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Bulgaria Ewopharma MedReps Training Course 14 December 2010.

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Presentation on theme: "Bulgaria Ewopharma MedReps Training Course 14 December 2010."— Presentation transcript:

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2 Bulgaria Ewopharma MedReps Training Course 14 December 2010

3 Agenda am  Who is the allergic patient ?  How the allergic patient is managed ?  Why the allergic patient is underdiagnosed ?  Why the allergic patient is undertreated ? Break – am  Grass rationalisation,  Posology - arguments to increase to 8 drops per day  Patient follow up,  Post graduate course presentation and arguments

4 Allergic 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 ?

5 Who is the allergic patient ?  Epidemiology of respiratory allergic diseases  ECHRS  ISAAC  Classification of respiratory allergic diseases  ARIA  GINA  The natural course of allergic diseases

6 Allergic Rhinitis: prevalence in Europe 20.6% % % % % % 2 AR European prevalence is 23%, of which 45% are undiagnosed % 1 1.Bauchau V., Durham S.R., Eur Respir J 2004: Bachert C. Allergy 2006: 61: Brehl P. Ind Health 2003 Apr; 41 (2): Prevalence of AR in a population-based survey in 6 EU countries 1 : UK, Germany, France, Belgium, Italy and Spain 500 million people suffer from AR worlwide

7 Prevalence of clinical asthma in both adults and children : ISAAC Study Masoli et al. Allergy 2004; 59(5):  – – –5.0 0–2.5 No standardised data Proportion of population (%)

8 What is a severe allergic rhinitis ? Classification of allergic rhinitis*: New classification developed in 2001 by the ARIA consensus (Allergic Rhinitis and its Impact on Asthma) in order to characterise rhinitis and its impact on the quality of life according to its duration (intermittent or persistent) and the severity of the symptoms.  *Bousquet J. et al. Allergic Rhinitis and its Impact on Asthma (ARIA).Allergy 2008: 63 (Suppl. 86): 8–160 Intermittent Symptoms < 4 days per week or < 4 weeks Persistent Symptoms > 4 days per week and > 4 weeks Slight normal sleep normal social and leisure activities normal work and school life symptoms causing minimal discomfort Moderate - Severe sleep disturbed disrupted social and leisure activities disrupted work and school life unpleasant symptoms

9 8 Profile of patients consulting the allergist  ~ 80% of AR patients consulting an allergist have moderate-to- severe symptoms  They have had allergic rhinitis symptoms during 4 to 5 years before they look for an allergy specialist M.Migueres et al. French REALIS survey. Abstract at XXVIII EAACI 80.3% moderate to severe patients N=2714 REALIS survey: clinical and sensitization profile of patients consulting for respiratory allergies in France

10 Altered quality of life due to the allergic symptoms Impact on Allergic Respiratory Diseases SLEEP & TIREDNESS 77 % of patients had sleep troubles 46 % of patients felt tired SLEEP & TIREDNESS 77 % of patients had sleep troubles 46 % of patients felt tired LEARNING & COGNITIVE FUNCTIONS DISTURBED EMBARRASSMENT Adolescents embarassed to use inhalers EMBARRASSMENT Adolescents embarassed to use inhalers WORK & SCHOOL PRODUCTIVITY < 90 % effectiveness at work < 93 % impaired classroom performance WORK & SCHOOL PRODUCTIVITY < 90 % effectiveness at work < 93 % impaired classroom performance DAILY ACTIVITIES IMPAIRED

11 WHO – Initiative 2000 ALLERGIC RHINITIS AND ITS IMPACT ON ASTHMA (ARIA)  Allergic rhinitis has been defined by the WHO as major chronic disease of the airways  Allergic rhinitis is a risk factor for asthma  Expand the diagnosis: think of rhinitis in patients with asthma, think of asthma in patients with rhinitis A common treatment strategy for rhinitis and asthma patients is recommended!

12 Why 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 ?

13 Diagnosis Process in Allergology Patient with suspected respiratory allergy symptoms Clinical history for allergy Allergy testing

14 Stallerpoint® Allergens Skin prick-tests method

15 Measurement of the skin reaction 15 – 20 minutes after testing Wheal diameter

16 How the GPs diagnose the allergic diseases ? Patient with suspected respiratory allergy symptoms Clinical history for allergy Stop

17 Why the allergic patient is underdiagnosed ?  What’s going wrong with the allergy diagnosis ?

18 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 condition Maurer M, Zuberbier T, Allergy 2007: 62: Internet and telephone survey conducted in 2005 in general population from UK, Germany, Italy and Spain -N=2966 randomly selected adults with allergies  “How recently have you been seen by a health care professional?”

