Feb 2014 allergy b clinical and aqhi

Allergy B
Clinical and AQHI
Gimli Glider Pilot School/FMPE
Abbotsford/Mission & Langley/Aldergrove
19 February & 25 February 2014

Allergic Rhinitis
1. Small P, Frnkiel S, Becker A, et al. Rhinitis: A practical and comprehensive approach to assessment and therapy.
Journal of Otolaryngology. 2007;36(Supl 1):S5-S27.
● The previous classification of seasonal or perennial Allergic Rhinitis is
being replaced with intermittent and persistent Allergic Rhinitis1
● Intermittent episode = symptoms last <6 weeks
● Persistent episode = symptoms last >6 weeks
S O I R
Sneezing
E
Nasal
Obstruction
Nasal Itch
(pruritus)
Nasal
Rhinorrhea
+ Itchy Watery
Eyes
(conjunctivits)
Allergic Rhinitis Diagnosis:
2 or More of ‘S O I R E’ Symptoms
for More Than 1 Hour on Most Days

Allergic Shiners
The Patient with Allergies”:
Franzese, CB, Burkhalter, NW. “The Patient with Allergies.” Medical Clinics of North America, 2010, 94 (5), pp. 891-902

Immunotherapy by allergen injections for
seasonal allergic rhinitis ('hay fever')
Seasonal allergic rhinitis ('hay fever') is a global
health problem and its prevalence has increased
considerably in the last two decades.
Treatment includes allergen avoidance, drugs
such as antihistamine tablets and nasal sprays,
and immunotherapy (vaccination).
For those patients whose symptoms remain
uncontrolled despite drug treatment, specific
allergen immunotherapy (SIT) is advised.
Calderon MA, Alves B, Jacobson M, Hurwitz B, Sheikh A, Durham S. Immunotherapy by allergen injections for seasonal allergic rhinitis ('hay fever').
Cochrane Summaries. January 21, 2009
http://summaries.cochrane.org/CD001936/immunotherapy-by-allergen-injections-for-seasonal-allergic-rhinitis-hay-fever#sthash.7BSYsB2K.dpuf

Specific allergen immunotherapy is most commonly
administered as subcutaneous (under the skin) injections
by specialists requiring a building-up period followed by a
maintenance period of 3 to 5 years.
Immunotherapy may also be delivered by the oral, nasal
or sublingual route and these will be studied in separate
Cochrane reviews, as will immunotherapy for perennial
(all year round) allergic rhinitis.
In this review we aimed to evaluate the efficacy and
safety of injection immunotherapy, compared
with placebo, for reducing symptoms and the need for
medication.

We identified randomised, double-
blind, placebo controlled trials of specific allergen
immunotherapy in patients with seasonal
allergic rhinitis due to tree, grass or weed pollens.
51 studies satisfied our inclusion criteria. In total
there were 2871 participants (1645 in the
treatment groups and 1226 in the placebo), each
receiving on average 18 injections. The duration of
treatment varied from three days to three years.

• This review has shown that injection
immunotherapy in suitably selected patients
with hay fever results in significant reductions
in symptom scores and medication use.
Injection immunotherapy has a known and
relatively low risk of severe adverse events.
We found no long-term consequences from
adverse events and no fatalities.

TABLE 1 | Potential mechanisms of antigen-specific therapy of allergy
Rudolf Valenta; Nature Reviews Immunology 2, 446-453 (June 2002); http://www.nature.com/nri/journal/v2/n6/fig_tab/nri824_F1.html

Allergy: the unmet need A blueprint for better patient care. A report of the Royal College of Physicians Working Party on the provision of allergy services in the UK.
Royal College of Physicians June 2003. http://www.bsaci.org/pdf/allergy_the_unmet_need.pdf
Basic Mechanisms: Immunization
Replace IgE with IgG
IgE
IgG4

Basic Mechanisms: Replace IgE with IgG
FIGURE 3 | Proposed action of prophylactic allergy vaccines.
Rudolf Valenta; Nature Reviews Immunology 2, 446-453 (June 2002); http://www.nature.com/nri/journal/v2/n6/fig_tab/nri824_F1.html

