Presentation on theme: "Bulgaria Ewopharma MedReps Training Course 14 December 2010"— Presentation transcript:
1Bulgaria Ewopharma MedReps Training Course 14 December 2010
2Agenda 8.30-10.00 am Who is the allergic patient ? How the allergic patient is managed ?Why the allergic patient is underdiagnosed ?Why the allergic patient is undertreated ?Break10.15 – amGrass rationalisation,Posology - arguments to increase to 8 drops per dayPatient follow up,Post graduate course presentation and arguments
3Allergic patient: the current practice Who is the allergic patient ?How the allergic patient is managed ?Why the allergic patient is underdiagnosed ?Why the allergic patient is undertreated ?
4Who is the allergic patient ? Epidemiology of respiratory allergic diseasesECHRSISAACClassification of respiratory allergic diseasesARIAGINAThe natural course of allergic diseases
5Allergic Rhinitis: prevalence in Europe Prevalence of AR in a population-based survey in 6 EU countries1:UK, Germany, France, Belgium, Italy and SpainAR European prevalence is 23%, of which 45% are undiagnosed126.0%129.8%2500 million people suffer from AR worlwide20.6%121.0%324.5%116.9%1AR prevalence is quite high, with almost half of sufferers not being diagnosed.From those, a percentage have severe uncontrolled symptoms (target population for AIT).21.5%11.Bauchau V., Durham S.R., Eur Respir J 2004:2.Bachert C. Allergy 2006: 61:3.Brehl P. Ind Health 2003 Apr; 41 (2): 121-3
6Masoli et al. Allergy 2004; 59(5): 469-78. Prevalence of clinical asthma in both adults and children : ISAAC StudyProportion of population (%)10.12.5–5.07.6–10.00–2.55.1–7.5No standardised dataMasoli et al. Allergy 2004; 59(5):
7What is a severe allergic rhinitis ? Classification of allergic rhinitis*:New classification developed in 2001 by the ARIA consensus (AllergicRhinitis and its Impact on Asthma) in order to characterise rhinitis and itsimpact on the quality of life according to its duration (intermittent orpersistent) and the severity of the symptoms.*Bousquet J. et al. Allergic Rhinitis and its Impact on Asthma (ARIA).Allergy 2008: 63 (Suppl. 86): 8–160IntermittentSymptoms< 4 days per weekor < 4 weeksPersistent> 4 days per weekand > 4 weeksSlight• normal sleep• normal social and leisure activities• normal work and school life• symptoms causing minimal discomfortModerate - Severe• sleep disturbed• disrupted social and leisure activities• disrupted work and school life• unpleasant symptoms
8Profile of patients consulting the allergist REALIS survey:clinical and sensitization profile of patients consulting for respiratory allergies in France80.3%moderate to severe patientsN=2714Allergists and pulmonologists recruited patients consulting for respiratory allergy and who were being tested for allergy for the first time (September January 2008)The severity of allergic rhinitis or asthma was assessed by ARIA 2001 and GINA 2006 guidelinesAmong patients who were seen by a specialist, the majority (more than 8 in 10) had moderate to severe AR.~ 80% of AR patients consulting an allergist have moderate-to-severe symptomsThey have had allergic rhinitis symptoms during 4 to 5 years before they look for an allergy specialistM.Migueres et al. French REALIS survey. Abstract at XXVIII EAACI
9Altered quality of life due to the allergic symptoms SLEEP & TIREDNESS77 % of patients had sleep troubles46 % of patients felt tiredDAILY ACTIVITIES IMPAIREDLEARNING & COGNITIVE FUNCTIONS DISTURBEDImpact on Allergic Respiratory DiseasesWORK & SCHOOL PRODUCTIVITY< 90 % effectiveness at work< 93 % impaired classroom performanceEMBARRASSMENTAdolescents embarassed to use inhalers
10Allergic rhinitis is a risk factor for asthma WHO – Initiative ALLERGIC RHINITIS AND ITS IMPACT ON ASTHMA (ARIA)Allergic rhinitis has been defined by the WHO as major chronic disease of the airwaysAllergic rhinitis is a risk factor for asthmaExpand the diagnosis: think of rhinitis in patients with asthma, think of asthma in patients with rhinitisWHO – Initiative 2000: Ein aktuelles Dokument der Weltgesundheitsorganisation WHO mit dem Titel „ALLERGIC RHINITIS AND IT´S IMPACT ON ASTHMA (ARIA)“ weist auf die enge Bezeihung zwischen einer Allergie an der Nase und der Lunge hin und fordert eine gemeinsame Behandlungsstrategie für beide Organsysteme.A common treatment strategy for rhinitis and asthma patients is recommended!
