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Treatment Summary Perspectives CAP RAST CHDsURDs LRDs Allergy and Asthma: Improving Outcomes in Primary Care El Paso November, 2007 Len Fromer, M.D., FAAFP.

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Presentation on theme: "Treatment Summary Perspectives CAP RAST CHDsURDs LRDs Allergy and Asthma: Improving Outcomes in Primary Care El Paso November, 2007 Len Fromer, M.D., FAAFP."— Presentation transcript:

1 Treatment Summary Perspectives CAP RAST CHDsURDs LRDs Allergy and Asthma: Improving Outcomes in Primary Care El Paso November, 2007 Len Fromer, M.D., FAAFP

2 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives The Etiology Challenge Common symptoms and diseases have many possible etiologies IgE-mediated allergies trigger symptoms from infancy into adulthood Identification of true underlying cause is essential for effective management

3 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives The Allergic Inflammatory Response

4 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Common Childhood Diseases 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 URDs LRDs Treatment CAP RASTSummary Perspectives The Allergy March: A Progression of Seemingly Unrelated Diseases CHDs Atopic Dermatitis GI Distress Recurrent Otitis Media Allergic Asthma Allergic Rhinitis Food Sensitivity Inhalant Sensitivity Time (~years) Genetic Predisposition

6 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives 0 10 20 30 40 50 Age (years) Prevalence of Atopic Disease 1 3510 17 Symptoms GastrointestinalRespiratory Skin Prevalence (%) Saarinen UM, Kajosaari M. Lancet. 1995;346:1065-1069. Allergy March CHDs

7 URDs LRDs Treatment CAP RASTSummary Perspectives Age (years) 0 1 2 3 IgE Antibody Level 4 - 9 0 - 3 10 - 15 n= 122912 Mean score ( Phadebas RAST Class) Sigurs N, et al. J Allergy Clin Immunol. 1994;94:757-763. Allergy March CHDs Birch pollen Peanut Egg white

8 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Common Childhood Diseases 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 CHDs 1.Leung DYM. In: Pediatric Allergy: Principles and Practice. Mosby-Year Book, Inc; 2003:561-573. CHDs

9 URDs LRDs Treatment CAP RASTSummary Perspectives Common Childhood Diseases GI distress 1 –Colic, diarrhea, vomiting, constipation, reflux –Multiple etiologies: atopy, infection, intolerance, malabsorption, inflammatory bowel, anatomic defect –10%-42% of symptomatic patients are atopic 2,3 –50%-60% of infants with food sensitivities show GI symptoms (not necessarily full-blown food allergy) – Empirical treatment: trials of formulas 1.Høst A, Halken S. In: Pediatric Allergy: Principles and Practice. Mosby-Year Book, Inc; 2003:488-494. 2.Australasian Society of Clinical Immunology and Allergy. Adverse reactions to food. Available at: http://www.allergy.org.au/aer/infobulletins/adverse_reactions.htm. 3.Sicherer SH. Pediatrics. 2003;111:1609-1616. CHDs

10 URDs LRDs Treatment CAP RASTSummary Perspectives Common Childhood Diseases Recurrent otitis media (OM) –26% prevalence in US 1 –Key risk factors include attendance in daycare, cigarette smoke exposure 2 –40%-50% involve atopy 3,4 –Common underlying cause = eustachian tube dysfunction Caused by inflammation related to allergy or infection Recurrence = not treating the underlying cause –Empirical treatment: antibiotics, surgery 1.Lanphear BP, et al. Pediatrics. 1997;99:1-7. 2.AAAAI. The Allergy Report. 2000;2:155-161. 3.Data on file, Pharmacia Diagnostics. 4.Fireman P. J Allergy Clin Immunol. 1997;99:S787-S797 CHDs

11 URDs LRDs Treatment CAP RASTSummary Perspectives Atopys Long-Term Consequences Nearly 80% of children with AD go on to develop allergic rhinitis and/or asthma 1 Children with early and long-lasting food sensitization: – 3x more likely to develop allergic rhinitis (AR) than those transiently sensitized 2 – 5x more likely to develop asthma than those transiently sensitized 2 Young wheezers with confirmed atopy are more likely to develop asthma 3 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 URDs LRDs Treatment CAP RASTSummary Perspectives Knowledge of Etiology Guides Treatment for Today and Tomorrow 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 March 1-5 – ETAC: Cetirizine and avoidance halved asthma risk in children with AD 1 – PAT: Immunotherapy significantly reduced asthma risk in children with AR 2 – CCAPPS: Multifaceted avoidance intervention reduced asthma prevalence 56% in high-risk children 5 1.ETAC ® Study Group. Pediatr Allergy Immunol. 1998;9:116-124. 2.Möller C, et al. J Allergy Clin Immunol. 2002;109:251-256. 3.Platts-Mills TAE. N Engl J Med. 2003;349:207-208. 4.Sampson H. Ann Allergy Asthma Immunol. 2004;93:307-308. 5.Chan-Yeung M, et al. J Allergy Clin Immunol. 2005;116:49-55. CHDs

