World Allergy Organization Grade Research Articles

Evaluation of the safety of dose escalation period of subcutaneous specific allergic immunotherapy in patients with rhino-conjunctivitis or allergic asthma previously vaccinated against SARS-CoV-2

BACKGROUND: More than 90% of the Spanish population has been vaccinated against the SARS-CoV-2 virus in our setting. The administration of this vaccine is not contraindicated in allergic subjects; however, it is unknown whether any precaution should be taken when initiating subcutaneous allergen immunotherapy after this vaccination. The objective of the study was to analyze the safety of subcutaneous allergen immunotherapy during the dose escalation phase in subjects sensitized to pollens or mites previously vaccinated against SARS-CoV-2. METHODS: An observational study with retrospective data collection from protocolled patients' medical records was designed. Outpatients older than 12 years with diagnosis of pollen or house dust mite allergic rhinitis with or without bronchial allergic asthma were selected who had completed the subcutaneous immunotherapy dose escalation phase. A complete SARS-CoV-2 vaccination was required for the inclusion. RESULTS: Three hundred and seventy-nine patients were included by 53 investigators. The mean age was 31 years old and 55,9% female. Time from last SARS-Cov-2 vaccination dose to subcutaneous immunotherapy initiation was 4.1 months (95%CI 3.8-4.4). subcutaneous immunotherapy with a pollen allergoid was administered to 135 patients (35.6%) with a total of 739 injections, while subcutaneous immunotherapy using a house dust mite allergoid was administered to 244 patients (64.4%) with a total of 1311 doses. During the dose escalation phase with the pollen allergoid, 45 patients (33.3%) suffered 93 local adverse reactions (12.6% of injections), while 17 patients (12.6%) experienced 17 systemic allergic reactions (2.3% of injections) of them 14 were World Allergy Organization Grade 1 and 3 of Grade 2. During the dose escalation phase with the house dust mite allergoid, 55 patients (22.5%) reported 133 local adverse reactions (10.1% of injections), and 7 patients (2.9%) showed 7 World Allergy Organization Grade 1 systemic reactions (0.5% of injections). No systemic reactions Grade 3 or higher were reported. CONCLUSIONS: The well-known safety profile of the subcutaneous allergen immunotherapy using pollen or house dust mite allergoids has not been changed after the SARS-CoV-2 vaccine administration. No relevant differences in the incidence of local or systemic allergic reactions during the dose escalation phase were identified, so it is considered that the patient’s safety has not been compromised to initiate this treatment after the SARS-CoV-2 vaccine administration.

Updating the CoFAR Grading Scale for Systemic Allergic Reactions in Food Allergy

Immunotherapy is promising as an efficacious treatment for food allergy. Other food allergy treatments are also under development. However, adverse allergic events during treatment, as well as during oral food challenges, are common and reporting is not standardized. A more nuanced grading scale is needed to create a comprehensive and universal system to categorize adverse events and their severity for food allergy clinical trials. Starting with the 2012 Consortium for Food Allergy Research (CoFAR) Grading Scale and the World Allergy Organization Grading System, we developed the CoFAR Grading Scale for Systemic Allergic Reactions, Version 3.0, in collaboration with industry partners with expert opinion. The revised CoFAR Grading Scale for Systemic Allergic Reactions has 5 levels of increasing severity, ranging from generalized urticaria, localized angioedema, rhinitis, and abdominal pain (grade 1) to death (grade 5). Systemic reactions are further categorized within each grade by relevant organ system. Mild, single-system reactions are differentiated from mild, multisystem reactions. Lower respiratory tract symptoms are graded on the basis of response to therapy; those that are refractory to standard treatment (eg, requiring >3 doses of intramuscular epinephrine, continuous intravenous epinephrine infusion, and continuous albuterol nebulization) and respiratory compromise requiring mechanical ventilation are classified as grade 4, life-threatening reactions. Universal and consistent use of the revised CoFARGrading Scale beyond the CoFAR centers would allow for better data aggregation and safety comparisons in clinicaltrials for food allergy.

