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Optimal patient selection for oral immunotherapy

Authors:

Abstract

Standard criteria for ideal patient selection with food oral immunotherapy (OIT) have yet to be determined. Although there are a handful of contraindications to consider before recommending OIT, most patients with confirmed immunoglobulin E‐mediated food allergies are appropriate candidates. Success rates of OIT can vary widely and be influenced by several factors. Choosing the most appropriate candidate for an OIT program can mitigate risks and provide the best chance for patients to be successful.
Optimal patient selection for oral immunotherapy
Justin Greiwe, M.D.
1,2
ABSTRACT
Standard criteria for ideal patient selection with food oral immunotherapy (OIT) have yet to be determined. Although there
are a handful of contraindications to consider before recommending OIT, most patients with conrmed immunoglobulin
Emediated food allergies are appropriate candidates. Success rates of OIT can vary widely and be inuenced by several fac-
tors. Choosing the most appropriate candidate for an OIT program can mitigate risks and provide the best chance for patients
to be successful.
(J Food Allergy 4:4952, 2022; doi: 10.2500/jfa.2022.4.210013)
TAKING BACK CONTROL
Whether it is improved quality of life, increased
peace of mind, or protection against accidental
exposure, there are a multitude of reasons why
patients might choose to seek out oral immunotherapy
(OIT) as a treatment option. Whatever their rationali-
zation, the common thread that connects all these
patients is their desire to take back control of their
lives. Before having OIT as a treatment option, most
patients with food allergy had always been on the de-
fensive, maintaining constant vigilance in a world that
was unpredictable and unsafe. The only help that aller-
gists seemed to offer was a yearly renewal of an epi-
nephrine autoinjector and the sage advice of strict
avoidance. When OIT rst became available approxi-
mately a decade ago, it was not surprising that many
patients with food allergy embraced the chance of
changing this dynamic. Some viewed desensitization
as the rst opportunity to ip the script and nally go
on the offensive. Parents of children with food allergy,
however, have the opposite problem. Instead of trying
to take back control, they are looking for ways to safely
give some of that control up. One of the biggest fears
that parents face is not being able to manage their
childs environment when they leave the house. This
includes any situation in which they are not directly
involved in the preparation of meals. Whether it is a
restaurant, a sleepover, or a college cafeteria, parents
have trouble trusting anyone not familiar with the se-
verity of their childs food allergy to provide them a
safe meal. As a result, many parents attempt to inu-
ence every aspect in their childs life in a well-inten-
tioned attempt to keep them protected. Although this
level of control often prevents accidental exposures, it
can unknowingly lead to increased childhood anxiety
and isolation from normal peer interactions.
1,2
For
many parents who deal with these crippling anxieties,
OIT provides an outlet to give up some of that control
and give their children the freedom to make mistakes
and live their lives with more autonomy.
3
PATIENT-CENTERED CARE AND SHARED
DECISION-MAKING
With OIT, allergists can nally offer something other
than just strict avoidance, an epinephrine autoinjector,
and a written anaphylaxis action plan. However, just
because allergists have a new tool for treating food
allergies does not mean that it should be used in every
case. In fact, not all patients who come in for a food
OIT consultation are willing participants. For many,
especially adolescents, maintaining the status quo is
preferable to the rigors that OIT treatment demands,
including daily dosing and frequent ofce visits.
Oftentimes, parents and their children are on opposing
sides of the treatment paradigm, which can lead to
resentment and problems with long-term compliance.
Although many parents are desperate to nd an
answer for their childs condition, it is important to
remember that the best outcomes in OIT come when
the discussion is focused on patient-centered care and
shared decision-making.