Sublingual Immunotherapy for the Treatment of
Allergic Rhinoconjunctivitis and Asthma
s/l pill
Radulovic S, Calderon MA, Wilson D, Durham S. Sublingual immunotherapy for allergic rhinitis (including hay fever). Cochrane Summaries. February 16, 2011. :
http://summaries.cochrane.org/CD002893/sublingual-immunotherapy-for-allergic-rhinitis-including-hay-fever#sthash.3xD98siS.dpuf

File:Illustration Phleum pratense0.jpg
http://en.wikipedia.org/wiki/File:Illustration_Phleum_pratense0.jpg

Product Monograph Description
s/l tablet: 2800 BAU
Standardized Allergenic
Extract, Timothy Grass
(Phleum pratense)
Sublingual Tablet) is an
allergy immunotherapy
tablet for the treatment of
signs and symptoms of
grass allergy.
PRODUCT MONOGRAPH: GRASTEK™ Standardized Allergenic Extract, Timothy Grass (Phleum pratense) ; Sublingual Tablet, 2800 BAU; Allergy Immunotherapy table;
Submission Control No: 148335 ; Merck Canada Inc. Date of Preparation: December 12, 2013. http://www.merck.ca/assets/en/pdf/products/GRASTEK-PM_E.pdf

The active substance is a
natural grass pollen
extract which is purified
and standardized from
Timothy Grass.

It is formulated as an
orally disintegrating tablet
designed to rapidly
dissolve under the tongue.
Each sublingual tablet has
a strength of 2800 BAU.

A1. Indications and Clinical Use
Indicated for reducing the signs and symptoms
of moderate to severe seasonal Timothy and
related grass pollen induced allergic rhinitis
(with or without conjunctivitis) in adults and
children 5 years of age and older [ages 5 to 65].

A2. Indications and Clinical Use
1. Confirmed by clinically relevant symptoms for
at least 2 pollen seasons
2. and a positive skin prick test and/or a
positive titre to Phleum pratense specific IgE;
3. and who have responded inadequately, or
are intolerant to conventional
pharmacotherapy.

B1. Contraindications
1. Are hypersensitive to any of the excipients in the
formulation or component of the Container.
2. Have previously had a severe systemic allergic
reaction to Timothy or related grass immunotherapy.

3. Have unstable, severe chronic or severe seasonal
asthma (FEV1 < 70% of predicted value after adequate
pharmacologic treatment in adults; < 80% in children).

Sublingual Tablet, 2800 BAU Efficacy
• All studies included patients with concomitant
asthma, but none included patients with
severe or unstable asthma. Autoinjected
epinephrine was provided to all patients
enrolled in the US studies.
Medscape Medical News: Grastek Recommended by FDA Panel for Timothy Grass Allergy; FDA Allergenic Products Committee Meeting. December 12, 2013
http://www.medscape.com/viewarticle/817771

4. Are taking β-blockers, as they can be non-responsive
to beta-agonists that may be required to reverse a
systemic reaction

5. Have active inflammatory conditions in the oral
cavity, e.g., oral lichen planus with ulcerations, severe
oral candidiasis, dental extraction

C1. Warnings and Precautions
Treatment with 2800 BAU should only be
prescribed and initiated by physicians with
adequate training and experience in the
treatment of respiratory allergic diseases.
In case of pediatric treatment, the physicians
should have the corresponding training and
experience in children.

Systemic allergic reactions, including life-
threatening anaphylactic shock and severe local
allergic reactions, have been observed in
patients receiving 2800 BAU, and may require
emergency administration of epinephrine,
antihistamines, bronchodilators or systemic
corticosteroids.