Patients with suspected allergic reactions to COVID-19 vaccines can be safely revaccinated after diagnostic work-up.

BackgroundWhen initiating the Danish vaccination program against COVID‐19, the incidence of anaphylaxis was estimated to be 10 times higher compared to other virus‐based vaccines. In this study, we present data on patients referred with suspected allergic reactions to COVID‐19 vaccines. The main purpose of the study is to investigate the incidence and severity of the allergic reactions, and to evaluate the safety of revaccination.MethodsAll patients in the region of Southern Denmark with case histories of allergic reactions to COVID‐19 vaccines in a defined period are included in this study. Diagnostic work up consisted of a detailed case history, evaluation of Brighton level of diagnostic certainty and World Allergy Organization grade of anaphylaxis and skin prick testing‐ and basophil histamine release testing with COVID‐19 vaccines and relevant drug excipients. Patients were revaccinated at the Allergy Center when possible.ResultsSixty‐one patients are included in this study. In 199,377 doses administered, nine patients fulfilled the criteria of anaphylaxis when using the Brighton Criteria (incidence being 45 per million). Of 55 patients with reactions to the first dose, 52 patients were revaccinated without adverse reactions. We found no proven cases of immediate anaphylaxis due to COVID‐19 vaccines. By skin prick test, we diagnosed three patients with drug excipient allergy and further a patient with mastocytosis was found.ConclusionsAnaphylactic reactions to COVID‐19 vaccines are rare and the incidence is similar to what is seen with other virus‐based vaccines. Revaccination is safe in the majority of patients; however, allergological evaluation is important since some prove to have drug excipient allergy.

Incidence and severity of systemic allergic reactions (SAR) reported with chemotherapeutic drugs.

e18802 Background: SAR, a known adverse event of cancer therapy has variable severity. Despite the availability of many approved grading tools, there is still a lack of a globally applicable grading system. To address this, World Allergy Organization (WAO) created a uniform 5-grade classification system which was modified recently to be applicable for all SAR’s. This study aims to understand the incidence and severity of chemotherapy induced SAR and overall response rate (ORR) of rechallenged drugs in a tertiary cancer center. Methods: A retrospective single centered analysis of 103 patients with chemotherapy induced SAR was carried out. Patients were stratified based on age, gender, drugs given, dose number and severity of reaction. We used Modified WAO Grading System for assessing the severity. Descriptive statistics was applied to decipher the data. ORR is defined as the proportion of patients who have a partial or complete response to rechallenged drugs using RECIST Criteria for solid tumors and Lugano Classification for lymphoma. Results: Among 103 patients who reported SAR, 63.1% were female and 64.1% patients were less than 60 years of age. Among the 22 drugs, median dose number was high for Oxaliplatin (6) and Carboplatin (5). SAR was more observed with Paclitaxel (20.39%), Carboplatin (17.48%) and Rituximab (13.59%). However, carboplatin and rituximab had more incidence of grade 1 SAR(25.92% and 29.63% respectively). Grade 1 SAR (39.80%) were reported the highest followed by grade 3 (29.13%), grade 5 (13.59%), grade 2 (11.65%), and grade 4 (5.83%). Cetuximab precipitated the most grade 5 reactions (33.33%). Among patients exhibiting SAR with Paclitaxel, 42.86% were switched to alternatives, Nab-paclitaxel (28.57%) being preferred the most. Carboplatin was changed to cisplatin in 16.66% patients and Nanosomal docetaxel lipid suspension replaced docetaxel in 42.86% patients who reported SAR with carboplatin and docetaxel respectively. Rituximab was rechallenged the most (11.65%) off which one patient had reaction. ORR was observed to be 62.5% and 50% among rechallenged Paclitaxel and Rituximab respectively. The incidence of SAR is depicted in the below table. Conclusions: The study inferred that most SAR reactions occurred with Paclitaxel and Carboplatin. Oxaliplatin and Carboplatin presented with delayed SAR. Grade 1 and grade 3 reaction were relatively more. Cetuximab reported the most grade 5 reactions. ORR of rechallenged drugs should be monitored in further larger studies.[Table: see text]

Amoxicillin oral provocation challenge in a primary care clinic: a descriptive analysis.