13 URDs LRDs Treatment CAP RASTSummary Perspectives Etiology Is Elusive URDs

14 Treatment Summary Perspectives CAP RAST CHDsURDs LRDs Overlapping Symptoms Allergic Rhinitis –Nasal congestion –Rhinorrhea –Increased secretions –Sneezing –Itchy, watery eyes Non-allergic Rhinitis –Nasal congestion –Rhinorrhea –Increased secretions –Postnasal drainage Chronic Sinusitis –Nasal congestion –Rhinorrhea –Increased secretions –Postnasal drainage –Headache –Facial pain URDs

15 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Upper Respiratory Diseases 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 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Productivity Loss $ per 1000 Employees

17 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Comparison of Quality-of-Life in Asthmatic & Chronic Rhinitis Patients

18 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Distribution of URD in US 1-3 39% of total population (115M of 295M) have URD 1.AHRQ. Management of allergic and nonallergic rhinitis. May 2002: AHRQ Pub. No. 02-E023. 2.Spector SL, ed. Dialogues in Redefining Rhinitis. 1996;1(1,4):1-16. 3.Allergy Statistics.AAAAI Web site. Available at: http://www.aaaai.org/media/resources/media_kit/allergy_statistics.stm. URDs 40M 35M 40M Sinusitis 30% Non-allergic Rhinitis 35% Allergic Rhinitis 35% URDs

19 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Actual Atopy and Antihistamine Use 1. Szeinbach SL, et al. J Manag Care Pharm. 2004;10(3):234-238. URDs Identification of allergic disease among users of antihistamines 1 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-atopic symptom etiology in 2/3 of patients 35% Atopic E tiology 65% Non-atopic E tiology

20 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Non-allergic Rhinitis Wide array of types and etiologies 1,2etiologies –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 1.AAAAI. The Allergy Report. 2000;2:1-31. 2.Dykewicz MS, et al. Ann Allergy Asthma Immunol. 1998;81:478-518. URDs

21 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives URDs Non-allergic Rhinitis: Many Possible Etiologies URDs Return to pre v ious slide

22 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Allergic Rhinitis Triggered by seasonal or perennial allergen(s) Symptoms may include: –nasal congestion, rhinorrhea, increased secretions, sneezing, itchy nose/eyes, watery eyes, coughing, postnasal drip 1,2 Cumulative threshold disease 3,4 : –Patients are rarely monosensitized –Symptoms emerge after allergic threshold has been exceeded 1.AAAAI. The Allergy Report. 2000;2:1-31. 2.Dykewicz MS, et al. Ann Allergy Asthma Immunol. 1998;81:478-518. 3.Pharmacia & Upjohn Diagnostics. The Value of Allergen Identification.1998. Publication 98006.01. 4.Wickman M. Allergy. 2005;60 (Suppl 79):14-18. URDs

23 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Cumulative Threshold Disease 1 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 Symptoms Situation A 2 No avoidance measures Situation B 3 No avoidance measures Third allergen Situation C 3 AvoidanceAvoidance measures employed Third allergen Cat dander Dust mites Ragweed URDs

24 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Support for Avoidance in the Management of Allergies and Asthma …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 management 3-5 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 URDs

25 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Sinusitis Multiple etiologies –Caused by inflammation from infection, allergy, structural abnormalities, other causes 1 –ENT experts use term rhinosinusitis due to epithelial continuum of sinus/nasal passages 1,2 Common comorbidity–often with atopy –Rarely occurs without concurrent rhinitis 2 –>50% of moderate to severe asthmatics have chronic rhinosinusitis 3 1.Brook I, et al. Ann Otol Rhinol Laryngol. 2000;109:2-20. 2.AAO-HNS. Fact sheet. ENT Link Web site. Available at: http://www.entnet.org/healthinfo/sinus/allergic_rhinitis.cfm. 3.AAAAI. The Allergy Report. 2000;2:7,137-153. URDs

26 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Why Should You Test? History and physical alone yield a correct diagnosis only 50% of the time 1 Different etiologies demand different treatment approaches Testing for specific IgE levels can rule in/out atopy If atopic: – NSAs probably drug of choice – T esting 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 URDs 1. Homburger HA. Arch Pathol Lab Med. 2004;128:1028-1031.