11Why the allergic patient is underdiagnosed ? How the allergy diagnosis must be performed ?How the GPs diagnose the allergic diseases ?What’s going wrong with the allergy diagnosis ?
12Diagnosis Process in Allergology Patient with suspected respiratory allergy symptomsClinical history for allergyAllergy testingIn allergy medicine, the diagnostic process itself is relatively simple but does need to follow a specific sequence. Firstly, one has to draw up a detailed medical profile of the patient on the basis of his or her clinical history and a detailed interview. This will enable the practitioner to broadly identify the allergen or group of allergens that are most likely to cause the patient's symptoms.During the patient interview, the practitioner seeks to establish the individual's personal medical history. Did he or she suffer from asthma or rhinitis as a child? And how about atopic dermatitis (an aggravating factor for the appearance of allergy)? In childhood, did the patient suffered from hypersensitivity to known allergenic foods?The second phase will then involve specific allergen testing.
14Measurement of the skin reaction 15 – 20 minutes after testing Wheal diameter
15How the GPs diagnose the allergic diseases ? Patient with suspected respiratory allergy symptomsClinical history for allergyStopIn allergy medicine, the diagnostic process itself is relatively simple but does need to follow a specific sequence. Firstly, one has to draw up a detailed medical profile of the patient on the basis of his or her clinical history and a detailed interview. This will enable the practitioner to broadly identify the allergen or group of allergens that are most likely to cause the patient's symptoms.During the patient interview, the practitioner seeks to establish the individual's personal medical history. Did he or she suffer from asthma or rhinitis as a child? And how about atopic dermatitis (an aggravating factor for the appearance of allergy)? In childhood, did the patient suffered from hypersensitivity to known allergenic foods?The second phase will then involve specific allergen testing.
16Why the allergic patient is underdiagnosed ? What’s going wrong with the allergy diagnosis ?
17Consultation is not frequent “How recently have you been seen by a health care professional?”-Internet and telephone survey conducted in 2005 in general population from UK, Germany, Italy and Spain-N=2966 randomly selected adults with allergiesDespite a high number of European population suffering from allergy, the consultation is not frequent.~10% of the European population with rhinitis symptoms was never seen by a health care professional (nurse or doctor) for their conditionMaurer M, Zuberbier T, Allergy 2007: 62:
1819% have consulted a specialist Only 1 patient over 5 consulted a specialistTNS STUDY:TNS survey conducted in France N= 623 subjects with AR symptoms from 2003 generalpopulationTYPE OF DOCTORS CONSULTED BY PATIENTS:19% have consulted a specialist*Several consultations per doctor were possible**in France, a first consultation with a GP is mandatory before referral to a specialistWhen patients consult a doctor, the majority sees a GP. Only one patient in 5 consult a specialist.It is important to note that in France a patient must first be seen by a GP, who then decides if the patient should be referred to a specialist.In94% of patients consulting a GP in 1st line treatment19% consulted a specialist (13% an allergist**), in 2nd line treatmentA.Didier et al. Unmet therapeutic needs in AR. Abstract at XXIX EAACI 2010
19How the allergic patient is managed ? The allergen avoidanceThe pharmacotherapyThe allergen immunotherapy (AIT)
20The optimal management of the allergic patient The patient educationAllergen avoidanceAllergen ImmunotherapyPharmacotherapy
21Why the allergic patient is undertreated ? The efficacy of the allergen avoidance ?
22Allergen avoidance : recommended but a limited efficacy Mites: efficacy not well demonstratedAnimals : patients can be sensitized without direct contact with petsPollen: Unfeasible
23Why the allergic patient is undertreated ? The efficacy of the pharmacotherapy ?
