The presentation is regarding treatment and is not a study; it is a collection of observations made during the treatment of patients. The presentation covers food allergy management strategies, psychological and social impact of food allergy, risk management, food allergen desensitization treatment, and OIT treatment findings. Presentation By: Dr Richard L Wasserman of Dallas Allergy Immunology

1. TREATMENT OF FOOD
ALLERGY:
A FIVE YEAR EXPERIENCE
Richard L. Wasserman, MD, PhD
Clinical Professor of Pediatrics
University of Texas Southwestern Medical School

2. Disclaimer/Disclosure
 The information presented regarding treatment
is not a study; it is a collection of observations
made during the treatment of patients.
 DallasAllergyImmunology has supported this
project.
 There is no external funding for this work.
 The retrospective review of patient charts
reported herein was approved by The North
Texas Institutional Review Board.

3. Acknowledgements
• Dr. Lyndon Mansfield, El Paso provided the protocol
that he has used and invaluable advice and experience
that have made this treatment possible.
• Angela Hague, PA-C, Nancy Long, RN and Deanna
Pence, RRT devised the approaches to antigen delivery.
Ms. Hague wrote the EMR graphic interfaces to
document the process.
• Robert W. Sugerman and Stacy K. Silvers contributed
patients and provided invaluable advice.

4. Prevalence of Food Allergy
 Perception by public: 20-25%
 Confirmed allergy (oral challenge)
 Adults: 2-3.5%
 Infants/young children: 6-8%
 Specific Allergens
 Dependent upon societal eating and cooking patterns
 Prevalence higher in those with:
 Atopic dermatitis
 Certain pollen allergies
 Latex allergy
 Prevalence seems to be increasing

5. Food Allergy Evaluation
 Elimination diet should result in the resolution of
the problem
 The etiologic role of a food is confirmed by oral
challenge
 Challenges for IgE mediated food allergy must be
done in a controlled medical setting
 Challenges for atopic dermatitis may be done at home
 NEVER apply the suspect food to the skin

6. Avoidance Management
Strategy
 Standard of care in the US
 Careful avoidance of the offending food
 Epinephrine auto-injector always available
 203,000 emergency department visits/year
 90,000 episodes of anaphylaxis/year
 Annual rate of accidental peanut exposure
was 12.6%
 Epinephrine often not available or not used

7. Psychological Impact of Food Allergy:
Parents and Families
 Anxiety (especially with peanut)
 Conflict with daycare/schools
 Relationships with friends and family members
 Distortion of family life
 Social limitations
 Restaurants
 Anxiety at family gatherings

8. Psychological Impact of Food
Allergy:
Children with Food Allergy
 Anxiety about having a reaction
 Peanut allergic children report more impairment of
daily activities and social interactions than children
with rheumatologic disease1
 Greater anxiety about eating and fear of a reaction
than children with diabetes2
 Social stigmatization
 “The peanut table”
 40% have been bullied
Primeau, et al, Clin Exp Allergy. 2000 Aug;30(8):1135-43.
Avery, et al, Pediatr Allergy Immunol. 2003 Oct;14(5):378-82.

9. Social Isolation

10. Bullying

11. MYTH:
Prior Episodes Predict Future
Reactions
• No predictable pattern of anaphylaxis
• Severity depends on:
– Sensitivity of the individual
– Dose of the allergen
– Other factors (e.g., food matrix effects, exercise, concurrent
medications, airway hyper-responsiveness)
• Patients/parents must always be prepared for an
emergency
.

12. Key Point:
Diphenhydramine will not block anaphylaxis
 Unfortunately, reaction severity CANNOT be
predicted to again be mild with the next episode
 In a United Kingdom series of anaphylaxis fatalities,
1/3 of food allergy deaths were in patients with such
mild reactions to foods (mainly peanuts/tree nuts)
that they had not been prescribed self-injectable
epinephrine*
 Consider self-injectable epinephrine for all at risk of
anaphylaxis
*Pumphrey RS. Clin Exp Allergy. 2000 Aug;30(8):1144-50.

13. Emergency Department
Management of Food Allergy
•Patients with severe food
allergy may not receive
education on avoidance,
self-injectable epinephrine
or referral to an allergist at
emergency department
visits.
• It is imperative for primary
care doctors and allergists
to recognize the risks and
help patients avoid a future
accident.
Clark S, et al. J Allergy Clin Immunol 2004;113:347-352.

14. Risk Management
 Pediatrician and allergist found liable in 2002
verdict: $10 million settlement
 13 y.o. boy in vegetative state after anaphylaxis to
peanut in a candy on Dec. 25, 1996, when he was 7
years old. The most recent previous reaction at age 6
was a generalized rash with wheezing.
 Both physicians failed to prescribe self-injectable
epinephrine. Antihistamines were previously used.
 Both failed to warn parents of the potential severity of
the boy’s peanut allergy
Varghese v. Yerramilli, No. L-10913-97 (Middlesex Co., N.J., Super. Ct.) 2002.

