Transcript Allergic Rhinitis

Bulgaria
Ewopharma
MedReps Training Course
14 December 2010
Agenda
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 ?
Break
10.15 – 12.30 am
 Grass rationalisation,
 Posology - arguments to increase to 8 drops per day
 Patient follow up,
 Post graduate course presentation and arguments
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 ?
Who is the allergic patient ?

Epidemiology of respiratory allergic diseases



Classification of respiratory allergic diseases



ECHRS
ISAAC
ARIA
GINA
The natural course of allergic diseases
Allergic Rhinitis: prevalence in Europe
Prevalence of AR in a population-based survey in 6 EU countries1:
UK, Germany, France, Belgium, Italy and Spain
AR European prevalence
is 23%, of which 45% are
undiagnosed1
26.0%1
29.8%2
20.6%1 21.0%3
24.5%1
500 million people suffer
from AR worlwide
16.9%1
21.5%1
1.Bauchau V., Durham S.R., Eur Respir J 2004:758-764
2.Bachert C. Allergy 2006: 61: 693-698
3.Brehl P. Ind Health 2003 Apr; 41 (2): 121-3
Prevalence of clinical asthma in both adults and
children : ISAAC Study
Proportion of population (%)
10.1
2.5–5.0
7.6–10.0
0–2.5
5.1–7.5
No standardised data
Masoli et al. Allergy 2004; 59(5): 469-78.
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.
Intermittent
Symptoms
< 4 days per week
or < 4 weeks
Slight
• normal sleep
• normal social and leisure activities
• normal work and school life
• symptoms causing minimal discomfort
Persistent
Symptoms
> 4 days per week
and > 4 weeks
Moderate - Severe
• sleep disturbed
• disrupted social and leisure activities
• disrupted work and school life
• unpleasant symptoms

*Bousquet J. et al. Allergic Rhinitis and its Impact on Asthma (ARIA).Allergy 2008: 63 (Suppl. 86): 8–160
Profile of patients consulting the allergist
REALIS survey:
clinical and sensitization profile of patients consulting for respiratory allergies in France
8,5%
14,5%
80.3%
moderate to severe
patients
11,2%
65,8%
Mild intermittent
Moderate-severe intermittent
Mild persistent
Moderate-severe persistent
N=2714
 ~ 80% of AR patients consulting an allergist have moderate-tosevere 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
8
Altered quality of life due to the allergic symptoms
SLEEP & TIREDNESS
77 % of patients had sleep troubles
46 % of patients felt tired
DAILY ACTIVITIES
IMPAIRED
LEARNING & COGNITIVE
FUNCTIONS DISTURBED
Impact on
Allergic
Respiratory
Diseases
WORK & SCHOOL
PRODUCTIVITY
< 90 % effectiveness at work
< 93 % impaired classroom
performance
EMBARRASSMENT
Adolescents embarassed to
use inhalers
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!
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 ?
Diagnosis Process in Allergology
Patient with suspected respiratory allergy symptoms
Clinical history for allergy
Allergy testing
Skin prick-tests method
Allergens
Stallerpoint®
Measurement of the skin reaction
15 – 20 minutes after testing
Wheal diameter
How the GPs diagnose the allergic diseases ?
Patient with suspected respiratory allergy symptoms
Clinical history for allergy
Stop
Why the allergic patient is underdiagnosed ?

What’s going wrong with the allergy diagnosis ?
Consultation 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 allergies
~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: 1057-1063.
Only 1 patient over 5 consulted a specialist
TNS STUDY:
TNS survey conducted in France 2009. N= 623 subjects with AR symptoms from 2003 general
population
TYPE OF DOCTORS CONSULTED BY PATIENTS:
94%*
19% have consulted a
specialist
13%*
GP
Allergist
5%*
ENT
1%*
Pulmonologist
*Several consultations per doctor were possible
6%*
**in France, a first consultation with a GP is
mandatory before referral to a specialist
Others*
 94% of patients consulting a GP in 1st line treatment
 19% consulted a specialist (13% an allergist**), in 2nd line
treatment
A.Didier et al. Unmet therapeutic needs in AR. Abstract at XXIX EAACI 2010
How the allergic patient is managed ?