24Therapy of Allergic Rhinitis ARIA Update 2007WHOIntermittent symptomsPersistent symptomsMildintermittentSevereintermittentMildpersistentSeverepersistentSeverity of Allergic Rhinitis patientsAllergen and irritant avoidanceOral or local non-sedative H1-blockerIntra-nasal or oral decongestantIntranasal steroidLocal cromoneSpecific Immunotherapy11 % % % %
26Total rhinitis score: Nasal Mometasone %MFNS 100mcg/QDMFNS 200mcg/QD79Placebo7575717063596053534445Mean improvement from baseline363429Slide 21: Safety and tolerability of grass pollen tablet sublingual immunotherapyThe oral mucosa contains a limited number of proinflammatory cells, such as mast cells, which probably contributes to the absence of anaphylactic reactions with sublingual immunotherapy the basis of the therapy’s excellent safety profile.In this study all treatment doses were well-tolerated and as in previous studies of sublingual immunotherapy there were few serious and no fatal adverse events. The slide shows the treatment-emergent adverse events with an incidence of more than 5% in the safety population. These were almost all local reactions related to direct oral contact with the allergen and mainly occurred at the beginning of the treatment course during the initiation phase. They were seen rarely or were absent from the placebo treated group. All local reactions resolved without medical intervention. Other frequently reported adverse events were headache and nasopharyngitis the incidence of which was similar across all treatment groups including the placebo group. Can we say something about formulation or adjuvants improvements underway here to reduce these AEs?The number of patients reporting “severe” AEs was similar in each of the active treatment groups, 10 for 100 IR and 500 IR and 8 for 300 IR. Not all patients experiencing severe adverse events left the study, only 3 withdrew from the 100 IR, 6 from the 300 IR and 8 from the 500 IR. No patients withdrew from the placebo group because of treatment-emergent adverse events. One patient in the 300 IR group and two in the 500 IR group experienced serious adverse events but these were not related to the study medication.Time (day)* p0.01 relative to placeboVan Drunen et al., Allergy 2005: 60 (Suppl. 80): 5-19
27Total rhinitis score : Nasal Mometasone MFNS 50mcg/QDMFNS 100mcg/QD60MFNS 200mcg/QDMFNS 800mcg/QDPlacebo5040Improvement in total nasal symptom scores302010Baseline37142128EndpointTime (day)Van Drunen et al., Allergy 2005; 60 (Suppl. 80): 5-19
28Rhinitis symptoms in seasonal AR Montelukast vs. placebo and Loratadin Daytime nasal symptomsDaily composite (daytime nasal & night-time)Night-time symptoms-0.6-0.5-0.4-0.3-0.2-0.1-9%-16%-22%-8%-20%-15%-9%-16%-20%Change from baseline (0-3 scale; LS mean SE)PlaceboMontelukastLoratadinePhilip et al., Clin Exp Allergy 2002; 32:
29A patient uncontrolled and not satisfied by the pharmacotherapy 35-40 % of patients receiving optimal standard symptomatic treatment experience poor symptom controlThe level of patient dissatisfaction are high with these medications
30What are the unmet needs ? Patient satisfaction / perceptionPatient expectation: a long term efficacy
31What are the unmet needs ? Patient satisfaction / perception
32Allergic Rhinitis Management Good100%MediumBad75%50%25%0%Nasal corticosteroidregularregularintermittentintermittentAnti-histamineregularintermittentregularintermittentHow do patients feel after their symptomatic treatment (anti H1, corticosteroid) ?White et al. , Clin Exp Allergy1998
33everybody knows this word. The paradox of allergy„Allergy“everybody knows this word.Only 10 per cent ofallergic patients aretreated correctly.