15. Food Oral Immunotherapy
 First reported >100 years ago
 Extensive anecdotal (case collection) literature
 Growing prospective controlled trial literature
 Many strategies have been used (similar to
subcutaneous aeroallergen immunotherapy)

16. Food Allergens
 Egg white powder (initially, whole egg powder)
 Starting dose 250 ug of protein
 Milk – whole organic milk (longer shelf life)
 Starting dose 200 ug of protein
 Peanut flour/peanuts, peanut butter, M&M’s®
 Starting dose 2.05ug of protein
 Wheat – whole wheat pastry flour/Wheat Chex®
 Starting dose 100 ug of protein
 Tree nuts – cashew, pecan, walnut butters
 Starting dose 1 ug of protein

17. Patients
 Patients treated to date
 Age 4.5 years and older (most >5 years)
 Most have had a systemic reaction to a food
involving two or more organ systems
 May have a history of eczema or urticaria
 Objective evidence of systemic reaction to
food. Patients must have either:
 Positive food challenge
 Significantly elevated serum specific IgE antibody
to the food and a history of a systemic reaction

18. Reaction Sensitivity
 Serum antigen specific IgE (kU/L) predicts
>90% risk of a reaction
 Egg: 7 kU/L
 Milk: 15 kU/L
 Peanut: 14 kU/L
 OR a recent (within the past year) episode
of a food reaction involving ≥ two systems
 OR a positive food challenge involving ≥ two
systems
Sampson H. J Allergy Clin Immunol 2004;113:805-19
Garcia-Ara C, et al. J Allergy Clin Immunol 2001;107(1);185-90

19. The Process
 Patients or parents of appropriate patients are
offered the opportunity to be treated or to have
their child treated
 Parents/Patients are provided a custom consent
form
 Approximately two weeks prior to the initiation of
treatment, patients are evaluated for stability of
asthma and allergy and do a pulmonary function
test if they are able

20. The Protocol – Day One
 Patients arrive and are examined
 Vital signs, weight, epinephrine and
diphenhydramine doses are recorded on the flow
sheet
 First five peanut desensitization patients had an IV
hep lock, this is no longer done
 Dosing is initiated
 Before each dose the patient is asked how
they feel, response is recorded
 Up to twenty five doses are administered at 15
minute intervals
 One hour observation after the last dose

21. Protocol – Escalation Phase
 Patients take the last tolerated dose twice a
day for at least four days (peanut/tree nut
seven days)
 Return to the office for a challenge to the next
dose
 Brief history is taken and patient is examined
 Dose is administered
 Patients are observed for one hour

22. Safety
 At each visit the patient or the child and parent
are required to confirm the food for
desensitization.
 Forms have been designed for each food with
dosing guidelines.
 The previous dose and the next scheduled dose
are entered in the form
 Every step is signed, timed and dated
 Doses are signed and co-signed

23. Protocol – Maintenance Phase
 Maintenance
 Egg – egg white powder equivalent of one egg per day
 Milk – 240 ml per day
 Peanut – eight peanuts per day
 Wheat – two slices of whole wheat bread per day or
equivalent
 Tree nuts – eight nuts per day
 Additional food allowed
 Most patients – unlimited
 Selected patients – no intentional exposure
 Duration of treatment required to convert from
desensitization to tolerance – UNKNOWN

24. Reactions
 Any reaction on Day One is a reason to stop for
the day.
 Parents are instructed not to treat mild
cutaneous reactions for one hour to see if they
resolve spontaneously.
 Systemic reactions are treated in the standard
manner.
 After a reaction, the dose is decreased to the
last tolerated dose.

25. Reactions
 Egg
 Lowest triggering dose – 417 ug egg white protein
 Average triggering dose – 787mg egg white protein
or approximately 1/6 of an egg
 Milk
 Lowest triggering dose – 0.5mg of milk protein
 Average triggering dose –1066mg milk protein or 32
ml whole milk
 Peanut
 Lowest triggering dose – 20.5 ug of protein
 Average triggering dose – 495mg protein or 2
peanuts

26. Reasons For Withdrawal
 Frequent systemic reactions
• Frequent cutaneous reactions
 Abdominal discomfort with doses
 Frequent vomiting ? eosinophilic esophagitis
 Refusal because of taste
 Anxiety
 Allergic sibling had a reaction
 Scheduling difficulties