19 Only 1 patient over 5 consulted a specialist 19% have consulted a specialist A.Didier et al. Unmet therapeutic needs in AR. Abstract at XXIX EAACI 2010 *Several consultations per doctor were possible **in France, a first consultation with a GP is mandatory before referral to a specialist  94% of patients consulting a GP in 1 st line treatment  19% consulted a specialist (13% an allergist**), in 2 nd line treatment TYPE OF DOCTORS CONSULTED BY PATIENTS: TNS STUDY: TNS survey conducted in France N= 623 subjects with AR symptoms from 2003 general population

20 How the allergic patient is managed ?  The allergen avoidance  The pharmacotherapy  The allergen immunotherapy (AIT)

21 The optimal management of the allergic patient The patient education Allergen avoidance Pharmacotherapy Allergen Immunotherapy

22 Why the allergic patient is undertreated ?  The efficacy of the allergen avoidance ?

23 Allergen avoidance : recommended but a limited efficacy  Mites : efficacy not well demonstrated  Animals : patients can be sensitized without direct contact with pets  Pollen: Unfeasible

24 Why the allergic patient is undertreated ?  The efficacy of the pharmacotherapy ?

25 Therapy of Allergic Rhinitis ARIA Update 2007 Severe persistent Mild persistent Severe intermittent Mild intermittent Intermittent symptoms Persistent symptoms Severity of Allergic Rhinitis patients Allergen and irritant avoidance Oral or local non-sedative H1-blocker Intra-nasal or oral decongestant Intranasal steroid Local cromone Specific Immunotherapy 11 % 35% 8% 46% WHO

26 Current Symptomatic Treatments Rhinitis Asthma Rhinitis Asthma

27 Total rhinitis score: Nasal Mometasone Mean improvement from baseline % MFNS 100mcg/QD MFNS 200mcg/QD Placebo n=497 * p  0.01 relative to placebo Time (day) Van Drunen et al., Allergy 2005: 60 (Suppl. 80): 5-19

28 Total rhinitis score : Nasal Mometasone Van Drunen et al., Allergy 2005; 60 (Suppl. 80): 5-19 n=479 Improvement in total nasal symptom scores Time (day) MFNS 50mcg/QD MFNS 100mcg/QD MFNS 200mcg/QD MFNS 800mcg/QD Placebo Baseline Endpoint

29 Rhinitis symptoms in seasonal AR Montelukast vs. placebo and Loratadin n=1 302 Change from baseline (0-3 scale; LS mean  SE) Daytime nasal symptoms Night-time symptoms Daily composite (daytime nasal & night-time) (a)(b)(c) -9%-16%-22%-8%-20%-15%-9%-16%-20% Montelukast Loratadine Placebo Philip et al., Clin Exp Allergy 2002; 32:

30 A patient uncontrolled and not satisfied by the pharmacotherapy % of patients receiving optimal standard symptomatic treatment experience poor symptom control The level of patient dissatisfaction are high with these medications

31 What are the unmet needs ?  Patient satisfaction / perception  Patient expectation: a long term efficacy

32 What are the unmet needs ?  Patient satisfaction / perception

33 Allergic Rhinitis Management White et al., Clin Exp Allergy1998 0% 25% 50% 100% regular Medium Good regularintermittent How do patients feel after their symptomatic treatment (anti H1, corticosteroid) ? Bad Nasal corticosteroid Anti-histamine 75% regularintermittentregularintermittent

34 The paradox of allergy „Allergy“ everybody knows this word. Only 10 per cent of allergic patients are treated correctly.