34symptomatic treatments 48 % have bad quality of life Allergic Rhinitis and unmet therapeutic needsTNS 2009: 623 subjects with AR/ 2003 individuals from general populationControl withsymptomatic treatmentsQuality of lifeThree quarters of patients who have consulted a doctor within the last 12 months remain uncontrolled despite the use of symptomatic treatments.Half of those uncontrolled patients have a bad quality of life.73% remain uncontrolled(19% of total population)48 % have bad quality of life(13% of total population)19% of allergic rhinitis patients remain uncontrolled and 13% have a poor quality of life despite using symptomatic treatmentsA.Didier et al. Unmet therapeutic needs in allergic patients . Abstract at XXIX EAACI 2010
35Unsatisfied needs Symptomatic treatment Social and financial impact No long term efficacyNo effect on the disease modifyingLack of complianceDissatisfactionSocial and financial impactCost of the diseaseQuality of life decreaseChronicity of the diseaseResignation
36What are the unmet needs ? Patient expectation: a long term efficacy
37Why AIT can satisfy the unmet needs ? Immunomodulatory effectLong term and sustained effect
38DefinitionSpecific immunotherapy is the repeated administration of allergen products to allergic subjects to activate immunomodulatory mechanisms and provide sustained relief of symptoms during subsequent natural allergen exposureWHO Guideline 1998EMEA Guideline 2008
39Immunomodulatory effect of AIT Natural exposureto the allergenLymphocytes BIgEIL- 4CPATh2Lymphocytes TMastocytesAITAllergyT regLymphocytes T regulator
40Recruitment and activation of mast cells and eosinophils Allergen Immunotherapy: from the immunological effects to the symptomatic effectRecruitment and activation ofmast cells and eosinophilsNasal, ocular and bronchialhyperreactivityAITdecreaseSymptomsUse of antiallergic drugs
41Allergen Immunotherapy AIT is the only treatment that modifies the natural evolution of allergyOneallergyTwo allergiesSeveralallergiesAllergen ImmunotherapyAllergic AsthmaAllergic Rhinitis
42Why the allergist is the expert ? DiagnosisAIT indicationsPatient management and follow-up
43Diagnostic Approach In Allergology Allergy HistorySkin Tests/IgESymptoms Moderate/severePoor QOLPositive
44AIT Indication Pathway Allergy HistorySkin Tests/IgESymptoms Moderate/severePoor QOLDIAGNOSSPositiveIndication for AIT ?Contra indications:Immunoptahologic diseasesSevere asthma- Malignancy- Treatment withβ-blockers- Chronic mouth disease- Pregnancy: avoid initiaition of immunotherapy during pregnancyNOYESAge ≥ 4 yrs oldSLIT with pollens mixtures or 2 non related allergensSLIT with one allergen
45Which Allergen for AIT ? Monosensitization Polysensitization A patient with moderate/severe symptoms during/after allergen exposureA patient with an altered quality of life due to the allergic symptomsA patient not improved and not satisfied by the pharmacotherapyA patient accurately diagnosedFor allergic respiratory diseasesMonosensitizationPolysensitization
46What are the key success factors for AIT ? Patient InformationPatient’s Action PlanPatient Follow-UpPatientDoctorRelationship
47Key success factors for AIT Patient information = Patient Education Patient should understand :His/her allergic diseaseThe goals of SITThe disease modifyer effect of SITWhy 3-5 years of SLIT ?The onset of action of SLITThe importance of compliance for the success of SLIT
49Agenda 10.15 – 12.30 am Grass rationalisation Posology - arguments to increase to 8 drops per dayPatient follow upPost graduate course: presentation and arguments
50Grass rationalisation 5 Grasses / 4 cereals mixture: is it still relevant ?High level of allergens cross-reactivity between 5 grasses and cereals5 grasses alone is sufficient to treat the allergic patient sensitized to grass pollen and cereal pollen.