27. Egg Allergic Patients
 36 patients were started on the protocol (22 with a
history of systemic reactions)
 Serum specific IgE concentrations
 Whole egg – mean 23.13 kU/mL
 Egg white – mean 14.11 kU/mL
 15/32 > 7 kU/ml
 >7 kU/mL predicts >95% risk of a reaction
 30 patients have completed the protocol (94%
completion rate)
 Time to maintenance – 109 to 354 days
 3 patients have passed a tolerance challenge
 2 patients discontinued, both with IgE >7 kU/L
 One patient >100 kU/L – discontinued
 4 patients are in process

28. Reactions to Egg
 Nine patients experienced no reactions
 Total of 84 reactions*
 8 reactions treated with epinephrine
 21 reactions in the office
 63 reactions at home
 16 reactions on maintenance, one treated with
epinephrine
*Reactions graded according to Hugh A. Sampson. Anaphylaxis and
Emergency Treatment. PEDIATRICS vol. 111 No. 6 June 2003 pp 1601 -1608.

29. Milk Allergic Patients
 66 patients began the protocol (39 with a history of
systemic reactions)
 Serum specific IgE concentrations
 Mean 20.35 kU/mL
 24 patients with IgE >15 kU/mL
 >15 kU/mL predicts >95% risk of a reaction
 48 patients have completed in 94 – 844 days (87%
completion rate)
 5 patients have passed a tolerance challenge
 7 patients have discontinued
 Two patients >100 kU/L – both completed
 11 patients in process

30. Reactions to Milk
 16 patients experienced no reactions
 Total of 169 reactions
 31 reactions treated with epinephrine
 23 reactions in the office
 146 reactions at home
 36 reactions on maintenance, 10 treated with
epinephrine

31. Peanut Allergic Patients
 144 patients began the protocol (69 with a history
of systemic reactions)
 95 have completed peanut desensitization (80% completion rate)
 Time to maintenance 104 – 392 days
 4 patients have passed tolerance challenges
 30 have discontinued – 6 on maintenance
 Serum specific IgE concentrations
 Mean 44.8 kU/mL
 82 patients with IgE >14 kU/mL
 >14 kU/mL predicts >95% risk of reaction on exposure
 29 patients >100 kU/mL – 21 completed, 8 discontinued

32. Reactions to Peanut
 39 patients experienced no reactions
 Total of 227 reactions
 66 reactions treated with epinephrine
 57 reactions in the office
 170 reactions at home
 67 reactions on maintenance, 21 treated with
epinephrine

33. Wheat
 Two patients started the treatment and both
finished without any reactions. One
discontinued on maintenance
 Serum wheat specific IgE >100 kU/mL, 15.24
 Time to maintenance 118-139 days
 One currently escalating

34. Immunologic Changes
 Serum allergen specific IgE is measured within
six months of starting the treatment, one month
after reaching maintenance and yearly after that
 Virtually all patients develop very high serum
allergen specfic IgG4 and we have stopped
measuring it

35. Mean Antigen Specific IgE
(kU/mL)
(completed patients only)
Food Pre-treatment
IgE
1 month
post-treatment
IgE
≥ 75% 
at 1 month
2nd post-treatment
IgE
3rd post-treatment
IgE
Egg
(Whole)
17.41 3.67 46% 3.56
Egg
(White)
14.26 2.21 42% 2.0 2.13
Milk 19.2 7.47 44% 3.77 1.19
Peanut 40 19.32 20% 11.81 6.24
Wheat 57.6 18.8 50%

36. Psychological Issues During
Treatment
 Fear of the protocol
 Patients who have had reactions are afraid of the risk of
a reaction
 Fear of desensitization
 Children remember the previous systemic reaction and
its treatment
 Children who have been taught food avoidance feel “in
control”
 Freedom to eat the avoided food represents a loss of
control

37. Food Allergy Quality of Life
 Pilot retrospective chart review
 Validated questionnaire*
 Historical controls* score 2.8
 24 OIT patients at least six months after
reaching maintenance score 0.21
*Cohen BL, et al. Development of a questionnaire to measure
quality of life in families with a child with food allergy.
JACI Nov 2004; 1159-63

38. Quality of Life

39. Summary
 A total of 225 children were treated for allergy
to egg, milk, peanut or wheat.
 153/186 completed/(completed + discontinued)
(82.2%) successfully completed the treatment
 Egg 93%
 Milk 89%
 Peanut 79%
 41 are in process

40. Outcome
“I took Cullen to IHop today for pancakes and
eggs for the first time…He was happy.”
“The holidays were so different this year with no
fear. Kalli was able to eat my sister’s special
Christmas cookies for the first time in her life.”

41. Worth It

42. Family Centerpiece

43. How Often Can a Physician Do
This?

44. DIAGNOSIS AND
TREATMENT OF
FOOD ALLERGY
Richard L. Wasserman, MD, PhD, FAAAAI
Director of Pediatric Allergy and Immunology
Medical City Children’s Hospital