4
When a young patient is
brought into the fold of the discussion, he or she feels
like an active participant in his or her health care rather
From the
1
Bernstein Allergy Group Inc., Cincinnati, Ohio; and
2
Division of
Immunology/Allergy Section, Department of Internal Medicine, The University of
Cincinnati College of Medicine, Cincinnati, Ohio
J Greiwe is a consultant and advisor for Aimmune, Sanofi Genyme, Regeneron and ALK
No external funding sources reported
Address correspondence to Justin Greiwe, M.D., 4665 E. Galbraith Rd., Cincinnati,
OH 45236
E-mail address: jcgreiwe@gmail.com
This manuscript is part of the Journal of Food Allergy collection of published works
referred to as the Oral Immunotherapy Manual.The contents of this work reflects
the opinion(s) of the author(s) and is not intended to replace published guidelines or
the clinicians medical advice in the doctor-patient relationship
This article is distributed under the terms of the Creative Commons Attribution
License-NonCommercial-N oDerivatives 4.0 International (CC BY-NC-ND 4.0)
license (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits reproduction
and redistribution in any medium or format according to the license terms, provided the
work is not used for commercial purposes and provided the original authors and source
are properly credited and a link is provided to the Creative Commons license. For com-
mercial permissions, visit https://oceansidepubl.com/permission-to-use-content/
Copyright ©2022, The Author(s). Published by OceanSide Publications, Inc., U.S.A.
J Food Allergy (USA) 4:2 JFoodAllergy.com 2022 49
than as a passive observer. This concept was consid-
ered important enough to include in the most recent
Canadian Society of Allergy and Clinical Immunology
guidelines for OIT, which stated, the ultimate goal
of food allergy care should be the empowerment of
patients and their caregivers to manage the risk of
food allergy reactions, reduce food-related anxiety,
and achieve a sense of control over their condition.
5
OPTIMIZING PATIENT SELECTION
Because not all patients are good candidates for OIT,
it is important to have a better understanding of which
patients have the best chance to safely and successfully
complete OIT. First and foremost, there needs to be
conrmation of an immunoglobulin E (IgE) mediated
food allergy before any OIT program can begin. This
can be accomplished through a comprehensive clinical
history followed by skin-prick testing or serum specic
IgE (sIgE) testing if indicated. A substantial number of
patients coming in for OIT consultations might not be
truly allergic and putting patients through months of
unnecessary ofce visits and daily food ingestion
should be avoided. Oral food challenge is required if
there is any doubt with regard to the diagnosis or if
the clinician wants to establish a baseline threshold
before therapy.
6,7
Once a food allergy diagnosis has
been established, the next step is to determine who
would be a good OIT candidate. OIT is especially effec-
tive for those patients with evidence of an IgE-medi-
ated food allergy in whom avoidance measures are
ineffective, are undesirable, or cause severe limitations
to a patients quality of life.
8
Patients who experience
severe anxiety from food avoidance, cross-contamina-
tion exposure, or a previous systemic reaction would
benet from OIT. Parents with toddlers who are close to
school age often seek out OIT to help mitigate risks
before enrolling them in school. Similarly, parents of
adolescents who are close to graduating high school look
to OIT to provide a sense of security before moving on
to college. Anyone who has failed a recent OFC or has
high or unchanged serum sIgE levels and/or skin-prick
test wheals over several years can also be considered.
There are several risk factors to consider before start-
ing OIT.
9
Interestingly skin-prick testing and serum
sIgE levels do not seem to correlate with the severity of
a reaction after exposure and, therefore, should not be
used to risk stratify patients with OIT.
10
One risk factor
that seems to garner a lot of questions is age. What age
is too early to start OIT, and, conversely, what age is
too late? There denitely seems to be a correlation
between increasing age and diminishing returns when
it comes to OIT treatment. Older patients tend to have
more adverse effects, especially gastrointestinal, which
makes it more difcult for them to complete therapy.
11
Determining the appropriate starting age for OIT
cannot be standardized but rather depends on the indi-
vidual patient, his or her parents, and the food being
considered. In the past, some OIT programs restricted
starting ages to 3 or even 5 years of age, depending on
the patients maturity, ability to communicate, and
capacity to follow directions. With more experience,
these restrictions are likely unnecessary, especially
because there is growing evidence that starting OIT in
younger ages may be associated with better outcomes
and fewer systemic reactions.
1215
In some cases, suc-
cessful peanut OIT has been reported in children 12
months of age with some allergists starting OIT soon
after a failed infant peanut introduction.
12
In addition,
the natural history of food allergy resolution can differ,
depending on the food, and should be balanced when
determining if a patient is a good candidate for OIT.
