Background: Data on the presentation and management of patients with eosinophilic granulomatosis with polyangiitis (EGPA) in private practice are limited. Objective: We sought to characterize the profiles and disease burden of patients with EGPA in a real-world private practice setting. Methods: This was a retrospective, noninterventional, longitudinal study (GSK ID: 217426) of US Allergy Partners network data. For patients with a diagnosis of EGPA, confirmed by 2 or more EGPA clinical features, index was defined as their first visit with an Allergy Partners physician (January 2007-June 2021); postindex lasted until loss of follow-up or study end (December 2021). Patient characteristics at index, physician characteristics at any time, symptoms, treatment characteristics, and clinical outcomes postindex were assessed. Results: Of 52 patients (median follow-up, 3.7 years), 75% were diagnosed with EGPA outside the Allergy Partners network. Each patient received care from a median (Q1-Q3) of 4.0 (3.0-5.0) physician specialties. Most had asthma (92%), rhinitis (75%), and sinusitis (62%) and experienced a mean +/- SD of 18.1 +/- 4.3 distinct self-reported symptoms. Most (85%) used oral corticosteroids, with 73% (32 of 44) on daily doses of more than 12 mg; 60% used mepolizumab. Overall, 75% of patients (39 of 52) achieved a response (improved/controlled symptoms); 46% (24 of 52) achieved controlled status after worsened, unchanged, or active symptoms, and of these 38% (9 of 24) relapsed. Conclusions: The complex private practice presentation of EGPA, with heterogeneous patient response to standard treatments, highlights a significant disease burden and continued need for optimized treatment strategies within a multidisciplinary team approach. (J Allergy Clin Immunol Global 2025;4:100437.)

BACKGROUND:The Asthma Impairment and Risk Questionnaire (AIRQ) is a 10-item, yes/no, equally weighted control tool. Lower scores indicate better control. Moreover, 7 impairment items reflect previous 2-week symptoms, and 3 risk items assess previous 12-month exacerbations. The Follow-up AIRQ for use between annual assessments has a 3-month recall period for exacerbation items. OBJECTIVE:To evaluate the responsiveness of the AIRQ over time and identify a minimal important difference (MID). METHODS:The AIRQ longitudinal study data were analyzed from patients with asthma aged 12 years and older. Anchor-based methods assessed differences in AIRQ scores relative to Patient Global Impression of Change, the accepted MIDs for St. George's Respiratory Questionnaire and Asthma Control Test, and exacerbation occurrence over 12 months. Baseline and 12-month data reflected 12-month recall AIRQ scores; Follow-up AIRQ scores were used for 3-, 6-, and 9-month analyses. RESULTS:A total of 1070 patients were included. The Patient Global Impression of Change rating of "much improved" was associated with AIRQ mean score changes from baseline to months 3, 6, 9, and 12 of -2.0, -1.9, -1.9, and -1.8, respectively. The mean AIRQ score change among patients who met the St. George's Respiratory Questionnaire MID (≥4-point decrease) was -1.8 at 6 and 12 months. The AIRQ mean scores decreased from baseline by -2.2 to -2.5 points at months 3, 6, 9, and 12 for patients who met the Asthma Control Test MID (≥ 3-point increase). A 2-point higher baseline AIRQ score was associated with a 1.7 odds ratio of 12-month exacerbation occurrence (95% CI, 1.53-1.89). CONCLUSION:A change score of 2 is recommended as the AIRQ MID.

Bradley E Chipps,1 Robert S Zeiger,2 David A Beuther,3 Robert A Wise,4 William McCann,5 Joan Reibman,6 Maureen George,7 Ileen Gilbert,8 James M Eudicone,8 Karin S Coyne,9 Gale Harding,9 Kevin R Murphy10 1Capital Allergy & Respiratory Disease Center, Sacramento, CA, USA; 2Department of Clinical Science, Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, CA, USA; 3Department of Medicine, National Jewish Health, Denver, CO, USA; 4Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA; 5Allergy Partners, Asheville, NC, USA; 6Department of Medicine, New York University School of Medicine, New York, NY, USA; 7Columbia University School of Nursing, New York, NY, USA; 8BioPharmaceuticals Medical, AstraZeneca, Wilmington, DE, USA; 9Evidera, Bethesda, MD, USA; 10Boys Town National Research Hospital, Boys Town, NE, USACorrespondence: Bradley E Chipps, Capital Allergy & Respiratory Disease Center, 5609 J Street, Suite C, Sacramento, CA, 95819, USA, Tel +1 916-453-1454, Email bchipps@capitalallergy.com

