies. ONLY CAP RAST had consistently acceptable regression values. **Alastat was recently replaced by 3gAllergy. Studies show 93% agreement between both methods. Williams PB, et al. J Allergy Clin Immunol. 2000;105:1221-1230. CAP RAST®

  45. Predictive Value vs. Skin Prick Testing (SPT)* CAP RAST Return to previous slide • Authors concluded that CAP RAST Specific IgE blood test and SPT values both exhibited excellent efficiency1 *Adapted from Reference 1. †CAP RASTSpecific IgE blood test was used in this study. 1. Wood RA, et al. J Allergy Clin Immunol. 1999;103:733-779. CAP RAST®

  46. Profiles Carefully Designed CAP RAST • Profiles engineered to detect >95% of patients with allergy1-3 • Regional respiratory profiles include key indoor/outdoor allergens selected according to: • Geographic pollen patterns • Regional disease prevalence • Cross reactivity to other allergens in each inhalant class • Allergy March profiles include key food/inhalant allergens • Six foods account for 90% of food allergy reactions in children4 • Inhalants include common/cross-reactive indoor and outdoor allergens • Generally recommended for children ≤6 years of age, based on symptoms • Sampson HA, Ho DG. J Allergy Clin Immunol. 1997;100:444-451. • Yunginger JW, et al. J Allergy Clin Immunol. 2000;105:1077-1084. • Poon AW, et al. Am J Man Care. 1998;4:969-985. • AAAAI. The Allergy Report. 2000;3:69. CAP RAST®

  47. Understanding Total IgE1 CAP RAST • Total IgE often of little practical value when considered alone • Levels rarely high when specific IgE titers are not • Lacks sensitivity as a rule-out screen: Specific IgE levels may be significantly high when total IgE is low/normal • Extremely high total IgE may be seen in some very rare non-atopic conditions2: • Certain immunodeficiency diseases (including HIV) • IgE myeloma • Drug-induced interstitial nephritis • Graft-versus-host disease • Parasitic diseases • Skin diseases in addition to eczema • Hyper-IgE syndrome (dermatitis, recurrent pyogenic infection) • Fromer LM. J Fam Pract. 2004;suppl:S4-S14. • AAAAI. The Allergy Report. 2000;1:35. CAP RAST®

  48. Interpretation of Total IgE* Results Total IgE Reading Negative (Normal) Positive (Abnormal, Elevated) Non-allergic Patient Scenario A Rare1 Scenario B Negative (Normal) Specific IgE Reading Allergic Patient Scenario C Allergic Patient Scenario D Positive (Abnormal, Elevated) Understanding Total IgE CAP RAST Return to previous slide *Includes URDs (Upper Respiratory Diseases), CHDs (Childhood Diseases), and LRDs (Lower Respiratory Diseases) 1. AAAAI. The Allergy Report. 2000;1:35. CAP RAST®

  49. Summary Summary • Diagnostic precision leads to evidence-based medical care • Improves patient care • Creates better patient satisfaction • Provides more appropriate referrals • CAP RAST Specific IgE blood test is an accurate test to differentiate atopic from non-atopic patients • Experts, specialty organizations, and government agencies support allergy testing in primary care Summary

  50. URD Inhalant Panel Interpretation Of Results

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