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© 2008 Universitair Ziekenhuis Gent 1
ARIA-guidelines, an update
Van Cauwenberge P, MD, PhDVan Hoecke H, MD
Philippe Gevaert, MD, PhD
Department of OtorinolaryngologyGhent University, Belgium
22© 2008 Universitair Ziekenhuis Gent
Allergic rhinitis: treatment modalities
From Diamant Z
33© 2008 Universitair Ziekenhuis Gent
allergenavoidanceindicated
when possible
allergenavoidanceindicated
when possible
pharmacotherapysafety
effectivenesseasy to be
administered
pharmacotherapysafety
effectivenesseasy to be
administered
immunotherapyeffectiveness
specialist prescription may alter the
natural course of the
disease
immunotherapyeffectiveness
specialist prescription may alter the
natural course of the
disease patient'seducation
always indicated
patient'seducation
always indicated
COSTS
Cornerstones of AR treatment
44© 2008 Universitair Ziekenhuis Gent
Clinical guidelines
‘Clinical guidelines are systematically
developed statements to assist practioners
and patients in making decisions about
appropriate and effective health care in
specific circumstances.’
Jackson R, et al. BMJ
1998
55© 2008 Universitair Ziekenhuis Gent
1994 20011996, 1998 2000
Opinion-based guidelines
Evidence-based guidelines
Guidelines for allergic rhinitis
QuickTime™ en een-decompressor
zijn vereist om deze afbeelding weer te geven.
2008
66© 2008 Universitair Ziekenhuis Gent
Allergy 1994;49:1-34
V.J. LundD. AaronsonJ. Bousquet
R. DahlR.J. DaviesS. Durham
R. Gerth van WijkK. HolmbergE. Juniper
Ian S. MackayL. Malm
N. MygindM. OkudaC. Ortolani
H.M. SchankerS.L. Spector
P. van CauwenbergeM.R. Wayoff
International Consensus Report
1994
77© 2008 Universitair Ziekenhuis Gent
Scan pag 28
International Consensus Report: Flow Chart
88© 2008 Universitair Ziekenhuis Gent
D. Skoner
M. Dykewicz
S. Fineman
R. Nicklas
R. Lee
J. Blessing-Moore
Ann All Asthma Immunol 1998; 81:478-518
J. Li
I. Bernstein
W. Berger
S. Spector
D. Schuller
American Guidelines on
Rhinitis1998
99© 2008 Universitair Ziekenhuis Gent
P. van Cauwenberge
C. Bachert
J. Bousquet
G. Canonica
S. Durham
W. Fokkens
P. Howarth
Allergy 2000;55:116-134
V Lund
N. Mygind
G. Passalacqua
D. Passali
G. Scadding
D. Wang
EAACI Position Paper 2000
1010© 2008 Universitair Ziekenhuis Gent
Nasal Corticosteroids
Inadeq.control
Inadeq.control
Inadeq. control
Need for therapy ?
Mild disease or occasional symptoms
Moderate disease or long duration Severe disease
Oral or NasalAntihistamines
(Cromones)
Nasal Corticosteroids
+Oral or Nasal
Antihistamines
Add further symptomatic treatment
Short-course Oral Steroids
Consider Immunotherapy
For eye symptoms :
topical antihistamines or
cromones
Seasonal allergic rhinitis
1111© 2008 Universitair Ziekenhuis Gent
Perennial allergic rhinitis in adults
Inadeq. control
Need for therapy ?
