Immunotherapy Safety for the Primary Care ... - U.S. Coast Guard

S28 Cox et al
J ALLERGY CLIN IMMUNOL
SEPTEMBER 2007
TABLE I. Classification of evidence and
recommendations*
Category of evidence
Ia Evidence from meta-analysis of randomized
controlled trials
Ib Evidence from at least 1 randomized controlled
trial
IIa Evidence from at least 1 controlled study without
randomization
IIb Evidence from at least 1 other type of
quasiexperimental study
III Evidence from nonexperimental descriptive
studies, such as comparative studies,
correlation studies, and case-control studies
IV Evidence from expert committee
reports or opinions, clinical experience
of respected authorities, or both
LB Evidence from laboratory-based studies
NR Not rated
Strength of recommendation
A
Directly based on category I evidence
B
Directly based on category II evidence
or extrapolated from category I evidence
C
Directly based on category III evidence or
extrapolated from category I or II evidence
D
Directly based on category IV evidence or
extrapolated from category I, II, or III evidence
NR Not rated
*Adapted with permission from Shekelle PG, Woolf SH, Eccles M,
Grimshaw J. Clinical guidelines: developing guidelines. BMJ
1999;318:593-6. 3
The selection of allergens for immunotherapy is based
on clinical history, the presence of specific IgE antibodies,
and allergen exposure. This parameter offers suggestions
and recommendations derived from known patterns of
allergen cross-reactivity. Recognizing that the immunotherapy
terminology used to describe extract dilutions is
sometimes ambiguous, the 2003 ‘‘Allergen immunotherapy:
a practice parameter’’ established standardized terminology
for describing allergen immunotherapy extract
dilutions. These parameters also provided specific recommendations
for immunotherapy maintenance doses for
some standardized allergens and a suggested dosing range
for nonstandardized allergen extracts. The therapeutic
preparations for allergen immunotherapy are extracted
from source materials, such as pollen, mold cultures, and
pelt, hence the traditional term allergen extract. The terms
allergen extract or extract refer to solutions of proteins or
glycoproteins extracted from source material not yet incorporated
into a therapeutic allergen immunotherapy extract.
The term maintenance concentrate should be used to identify
the allergen immunotherapy extract that contains a therapeutic
effective dose for each of its individual constituents
(see the Immunotherapy schedules and doses section).
The term manufacturer’s extract refers to the allergy
extract purchased from the manufacturer. The terms
stock, full-strength, and concentrate are ambiguous and
should not be used. All dilutions should be referenced
to the maintenance concentrate and should be noted as a
volume-to-volume dilution (eg, 1:100 vol/vol dilution of
a maintenance concentrate).
Allergen immunotherapy is effective when appropriate
doses of the allergens are administered. ‘‘Allergen immunotherapy:
A practice parameter’’ recommends that vials of
allergen immunotherapy extracts should be prepared individually
for each patient to enhance the individualization
of therapy, reduce the risk of allergen cross-contamination,
and reduce the risk of error in administration. 4,5 This
parameter recommends the use of standardized allergen
immunotherapy prescription and administration forms to
improve the safety, uniformity, and standardization of
allergen immunotherapy practice. 4,5 The suggested forms
are found in the Appendix (Appendices 7, 8, 11, 12, and
14) and in the members’ section of the www.aaaai.org
Web site. The routine use of these standardized forms
should improve the quality of immunotherapy practice.
Members’ feedback comments on the recommended
allergen extract dilution dating in the 2003 ‘‘Allergen
immunotherapy: A practice parameter’’ led to an allergen
immunotherapy extract dilution stability study designed
by the AAAAI Immunotherapy and Allergy Diagnostics
Committee and funded by the AAAAI Board of Directors.
The study was designed to investigate the effect of time,
temperature, and dilution of standardized allergen extract
potency, and the results of this study were considered in
this update.
This document was approved by the sponsoring organizations
and represents an evidence-based, broadly accepted
consensus opinion. These clinical guidelines are
designed to assist clinicians by providing a framework for
the evaluation and treatment of patients and are not intended
to replace a clinician’s judgment or establish a protocol for
all patients. Not all recommendations will be appropriate
for all patients. Because this document incorporates the
efforts of many participants, no individual, including
anyone who served on the Joint Task Force, is authorized
to provide an official AAAAI or ACAAI interpretation
of these guidelines. Recognizing the dynamic nature of
clinical practice and practice parameters, the recommendations
in this document should be considered applicable
for 3 years after publication. Requests for information
about or an interpretation of these practice parameters
should be directed to the Executive Offices of the AAAAI,
ACAAI, and JCAAI. These parameters are not designed
for use by pharmaceutical companies in drug promotion.
ALGORITHM AND ANNOTATIONS FOR
IMMUNOTHERAPY
Fig 1 provides an algorithm for the appropriate use of
allergen immunotherapy. Given below are annotations
for use with the algorithm.
Box 1
Immunotherapy is effective in the management of
allergic asthma, allergic rhinitis/conjunctivitis, and
stinging insect hypersensitivity. Allergen immunotherapy