The allergen avoidance

The pharmacotherapy

The allergen immunotherapy (AIT)
The optimal management of the allergic patient
The patient education
Allergen Immunotherapy
Allergen avoidance
Pharmacotherapy
Why the allergic patient is undertreated ?

The efficacy of the allergen avoidance ?
Allergen avoidance : recommended but a limited
efficacy
 Mites: efficacy not well demonstrated
 Animals : patients can be sensitized without direct
contact with pets

Pollen: Unfeasible
Why the allergic patient is undertreated ?

The efficacy of the pharmacotherapy ?
Therapy of Allergic Rhinitis
ARIA Update 2007
WHO
Intermittent symptoms
Mild
intermittent
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 %
Severe
intermittent
35%
Persistent symptoms
Mild
persistent
8%
Severe
persistent
46%
Current Symptomatic Treatments
Rhinitis
H1Antihistamines
Rhinitis
Asthma
Nasal
corticosteroids
Rhinitis
Asthma
Antileucotriens
Inhaled
corticosteroids
B2-agonists &
Bronchodilators
Asthma
Total rhinitis score: Nasal Mometasone
Mean improvement from baseline
%
90
MFNS 200mcg/QD
80
Placebo
 71

63
 59
60
50
60
53
53

44

79 
75

 75
70

70
40
n=497
MFNS 100mcg/QD
45
36
34
29
30
20
10
0
4
8
15
22
29
Time (day)
* p0.01 relative to placebo
Van Drunen et al., Allergy 2005: 60 (Suppl. 80): 5-19
Improvement in total nasal symptom scores
Total rhinitis score : Nasal Mometasone
60
n=479
MFNS 50mcg/QD
MFNS 100mcg/QD
MFNS 200mcg/QD
MFNS 800mcg/QD
Placebo
50
40
30
20
10
0
Baseline
3
7
14
21
28
Endpoint
Time (day)
Van Drunen et al., Allergy 2005; 60 (Suppl. 80): 5-19
Rhinitis symptoms in seasonal AR
Montelukast vs. placebo and Loratadin
n=1 302
(a)
(b)
Daytime nasal
symptoms
(c)
Night-time symptoms
Daily composite (daytime
nasal & night-time)
-8% -20% -15%
-9% -16% -20%
0
Change from baseline
(0-3 scale; LS mean  SE)
-9% -16% -22%
-0.1
-0.2
-0.3
-0.4





Placebo
-0.5

Montelukast
Loratadine
-0.6
Philip et al., Clin Exp Allergy 2002; 32: 1020-1028
A patient uncontrolled and not satisfied by the
pharmacotherapy
•
35-40 % of patients receiving optimal standard symptomatic
treatment experience poor symptom control
•
The level of patient dissatisfaction are high with these
medications
What are the unmet needs ?

Patient satisfaction / perception

Patient expectation: a long term efficacy
What are the unmet needs ?

Patient satisfaction / perception
Allergic Rhinitis Management
Good
100%
Medium
Bad
75%
50%
25%
0%
Nasal corticosteroid
regular
regular
intermittent
intermittent
Anti-histamine
regular
intermittent
regular
intermittent
How do patients feel after their symptomatic treatment (anti
White et al. , Clin Exp Allergy1998
H1, corticosteroid) ?
The paradox of allergy
„Allergy“
Only 10 per cent of
everybody knows
allergic patients are
this word.
treated correctly.
Allergic Rhinitis and unmet therapeutic needs
TNS 2009: 623 subjects with AR/ 2003 individuals from general population
Control with
symptomatic treatments
Quality of life
73% remain
uncontrolled
48 % have bad
quality of life
(19% of total
population)
(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
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
What are the unmet needs ?