Avoidance
Environment control
Moderate disease or long duration Severe symptoms
Oral or NasalAntihistamines
Nasal Corticosteroids
Nasal Corticosteroids
+Antihistamines
Inadeq. control
Further examinations
Inadeq. control
Mild disease or occasional symptoms
1212© 2008 Universitair Ziekenhuis Gent
Perennial allergic rhinitis in adults
If resistant
RESISTANT CASES
Resistant rhinorrhea
Short Course of Topical Decongestants/ Oral Decongestants/Oral Steroids
Nasal Ipratropium
bromide
Immunotherapy
Nasal blockage
Surgical turbinate reduction
1313© 2008 Universitair Ziekenhuis Gent
J. BousquetP. van CauwenbergeN. Khaltaev
N. Ait-KhaledI. Annesi-MaesanoC. BachertC. Baena-CagnaniE. BatemanS. BoniniG. CanonicaK. CarlsenP. DemolyS. DurhamD. EnarsonW. FokkensR. Gerth van Wijk
P. HowarthN. IvanovaJ. KempJ. KlossekR. LockeyV. LundI. MacKayH. MallingE. MeltzerN. MygindM. OkudaR. PawankarD. PriceG. ScaddingF. SimonsA. SzczeklikE. ValovirtaA. VignolaD. WangJ. WarnerK. Weiss
ARIA 2001In collaboration with WHO
JACI 2001;108 (Suppl 5):S147-S333
1414© 2008 Universitair Ziekenhuis Gent
• Patients with (persistent) AR should be
evaluated for asthma
• Patients with (persistent) asthma should be
evaluated for AR
• A combined strategy should be developed to
treat co-existing diseases of the upper and
lower airways
Combined approach for AR and asthma
1515© 2008 Universitair Ziekenhuis Gent
Changed classification for AR
Moderate-severeone or more items
. abnormal sleep
. impairment of daily activities, sport, leisure
. abnormal work and school
. troublesome symptoms
Persistent . > 4 days per week . and > 4 weeks
Mild normal sleep& no impairment of
daily activities, sport, leisure
& normal work and school
& no troublesome symptoms
Intermittent . 4 days per week. or 4 weeks
in untreated patients
1616© 2008 Universitair Ziekenhuis Gent
PersistentPersistent33%33%
PersistentPersistent33%33%
IntermittentIntermittent67%67%
IntermittentIntermittent67%67%
N=1,265 subjects with physician-based diagnosis N=1,265 subjects with physician-based diagnosis
SAR: SAR: symptomssymptoms restricted to spring and/or summer restricted to spring and/or summer
N=1,265 subjects with physician-based diagnosis N=1,265 subjects with physician-based diagnosis
SAR: SAR: symptomssymptoms restricted to spring and/or summer restricted to spring and/or summer
PARPAR51%51%PARPAR51%51%
SARSAR49%49%SARSAR49%49%
SAR/PAR SAR/PAR ARIAARIAstudy step 1 (N=1,230)study step 1 (N=1,230)
Prevalences are different
Bauchau et al, Eur Respir J 2004
1717© 2008 Universitair Ziekenhuis Gent
Classification of AR Patients in General Practice during Pollen Season
2% 9%
55%
34%Mild persistent
Mild intermittent
Mod/sev intermittent
Mod/sev persistent
N=804 subjects with GP-based diagnosis Van Hoecke et al, 2005
persistent
Intermittent
Mod/Sev
2%9%
55%
Mild
33%
1818© 2008 Universitair Ziekenhuis Gent
0
10
20
30
40
50
60
70
80
Grass Tree Mite Animal Other
persistent
intermittent
Van Hoecke et al, 2005
NSNS
NS
NS
NS
N=351 subjects with GP-based diagnosis, responsible allergens confirmed
by allergy testing
Responsible Allergens in Persistent vs Intermittent AR
1919© 2008 Universitair Ziekenhuis Gent
Symptom Severity in Persistent vs Intermittent AR
N=804 subjects with GP-based diagnosis
Van Hoecke et al, 2005
Intermittent Persistent p value
Runny nose 59.1 59.3 NS
Blocked nose 58.4 66.2 0.03
Itchy nose 50.2 43.8 0.09
Sneezing 61.9 62.4 NS
Conjunctivitis 37.4 43.8 0.09
Severity of each symptom is measured on a scale 1-4, expressed as % with score 3 or 4 - N=804
Headache 11.7 15.5 0.1
Somnolence 6.8 13.8 0.002
2020© 2008 Universitair Ziekenhuis Gent
Burden of Persistent Rhinitis
N=804 subjects with GP-based diagnosisVan Hoecke et al, 2005
Intermittent Persistent p value
33.5 43.4 0.006
69.8 73.8 NS
51.4 56.6 NS
73.5 84.8 <0.001
Impaired sleep
Impaired activities/sports/leisure
Impaired school/work
Troublesome symptoms
Moderate/severe AR 86.6 94.1 0.001
%
Allergy testing 44.2 69.3 <0.001
Specialist referral 7.0 12.4 0.01
2121© 2008 Universitair Ziekenhuis Gent
Persistent AR Has Specific Clinical Characteristics
T5SS (from 0 to 15): 8.97 (2.27)*
RQLQ (from 0 to 6): 3.04 (0.93)*
Loss of 17.9 work days per patient per year **
On co-morbidity = asthma, sinusitis, otitis media, upper respiratory infections: 11.8 events per month per 100 patients **
10% mild vs 90% moderate Severe allergic rhinitis:
Mild –moderate –severe subgroups?