BackgroundNational and international asthma guidelines and reports do not include control tools that combine impairment assessment with exacerbation history in one instrument.ObjectiveTo analyze performance of the composite Asthma Impairment and Risk Questionnaire (AIRQ®) in assessing both domains of control and predicting exacerbation risk compared to Global Initiative for Asthma's 4-question symptom control tool (GINA SCT), Asthma Control Test (ACTTM), and physician expert opinion (EO) informed by GINA SCT responses and appraisal of GINA-identified risk factors for poor asthma outcomes.MethodsMultivariable logistic regressions evaluated AIRQ and GINA SCT as predictors of ACT. McNemar's test compared the proportion of patients categorized at baseline as completely or well-controlled by each assessment but with current impairment or prior- and subsequent-year exacerbations.ResultsThe analysis included 1064 patients aged ≥12 years; mean(SD) age 43.8(19.3) years; 70% female; 79% White; 6% Hispanic or Latino. AIRQ and GINA SCT were highly predictive of ACT well-controlled versus not well- and very poorly controlled (ROC AUC AIRQ=0.90, GINA SCT=0.86, P=0.03 AIRQ vs GINA SCT) and ACT very poorly controlled versus well- and not well-controlled asthma (ROC AUC AIRQ=0.91, GINA SCT=0.87, P=0.01 AIRQ vs GINA SCT). AIRQ rated fewer patients as completely or well-controlled who had current impairment (P<0.01) or with prior- and subsequent-year exacerbations (P<0.001) compared with GINA SCT, ACT, and EO.ConclusionRelative to other control tools and EO informed by GINA SCT and risk factors for poor asthma outcomes, AIRQ performs better in assessing both domains of current control and predicting exacerbation risk.