27 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives URD Management Options Specific IgE-Positive/Abnormal Atopic Etiology Specific Allergen Avoidance Adequate Response Allergy-Targeted Pharmacotherapy (eg, NSAs, LTRAs) Stop Inadequate Response Referral? Inadequate Response URDs Specific IgE-Negative/Normal Non-Atopic Etiology Adequate Response Pharmacotherapy (allergy-targeted Rx not helpful) Stop Inadequate Response Referral?

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

29 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives The Experts on Differential Diagnosis of Rhinitis 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 tests 1 : –Offer a well standardized alternative to skin testing –Are easily used by generalist physicians –Are effective in the diagnosis of allergy URDs 1. Selner JC, et al. Ann Allergy Asthma Immunol. 1999;82:407-412.

30 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives The Experts on Differential Diagnosis of Rhinitis Allergy [IgE] testing should be considered in all patients with a suspected diagnosis of allergic rhinitis. 1 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

31 Treatment Summary Perspectives CAP RAST CHDsURDs LRDs Etiology Linked to Triggers LRDs

32 Treatment Summary Perspectives CAP RAST CHDsURDs LRDs Overlapping Symptoms All that wheezes is not asthma. – Chevalier Jackson [1865-1958] LRDs Allergic Asthma –Wheezing –Cough –Dyspnea –Chest tightness –Rhinitis –Conjunctivitis Non-allergic Asthma –Wheezing –Cough –Dyspnea –Chest tightness Bronchitis –Wheezing –Cough –Dyspnea LRDs

33 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Lower Respiratory Diseases 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

34 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Asthma Widespread –7% prevalence (>20 million 1 ) and rising –73% managed by PCPs 2 Allergic vs. non-allergic asthma –60% of asthmatics have allergic asthma 3 –90% of children with asthma also have allergies 4 LRDs 1.NCHS. Asthma prevalence, health care use and mortality 2002. Available at: http://www.cdc.gov/nchs/Default.htm. 2.NCHS. Ambulatory care visits 1999–2000. Available at: http://www.cdc.gov/nchs/Default.htm. 3.Milgrom H. Understanding allergic asthma [AAAAI News Release]. June 18, 2003. 4.H Ø st A, Halken S. Allergy. 2000;55:600-608. LRDs

35 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives The One Airway Concept Common inflammatory process links upper and lower airways 1 –Asthma and allergic rhinitis commonly co-exist 2,3 –In concomitant disease, experts recommend evaluation and treatment of one condition to aid management of the other 4 –Asthma management guidelines from ARIA, 4 the NIH, 5 AAFP, 6 and AAAAI 7 encourage treatment of AR (and other URDs) to help control asthma 1.Bachert C, et al. Immunol Allergy Clin N Am. 2004;24:19-43. 2.Nayak AS. Allergy Asthma Proc. 2003;24:395-402. 3.Halpern MT, et al. J Asthma. 2004;41:117-126. 4.Bousquet J, et al. Allergic Rhinitis and its Impact on Asthma (ARIA). Allergy. 2002;57:841-855. 5.NIH. Guidelines for the Diagnosis and Management of Asthma.1997. NIH publication 97-4051. 6.AAFP. Asthma & Allergy Resource Guide. 2004:18. 7.AAAAI. The Allergy Report. 2000;2:33,54. LRDs

36 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives NIH Asthma Guidelines 1 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 patients history to assess sensitivity to seasonal allergens –Use skin testing or in vitro [blood] testing to assess sensitivity to perennial indoor allergens –Assess the significance of positive tests in context of the patients medical history LRDs 1.NIH. Guidelines for the Diagnosis and Management of Asthma.1997. NIH publication 97-4051. LRDs

37 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives NIH Asthma Guidelines 1 (contd) Use skin testing or in 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 patients atopic status. LRDs 1.NIH. Guidelines for the Diagnosis and Management of Asthma. 1997. NIH publication 97-4051. LRDs Return to >> Third-party Perspectives

38 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Knowledge of Symptom Triggers Guides Management Allergy testing may be conducted along with pulmonary function tests and other diagnostic evaluations 1 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 1.NIH. Practical Guide for the Diagnosis and Management of Asthma. 1997. NIH publication 97-4053. LRDs