Background:Penicillin is the most frequently reported drug allergen; however, most of these allergies are not true allergies and do not justify the prescription of alternative, less effective and more expensive antibiotic drugs. We aimed to show that patients at low risk of amoxicillin allergy can safely and efficiently undergo oral provocation challenge (OPC) by their primary care physician.Methods:In this descriptive analysis, we conducted a retrospective chart review of all primary care patients who had undergone OPC from November 2017 to October 2019 in the Amoxicillin Allergy Clinic at the North Perth Family Health Team, Listowel, Ontario. Eligibility for OPC among patients 18 months and older was determined through review of a self-reported patient intake form asking about symptoms, onset, duration, history and family history of allergic reactions, as well as the patient’s electronic medical record. Patients were considered to be at low risk of true penicillin allergy if there was no history of anaphylaxis or severe cutaneous reactions. Those with low-risk allergic reactions returned for testing with an OPC to amoxicillin. We collected data on clinical characteristics, antibiotic exposure, parental drug allergy, response to OPC and wait time from referral. We used t tests to describe and compare these variables. Our primary outcome was reaction to OPC by severity as categorized by the World Allergy Organization grading system. Our secondary outcome was the time from referral to completed testing.Results:In total, we included 99 patients (mean age 28.3, standard deviation [SD] 21.2 yr); 72 (73%) were female. Of those tested, 97% (n = 96) completed the OPC with no reaction, 3% (n = 3) had mild immediate reactions, and no serious immediate reactions developed. Mean wait time to testing was 59.0 (SD 69.8) days, with a median (interquartile range) of 39.5 (13.5–70.0) days.Interpretation:Oral provocation challenge presents a safe and accessible opportunity for primary care providers to address erroneous allergy labels to penicillin and related drugs within the primary care office setting. There could be positive public health implications if OPC to penicillin drugs is implemented in primary care.

Subcutaneous Allergen-Specific Immunotherapy Is Safe in Pediatric Patients with Allergic Rhinitis

Introduction: Subcutaneous allergen-specific immunotherapy (SCIT) is one of the main cornerstones in the treatment of allergic rhinitis in pediatric patients. It has demonstrated symptoms and quality of life improvement, but it is not exempt from adverse reactions (ADVrs). Nevertheless, there are a few reports that have evaluated their safety. Our objective was to evaluate the ADVr to SCIT in pediatric patients. Methods: We reviewed 786 clinical records with SCIT from 2005 to 2018, comparing the clinical characteristics of patients with ADVrs with SCIT versus a group of a similar number of patients who completed SCIT (control group, CG). The analysis of ADVrs was according to the World Allergy Organization (WAO) 2010 grading system by frequency analysis, survival curve, and log rank. Results: Of 786 patients, 106 (13.4%) presented ADVrs, and the patients with ADVr had sensitivity and immunotherapy with at least 2 allergens versus CG p < 0.001, containing a combination of standardized and nonstandardized allergens (p = 0.003). The ADVrs were in the buildup phase (p < 0.001). The survival curve showed that 50% had some reaction at 12 weeks of SCIT. The most frequent ADVr was grade 1 in 73/106 patients (68.8%) and grade 2 in 33/106 (31.1%). The log-rank analysis between the grades of the WAO grading system showed a statistically significant difference (p = 0.02). Conclusions: The SCIT is safe in pediatric patients. The ADVrs are infrequent, grade 1 being the most reported; however, at >12 weeks, the risk of ADVrs that involve 2 organs systems increases.

World Allergy Organization Grading System for Systemic Allergic Reactions: it Is Time to Speak the Same Language When it Comes to Allergic Reactions

To discuss current methods for grading severe allergic reactions (SARs) in view of the new WAO modified classification system. While there is not universally accepted system for classifying SAR severity, and due to the high degree of heterogeneity and difficulties for comparisons between the various methods, the new WAO proposal is simple, suitable for use in clinical practice and universally applicable for all allergic reactions, covering the full spectrum of possible grades of severity. There is a requirement for a simple and comprehensive system to classify systemic allergic reaction severity. The modification to WAO’s classification of SARs to allergen immunotherapy recently proposed by Cox et al. constitutes an important contribution in the goal of obtaining useful and helpful information for all involved stakeholders.