Clinical ImplicationsAlthough asthma control is defined by impairment and risk, many control tools assess only symptoms. Confirmatory cross-sectional performance metrics demonstrate that the Asthma Impairment and Risk Questionnaire, a composite measure, is an accurate control assessment of all asthma severities for patients aged 12 years and older. Although asthma control is defined by impairment and risk, many control tools assess only symptoms. Confirmatory cross-sectional performance metrics demonstrate that the Asthma Impairment and Risk Questionnaire, a composite measure, is an accurate control assessment of all asthma severities for patients aged 12 years and older. Although asthma control is defined by symptom impairment and exacerbation risk,1National Asthma Education and Prevention ProgramThird Expert Panel on the Diagnosis and Management of Asthma. Expert panel report 3: guidelines for the diagnosis and management of asthma - full report. National Heart, Lung, and Blood Institute, Bethesda, Md2007Google Scholar many control questionnaires assess only impairment.2Nathan R.A. Sorkness C.A. Kosinski M. Schatz M. Li J.T. Marcus P. et al.Development of the Asthma Control Test: a survey for assessing asthma control.J Allergy Clin Immunol. 2004; 113: 59-65Abstract Full Text Full Text PDF PubMed Scopus (2156) Google Scholar,3Juniper E.F. O'Byrne P.M. Guyatt G.H. Ferrie P.J. King D.R. Development and validation of a questionnaire to measure asthma control.Eur Respir J. 1999; 14: 902-907Crossref PubMed Scopus (1911) Google Scholar The Asthma Impairment and Risk Questionnaire (AIRQ) is an equally weighted, 10-item, "yes"/"no" control tool that assesses symptoms over the prior 2 weeks and exacerbations over the prior 12 months. The AIRQ was cross-sectionally validated against a standard of the current Asthma Control Test (ACT) score plus prior 12-month, chart-documented exacerbations in a study of 442 patients with asthma of all severities who were aged 12 years and older.4Murphy K.R. Chipps B. Beuther D.A. Wise R.A. McCann W. Gilbert I. et al.Development of the Asthma Impairment and Risk Questionnaire (AIRQ): a composite control measure.J Allergy Clin Immunol Pract. 2020; 8: 2263-2274.e5Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar The 10 AIRQ items address symptoms, activity limitations, sleep, rescue medication use, social activities, exercise, difficulty controlling asthma, and exacerbations. Fewer "yes" responses indicate better asthma control (0-1 indicates well-controlled; 2-4, not well-controlled; and 5-10, very poorly controlled). The receiver operating characteristic (ROC) area under the curve (AUC) to identify well- versus not well- or very poorly controlled asthma was 0.94 and well-controlled or not well-controlled versus very poorly controlled asthma was 0.92. Cut points of 2 or more "yes" responses yielded a sensitivity of 0.90 to identify not well-controlled or very poorly controlled asthma, and 5 or more yielded a specificity of 0.96 to detect very poorly controlled disease. The objective of this analysis was to explore the consistency of these robust performance metrics by conducting a confirmatory validation of the previously determined AIRQ items and control cut points in differentiating current control levels in a separate patient cohort. The original AIRQ cross-sectional validation was an analysis of the first 442 patients enrolled from 12 specialty practices whose data were collected before August 9, 2019.4Murphy K.R. Chipps B. Beuther D.A. Wise R.A. McCann W. Gilbert I. et al.Development of the Asthma Impairment and Risk Questionnaire (AIRQ): a composite control measure.J Allergy Clin Immunol Pract. 2020; 8: 2263-2274.e5Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar The confirmatory convenience sample was composed of 400 patients enrolled after August 9, 2019, from a different selection of 12 specialty practices and one specialty-affiliated primary care site. All patients participated in a longitudinal study assessing the ability of AIRQ to predict future 12-month exacerbations.4Murphy K.R. Chipps B. Beuther D.A. Wise R.A. McCann W. Gilbert I. et al.Development of the Asthma Impairment and Risk Questionnaire (AIRQ): a composite control measure.J Allergy Clin Immunol Pract. 2020; 8: 2263-2274.e5Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar,5Chipps B.E. Murphy K.R. Wise R.A. McCann W.A. Beuther D.A. Reibman J. et al.Evaluating construct validity of the Asthma Impairment and Risk Questionnaire using a 3-month exacerbation recall.Ann Allergy Asthma Immunol. 2022; 128: 544-552.e3Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar At enrollment, patients completed the AIRQ items assessed in the original cross-sectional study. Responses were evaluated against the same composite comparator for validation: baseline symptom control per ACT plus prior-year, chart-documented exacerbations.4Murphy K.R. Chipps B. Beuther D.A. Wise R.A. McCann W. Gilbert I. et al.Development of the Asthma Impairment and Risk Questionnaire (AIRQ): a composite control measure.J Allergy Clin Immunol Pract. 2020; 8: 2263-2274.e5Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar At study entry, each patient's physician completed a chart abstraction form for clinical data and prior-year exacerbations.4Murphy K.R. Chipps B. Beuther D.A. Wise R.A. McCann W. Gilbert I. et al.Development of the Asthma Impairment and Risk Questionnaire (AIRQ): a composite control measure.J Allergy Clin Immunol Pract. 2020; 8: 2263-2274.e5Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar This study was conducted with informed consent or assent and institutional approval, and was consistent with recognized ethical standards. We used descriptive statistics to characterize patients in the confirmatory convenience group by sociodemographic and clinical features and compare them with patients in the cross-sectional validation group. Logistic regression analyses on the confirmatory sample data were run for the 10 cross-sectionally validated AIRQ items to examine reproducibility of AIRQ performance metrics for identifying current asthma control in two models. Model 1 evaluated well-controlled versus not well-controlled or very poorly controlled asthma, and model 2 evaluated well-controlled or not well-controlled versus very poorly controlled asthma. We compared the ROC curves of the cross-sectional and confirmatory sample analyses using χ2 test. The sensitivity and specificity of the cut points determined by the previous cross-sectional validation (two or more "yes" responses for not well-controlled or very poorly controlled vs well-controlled asthma, and five or more responses for very poorly controlled vs well-controlled or not well-controlled asthma) were assessed for the confirmatory sample. The confirmatory convenience sample included 400 patients; the mean (SD) age was 45.5 (18.7) years; 48 (12.0%) were adolescents (see Table E1 in this article's Online Repository at www.jaci-inpractice.org). There were no differences between the confirmatory convenience and cross-sectional samples in symptom-based control or lung function at entry, as reflected by mean (SD) ACT score (18.6 [4.5] vs 18.4 [4.6]; P = .61), mean (SD) percentage of predicted prebronchodilator FEV1 (83.8% [17.4%] vs 85.3% [16.9%]; P = .20), and mean (SD) percentage of postbronchodilator FEV1 (88.0 [17.4%] vs 88.7% [17.0%]; P = .55), respectively. Baseline AIRQ control level distributions were also similar for patients in the confirmatory convenience (38.8% well-controlled, 35.5% not well-controlled, and 25.8% very poorly controlled) and cross-sectional (31.9% well-controlled, 38.9% not well-controlled, and 28.5% very poorly controlled) groups (P = .08). However, patients within the confirmatory convenience sample differed from those in the cross-sectional validation sample4Murphy K.R. Chipps B. Beuther D.A. Wise R.A. McCann W. Gilbert I. et al.Development of the Asthma Impairment and Risk Questionnaire (AIRQ): a composite control measure.J Allergy Clin Immunol Pract. 2020; 8: 2263-2274.e5Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar regarding sex (65.8% vs 72.6% female [P = .03]), race (19.8% vs 8.1% Black [P < .001] and 68.3% vs 84.4% White [P < .001]), and ethnicity (11.3% vs 2.9% Hispanic [P < .001]). In addition, fewer patients in the confirmatory convenience sample had an exacerbation in the past year compared with the cross-sectional validation sample (37.5% vs 44.6% [P = .04]), and the prescribed Global Initiative for Asthma (GINA)6Global Initiative for AsthmaGlobal strategy for asthma management and prevention.http://www.ginasthma.orgDate: 2018Date accessed: December 12, 2022Google Scholar step levels of asthma therapy were significantly different among groups (12.0% vs 6.6% GINA 1, 11.0% vs 14.7% GINA 2, 13.0% vs 11.3% GINA 3, and 64.0% vs 67.4% GINA 4/5 [P = .02]). Both models performed well, exceeding the model-fit criteria. For model 1 (well-controlled vs not well-controlled or very poorly controlled), there was no difference in ROC AUC for the confirmatory versus cross-sectional samples (0.91 vs 0.94 [P = .12]) (Figure 1). For model 2 (well-controlled or not well-controlled vs very poorly controlled), the ROC AUC was lower for the confirmatory versus cross-sectional samples (0.88 vs 0.92 [P = .03]) (Figure 2). However, the 10 AIRQ items still provided excellent discriminatory ability.7Mandrekar J.N. Receiver operating characteristic curve in diagnostic test assessment.J Thorac Oncol. 2010; 5: 1315-1316Abstract Full Text Full Text PDF PubMed Scopus (1885) Google ScholarFigure 2Asthma Impairment and Risk Questionnaire receiver operating characteristic (ROC) curves comparing confirmatory convenience sample (dashed line) and cross-sectional validation sample (solid lines) using model 2 (well- or not well-controlled vs very poorly controlled). AUC, area under the curve.View Large Image Figure ViewerDownload Hi-res image Download (PPT) For the confirmatory patient group, an AIRQ score cut point of two or more "yes" responses yielded a sensitivity of 0.85 to identify not well-controlled or very poorly controlled asthma, and a cut point of five or more yes responses yielded a specificity of 0.94 to detect very poorly controlled disease. These results were clinically similar to sensitivity and specificity performance metrics in the original AIRQ cross-sectional validation: 0.90 and 0.96, respectively. This confirmatory validation of AIRQ items and cut points demonstrates that the AIRQ is a rigorous composite measure that accurately differentiates asthma control among demographically and clinically diverse patients aged 12 years and older. As with the developmental validation studies for the ACT2Nathan R.A. Sorkness C.A. Kosinski M. Schatz M. Li J.T. Marcus P. et al.Development of the Asthma Control Test: a survey for assessing asthma control.J Allergy Clin Immunol. 2004; 113: 59-65Abstract Full Text Full Text PDF PubMed Scopus (2156) Google Scholar and the Asthma Control Questionnaire,8Olaguibel J.M. Quirce S. Juliá B. Fernández C. Fortuna A.M. Molina J. et al.Measurement of asthma control according to Global Initiative for Asthma guidelines: a comparison with the Asthma Control Questionnaire.Respir Res. 2012; 13: 50Crossref PubMed Scopus (79) Google Scholar almost all patients in this study were recruited from specialty sites. However, race and ethnicity profiles for the ACT and Asthma Control Questionnaire analyses were unspecified, and the validity of ACT control-level cut points in Black adolescents with asthma is uncertain.9Burbank A.J. Todoric K. Steele P. Rosen J. Zhou H. Frye M. et al.Age and African-American race impact the validity and reliability of the Asthma Control Test in persistent asthmatics.Respir Res. 2018; 19: 152Crossref Scopus (3) Google Scholar Despite the differences in sex between the original AIRQ cross-sectional validation and confirmatory study patient groups,7Mandrekar J.N. Receiver operating characteristic curve in diagnostic test assessment.J Thorac Oncol. 2010; 5: 1315-1316Abstract Full Text Full Text PDF PubMed Scopus (1885) Google Scholar the latter of which encompassed a more representative inclusion of Black patients and Hispanic patients, the performance metrics of AIRQ were similar, with outstanding or excellent differentiation based on ROC AUC values.7Mandrekar J.N. Receiver operating characteristic curve in diagnostic test assessment.J Thorac Oncol. 2010; 5: 1315-1316Abstract Full Text Full Text PDF PubMed Scopus (1885) Google Scholar The AIRQ provides a rigorously validated composite asthma control measure for patients aged 12 years and older that evaluates both control domains in a single instrument. Although the current study used the AIRQ with a 12-month recall for the risk assessment items, the validated follow-up AIRQ with a 3-month recall for the risk items may be useful in studies or clinical assessments that are more frequent than yearly.5Chipps B.E. Murphy K.R. Wise R.A. McCann W.A. Beuther D.A. Reibman J. et al.Evaluating construct validity of the Asthma Impairment and Risk Questionnaire using a 3-month exacerbation recall.Ann Allergy Asthma Immunol. 2022; 128: 544-552.e3Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar Further analyses of AIRQ validity and effectiveness in clinical practice among patients in primary care and of varying socioeconomic, educational, racial, and ethnic backgrounds are ongoing. We thank Karin S. Coyne, PhD, of Evidera, for critical review of the manuscript; Melissa Ross, PhD, of Evidera, for project management of this study; and Ren Yu, MA, of Evidera, for statistical programming. Medical writing support was provided by Shravanthi Chidambaram, PhD, of Lumanity Communications Inc. (Yardley, Pa), which was in accordance with Good Publication Practice (GPP 2022) guidelines and funded by AstraZeneca (Wilmington, Del). The data that support the findings of this study are available from the corresponding author upon reasonable request. Table E1Sociodemographic and clinical characteristics of confirmatory convenience sample compared with cross-sectional validation sampleCharacteristicConfirmatory convenience sample (n = 400)Cross-sectional validation sampleE2Global Initiative for AsthmaGlobal strategy for asthma management and prevention.http://www.ginasthma.orgDate: 2018Date accessed: December 12, 2022Google Scholar (n = 442)PSociodemographic characteristics Mean age, y (SD)45.5 (18.7)44.0 (20.1).27 Adolescent, n (%)48 (12.0)77 (17.4).08 Female sex, n (%)263 (65.8)321 (72.6).03 Race, n (%)American Indian or Alaska Native3 (0.8)1 (0.2).53Asian8 (2.0)8 (1.8).95Black79 (19.8)36 (8.1)<.001White273 (68.3)373 (84.4)<.001Other∗Other race includes African American and Native Hawaiian/Pacific Islander; Asian and Native Hawaiian/Pacific Islander; biracial: African American and Caucasian; French, German, English, and some American Indian; Hispanic; Mexican; White, and African American (n = 4); White and American Indian (n = 2); White and American Indian/Alaska Native (n = 2); White and Asian (n = 2); White, American Indian/Alaska Native, and Spanish; and White, Asian, and American Indian; and White, Spanish, and other.30 (7.5)20 (4.5).19 Ethnicity, n (%)Hispanic45 (11.3)13 (2.9)<.001Clinical characteristics Baseline ACT score (mean [SD])18.6 (4.5)18.4 (4.6).61 Baseline ACT category, n (%).72Well-controlled196 (49.0)206 (46.6)Not well-controlled105 (26.3)111 (25.1)Very poorly controlled96 (24.0)121 (27.4)Missing3 (0.8)4 (0.9)≥1 exacerbation in prior year, n (%)150 (37.5)197 (44.6).04FEV1 (% predicted) prebronchodilator (mean [SD])83.8 (17.4)85.3 (16.9).20FEV1 (% predicted) postbronchodilator (mean [SD])88.0 (17.4)88.7 (17.0).55GINA step therapy, n (%)†As per GINA 2018 report.E2.02 GINA 148 (12.0)29 (6.6) GINA 244 (11.0)65 (14.7) GINA 352 (13.0)50 (11.3) GINA 4/5256 (64.0)298 (67.4)Biologics, n (%)43 (10.8)41 (9.3).48Asthma Impairment and Risk Questionnaire control group, n (%).08 Well-controlled155 (38.8)141 (31.9) Not well-controlled142 (35.5)172 (38.9) Very poorly controlled103 (25.8)126 (28.5) Missing03 (0.7)ACT, Asthma Control Test; GINA, Global Initiative for Asthma.∗ Other race includes African American and Native Hawaiian/Pacific Islander; Asian and Native Hawaiian/Pacific Islander; biracial: African American and Caucasian; French, German, English, and some American Indian; Hispanic; Mexican; White, and African American (n = 4); White and American Indian (n = 2); White and American Indian/Alaska Native (n = 2); White and Asian (n = 2); White, American Indian/Alaska Native, and Spanish; and White, Asian, and American Indian; and White, Spanish, and other.† As per GINA 2018 report.E2Global Initiative for AsthmaGlobal strategy for asthma management and prevention.http://www.ginasthma.orgDate: 2018Date accessed: December 12, 2022Google Scholar Open table in a new tab ACT, Asthma Control Test; GINA, Global Initiative for Asthma.