An Immunotherapy-Shot Alternative for
Respiratory Allergies?
Lin and colleagues reviewed the entire literature on this topic, accepting only studies that provided good
scientific data. Sixty-three studies that included 5131 persons aged 4-74 years received sublingual tablets of 1
or more allergens or placebo, which were taken on a maintenance basis at daily or weekly intervals over
extended periods ranging from 3 months to 5 years. The principal efficacy outcomes were symptom
improvement, need for additional (rescue) medication, and quality of life. Adverse events were included for
safety.
Local reactions were frequent, but anaphylaxis
was not reported and presumably absent.
The reviewers cautioned that their conclusions were limited by the great variations among studies in the type
of immunotherapy used and its dose, frequency, and duration.
1. Nicholas Gross, MD, PhD. An Immunotherapy-Shot Alternative for Respiratory Allergies?. http://www.medscape.com/viewarticle/804816
2. Lin SY, Erekosima N, Kim JM, et al . Sublingual Immunotherapy for the Treatment of Allergic Rhinoconjunctivitis and Asthma: a Systematic Review
JAMA. 2013;309:1278-1288
3. Nelson HS. Is sublingual immunotherapy ready for use in the United States? JAMA. 2013;309:1297-1298.
4. Radulovic S, Calderon MA, Wilson D, Durham S. Sublingual immunotherapy for allergic rhinitis (including hay fever). Cochrane Summaries. February 16,
2011. http://summaries.cochrane.org/CD002893/sublingual-immunotherapy-for-allergic-rhinitis-including-hay-fever Accessed April 30, 2013.

Safety Adults
• In pooled analyses of data from children and
adolescents, most adverse events occurred
within the first 1 to 2 weeks of treatment, and
the highest percentage of adverse events
occurred on day 1.

The first tablet of 2800 BAU must be taken at
the physician’s office under medical supervision
and the patient must be monitored for at least
30 minutes.
Extra precautions must be taken while treating
pediatric patients, including: each
administration of GRASTEK™ must be given
under direct adult supervision for
at least 30 minutes

s/l tablet: 2800 BAU Safety Adults
• The treatment-emergent adverse events that
were reported most frequently were:
1. oral pruritus (26.7%, MK-7243; 3.5%, placebo)
2. throat irritation (22.6%, MK-7243; 2.8%, placebo)
3. ear pruritus (12.5%, MK-7243; 1.1%, placebo)
4. mouth edema (11.1%, MK-7243; 0.8%, placebo).

s/l tablet: 2800 BAU Safety Child
• The treatment-emergent adverse events that
were reported most frequently were:
1. oral pruritus (24.4%, MK-7243; 2.1%, placebo)
2. throat irritation (21.3%, MK-7243; 2.5%, placebo)
3. tongue pruritus (9.2%, MK-7243; 0.9%, placebo)
4. mouth edema (9.8%, MK-7243; 0.2%, placebo).

Sublingual immunotherapy for allergic
rhinitis (including hay fever)
Allergic rhinitis is characterised by red, itchy
eyes, a blocked and runny nose, and sneezing.
The most common causes of allergic rhinitis are
different pollens (grass and tree), house dust
mites, mould and animal dander.
Allergic rhinitis can be intermittent (such as hay
fever) or persistent (all year round).

The treatment of allergic rhinitis depends on its
severity and duration, and is usually based on
the use of antihistamines and nasal
corticosteroids.
If these drugs cannot control symptoms
immunotherapy is recommended.

Immunotherapy involves the administration of
gradually increasing doses of the allergen over a
period of time to desensitise the patient.
It is the only known treatment that modifies the
immune response and treats the cause rather
than the symptoms.

In reviewing 60 trials we found a significant
reduction in symptom and medication scores in
patients treated with sublingual immunotherapy
compared to placebo.
There were no serious adverse reactions reported
in the included trials and no patient needed the use
of adrenaline.
This updated Cochrane Review therefore reinforces
the conclusions of the earlier review in confirming
the efficacy and safety of sublingual
immunotherapy.

Sublingual Immunotherapy for the Treatment of
Allergic Rhinoconjunctivitis and Asthma:
Our review found moderate strength in the evidence to
support the use of sublingual immunotherapy for
allergic rhinitis and asthma. This indicates moderate
confidence that the evidence reflects a true efficacy.
There were limitations in the standardization of adverse
event reporting, but no life-threatening adverse events
were noted.
Lin S.Y.; Sublingual Immunotherapy for the Treatment of Allergic Rhinoconjunctivitis and AsthmaA Systematic Review
JAMA. 2013;309(12):1278-1288. doi:10.1001/jama.2013.2049.[March 27, 2013, Vol 309, No. 12 ]

safety.
There were 13 studies of allergic asthma, of
which 9 provided "strong evidence...that
sublingual immunotherapy improved
symptoms" and decreased the need for
supplemental medications.
JAMA. 2013;309:1278-1288

safety.
36 studies of allergic rhinoconjunctivitis
provided "moderate evidence" that supported a
decrease in symptoms and improvements in
disease-specific quality of life.
JAMA. 2013;309:1278-1288

How long is the patient advised to wait after
immunotherapy ?