Patient expectation: a long term efficacy
Why AIT can satisfy the unmet needs ?

Immunomodulatory effect

Long term and sustained effect
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
Immunomodulatory effect of AIT
Natural exposure
to the allergen
Lymphocytes B
IgE
IL- 4
CPA
Th2
Lymphocytes T
A
I
T
Mastocytes
Allergy
T reg
Lymphocytes T regulator
Allergen Immunotherapy: from the immunological
effects to the symptomatic effect
Recruitment and activation of
mast cells and eosinophils
Nasal, ocular and bronchial
hyperreactivity
AIT
decrease
Symptoms
Use of antiallergic drugs
AIT is the only treatment that modifies the natural
evolution of allergy
One
allergy
Two
allergies
Several
allergies
Allergen Immunotherapy
Allergic Rhinitis
Allergic Asthma
41
Why the allergist is the expert ?

Diagnosis

AIT indications

Patient management and follow-up
Diagnostic Approach In Allergology
D
I
A
G
N
O
S
I
S
Allergy
History
Positive
Symptoms
Moderate/severe
Poor QOL
Skin
Tests/
IgE
Positive
AIT Indication Pathway
D
I
A
G
N
O
S
I
S
Allergy
History
Symptoms
Moderate/severe
Poor QOL
Positive
Positive
Indication for AIT ?
Age ≥ 4 yrs
old
SLIT with one
allergen
Skin
Tests/
IgE
NO
Contra indications:
YES
SLIT with pollens
mixtures or 2 non
related allergens
-Immunoptahologic
diseases
-Severe asthma
- Malignancy
- Treatment withβ-blockers
- Chronic mouth disease
- Pregnancy: avoid
initiaition of immunotherapy
during pregnancy
Which Allergen for AIT ?
•
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
What are the key success factors for AIT ?
 Patient Information
 Patient’s Action Plan
 Patient Follow-Up
Doctor
Relationship
Patient
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
Agenda
10.15 – 12.30 am
 Grass rationalisation
 Posology - arguments to increase to 8 drops per day
 Patient follow up
 Post graduate course: presentation and arguments
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.
RATIONALE TO INCREASE TO 8 DROPS
PER DAY
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 ?
SLIT - pollen
Pollen season
1st year
Pre-seasonal IT
Co-seasonal
3 – 4 MONTHS
2 Months
10
8
8
6
6
2
2
1
1
Minimal Maintenance dose:
300 IR / 4 press/day
4
4
1
2
3
4
5
6
7
8
9
10 11
Initial phase
9-11 days
Maintenance phase
5 – 6 months
Withdraw
SLIT
for 6 months
Patient follow up
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…”
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)
Patient compliance: a major issue
Factors of non-compliance :
•
Daily intake
•
Treatment duration: 3-5 years
Key success factors for AIT
Patient compliance: a major issue
Patient Follow-Up
•
Optimal patient follow-up
•
SIT efficacy assessment
An optimal follow-up for a patient treated with perennial
SLIT
maintenance (Year 1) 5 visits
Build-up
Start
Visit
Visit
Visit
6th month
9th month
Visit
1st month
3rd month
Visit
12th month
Go/No Go
maintenance (Year 2) 3 visits
Visit
16th
Visit
month
20th
month
Visit
24th month
maintenance (Year 3) 3 visits
Visit
28th month
Visit
32th month
Visit
36th month
Stop
An optimal follow-up for a patient treated with seasonal
SLIT
maintenance (année 1) 3 visits
Build-Up
Start
Go/No Go
Visit
Visit
3-4 months before
season
Build-Up
Pollen season
3-4 months before
season
3-4 months post-season
maintenance (Year 2) 3 visits
3-4 months before
season
Build-Up
Visit
Pollen season
3-4 months post-season
maintenance (Year 3) 3 visits
Pollen season
3-4 months post-season
STOP
Content of follow-up visits
One month