The patient profile and treatment pattern for EGPA in the real-world setting are poorly understood because of the condition's rarity and lack of recognition. We performed a retrospective chart review to characterize demographics, clinical characteristics, and symptoms of patients with EGPA managed within the US Allergy Partners (AP). Patients with EGPA were identified in the AP network EMR (2007–2021) based on a clinical diagnosis of EGPA and confirmation through lab and histopathology. Patients were followed longitudinally from index date (first AP visit) until the end of data availability. Of the 94 EGPA patients identified, 52 patients met all eligibility criteria (female:63.5%, white:57.7%, median age of EGPA diagnosis:52.5 years, median age at index:56.0 years). 3 out of every 4 patients received their first EGPA diagnosis outside the AP network and primary care physicians (50.0%) were the most commonly referring physician, followed by pulmonologist (21.2%). Most patients had asthma (92.3%) followed by rhinitis (75.0%), sinusitis (61.5%). The median of the peak absolute eosinophil count (AEC) was 700/μL. Most patients reported >=17 distinct symptoms reported during entire study period and the most frequently occurring symptoms included fatigue, headache, dizziness, rash, itch, vomiting, diarrhea, chest pain, palpitations, respiratory symptoms, and weight loss. Majority of the patients received oral corticosteroids (84.6%). Most commonly used immunosuppressive agent was azathioprine (25.0%). Care of EGPA patients outside of referral centers reveals a significant disease burden featuring high comorbidity, numerous symptoms, and considerable medication usage, illustrating the need for improved diagnosis and management.