35 Allergic Rhinitis and unmet therapeutic needs Control with symptomatic treatments 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 treatments A.Didier et al. Unmet therapeutic needs in allergic patients. Abstract at XXIX EAACI 2010 TNS 2009: 623 subjects with AR/ 2003 individuals from general population

36 Unsatisfied needs Symptomatic treatment No long term efficacy No effect on the disease modifying Lack of compliance Dissatisfaction Social and financial impact Cost of the disease Quality of life decrease Chronicity of the disease Resignation

37 What are the unmet needs ?  Patient expectation: a long term efficacy

38 Why AIT can satisfy the unmet needs ?  Immunomodulatory effect  Long term and sustained effect

39 Definition Specific 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 exposure WHO Guideline 1998 EMEA Guideline 2008

40 Immunomodulatory effect of AIT CPA Th2 Mastocytes IgE Allergy IL- 4 Natural exposure to the allergen Lymphocytes T Lymphocytes B AITAIT T reg Lymphocytes T regulator

41 Allergen Immunotherapy: from the immunological effects to the symptomatic effect Symptoms Use of antiallergic drugs Nasal, ocular and bronchial hyperreactivity Recruitment and activation of mast cells and eosinophils AIT decrease

42 AIT is the only treatment that modifies the natural evolution of allergy One allergy Allergen Immunotherapy Allergic Rhinitis Allergic Asthma 41 Two allergies Several allergies

43 Why the allergist is the expert ?  Diagnosis  AIT indications  Patient management and follow-up

44 Diagnostic Approach In Allergology Allergy History Skin Tests/ IgE Symptoms Moderate/severe Poor QOL Positive DIAGNOSISDIAGNOSIS

45 AIT Indication Pathway Allergy History Skin Tests/ IgE Symptoms Moderate/severe Poor QOL SLIT with pollens mixtures or 2 non related allergens SLIT with one allergen Indication for AIT ? Contra indications: -Immunoptahologic diseases -Severe asthma - Malignancy - Treatment withβ-blockers - Chronic mouth disease - Pregnancy: avoid initiaition of immunotherapy during pregnancy NO Positive YES Age ≥ 4 yrs old DIAGNOSISDIAGNOSIS

46 A patient with moderate/severe symptoms during/after allergen exposure A patient with an altered quality of life due to the allergic symptoms A patient not improved and not satisfied by the pharmacotherapy A patient accurately diagnosed For allergic respiratory diseases Monosensitization Polysensitization Which Allergen for AIT ?

47 What are the key success factors for AIT ?  Patient Information  Patient’s Action Plan  Patient Follow-Up Doctor Patient Relationship

48 Key success factors for AIT Patient information = Patient Education I. Patient should understand : His/her allergic disease The goals of SIT The disease modifyer effect of SIT Why 3-5 years of SLIT ? The onset of action of SLIT The importance of compliance for the success of SLIT

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50 Agenda – am  Grass rationalisation  Posology - arguments to increase to 8 drops per day  Patient follow up  Post graduate course: presentation and arguments

51 Grass rationalisation  5 Grasses / 4 cereals mixture: is it still relevant ?  High level of allergens cross-reactivity between 5 grasses and cereals  5 grasses alone is sufficient to treat the allergic patient sensitized to grass pollen and cereal pollen.

52 RATIONALE TO INCREASE TO 8 DROPS PER DAY

53 STALORAL pollen: The optimal posology  Currently:STALORAL 4 press/day = 120 IR/day  ORALAIR clinical trial:  100 IR/day = No efficacy  300 IR/day = Efficacy  STALORAL 8 press/day = 240 IR/day  STALORAL 10 press/day = 300 IR/day ?

54 SLIT - pollen Initial phase 9-11 days Maintenance phase 5 – 6 months Pre-seasonal IT Co-seasonal Pollen season 1 st year 2 Months3 – 4 MONTHS Minimal Maintenance dose: 300 IR / 4 press/day Withdraw SLIT for 6 months

55 Patient follow up

56 Patient 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…”

57 Key success factors for SIT Patient Information/Education needs from the doctor  Time  Conviction / Enthousiasm/Persuasion  To be done at regular intervals (not a one shot issue)

58 Patient compliance: a major issue Factors of non-compliance : Daily intake Treatment duration: 3-5 years

59 Key success factors for AIT Patient compliance: a major issue Patient Follow-Up Optimal patient follow-up SIT efficacy assessment

60 An optimal follow-up for a patient treated with perennial SLIT maintenance (Year 1) 5 visits Build-up 1 st month3 rd month6 th month9 th month 12 th month maintenance (Year 2) 3 visits maintenance (Year 3) 3 visits 16 th month20 th month 24 th month 28 th month 32 th month 36 th month Visit Start Stop Go/No Go Visit

61 An optimal follow-up for a patient treated with seasonal SLIT maintenance (année 1) 3 visits Build-Up Visit 3-4 months before season maintenance (Year 2) 3 visits maintenance (Year 3) 3 visits Start STOP Go/No Go Pollen season 3-4 months post-season Build-Up Visit 3-4 months before season Pollen season3-4 months post-season 3-4 months before season Pollen season3-4 months post-season