Comparison of International Systemic Adverse Reactions Due to Allergen Immunotherapy

Several classifications of systemic adverse reactions (SARs) during allergen immunotherapy have been proposed, but the comparison of their usefulness in daily clinical practice is lacking. The present post hoc analysis was aimed at investigating the practicality of the most relevant international classifications proposed by the European Academy of Allergology and Clinical Immunology (EAACI), the American Academy of Asthma, Allergology and Clinical Immunology/American College of Allergy, Asthma and Immunology (AAAACI/ACAAI), and the World Allergy Organization (WAO) using data provided by the longitudinal European Survey on Adverse Systemic Reactions in Allergen Immunotherapy (EASSI) based on daily clinical practice in 3 countries in Europe. One hundred nine SARs over 4363 allergen immunotherapy courses were classified as mild (n= 78 [71.5%]), moderate (n= 27 [24.8%]), and severe (n= 4 [3.7%]) by EASSI-doctors, which served as a criterion standard. Every SAR was further classified according to the following grading systems: EAACI 2006 Grading System (EAACI2006), WAO 2010 Grading System (WAO2010), WAO 2017 Grading System (WAO2017), and AAAAI/ACAAI Grading System. All SAR rankings were also cross-compared among each other (Kendall correlation coefficient Tau-b). In general, a low epinephrine use was identified, severe reactions occurred within 15 minutes, and milder reactions were skin only. The analysis indicated disparities in mild and moderate SARs in the different grading systems. The correlation between EASSI-severity and EAACI2006, WAO2010, WAO2017, and AAAAI/ACAAI Grading System was 0.639, 0.502, 0.315, and 0.663, respectively (P < .001 in all cases). However, correlation of severe reactions was good. The best correlation with the onset of the reaction and the number of System Organ Class involved were detected in WAO grading systems. Despite having a lower correlation than EAACI and AAAAI/ACAAI, the WAO grading appears to provide a moderate correlation among these classifications. The analysis might help to inform clinicians and investigators on selecting the most appropriate classification.

Development of a Report Card for Identifying Local Sublingual Immunotherapy Events in Clinical Trials.

The sublingual immunotherapy (SLIT) Report Card was developed to capture patient-reported local reactions from the administration of SLIT, based on the World Allergy Organization side-effect grading system. The objective was to evaluate understandability, usability, and translatability of the paper and electronic versions of the SLIT Report Card. Adults (aged 18+ years), adolescents (aged 12-17years), and parents/caregivers and their children (aged 5-11years) participated in two rounds of interviews, testing the paper version in Round 1, and both the paper and electronic versions in Round 2. Interviews assessed comprehension and usability by subjects. Translatability identified potential issues related to translation or cultural relevance. Ten adults, ten adolescents, and ten parent/child dyads were interviewed. In general, subjects demonstrated a clear understanding of the instrument's content. However, some subjects were uncertain of or suggested clarifying the meaning of certain terms, including tablet, ulcer, taste alteration, uvula, nausea, and itching in the ear. The translatability assessment also identified uvula and nausea as potentially problematic for translation. Subjects could use the electronic device and found navigation 'easy', with only a few minor suggestions made to improve usability. Some wording and formatting changes were made based on subjects' feedback and the translatability assessment. The SLIT Report Card was refined following best practices for instrument development, including cognitive interviewing, usability, and translatability assessment. The refined SLIT Report Card is appropriate for comprehensively and systematically collecting SLIT-related local reactions directly from subjects in a clinical trial setting, taking into account the World Allergy Organization grading system.