BACKGROUND:Asthma control is often overestimated in routine practice, and despite advances in the understanding of immunopathology and the availability of new precision therapies, the burden of disease remains unacceptably high. OBJECTIVE:To compare the performance of the Asthma Impairment and Risk Questionnaire (AIRQ) with patient and physician assessments and the Asthma Control Test (ACT) in identifying asthma control. METHODS:Baseline data from a longitudinal study of the AIRQ were analyzed. Patients with asthma in the United States aged 12 years and older followed in 24 specialty practices and 1 specialty-affiliated primary care clinic were enrolled between May and November 2019. At entry, participants completed AIRQ and ACT, and participants and physicians completed 5-point Likert scale assessments of control. RESULTS:A total of 1112 participants were enrolled (mean [SD] age = 43.9 [19.3] years, 70% of the female sex, 78% White). Overall, 62% of participants rated themselves as well- or completely controlled, and 54% were rated comparably by physicians. The ACT classified 49% of participants as well-controlled, with 35% similarly categorized by AIRQ. Previous-year exacerbations were experienced by 32% of participants who self-rated as well- or completely controlled, 30% who were rated as well- or completely controlled by physicians, and 29% assessed as well-controlled by ACT, but only 15% of those classified as well-controlled by AIRQ. CONCLUSION:The burden of asthma is substantial in patients cared for by asthma specialists, and asthma control is overestimated by patients, physicians, and the symptom-based ACT. The AIRQ assesses risk in addition to symptom control and may serve to improve asthma control determination by assessing previous exacerbations.