Validation ARIA
2222© 2008 Universitair Ziekenhuis Gent
Ia Evidence from meta-analysis of randomised controlled trials
Ib Evidence from at least one randomised controlled trial
IIa Evidence from at least one controlled study without randomisation
IIb Evidence from at least one other type of quasi-experimental study
III Evidence from non-experimental descriptive studies, such as comparative studies, correlation studies and case-control studies
IV Evidence from expert committee reports or opinions or clinical experience of respected authorities, or both
A
B
C
D
Shekelle et al, BMJ 1999
Evidence-based recommendations
2323© 2008 Universitair Ziekenhuis Gent
Strength of evidence for rhinitis treatments
Intervention SAR
Adult
SAR
Children
PAR
Adult
PAR
Children
Oral anti-H1 A A A A
Nasal anti-H1 A A A A
Nasal CS A A A A
Nasal cromone A A A A
Antileukotriene A A
Subcut SIT A A A A
Subling/nasal IT A A A
Allergen avoidance D D D D
2424© 2008 Universitair Ziekenhuis Gent
mildintermittent
mildpersistentmoderate
severeintermittent
moderatesevere
persistent
allergen and irritant avoidance
immunotherapy
intra-nasal decongestant (<10 days) or oral decongestant
local cromone intra-nasal steroid
oral or local non-sedative H1-blocker
Stepwise rhinitis treatment
2525© 2008 Universitair Ziekenhuis Gent
ARIA 2008In collaboration with WHO,
Ga2len and AllerGen
QuickTime™ en een-decompressor
zijn vereist om deze afbeelding weer te geven.
Allergy 2008; 63(Suppl 86):8-160
J. BousquetN. KhaltaevA. CruzJ. DenburgW. FokkensA. TogiasT. Zuberbier C. Baena-CagnaniG. CanonicaC. van WeelI. AgacheN. KhaledC. BachertM. BlaissS. BoniniL. BouletP. BousquetP. CamargosK. CarlsenY. Chen
A. CustovicB. DahlP. DemolyH. DouaguiS. DurhamR. Gerth van WijkO. KalayciM. Kaliner Y. KimM. KowalskiP. KunaL. LeC. LemiereJ. LiR. LockeyS. Mavale-Manuel E. MeltzerY. MohammadJ. MullolR. NaclerioR. Hehir
K. OhtaS. OuedraogoS. PalkonenN. PapadopoulosG. PassalacquaR. PawankarT. A. PopovK.RabeJ. Rosado-PintoG. ScaddingF. SimonsE. ToskalaE. ValovirtaP. Van CauwenbergeD.-Y. WangM. WickmanB. Yawn A. YorganciogluA. YusufA. Zar
2626© 2008 Universitair Ziekenhuis Gent
International
Consensus 1994EAACI 2000 ARIA 2001 ARIA 2008
Nr of members (should be between 6 & 15
(Shekelle, 1999)
(18) OK (14) (37)
(61)
+ 35
reviewers
Composition of
group
ENT-All: OK
No GP’s
ENT-All: OK
No GP’s
OK
OK
OK
OK
Countries 11 7 17 34
Continents 3 2 4 5
Gender (M/F) 16/2 12/2 30/7 46/15
University vs
non-university16/2 14/0 34/3 53/8
Conflict of interest
(pharmaceutical
industry)
Not
mentioned
Not
mentioned
Not specified
whoSpecified
Expert panel for guideline development
2727© 2008 Universitair Ziekenhuis Gent
Need for ARIA update
• Increasing knowledge on epidemiology, diagnosis,
management and comorbidities of AR since 1999
• Need for validation of ARIA classification and
management recommendations
• Availability of new evidence-based systems to guide
recommendations, including safety, costs and efficacy of
treatments
• Need to address previous gaps in knowledge (e.g.