55Patient Information/Communication Give the right message to the patient !! “Allergy is a chronic disease not curable by pharmacotherapy alone..”“Rhinitis will develop into asthma in 50 % of the patients..”“You may develop new allergic sensitizations..”“The only way to affect the disease is by immune intervention..”“ SIT is a three years treatment but compared to lifelong drug intake..”“ Efficacy of SIT persists longtime after cessation ““ SIT would positivily affect your quality of life…”
56Key success factors for SIT Patient Information/Education needs from the doctor TimeConviction / Enthousiasm/PersuasionTo be done at regular intervals (not a one shot issue)
57Patient compliance: a major issue Factors of non-compliance :Daily intakeTreatment duration: 3-5 years
58Key success factors for AIT Patient compliance: a major issue Patient Follow-UpOptimal patient follow-upSIT efficacy assessment
61Content of follow-up visits One monthafter starting3 months6 months9 months12 monthsSafetyStaloral intakeSafetyStaloral intakeComplianceComplianceEfficacyComplianceSatisfactionEfficacyComplianceSatisfactionEfficacyWillingness to continue
62SIT efficacy assessment is based only the clinical parameters Reduction of symptomsRhinitisConjunctivitisAsthmaReduction of anti-allergic drugs intakeImprovement of Quality of lifeComplianceSatisfactionEfficacyWillingness to continue
63Efficacy Assessment using a color-coded VAS (1/3) Symptoms :Before SLITGood Average BadHow was your daytime rhinitiscondition ?How was your nighttime rhinitiscondition ?How was your daytime asthmacondition ?How was your nighttime asthmacondition ?GreenareaOrangeareaRedarea
64Efficacy Assessment using a color-coded VAS ((2/3) Symptoms6 months laterGood Average BadHow was your daytime rhinitiscondition ?How was your nighttime rhinitiscondition ?How was your daytime asthmacondition ?How was your nighttime asthmacondition ?GreenareaOrangeareaRedarea
65Efficacy Assessment using a color-coded VAS (3/3) Symptoms12 months laterGood Average BadHow was your daytime rhinitiscondition ?How was your nighttime rhinitiscondition ?How was your daytime asthmacondition ?How was your nighttime asthmacondition ?GreenareaOrangeareaRedarea
66Rescue Medication for allergic rhinitis Efficacy Assessment ?Rescue Medication for allergic rhinitisH1-AntihistamineNasal Steroids%100- 25%- 50 %50-J09 M12 MMonths
67Rescue Medication for allergic asthma Efficacy Assessment ?Rescue Medication for allergic asthmaβ2-agonistsInhaled Steroids%100- 25%- 50 %50-J09 M12 MMonths
68Items Quality of life Efficacy Assessment ? SLEEP & TIREDNESS DAILY ACTIVITIES IMPAIRED (sport, work, school)WORK & SCHOOL PRODUCTIVITYLEARNING & COGNITIVE FUNCTIONS DISTURBED
69After 12 months of SIT: Efficacy assessment %≥ 50 %MonthsAt least 50 % reduction of symptoms and rescue medicaction use and a significant QOL improvement should be achieved at 12 months
70After 36 months of SIT: Stop & Follow-Up ≥ 50 %%≥ 80 %Stopand follow-upMonthsAt least 80 % reduction of symptoms and rescue medicaction use and a significant QOL improvement should be achieved at 36 months
72Sustained long term efficacy of SIT ≥ 80 %SITStopMonthYears
73Add one or two additionals years if necessary ≥ 50 %%Months
74Post - SIT : Patient follow-up year2ndyear3rdyear4thyear5thyearA visit once a year
75After 12 months of SIT: a key milestones STOP ? Symptoms weakly improved No change in rescue medications QOL not improved Compliance poor Safety average / bad Patient/parent not satisfied
76After 12 months of SIT: Why to stop ? %MonthsLess than 50 % reduction of symptoms and rescue medicaction use and a poor QOL improvement have been achieved at 12 months
77After 12 months of SIT: a key milestones Before taking the decision to Stop, Check:Compliance :vials renewal; missing periods : changes in personal or familial conditions , cost issue, willingness to pursue the treatmentEnvironmental changes:increase in allergenic load/ Co-factors irritantCo-morbidities :not treatedIf none of these factors are found, go-back to the diagnosis and recheck the indications
78Key MessageTo be successful SLIT needs: A good indication The best candidate An optimal patient management
79Post graduate course presentation and arguments ObjectivesContentsOrganisation
80Post graduate course presentation and arguments (1) STALLERGENESPost Graduate CourseAn Essential Half-Day Training Course On :Sublingual Immunotherapy in Practice
81Post graduate course What The Course Will Cover ? A stepwise approach for the indications of SLITThe place of SLIT in the treatment of allergic respiratory diseasesThe key factors to make SLIT a successThe compliance/adherence issue and how to tackle it
82Post graduate course : the agenda Welcome – Introduction 15’The basics of SLIT : recall 15’Workshop 1 : Choosing the right patient for SLIT 60’Coffee Break ’Workshop 2 : Managing the patient optimally 60’The patient follow-up handbook 15’Interactive Quizz ’Take-home messages ’3 hours 30 duration
83Post graduate course Who Should Attend ? AllergistsExperience with SLIT: at least 1 year10 to 15 attendees/ session
84Post graduate course : Meeting Date 2011 March 2011VarnaPlovdivSofia