This work analyzes 2,324 reports of systemic reactions (SR) related to SCIT provided at Allergy Partners® locations during 2019 and 2020. The interest was in the frequency, grade, and associated factors with SR to SCIT. Allergy Partners monitors all adverse events associated with SCIT within the organization. When an event occurs, the specifics are reported per organization protocol and include; date, immunotherapy content, grade of reaction, years on AIT, program phase, schedule, timing, and body mass index (BMI). Reports of SR to SCIT for the years 2019 & 2020 were evaluated. A Chi-Square statistical analysis was performed. Allergy Partners practices administered almost 4.2 million allergen immunotherapy injections over 1,987,426 visits during 2019-2020. A total of 2,324 systemic reactions were reported for a reaction rate of 0.12% per visit. Most reactions were grade 1 (n=933, 40.1%) and grade 2 (n=1,226, 52.8%). In patients for whom data was available, 74% (1350 of 1823) reported awareness of symptoms within 30 minutes after injection. There was no clear pattern for the assessed variables on time to reaction except schedule. Patients on a rapid/cluster schedule tended to have a later reported awareness of symptom onset. The grade of reaction was not related to any variables assessed. 74% of systemic reactions had symptom onset within 30 minutes after SCIT, reinforcing current clinical guidelines for post-SCIT monitoring. Analyzed variables showed no clear pattern on time to reaction, except for schedule. The grade of reaction was not related to any variable assessed.

Purpose:Critical asthma outcomes highlighted in clinical guidelines include asthma-related quality of life, asthma exacerbations, and asthma control. An easy-to-implement measure of asthma control that assesses both symptom impairment and exacerbation risk and reflects the impact of asthma on patients' lives is lacking. Hence, the objective of this study was to assess the Asthma Impairment and Risk Questionnaire (AIRQ®) construct validity relative to patient self-perception of asthma status and validated disease-specific patient-reported outcome (PRO) measures. Patients and methods:Baseline data were analyzed from patients (aged ≥ 12 years) with asthma participating in a 12-month observational study assessing the ability of AIRQ to predict exacerbations. At entry, patients completed a sociodemographic questionnaire, AIRQ, 3 questions addressing self-perceived asthma status, Saint George's Respiratory Questionnaire (SGRQ), mini-Asthma Quality of Life Questionnaire (AQLQ), and Adult Asthma Adherence Questionnaire (AAAQ). Descriptive statistics were calculated for demographic and clinical characteristics. AIRQ construct validity was evaluated by assessing correlations between total AIRQ score and patient self-assessments, SGRQ, mini-AQLQ, and AAAQ scores. Comparisons of SGRQ, mini-AQLQ, and AAAQ total and component/domain scores by AIRQ control category were performed using general linear models and Scheffe's post hoc adjustments for pairwise comparisons. Results:A total of 1112 patients were enrolled: 70% female, 78% White, mean (standard deviation) age 43.9 (19.5) years. There were highly significant correlations between AIRQ score and patient self-perception of overall control (r = 0.69; p < 0.001), total SGRQ (r = 0.74, p < 0.001), and mini-AQLQ (r = -0.78, p < 0.001) scores. As AIRQ control category worsened, so did total and domain SGRQ, mini-AQLQ, and AAAQ impediment-to-inhaled-corticosteroid-adherence scores (all pairwise comparisons p < 0.001). Conclusion:Findings demonstrate the construct validity of AIRQ relative to patient self-perception of asthma status, disease-specific PRO measures, and treatment adherence barriers. AIRQ can be a useful instrument to raise awareness of the unrecognized impacts of asthma on patients' lives.

BACKGROUND:Peanut (Arachis hypogaea) allergen powder-dnfp (PTAH) is the first oral immunotherapy indicated for children aged 4 to 17 years with peanut allergy. There are limited real-world data on patients treated with PTAH.OBJECTIVE:To characterize pediatric patients treated with PTAH and associated treatment patterns in US clinical practice.METHODS:US-based physicians with allergy and immunology training treating patients with peanut allergy aged 4 to 17 years with PTAH were recruited from an existing physician panel and completed an online case report form (October to December 2021) with data abstracted from patient medical charts. Physician practice circumstances, patient characteristics, and PTAH treatment patterns were reported. Time to reach the 300-mg dose and treatment persistence were assessed using Kaplan-Meier analysis.RESULTS:A geographically balanced sample of 43 physicians contributed data for 118 demographically diverse pediatric patients. Patients had heterogeneous diagnostic test results, with a wide range of peanut-specific immunoglobulin E levels; 6.8% received an oral food challenge. During the updosing phase, there were no temporary interruptions and 5.1% of the patients required downdosing. Patients reached the 300-mg dose at a median of 21.3 weeks post-initiation. The rate of PTAH persistence at 24 weeks was 93.4%. Only 1 patient discontinued treatment because of treatment-related systemic allergic symptoms, and the remaining discontinuations were for reasons other than treatment-related symptoms. Prophylactic antihistamines were used by 33.9% of the patients to prevent PTAH adverse effects.CONCLUSION:PTAH was prescribed in demographically diverse patients with a wide range of peanut-specific immunoglobulin E levels. Treatment persistence with PTAH was high in this study population, with a small number of patients experiencing treatment modification.