complementary and alternative medicine)
2008 Update
2828© 2008 Universitair Ziekenhuis Gent
Strength of evidence for rhinitis treatmentsIntervention SAR
Adult
SAR
Children
PAR
Adult
PAR
Children
PER
Oral anti-H1 A A A A A
Nasal anti-H1 A A A A A*
Nasal GCS A A A A A*
Nasal cromone A A A A A*
Antileukotriene A A (>6y) A A A*
Subcut SIT A A A A
Sublingual SIT A A A A
Anti-IgE A A (>12y) A A
Homeopathy D D D D
Accupuncture D D D D
Phytotherapy B D D D
Allergen avoidance D D D D
2008 Update
Indirect evidence*
2929© 2008 Universitair Ziekenhuis Gent
mildintermittent
mildpersistentmoderate
severeintermittent
moderatesevere
persistent
allergen and irritant avoidance
immunotherapy
intra-nasal decongestant (<10 days) or oral decongestant
local cromone intra-nasal steroid
oral or local non-sedative H1-blocker or anti-leukotriene
Stepwise rhinitis treatment
2008 Update
3030© 2008 Universitair Ziekenhuis Gent
Measure Evidence of effect on allergen levels Evidence of clinical benefit
HOUSE DUST MITES
Encase bedding in impermeable covers SomeNone (adults): Evidence ASome (children): Evidence B
Wash bedding on a hot cycle (55–60°C) Some None: Evidence A
Replace carpets with hard flooring Some None: evidence A
Acaricides and/or tannic acid Weak None: Evidence A
Minimize objects that accumulate dust None None: Evidence B
Use vacuum cleaners with integral HEPA filter and double-thickness bags
Weak None: Evidence B
Remove, hot wash or freeze soft toys None None: Evidence B
PETS Remove cat/dog from the home Weak None: Evidence B
Keep pet from main living areas/bedrooms Weak None: Evidence B
Use HEPA-filter air cleaners Some None: Evidence B
Wash pet Weak None: Evidence B
Replace carpets with hard flooring None None: Evidence B
Use vacuum cleaners with integral HEPA filter and double-thickness bags
None None: Evidence B
SET OF ALLERGEN CONTROL MEASURES Some Some: Evidence B
Effectiveness of avoidance measures in rhinitis and asthma for certain indoor allergens
3131© 2008 Universitair Ziekenhuis Gent
Validation of guidelines
Treat patients according Treat patients accordingto guidelines to usual practice
Investigators randomised to:
225 patients with SAR 244 patients with SARscreened and enrolled screened and enrolled
Patients treated for 3 weeksRecorded:– Reflective symptoms twice daily– Medicine utilisation daily – RQLQ and SF-36 at day 7 and day 20– Global evaluation at day 21
AA BB
Bousquet J, van Cauwenberge P, Lund V Allergy 2003
3232© 2008 Universitair Ziekenhuis Gent
Benefits of a guided strategyBousquet J, van Cauwenberge P, Lund V Allergy 2003
3333© 2008 Universitair Ziekenhuis Gent
Dissemination of ARIA guidelines
Have you heard about
ARIA?
3434© 2008 Universitair Ziekenhuis Gent
Implementation of ARIA guidelines
Mild intermittent
(n=69)
Mild persistent
(n=17)
Mod/sev intermittent
(n=445)
Mod/sev persistent
(n=273)
Treated according to ARIA
56,5% 64,7% 45,4% 63,0%
Undertreated 10,1% 0% 2,9% 30,4%
Overtreated 33,3% 35,3% 51,7% 6,6%
Treatment prescribed by 95 Belgian GPs in 804 AR patients
Van Hoecke H, Van Cauwenberge P, Allergy 2006
3535© 2008 Universitair Ziekenhuis Gent
Rhinitis treatment
improves asthma
EVIDENCE A
++ Anti-IgE mAb
Immunotherapy
Leucotriene modifiers
Nasal GCS
+ Antihistamines
Revised GINA 2006: Rhinitis treatment Revised GINA 2006: Rhinitis treatment
3636© 2008 Universitair Ziekenhuis Gent
Conclusion
• Aim of guidelines is to improve patient care and to
support physicians by informing them and by improving
their decisions
• Benefits of a guided strategy have been validated
• Several barriers to put guidelines into practice
• More efforts are needed to adapt guidelines to the
needs of the end-users