Safety of ultrarush allergen subcutaneous immunotherapy in children with allergic disease

Purpose: Ultrarush immunotherapy (ultra-RIT) is more convenient and higher compliant than conventional immunotherapy, but it has rarely used in clinical practice due to severe systemic reactions. This study aimed to determine the safety of ultra-RIT in children and adolescents. Methods: We investigated 19 patients who received ultra-RIT with the same schedule between January 2011 and May 2016. They were sensitized to house dust mites (HDMs) and/or pollen and had their symptoms associated with positive allergens. Over a 1-day hospitalization period, all patients received ultra-RIT subcutaneously 3 times, increasing at hourly intervals. Systemic reactions were classified according to the World Allergy Organization grade system. Results: Systemic reactions occurred in 14 patients (73.7%). The mean time to adverse reactions after the last injection was 36 min utes, and the majority of systemic reactions were pruritus and urticaria. In addition, the injection of HDM alone or HDM plus pollen caused more than grade 2 systemic reactions in about 50% each of the patients. Conclusion: Since ultra-RIT caused a higher incidence of systemic reactions in children and adolescents, it should be carried out cautiously in the hospitalization rather than the office. (Allergy Asthma Respir Dis 2017;5:336-343)

World Allergy Organization Systemic Allergic Reaction Grading System: Is a Modification Needed?

There is no universally accepted grading system to classify the severity of systemic allergic reactions (SARs), including anaphylaxis. Although a consensus definition for anaphylaxis was established in 2005, the signs and symptoms required to define a reaction as anaphylaxis are inconsistently applied in research and clinical practice. As a result, it is difficult to compare and evaluate safety outcomes in surveys, clinical practice and trials, and pharmacovigilance data. In 2010, the World Allergy Organization (WAO) proposed a uniform grading system to classify allergen immunotherapy SARs. The basis of the grading system is the organ system(s) involved and reaction severity. The final grade is determined by the physician/health care professional after the event is over. Although the 2010 WAO grading system was developed to classify allergen immunotherapy SARs, with appropriate modifications, it can be used to classify SARs from any cause. The purpose of this Rostrum is to present a proposed modification of the 2010 WAO SAR grading system that will make it applicable to all SARs due to any cause. The modified grading system allows for classification of less severe SARs, which may be underreported or overreported in clinical trials and surveillance studies, depending on the criteria specified for adverse event reporting. The universal use of the proposed modified SAR grading system will allow for better safety comparisons across different venues and treatment protocols.

Diurnal variations in subcutaneous allergen immunotherapy reactions

BackgroundCircadian rhythms underlie many immune responses and allergic diseases. Subcutaneous immunotherapy (SCIT) can result in adverse reactions; however, it is unclear whether such reactions have a diurnal pattern. ObjectiveTo assess whether the timing of SCIT affects the rate of adverse reactions. MethodsThis study was a retrospective medical record review of adult patients (n = 289) who received SCIT at the Northwestern Medical Faculty Foundation, Chicago, Illinois, during a 10-year period (2004–2014). Injections were given in the outpatient setting. There were a total of 17,457 injections with 574 reactions. Covariates included age, sex, median income, asthma status, vial contents, number of injections, and previous immunotherapy reactions. Logistical regression was used to calculate the odds of having a reaction with time of SCIT administration as the primary determinate. ResultsImmunotherapy reactions occurred more frequently after afternoon or evening (pm) injections (328/8721 = 3.8%) vs morning (am) injections (246/8736 = 2.8%), (χ2 = 12.26, P < .01). Systemic reactions, defined as World Allergy Organization grade 1 or higher, did not have diurnal variation (59/8721 = 0.67% for pm vs am 56/8736 = 0.64% for morning; χ2 = 0.08; P = .77). pm injections resulted in higher odds of reaction compared with am injection in a fully adjusted logistic regression model (odds ratio = 1.43; 95% confidence interval, 1.20–1.70; P < .01). When considering time as 4 categories, the highest odds of reaction were noted for the period from 15:01 to 17:30 (odds ratio, 1.55; 95% confidence interval, 1.21–2.00; P < .01). Conclusionpm injections of SCIT are associated with increased cutaneous reaction rates when compared with am injections. In patients experiencing bothersome local reactions, it may be beneficial to administer SCIT in the morning.