62 Content of follow-up visits Safety Staloral intake One month after starting 3 months Safety Staloral intake Compliance 6 months Compliance Efficacy 9 months Compliance Satisfaction Efficacy 12 months Compliance Satisfaction Efficacy Willingness to continue

63 SIT efficacy assessment is based only the clinical parameters  Reduction of symptoms Rhinitis Conjunctivitis Asthma  Reduction of anti-allergic drugs intake  Improvement of Quality of life Compliance Satisfaction Efficacy Willingness to continue

64 Efficacy Assessment using a color-coded VAS (1/3) I.Symptoms : Good Average Bad How was your daytime rhinitis condition ? How was your nighttime rhinitis condition ? How was your daytime asthma condition ? How was your nighttime asthma condition ? Green area Orange area Red area Before SLIT

65 Efficacy Assessment using a color-coded VAS ((2/3) I.Symptoms Good Average Bad How was your daytime rhinitis condition ? How was your nighttime rhinitis condition ? How was your daytime asthma condition ? How was your nighttime asthma condition ? Green area Orange area Red area 6 months later

66 Efficacy Assessment using a color-coded VAS (3/3) I. Symptoms Good Average Bad How was your daytime rhinitis condition ? How was your nighttime rhinitis condition ? How was your daytime asthma condition ? How was your nighttime asthma condition ? Green area Orange area Red area 12 months later

67 Efficacy Assessment ? Rescue Medication for allergic rhinitis J09 M12 M H1-Antihistamine Nasal Steroids % - 25% - 50 % - Months

68 Efficacy Assessment ? Rescue Medication for allergic asthma J09 M12 M β2-agonists Inhaled Steroids % - 25% - 50 % - Months

69 Efficacy Assessment ? Quality of life Items SLEEP & TIREDNESS DAILY ACTIVITIES IMPAIRED (sport, work, school) WORK & SCHOOL PRODUCTIVITY LEARNING & COGNITIVE FUNCTIONS DISTURBED

70 After 12 months of SIT: Efficacy assessment At least 50 % reduction of symptoms and rescue medicaction use and a significant QOL improvement should be achieved at 12 months Months % ≥ 50 %

71 After 36 months of SIT: Stop & Follow-Up Months ≥ 50 % % ≥ 80 % At least 80 % reduction of symptoms and rescue medicaction use and a significant QOL improvement should be achieved at 36 months Stop and follow-up

72 SIT efficacy assessment Month ≥ 50 % % ≥ 80 % SIT Stop

73 Sustained long term efficacy of SIT Month ≥ 80 % Years SIT Stop

74 Add one or two additionals years if necessary Months ≥ 50 % %

75 Post - SIT : Patient follow-up 1st year 2 nd year 3rd year 4th year 5th year A visit once a year

76 After 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

77 After 12 months of SIT: Why to stop ? Less than 50 % reduction of symptoms and rescue medicaction use and a poor QOL improvement have been achieved at 12 months Months %

78 After 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 treatment Environmental changes: increase in allergenic load/ Co-factors irritant Co-morbidities : not treated If none of these factors are found, go-back to the diagnosis and recheck the indications

79 Key Message To be successful SLIT needs: A good indication The best candidate An optimal patient management

80 Post graduate course presentation and arguments  Objectives  Contents  Organisation

81 Post graduate course presentation and arguments (1) STALLERGENES Post Graduate Course An Essential Half-Day Training Course On : Sublingual Immunotherapy in Practice

82 Post graduate course What The Course Will Cover ? A stepwise approach for the indications of SLIT The place of SLIT in the treatment of allergic respiratory diseases The key factors to make SLIT a success The compliance/adherence issue and how to tackle it

83 Post graduate course : the agenda Welcome – Introduction15’ The basics of SLIT : recall15’ Workshop 1 : Choosing the right patient for SLIT60’ Coffee Break15’ Workshop 2 : Managing the patient optimally60’ The patient follow-up handbook15’ Interactive Quizz15’ Take-home messages15’ 3 hours 30 duration

84 Post graduate course Who Should Attend ?  Allergists  Experience with SLIT: at least 1 year  10 to 15 attendees/ session

85 Post graduate course : Meeting Date 2011  March 2011  Varna  Plovdiv  Sofia


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