This is especially important when starting milk or egg
OIT at younger ages, given that most of these patients
will naturally develop tolerance over time.
Patients with multiple food allergies present another
scenario that is challenging because the benets of sin-
gle-allergen OIT might not be as apparent in this popu-
lation.
16
Although there are minimal differences in
effectiveness and safety when comparing single-food
OIT with multi-food OIT,
17
these patients require inges-
tion of larger volumes of food daily, which makes long-
term compliance more challenging. Furthermore, not all
these patients can complete OIT for every one of their
food allergies, which limits the benets enjoyed by those
on single-food OIT. Although multiple food allergies
are not a contraindication to OIT, these patients might
not achieve the same quality-of-life improvements that
individuals who are monosensitized experience.
ABSOLUTE AND RELATIVE
CONTRAINDICATIONS
Everyone involved in the OIT process must be fully
informed of the risks and benets of therapy. Having a
clear understanding of all treatment options currently
available as well as any possible future therapies being
investigated will allow families to make the most
informed decision possible. Providing a comprehen-
sive overview of the OIT program, including clear
treatment goals, prevents unrealistic expectations
about the benets of OIT and avoids an overestimation
of its risks.
5,18
Prociency in communication by using
simple language and by fostering a discussion on all
these important topics is essential to ensure universal
understanding.
In our institution, severe, poorly controlled asthma,
pregnancy, and poor adherence are absolute contrain-
dications for OIT, and these patients should not be
considered for OIT under any circumstances (Table 1).
In mirroring previously published safety guidelines
for subcutaneous immunotherapy,
19
our practice
50 J Food Allergy (USA) 4:2 JFoodAllergy.com 2022
continues OIT on patients who become pregnant while
on therapy and avoid any dose increases until after
delivery. If the patient or family has a history of poor
medication compliance with other chronic disease
states, e.g., asthma, OIT might not be the best t.
Similarly, if a patient is found to be noncompliant
while on OIT, then serious consideration should be
given to discontinuing treatment. Life-threatening sys-
temic reactions that require vasopressor support or
intubation do not necessarily exclude a patient from
considering OIT, although this history may be associ-
ated with more adverse effects and dissuade some of-
ces from offering therapy to these patients.
Relative contraindications for OIT include preexist-
ing eosinophilic esophagitis, active severe atopic der-
matitis or chronic urticaria, cardiovascular diseases,
mastocytosis, or the concomitant use of medications
such as
b
-blockers or angiotensin-converting enzyme
inhibitors.
5,7,8
Underlying atopic conditions such as
asthma, allergic rhinitis, and atopic dermatitis must be
controlled before starting OIT and proactively man-
aged throughout therapy. A patient and caregiver with
unhealthy psychosocial dynamics can sometimes jeop-
ardize the safety of OIT and can include but are not
limited to unreliable adherence, severe anxiety, psychi-
atric barriers, noncollaborative family dynamics, a lack
of schedule exibility for proper dosing, and a lack of
commitment from patients or caregivers.
5
Recognizing
these destructive patterns can be challenging, espe-
cially because they do not become apparent until well
into treatment. Other obstacles to successful OIT treat-
ment include reluctance to use epinephrine and lan-
guage barriers, which should be addressed as well if
applicable. A decision to pursue OIT in these at-risk
patient populations should be based on clinical judg-
ment, provider expertise, and shared decision-making.
All the above-mentioned factors need to be considered
and discussed with the patient and family in detail
before informed consent can be provided.
TEMPERING UNREALISTIC EXPECTATIONS
OIT is a substantial time, nancial, and emotional
commitment that requires highly motivated families
who are ready to put in the work necessary to success-
fully complete the program. As a result, families
should be given an estimation of the time commitment
required to reach maintenance as well as the under-
standing that this therapy could continue indenitely.
Parents and patients oftentimes have unrealistic
expectations of what OIT can accomplish, including
curing food allergy or allowing for unrestricting eat-
ing. Parents, for example, are often excited that their
child will be eating lots of peanut butter and jelly sand-
wiches once peanut OIT treatment is completed.