Anaphylaxis: still a ghost behind allergen immunotherapy.

Allergen immunotherapy has been shown to be an effective treatment for respiratory allergies and Hymenoptera venom allergy. However, concern regarding its potential to cause anaphylaxis may limit its use. This review aims to assess whether anaphylaxis is still a worry when administering subcutaneous (SCIT) and sublingual immunotherapy (SLIT). Retrospective surveillance surveys and one ongoing North American prospective study have helped to characterize the incidence and risk factors for fatal and nonfatal systemic reactions to SCIT. The latest rate of very severe, World Allergy Organization grade 4, systemic reactions was similar to the previously reported rates of near-fatal reactions, that is, 1 in 1 million injections. Regarding SLIT, no fatalities have been reported. Case reports of anaphylaxis in clinical practice and in some clinical trials have been described; however, given the number of doses administered daily throughout the world, the number is very small. Identification of possible risk factors and the introduction of safety guidelines and practice parameters have enabled the reduction in immunotherapy related systemic reactions. However, it is important that clinicians remain vigilant when administering immunotherapy and should be prepared to provide emergency treatment if required.

Systemic reactions to inhalant immunotherapy using 1:1 target dosing

BackgroundThe 2007 immunotherapy practice parameters advocate maintenance dosing at 1:1 (1:20 maintenance concentrate). There is limited literature exploring the effect of 1:1 dosing on the rate of systemic reactions to subcutaneous immunotherapy (SRITs). ObjectiveTo investigate the effects of 1:1 dosing on SRITs in a large, academic practice. MethodsWe conducted a retrospective cohort study of all nonvenom and noncluster SRITs that occurred between 2005 and 2011. SRITs that occurred from August 2008 through December 2011, postparameter dosing (post-PD) was initiated, were compared to SRITs that occurred from January 2005 to July 2008 with preparameter dosing (pre-PD) using 1:50 as a maintenance concentrate. ResultsA total of 269 SRITs occurred in a 7-year period. Significantly more post-PD SRITs (131 of 38,548 injections) occurred than pre-PD SRITs (132 of 52,833 injections) (0.34% vs 0.25%, P = .01). However, when excluding 44 SRITs that occurred in established pre-PD patients transitioned to post-PD, there was no significant difference in SRIT rate (0.25% vs 0.22%), World Allergy Organization (WAO) grade, or SRIT time to onset. Nonred (non-1:1) vials accounted for a significantly larger proportion of all post-PD SRITs compared with all pre-PD SRITs (50.7% vs 31.1%, adjusted P = .009). Prior SRITs were reported less frequently among persons with post-PD SRITs (29.2% vs 70.8%, adjusted P = .009). In an adjusted logistic regression model, male sex (odds ratio, 7.9; 95% CI, 2.4-26) and longer time to reaction onset (odds ratio, 0.94; 95% CI, 0.89-0.99) were associated with higher WAO severity grade reactions. ConclusionPre-PD vs post-PD SRIT rates were not significantly different, adjusting for patients transitioned from established pre-PD to post-PD. This finding suggests that post-PD is as safe as pre-PD. Male sex and faster time to reaction onset were associated with higher WAO grade reactions.

AAAAI/ACAAI Surveillance Study of Subcutaneous Immunotherapy, Years 2008-2012: An Update on Fatal and Nonfatal Systemic Allergic Reactions

