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Poster 2013: The safety of the united allergy services immunotherapy protocol

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POSTER PRESENTATION Open Access
Poster 2013: The safety of the united allergy
services immunotherapy protocol
Frederick Schaffer
1*
, Andrew Naples
2
, Myla Ebeling
3
, Thomas Hulsey
3
, Larry Garner
2
From 2013 WAO Symposium on Immunotherapy and Biologics
Chicago, IL, USA. 13-14 December 2013
Background
A small, but significant number of subcutaneous immu-
notherapy (SCIT) based systemic reactions (SR) result in
morbidity and mortality. SR range from 4 to 7% for tradi-
tional protocols and up to 34% if undergoing RUSH immu-
notherapy. There is estimated 1 death per 2.5 million
immunotherapy injections. We report the results of an IRB
approved study and contrast the safety of the United
Allergy Services (UAS) SCIT treatment protocol to pre-
viously published reports. We hypothesized that a slower
SCIT build up phase and pre-selection for low risk patients
would prove to be safer than traditional protocols.
Methods
A slow incremental SCIT build up phase (6 months vs.
3 months to achieve maintenance) and careful exclusion
of high risk patients were salient features of the SCIT pro-
tocol utilized for 18,971 adults who were administered
1,624,135 injections and 4,643 pediatric patients (< 18 y/o)
who were administered 397,466 SCIT injections for a
1 year period (2011-2012).
Results
The adult patient SR rate per patient was 0.15% and
0.002% per injection. The pediatric patient SR rate per
patient was 0.19% and per injection was 0.002%. SR rate
assessment for the entire patient population was 0.16%
per patient and 0.002%per injection. These results are in
contrast to a reported 4% SR rate for 773 adult patients
who were administered 28,000 injections (Allergy
Asthma Proc. 2011;32(4):288) and up to 4.6% per injec-
tion reported for pediatric patients (Pediatrics 2013:131,
1155). The remarkably low UAS SR rates are signifi-
cantly below (p < 0.0001) the cited published results.
The SR for all patients are: Anaphylaxis Grade I-18,
Grade II-17, Grade III-1, Grade IV-1; and for pediatric
patients: Grade I-5 & Grade II- 4. Of note, no Grade V
reactions (deaths) occurred in over 2 million injections.
Conclusions
These results demonstrate the safety of the UAS immu-
notherapy protocol. We conclude that the UAS SCIT pro-
tocol is safe with minimal SR in comparison to previously
published protocols. These safety results are due to a
slower incremental SCIT build up phase and a pre-selec-
tion of low risk patients.
Authorsdetails
1
Medical University of South Carolina, United Allergy Services, Charleston, SC,
USA.
2
United Allergy Services, San Antonio, TX, USA.
3
Medical University of
South Carolina, Dept. Pediatrics, Charleston, SC, USA.
Published: 3 February 2014
doi:10.1186/1939-4551-7-S1-P24
Cite this article as: Schaffer et al.: Poster 2013: The safety of the united
allergy services immunotherapy protocol. World Allergy Organization
Journal 2014 7(Suppl 1):P24.
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1
Medical University of South Carolina, United Allergy Services, Charleston, SC,
USA
Full list of author information is available at the end of the article
Schaffer et al.World Allergy Organization Journal 2014, 7(Suppl 1):P24
http://www.waojournal.org/content/7/S1/P24
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