after starting
3 months
6 months
9 months
12 months
Compliance
Safety
Safety
Staloral
intake
Staloral
intake
Compliance
Compliance
Satisfaction
Satisfaction
Efficacy
Efficacy
Willingness
to continue
Compliance
Efficacy
SIT efficacy assessment is based only the clinical
parameters
 Reduction of symptoms
Compliance
Satisfaction
Rhinitis
Conjunctivitis
Asthma
Efficacy
Willingness to
continue
 Reduction of anti-allergic drugs intake
 Improvement of Quality of life
Efficacy Assessment using a color-coded VAS (1/3)
I.
Symptoms :
Before SLIT
Good
Average
Bad
Orange
area
Red
area
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
Efficacy Assessment using a color-coded VAS ((2/3)
I.
Symptoms
6 months later
Good
Average
Bad
Orange
area
Red
area
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
Efficacy Assessment using a color-coded VAS (3/3)
I.
Symptoms
12 months later
Good
Average
Bad
Orange
area
Red
area
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
Efficacy Assessment ?
Rescue Medication for allergic rhinitis
H1-Antihistamine
Nasal Steroids
%
100
- 25%
- 50 %
50
-
0
J0
9M
Months
12 M
Efficacy Assessment ?
Rescue Medication for allergic asthma
β2-agonists
Inhaled Steroids
%
100
- 25%
- 50 %
50
-
0
J0
9M
Months
12 M
Efficacy Assessment ?
Quality of life
Items
SLEEP & TIREDNESS
DAILY ACTIVITIES IMPAIRED
(sport, work, school)
WORK & SCHOOL
PRODUCTIVITY
LEARNING & COGNITIVE
FUNCTIONS DISTURBED
After 12 months of SIT: Efficacy assessment
%
Symptoms
100
Medication
QOL Improvement
80
60
≥ 50 %
40
20
0
Start IT
3
6
9
12
Months
At least 50 % reduction of symptoms and rescue medicaction use and
a significant QOL improvement should be achieved at 12 months
After 36 months of SIT: Stop & Follow-Up
≥ 50
%
70 -80
%
≥ 80 %
Stop
and follow-up
Months
At least 80 % reduction of symptoms and rescue medicaction use and a
significant QOL improvement should be achieved at 36 months
SIT efficacy assessment
≥ 50
%
70 -80
%
Month
≥ 80 %
SIT
Stop
Sustained long term efficacy of SIT
≥ 80 %
Month
SIT
Stop
Years
Add one or two additionals years if necessary
≥ 50
%
Months
60 -80
%
Post - SIT : Patient follow-up
1st
year
2nd
year
3rd
year
4th
year
A visit once a year
5th
year
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
After 12 months of SIT: Why to stop ?
Symptoms
%
100
Medication
QOL Improvement
80
60
40
20
0
Start IT
3
6
9
12
Months
Less than 50 % reduction of symptoms and rescue medicaction use
and a poor QOL improvement have been achieved at 12 months
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
Key Message
To be successful SLIT needs:
A good indication
The best candidate
An optimal patient management
Post graduate course presentation and arguments

Objectives

Contents

Organisation
Post graduate course presentation and arguments (1)
STALLERGENES
Post Graduate Course
An Essential Half-Day Training Course On :
Sublingual Immunotherapy in Practice
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
Post graduate course : the agenda
•Welcome – Introduction
15’
•The basics of SLIT : recall
15’
•Workshop 1 : Choosing the right patient for SLIT
60’
•Coffee Break
15’
•Workshop 2 : Managing the patient optimally
60’
•The patient follow-up handbook
15’
•Interactive Quizz
15’
•Take-home messages
15’
3 hours 30 duration
Post graduate course
Who Should Attend ?

Allergists

Experience with SLIT: at least 1 year

10 to 15 attendees/ session
Post graduate course : Meeting Date 2011

March 2011

Varna

Plovdiv

Sofia