Background: Expert opinion highlights the need to decrease asthma exacerbations. Management recommendations and regulatory approvals often combine 12-17 yr-olds and adults, even if clinical trials have too few adolescents to confirm treatment efficacy. Aim: Compare clinical characteristics, biomarkers, and lung function of adolescent vs adult asthma patients (pts). Methods: Baseline data and subsequent-year exacerbations were compared for pts aged 12-17 vs 18-34, 35-64, and ≥65 yrs enrolled in an observational Asthma Impairment and Risk Questionnaire exacerbation prediction study (general linear models with Scheffe's post hoc adjustment for pairwise comparisons and Chi-square, significance p≤0.05). Results: 1112 pts were assessed. Higher proportions of adolescents vs adults had well-controlled asthma, did not have exacerbations, used lower levels of medication, and noted an inhaled corticosteroid adherence barrier (Table). Lung function and IgE differed across age groups, but were similar for those 12-17 and 18–34 yrs. Blood eosinophil and FeNO levels, percentage of patients with bronchodilator responsivity, and mean number of each subsequent-year exacerbation types were similar between 12-17 and the other age groups. Conclusion: Similarities in inflammatory biomarkers and responsivity to bronchodilators support extrapolating efficacy for adults to adolescents, especially for therapies that decrease exacerbations.

The Asthma Impairment and Risk Questionnaire (AIRQ®) is a 10-item, yes/no, control tool: 0-1 yes responses indicate well-controlled (WC); 2-4 not well-controlled (NWC); 5-10 very poorly controlled (VPC). AIRQ® predicts exacerbations within the next 12 months. This study examines the ability of AIRQ® to predict exacerbations within a short-term (0-3 months) and long-term (4-12 months) time frame. Patients aged ≥12 years completed a baseline AIRQ® and 12 monthly online reports of exacerbations (asthma-related oral corticosteroid courses, emergency department/urgent care visits, and hospitalizations). Logistic regressions using AIRQ® control level as the independent variable, with age, sex, race, and BMI as covariates, and ≥1 exacerbation within months 0-3 and months 4-12 as the dependent variable (adjusted odds-ratios [OR] and 95% Wald confidence intervals [CI]) were performed. 1070 patients completed ≥1 survey (mean[SD]: 10.5[2.8] surveys; 70.5% female; age 43.9[19.3] years; 20.4% non-White; AIRQ® WC 35.2%, NWC 38.1%, VPC 26.6%). Within months 0-3 and 4-12, 277 and 376 patients, respectively, experienced ≥1 exacerbation. Exacerbation rates, whether within the short- or long-term, increased with worsening AIRQ® control (0-3 months: 13.8% WC, 26.0% NWC, 45.4% VPC; NWC vs WC: OR=2.17 [CI: 1.49, 3.15], VPC vs WC: OR=4.51 [CI: 3.05, 6.67]; 4-12 months: 20.7% WC, 38.4% NWC, 53.5% VPC; NWC vs WC: OR=2.37 [CI: 1.70, 3.30], VPC vs WC: OR=3.83 [CI: 2.67, 5.48]). No significant difference in AIRQ® exacerbation prediction performance between time periods was observed. AIRQ® predicts short- and long-term exacerbations and can heighten awareness of potential imminent and distant exacerbation risk.

HES is a group of rare hematological disorders marked by a persistently elevated eosinophil count along with tissue and organ damage. Real-world data describing characteristics and treatment patterns of HES patients managed by specialists in non-academic centers is limited. We performed a retrospective chart review study using Electronic Medical Record (EMR) data from Allergy Partners (AP) network (2007–2021). HES patients were identified based on a clinical diagnosis of HES and an absolute eosinophil count (AEC) of >=1,500/microliter. Patients were followed longitudinally from index date (first AP visit) until end of data availability. Of the 99 HES patients identified, 52 patients met all eligibility criteria (53.8% female, 57.7% white, median age of diagnosis: 40.5 years, median age at index: 42.5 years). Half of the patients received their first HES diagnosis outside the AP network and primary care physicians were the most common referring physician (65.4%), followed by hematologist (11.5%). Rhinitis (71.2%) and asthma (44.2%) were common comorbidities. The median (interquartile range [IQR]) peak AEC was 2200.0/microliter (1700.0, 3300.5). Half of the patients reported >=15 distinct symptoms during entire study period, with >80% of the patients reporting fatigue, headache, dizziness, rash, itch, vomiting, diarrhea, abdominal pain, chest pain, palpitations, respiratory symptoms, and weight loss. 50.0% of the patients received oral corticosteroids (OCS) and 44.2% received chronic OCS dose (>=5 mg/day prednisone equivalent). Our findings highlight a substantial burden of illness and considerable unmet need in HES patients, emphasizing the need to improve diagnosis and management in this patient population.