39 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Asthma Management Options LRDs Specific IgE-Negative/Normal Non-Atopic Etiology Referral? Inadequate Response Adequate Response Pharmacotherapy Allergy Rx not helpful Controller(s) Rescue Rx Stop Focus on Non-allergic Triggers Specific IgE-Positive/Abnormal Atopic Etiology Specific Allergen Avoidance Adequate Response Pharmacotherapy Treat AR (eg, NSAs) LTRAs Controller(s) Rescue Rx Stop Inadequate Response Referral? Inadequate Response

40 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Bronchitis Generally acute or chronic The catchall diagnosis when symptom etiology is unclear 1 Chronic cough: a key symptom associated with 2,3 : –Postnasal drip (due to rhinitis, allergic rhinitis, or sinusitis) –GERD –Cough-variant asthma (documented as leading cause in children 4 ) In children: atopy is the most important risk factor for wheezing, diminished lung function, and asthma 5wheezing Empirical treatment: antibiotics, bronchodilators 1.Hueston WJ, Mainous AG. Am Fam Physician. 1998;57:1270-1276. 2.Lawler WR. Am Fam Physician. 1998;58(9):2015-2022. 3.Irwin RS, Madison JM. Am J Respir Crit Care Med. 2002;165:1469-74.. 4.Holinger LD, Sanders AD. Laryngoscope. 1991;101:596-605. 5.Martinez FD, Godfrey S. Wheezing Disorders in the Preschool Child. Martin Dunitz; 2003:2-35. LRDs

41 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Age (years) Prevalence of Childhood Wheezing 1 0 63 Wheezing Prevalence 11 Wheezing, Atopy, and Asthma LRDs 1.Martinez FD, et al. J Allergy Clin Immunol 1999;104:S169-S174. Transient early wheezers Non-atopic wheezers IgE-associated wheeze/asthma Return to pre v ious slide

42 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives What Is Happening to 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

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

44 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Disease Paradigms Treatment Hx & PElab tests diet & exercisepharmacotherapy Diabetes Mellitus Type 2 Hx & PElipid profile diet & exercisepharmacotherapy Hypercholesterolemia Hx & PEpharmacotherapy CHDs, URDs, LRDs ? IgE profileavoidance

45 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives CAP RAST: Gain Knowledge to Guide Treatment FDA-cleared quantitative measure of specific IgE Only a single blood draw required Covered under most insurance plans Accuracy superior to RAST TM*1 –Next-generation assay offers consistently improved sensitivity,2 –De facto standard, documented in >2,700 peer-reviewed publications 3 In vitro blood testing and skin prick testing (SPT) viewed as interchangeable 4interchangeable 4 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. 1.Williams PB, et al. J Allergy Clin Immunol. 2000;105:1221-1230. 2.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 ® CAP RAST ®

46 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives H. Drevin, 1989 A. Kober, 2004 Solid-phase Protein Binding Capacity Comparison Solid Phase 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.

47 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Accuracy of Immunoassays for Specific IgE *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 ® CAP RAST ® Line represents minimum acceptable R 2 performance values Alastat/ 3gAllergy TM** RAST/ Modified RAST Newest generation: CAP RAST Ideal Test (Correlation Coefficient).65.82.96 -.98 1.0

48 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Source: Williams PB, Barnes JH, Szeinbach SL, Sullivan T. Analytical precision and accuracy of commercial immunoassays for specific IgE: establishing a standard. J Allergy Clin Immunol. 2000;105(6):1221-1230. Poor Performance For Tests With R2 Below 0.80 Given the dilution range used in this study, values of R-Square below approximately 0.80 generally reflect poor performance in the ability to correctly detect levels of specific IgE antibodies. Only CAP RAST had consistently acceptable R-Square values, suggesting good performance in their ability to correctly detect the concentrations of specific IgE antibodies across the different samples and allergens.

49 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Predictive Value vs. Skin Prick Testing (SPT)* Performance parametersIn vitro SPT Sensitivity (%)87.293.8 Specificity (%)90.580.1 PPV (%)91.190.1 NPV (%)86.487.1 Clinical Efficiency (%)88.889.2 *Adapted from Reference 1. CAP RAST Specific IgE blood test was used in this study. 1. Wood RA, et al. J Allergy Clin Immunol. 1999;103:733-779. CAP RAST Authors concluded that CAP RAST Specific IgE blood test and SPT values both exhibited excellent efficiency 1 CAP RAST ® Return to pre v ious slide