Time to Onset of Systemic Reactions with
Allergen Immunotherapy
Greineder DK. J Allergy Clin Immunol 1996; 98:S330-S334. [Data from Matloff et al. Allergy Proc 1993; 14:347-50.]
Time not recorded
10% 2-24 hours
8%
60-120 minutes
minimum 2%
0-30 minutes
72%
30-60 minutes
8%
Note: based on this, patients should be advised that they must wait
30 minutes in the clinic after receiving subcutaneous immunotherapy

Immunotherapy for seasonal allergic rhinitis
SCIT vs SLIT
Radulovic S, Calderon MA, Wilson D, Durham S. Sublingual immunotherapy for allergic rhinitis (including hay fever). Cochrane Summaries. February 16,
2011. : http://summaries.cochrane.org/CD002893/sublingual-immunotherapy-for-allergic-rhinitis-including-hay-fever#sthash.3xD98siS.dpuf

Vial #0
1:1000
Vial #1
1:100
Vial #2
1:10
Vial #3
1:1
Dose mL Dose mL Dose mL Dose mL
1 0.10 6 0.10 11 0.05 17 0.05
2 0.20 7 0.20 12 0.10 18 0.07
3 0.30 8 0.30 13 0.20 19 0.10
4 0.40 9 0.40 14 0.30 20 0.15
5 0.50 10 0.50 15 0.40 21 0.20
16 0.50 22 0.25
***Hollister-Stier Extract***
Note: Record all injections in the treatment record.
Note: This dosage chart is offered as a suggested schedule. However, the degree of
sensitivity varies in many individuals. In these cases, the size of the dose and intervals
between doses may have to be adjusted and should be regulated by the patient’s
tolerance and reaction. Treatment is normally started with the weakest dilution in the set.
Beginning with dose #1 as listed in the schedule. Doses should be administered at
weekly or twice-weekly (at least two days apart) intervals while working up. The
maintenance level is […]
23 0.30
24 0.35
25 0.40
26 0.45
27 0.50
Gradually increase intervals
to monthly maintenance.
*Please read text to left*
Subcutaneous IT: Sample Dose Chart
Dr.: Patient: Content:
Lot No.: Expiry Date:
This is a suggested dose chart only. Please read the instructions before commencing desensitization.
Observe patients for 30 minutes after each injection.
Check extract dilution and dose: Check the patient for local or systemic reaction(s) to previous injection.

Timothy Grass Pollen Allergen Extract
• The recommended dose is 1 sublingual tablet
daily; patients begin treatment 12 weeks
before and continue throughout the grass
pollen season.
• The first dose is given at the healthcare
provider's office; all other doses are taken at
home. The tablet dissolves in less than 10
seconds, according to the company briefing.

SCIT vs SLIT
SCIT = subcutaneous immunotherapy SLIT = sublingual immunotherapy

1 2 3 4 5 6 7 8 9 10 +
1 2 3 4 5 6 7 8 9 10 +

http://www.ec.gc.ca/cas-aqhi/default.asp?lang=En&n=9E5D28AD-1
Environment Canada

http://www.bcairquality.ca/readings/index.html

Abelsohn A., Stieb DM; Health effects of outdoor air pollution; Approach to counseling patients
using the Air Quality Health Index; Clinical Review; Can Fam Physician 2011;57:881-7
Health effects of outdoor air pollution

Air Quality Health Index (AQHI)
Abelsohn A., Stieb DM; Health effects of outdoor air pollution; Approach to counseling patients
using the Air Quality Health Index; Clinical Review; Can Fam Physician 2011;57:881-7

Feb 2014 allergy b clinical and aqhi

Feb 2014 allergy b clinical and aqhi

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