Although free eating can be a goal for some patients,
most detest the taste of the food they are allergic to
and have difculty tolerating their daily maintenance
dose. Another assumption is that OIT therapy will
reduce the risk for systemic reactions. Although it is
true that patients who complete OIT have a higher
threshold for reaction when exposed to their food
allergy, there is a substantially greater risk for anaphy-
laxis and other allergic reactions when OIT treatment
is compared with placebo or food avoidance.
20,21
CONCLUSION
The main criteria for acceptance into an OIT program
include patients and caregivers who are motivated and
have a good grasp of the goals and expectations of treat-
ment. Patients do not necessarily have to be excluded
based on age, a high baseline food sIgE level, or a history
of anaphylaxis. Response to OIT can vary, depending on
the patient, the food allergen, and underlying comorbid-
ities, which makes it difcult to predict outcomes or to
strictly standardize protocols. Consequently, OIT should
be approached as an individualized treatment plan that
caters to the patientsevolving needs, which may change
throughout the course of therapy. Periodically reassess-
ing patientsgoals and perceived benets,therefore,is
required to ensure that clinical decisions continue to
reect personal objectives.
5
This requires patience, crea-
tivity, and exibility on behalf of the care provider,
patient, and family. In doing so, caregivers can provide
thebestchanceforpatientsandtheirfamiliestoachieve
their goals for OIT.
CLINICAL PEARLS
Patients with conrmed IgE-mediated food allergy
in whom avoidance measures are ineffective or
Table 1 Absolute vs relative contraindications for
oral immunotherapy
Absolute contraindications
Severe, poorly controlled asthma
Pregnancy
Poor adherence
Relative contraindications
Preexisting eosinophilic esophagitis
Active severe atopic dermatitis
Chronic urticaria
Cardiovascular disease
Mastocytosis
Use of
b
-blockers or angiotensin-converting
enzyme inhibitors
Lack of commitment from the patient or other psy-
chosocial barriers
J Food Allergy (USA) 4:2 JFoodAllergy.com 2022 51
undesirable, or cause severe limitations to a patients
quality of life are excellent candidates for OIT.
Severe, poorly controlled asthma, pregnancy, and
poor adherence are absolute contraindications for
OIT.
OIT is a substantial time, nancial, and emotional
commitment that requires families who are highly
motivated and who are ready to put in the work
necessary to successfully complete the program.
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Oral immunotherapy (OIT) provides an active treatment option for patients with food allergies. OIT may improve quality of life and raise the threshold at which a patient with food allergy may react to an allergen, but it is a rigorous therapy that requires a high degree of commitment by the clinician, patients, and families. Recent guidelines from the Canadian Society for Allergy and Clinical Immunology (CSACI) have provided a framework for the ethical, evidence-based and patient-oriented clinical practice of OIT, and the European Academy of Allergy Asthma and Immunology (EAACI) guidelines have also recommended that OIT can be used as a potential treatment. The recent FDA approval of an OIT pharmaceutical has accelerated the adoption of OIT. This review provides a summary of the recent CSACI guidelines and a consensus of practical experience of clinicians across the US and Canada related to patient selection, office and staff preparation, the general OIT process, OIT-related reaction management, and treatment outcomes.