Before 2002, there were an estimated 3.4 fatal reactions per year to subcutaneous allergen immunotherapy (SCIT). Recent incidences of SCIT-related systemic allergic reactions (SR) and fatal reactions are not well defined. To define the incidence of and clinical practices associated with SRs to SCIT and skin testing. From 2008 to 2012, 27% to 49% of the American College of Allergy, Asthma, and Immunology and American Academy of Allergy, Asthma, and Immunology members completed an annual survey of SCIT-related fatal and nonfatal SRs of varying severity. A shortened version of the World Allergy Organization (WAO) classification system for SRs was adopted in 2011 (grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, very severe). From 2011 to 2012, data were collected regarding nonfatal SRs to skin testing and strategies to lower the risk of SRs from SCIT. Between 2008 and 2012, data were gathered on 23.3 million injection visits. One confirmed fatality occurred in 2009. Overall SR rates remained stable at 0.1%. The rate of very severe, WAO grade 4, SRs was similar to previously reported rates of near-fatal reactions (1 in 1 million injections). Although almost one-third of practices experienced at least 1 SR from skin testing, no WAO grade 3 or 4 SRs from skin testing were reported. A lower target dose during cluster buildup before transitioning to maintenance may be associated with a lower risk of WAO grade 3 SRs (P = .07). Dose adjustment during pollen seasons was associated with fewer WAO grade 3 or 4 SRs (P < .001). Although SR rates have remained stable and fatalities appear to be declining, continued vigilance regarding SCIT safety is recommended. Additional surveillance and study regarding methods to decrease the risk of severe SRs is warranted.

A 5-year study of systemic reactions using both shared and patient-specific vaccines.

The safety of shared specific vaccines (SSVs) has been questioned by some experts. The purpose of this study was to evaluate the safety of SSVs. Details of systemic allergic reactions after subcutaneous immunotherapy injections were captured on a standardized form from July 2005 to July 2010. Patient records were evaluated for factors that might be associated with increased rate of systemic reactions and, in addition, were examined for any errors. Systemic reaction rates (SRRs) using a combination of shared and patient-specific vaccines (PSVs) were similar to previously reported studies (0.23 reactions per 100 shots). There were no systemic reactions resulting from errors where the incorrect shared allergen was administered, but we did note one reaction after an erroneously administered PSV. There were two dosage errors associated with both shared and patient-specific immunotherapy. Most reactions were mild to moderate (World Allergy Organization grade, 1 or 2). Severe reactions with 911 activations were noted in six patients. Thirty percent of reactions occurred out of the office and the average time to reaction was 48 minutes. Epinephrine was administered in only 60% of patients. Epicutaneous reactivity to mites, cats, dogs, and pollen but not mold occurred significantly more in reactors. Differences in SRRs were encountered between satellite offices. Using a combination of SSV and PSV, SRRs were similar to previously reported studies; moreover, no systemic reactions occurred where a SSV was erroneously administered. SRR surveillance is a useful safety tool.

35 Body Mass Index (BMI) and Immediate (“STAT”) Dose of Epinephrine im (EPI IM) Needed to Treat Subcutaneous Allergen Immunotherapy (SCIT) Systemic Reactions (SRS)

BackgroundThe purposes of this study are to document the number of SRs to SCIT, the relationship between BMI versus the severity of SRs [World Allergy Organization (WAO) Grade 1 to 5 reactions], and the possible relationship between BMI and the total amount of epi IM needed to treat the SRs.MethodsThis is a retrospective study of SRs to optimal dose SCIT with any combination of approximately 20 allergens (pollens, animal emanations, molds, and Hymenoptera) in 840 subjects representing 13,812 encounters over 12 months (June 2010–May 2011). Nurses administered stat epi IM (1:1000 v/v), 0.2 mg, immediately into the arm or thigh for any systemic signs or symptoms (SS) of a SR, including, but not limited to, itchy eyes, nose, pharynx, palms; rhinorrhea, nasal congestion, sneezing; and generalized erythema, pruritus, or urticaria. Repeat doses of epi IM were administered as necessary.Results32 subjects (3.8%) each had one SR: 21 (66%) Grade 1, 10 (31%) Grade 2, 1 (3%) Grade 3, and Grades 4 or 5. BMIs were missing in 3 subjects. Fifteen of 29 were in the normal weight range (BMI 18.5–24.9), 9 Grade 1 (mean epi IM, 0.27 mg) and 6 Grade 2 (mean epi IM, 0.3 mg). Mean epi IM was 0.28 mg. Eight of 29 subjects were overweight (BMI 25–29.9), 7 Grade 1 (mean epi IM, 0.23 mg), and 1 Grade 3 (mean epi IM, 0.3 mg). Mean epi IM was 0.24 mg. Six of 29 were obese (BMI >30), 4 Grade 1 (mean epi IM, 0.3 mg) and 2 Grade 2 (mean epi IM, 0.2 mg). Mean epi IM was 0.27 mg.ConclusionsSRs occurred in 3.8% of SCIT subjects. No significant association was found between BMI and the WAO Grade severity (P = 0.13 by Fisher's exact test) and BMI and total epi IM dose given (P = 0.82 by Kruskal-Wallis test). BMI should not influence risk assessment of SCIT or IM epi administered for SR.