50 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Profiles Carefully Designed Profiles engineered to detect >95% of patients with allergy 1-3 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 children 4 –Inhalants include common/cross-reactive indoor and outdoor allergens –Generally recommended for children 6 years of age, based on symptoms CAP RAST 1.Sampson HA, Ho DG. J Allergy Clin Immunol. 1997;100:444-451. 2.Yunginger JW, et al. J Allergy Clin Immunol. 2000;105:1077-1084. 3.Poon AW, et al. Am J Man Care. 1998;4:969-985. 4.AAAAI. The Allergy Report. 2000;3:69. CAP RAST ®

51 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Understanding Total IgE 1 Total IgE often of little practical value when considered aloneconsidered 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 conditions 2 : –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) CAP RAST 1.Fromer LM. J Fam Pract. 2004;suppl:S4-S14. 2.AAAAI. The Allergy Report. 2000;1:35. CAP RAST ®

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

53 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Third-party Perspectives Childhood diseases –EAACIEAACI –AAPAAP Upper respiratory diseases –JCAAI (guidelines for chronic rhinitis)JCAAI –AAAAI – The Allergy ReportAAAAI –AHRQ (Agency for Healthcare Research and Quality)AHRQ –Multiple textbooks Lower respiratory diseases –NIH (asthma guidelines)NIH –AAFP (asthma guidelines)AAFP –FDA (Xolair ® indications)FDA

54 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Generally, all individuals with severe, persisting or recurrent possible allergic symptoms and individuals with need for continuous prophylactic treatment should be tested for specific allergy regardless of the age of the child. 1.Høst A, et al. Allergy. 2003;58:559-569. Perspectives Return to >> Third-party Perspectives From the European Academy of Allergy and Clinical Immunology 1

55 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives 1. AAP Pediatric Update. 2001;22:1-8. Perspectives From the American Academy of Pediatrics 1 Panel Discussion: Recent Advances in Allergy Hugh A. Sampson, MD: The pediatrician could certainly order the blood test initially to see whether or not there were significant levels of antibody to milk, egg, or peanut in these children with atopic dermatitis…. Laurie J. Smith, MD: Its important to specify, however, that the only in vitro test with which such diagnostic assumptions can be made is with the CAP RAST and no other in vitro test that is available. Return to >> Third-party Perspectives

56 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives 1. Dykewicz MS, et al. Ann Allergy Asthma Immunol. 1998;81:478-518. Perspectives From the Joint Council of Allergy, Asthma, and Immunology 1 Rhinitis should be classified by etiology as allergic or non-allergic –Since approximately 50% of patients with rhinitis do not have allergic rhinitis, other potential causes must be ruled out Return to >> Third-party Perspectives

57 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives 1.AAAAI. The Allergy Report. 2000;1:31. From the American Academy of Allergy, Asthma & Immunology 1 Diagnostic evaluation, including specific testing, is necessary to: –Confirm the allergic diagnosis –Differentiate allergic disorders from other diseases –Uncover previously unsuspected allergens –Guide treatment Return to >> Third-party Perspectives

58 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives Given the absence of studies to differentiate nonallergic rhinitis, diagnostic testing rather than symptoms or signs is necessary to differentiate isolated vasomotor or nonallergic rhinitis from allergic rhinitis. 1.AHRQ. Management of allergic and nonallergic rhinitis. May 2002. AHRQ Pub. No. 02-E023. Perspectives From the Agency for Healthcare Research and Quality 1 Return to >> Third-party Perspectives

59 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives 1.AAFP. Asthma & Allergy Resource Guide. 2004:11-13. Perspectives From the American Academy of Family Physicians 1 Determining whether and how allergies play a role in a patients asthma is an important part of the clinical picture. Family physicians are in an ideal position to consider the full spectrum of potential allergic and non-allergic triggers in their evaluation of patients who have asthma. The CAP RAST serum specific immunoglobulin E (IgE) assay may also be appropriate for patients in whom skin testing is not an option….Quantitative testing…may be more useful because it identifies a patients specific causative allergens. CAP RAST testing is often less expensive than RAST and is a fairly simple way for family physicians to screen patients before referral to an allergist. Return to >> Third-party Perspectives

60 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives * Xolair is a registered trademark of Genentech, Inc. and Novartis Pharmaceuticals Corporation. 1. Xolair (omalizumab) Prescribing Information. Perspectives From the U.S. Food and Drug Administration 1 Indication fo omalizumab Omalizumab is indicated for adults and adolescents (12 years of age and above) with moderate to severe asthma who have a positive skin test or in vitro reactivity to a perennial allergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Return to >> Third-party Perspectives

61 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives 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

62 CHDsURDs LRDs Treatment CAP RASTSummary Perspectives URD Inhalant Panel Interpretation Of Results


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