Article
Background Peanut oral immunotherapy is an effective treatment for desensitizing peanut allergic patients, but the frequency of adverse reactions has limited its widespread use. Objective To review the frequency of adverse reactions that patients on peanut oral immunotherapy experience during build up and maintenance phases and explore factors that may contribute to adverse events. Methods A retrospective chart review of children and adults with peanut allergy undergoing peanut oral immunotherapy at the New England Food Allergy Treatment Center in West Hartford, CT was performed. Data on patient demographics, allergic profile, peanut allergy testing, and details of reactions in build up and maintenance phases was collected. A systemic reaction was defined as one of the following 1) severe reaction involving one system, such as generalized hives and/or angioedema, 2) two or more of the following symptoms: cutaneous or oral, respiratory, or gastrointestinal symptoms, 3) drop in blood pressure, or 4) need for epinephrine. Results Data was available on 783 patients ages 3.5-48.3 years. During build up, 78 patients (10%) experienced at least one systemic reaction, 660 (84%) at least one gastrointestinal adverse event, 369 (47%) at least one cutaneous adverse event, and 157 (20%) at least one respiratory adverse event. Thirty four patients (4%) required epinephrine during build up. Six hundred and ninety seven patients (89%) completed build up and progressed to maintenance. During maintenance, 131 patients (19%) experienced at least one systemic reaction, 190 (27%) at least one gastrointestinal adverse event, 104 (15%) at least one cutaneous adverse event, and 50 (7%) at least one respiratory adverse event. Seventy four patients (11%) required epinephrine during maintenance. None of the adverse events required hospitalizations, and there were no mortalities. Nine patients (1%) were diagnosed with eosinophilic esophagitis during build up or maintenance. Increasing pre-treatment peanut specific IgE were associated with increased odds of a systemic reaction during build up. Increasing age, pre-treatment peanut specific IgE and a systemic reaction in build up were associated with increased odds of a systemic reaction during maintenance. Conclusions Peanut oral immunotherapy may be an effective and safe treatment for carefully selected peanut allergic patients under the guidance of experienced providers. Specific patient characteristics and immunological factors may help predict adverse events.
Article
Background: Oral immunotherapy is an emerging experimental treatment for peanut allergy, but its benefits and harms are unclear. We systematically reviewed the efficacy and safety of oral immunotherapy versus allergen avoidance or placebo (no oral immunotherapy) for peanut allergy. Methods: In the Peanut Allergen immunotherapy, Clarifying the Evidence (PACE) systematic review and meta-analysis, we searched MEDLINE, EMBASE, Cochrane Controlled Register of Trials, Latin American & Caribbean Health Sciences Literature, China National Knowledge Infrastructure, WHO's Clinical Trials Registry Platform, US Food and Drug Administration, and European Medicines Agency databases from inception to Dec 6, 2018, for randomised controlled trials comparing oral immunotherapy versus no oral immunotherapy for peanut allergy, without language restrictions. We screened studies, extracted data, and assessed risk of bias independently in duplicate. Main outcomes included anaphylaxis, allergic or adverse reactions, epinephrine use, and quality of life, meta-analysed by random effects. We assessed certainty (quality) of evidence by the GRADE approach. This study is registered with PROSPERO, number CRD42019117930. Results: 12 trials (n=1041; median age across trials 8·7 years [IQR 5·9–11·2]) showed that oral immunotherapy versus no oral immunotherapy increased anaphylaxis risk (risk ratio [RR] 3·12 [95% CI 1·76–5·55], I²=0%, risk difference [RD] 15·1%, high-certainty), anaphylaxis frequency (incidence rate ratio [IRR] 2·72 [1·57–4·72], I²=0%, RD 12·2%, high-certainty), and epinephrine use (RR 2·21 [1·27–3·83], I²=0%, RD 4·5%, high-certainty) similarly during build-up and maintenance (pinteraction=0·92). Oral immunotherapy increased serious adverse events (RR 1·92 [1·00–3·66], I²=0%, RD 5·7%, moderate-certainty), and non-anaphylactic reactions (vomiting: RR 1·79 [95%CI 1·35–2·38], I²=0%, high-certainty; angioedema: 2·25 [1·13–4·47], I²=0%, high-certainty; upper tract respiratory reactions: 1·36 [1·02–1·81], I²=0%, moderate-certainty; lower tract respiratory reactions: 1·55 [0·96–2·50], I²=28%, moderate-certainty). Passing a supervised challenge, a surrogate for preventing out-of-clinic reactions, was more likely with oral immunotherapy (RR 12·42 [95% CI 6·82–22·61], I²=0%, RD 36·5%, high-certainty). Quality of life was not different between groups (combined parents and self report RR 1·21 [0·87–1·69], I²=0%, RD 0·03%, low-certainty). Findings were robust to IRR, trial sequential, subgroup, and sensitivity analyses. Interpretation: In patients with peanut allergy, high-certainty evidence shows that available peanut oral immunotherapy regimens considerably increase allergic and anaphylactic reactions over avoidance or placebo, despite effectively inducing desensitisation. Safer peanut allergy treatment approaches and rigorous randomised controlled trials that evaluate patient-important outcomes are needed. Funding: None.