Response to State Epinephrine IM (epi IM) Dose vs. BMI and WAO Systemic Reaction Grading in the Incidence of Systemic Reactions (SRs) to Prick (P) and Intradermal (ID) Skin Tests

To determine incidence of SRs to P and ID tests, response to stat epi IM, dosage of epi IM vs. BMI, and World Allergy Organization (WAO) Grading of SRs. From 07/2010 to 06/2011 SRs were recorded for combination of pollen, animal emanation, mold and Hymenoptera to P and ID testing in 1,332 subjects. Stat epi IM (1:1000 v/v), 0.2 mg was administered by medical staff for signs/symptoms (SS) of SRs, including, not limited to, itchy eyes, nose, pharynx, palms; rhinorrhea, nasal congestion, sneezing; generalized erythema, pruritus, or urticaria. Total epi IM dose and SS utilizing the WAO Grade system were recorded. BMIs were obtained from WHO criteria. 2%, 31 subjects, had SRs; 77% (24) female, 23% (7) male; 16% (5) pediatric, 84% (26) adult. 84% (26) Grade I, 16% (5) Grade II; no Grade III, IV, V occurred. During P 42% (13) experienced SS. During ID or at completion of P and ID 58% (18) experienced SS. All received stat epi IM. 28 SRs, mean BMI 28.5 (overweight range 25.0-29.9) received epi IM 0.2 mg; one BMI 20.4 (normal 18.5-24.9) received two epi IM (total 0.3 mg). No underweight (<18.5) or obese (>30.0) subjects had SS. There was no relationship of epi IM dose to BMI. 2% (31) of 1,332 tested subjects had SRs to P and/or ID tests; 30 received one stat epi IM dose (0.2 mg); 1 received two doses (total 0.3 mg). All but one were WAO Grade I reactions. Stat epi IM may prevent serious SRs.

Systemic reactions to subcutaneous allergen immunotherapy and the response to epinephrine

The use of epinephrine for anaphylaxis to subcutaneous allergen immunotherapy (SCIT) is the standard of care, but its use for mild systemic reactions (SRs) is somewhat controversial. The objective of this study is to determine the rate of SR to SCIT, the symptoms reported, and the response to intramuscular (i.m.) epinephrine over a 1 year period. This retrospective study was designed to evaluate SRs to SCIT to any combination of approximately 20 allergens (pollens, animal emanations, molds, and Hymenoptera) in 773 subjects representing 14,707 visits, receiving approximately 28,000 injections over 1 year. Nurses were instructed to administer epinephrine (1:1000 v/v) 0.2 mL i.m. for signs or symptoms of a SR. SRs were graded using the universal grading system proposed by the World Allergy Organization (WAO) Joint Task Force for Grading SR to Immunotherapy. Thirty-one patients (4%) had 32 SRs, 22 (71%) female, average age 40 yr. Nineteen (61%) had a history of asthma; 7 (22.6%) had a history of a previous SR. SRs were reported on average 24 minutes after injection. Symptoms included: generalized pruritus, 34.4%; upper airway pruritus, 28.1%; cough, 25.0%; shortness of breath, 21.9%. Fourteen SRs were classified as Grade 1, thirteen Grade 2, two Grade 3, and three Grade 4. No Grade 5 or late phase reactions were reported. 29 (90.6%) reactions were treated with epinephrine, 27 (84.4%) glucocorticosteroid, and 30 (93.8%) H1 antihistamine. SRs occurred in 4% of patients receiving SCIT and all who received early intervention with epinephrine responded successfully. The WAO Grading system was useful.