The Asthma Impairment and Risk Questionnaire (AIRQ®) is a 10-item, yes/no, control tool with scores of 0-1, 2-4, and 5-10 yes responses for well-controlled (WC), not well-controlled (NWC), and very poorly controlled (VPC) asthma, respectively. To determine whether scores 5-10 can differentiate risk levels for multiple exacerbations within the next 12 months in VPC patients, the predictive performance of AIRQ® was analyzed. 1070 patients aged ≥12 years completed monthly online reports of exacerbations (asthma-related oral corticosteroid courses, emergency department/urgent care visits, and hospitalizations). Logistic regressions were performed using patients with baseline AIRQ® scores of 5-10, adjusted for clinical characteristics and biomarkers as the independent variables, and ≥2 and ≥3 exacerbations within 12 months as the dependent variable (odds-ratios [OR] and 95% Wald confidence intervals [CI]). 285 patients with VPC AIRQ® scores completed ≥1 survey (mean[SD]: 10.3[3.0] surveys; 84.2% female; age 46.8[16.3 years]; 28.1% non-White). Within 12 months, 130 (45.6%) patients experienced ≥2 exacerbations and 83 (29.1%) patients experienced ≥3. For each 1-point increase in AIRQ® score from 5-10, odds of experiencing ≥2 or ≥3 exacerbations increased by 28% (OR=1.28 [CI: 1.05, 1.57]) and 34% (OR=1.34 [CI: 1.09, 1.65]), respectively. Each 2-point increase in AIRQ® score was associated with 59% (OR=1.59 [CI: 1.09, 2.33]) and 80% (OR=1.80 [CI: 1.19, 2.74]) higher odds of experiencing ≥2 or ≥3 exacerbations, respectively. Among patients with VPC asthma, AIRQ® score predicts risk of multiple exacerbations. Interventions to improve control, even if patients remain in the VPC category, may decrease this risk.

IntroductionThe GINA symptom control tool (GSCT), or a validated questionnaire such as the Asthma Control Test (ACT), combined with GINA-suggested risk factors are recommended for asthma assessment. The Asthma Impairment and Risk Questionnaire (AIRQ) is validated to identify current control and future exacerbation risk. The objective of this analysis was to contrast control assessment by AIRQ and ACT to expert opinion (EO) and compare patients with prior-year exacerbations categorized as completely/well-controlled (WC) by AIRQ, GSCT, ACT, and EO who report subsequent-year exacerbations.MethodsAIRQ, GSCT, ACT, and prior- and subsequent-year exacerbations were assessed in patients with asthma aged ≥12 years. History, exam, responses to the GSCT, and presence of the GINA-suggested risk factors were utilized by the clinicians to inform their EO. Control assessments were evaluated by logistic regressions with EO as the dependent variable. Tool categorization of patients with prior and subsequent exacerbations as WC was compared by McNemar's test for two diagnostic tests from one sample, p≤0.05.Results1112 patients were included; mean(SD) age 44(19) years, 70% female, 78% White, 7% Hispanic/Latino. ROC area under the curve for AIRQ (0.78) and ACT (0.80) to predict EO did not differ (Figure 1A). AIRQ was significantly less likely than GSCT, ACT, and EO to classify patients with prior exacerbations as WC who reported subsequent exacerbations (Figure 1B).ConclusionAIRQ aligns with accepted symptom control measures and addresses both impairment and risk, thus this composite tool is well-suited for point-of-care evaluation of current control and risk of future adverse outcomes.

The Asthma Impairment and Risk Questionnaire (AIRQ®) is a 10-item, equally weighted, yes/no control tool that assesses symptom impairment and exacerbation risk. AIRQ® control level (well-controlled [WC], not well-controlled [NWC], very poorly controlled [VPC]) predicts future 12-month exacerbations (odds-ratios [OR]95% Confidence Limits [CL] for ≥1 exacerbation: NWC vs WC=2.1[1.6-2.9], VPC vs WC= 4.6[3.3-6.5]; AUC=0.70). We examined whether adding clinical and biomarker covariates to AIRQ® improves exacerbation prediction. Patients completed monthly online surveys regarding exacerbation-related oral corticosteroid (OCS) use, emergency department/urgent care visits, and hospitalizations. Univariate logistic regressions to predict exacerbations were performed with relevant covariates (eg, sociodemographics, comorbidities, exacerbation history, FEV1, eosinophils, IgE, FeNO). Significant (p ≤0.05) variables were included in a multivariable logistic regression with AIRQ® control categories to predict exacerbations (OR[95%CL]). 1070 patients completed ≥1 survey over 12 months (mean[SD] surveys 10.5[2.8]); 70.1% female; mean age 43.9[19.4] years; 21.5% non-White; BMI 30.6[8.7]; AIRQ® WC 35%, NWC 38%, VPC 27%. 46% of patients reported ≥1 exacerbation (WC 31.9%, NWC 56.6%, VPC 83.4%). In the multivariate analysis, AIRQ® control category was predictive of exacerbations (NWC vs WC: OR=1.94[1.41, 2.66], VPC vs WC: OR=3.80[2.58, 5.60; AUC=0.72] as were age (10 year OR=1.12[1.02, 1.23], presence of sleep apnea (OR=1.48[1.00, 2.18]), FeNO <25 ppb (OR=1.36[1.02, 1.82]), and ≥2 prior 12-month OCS courses (OR=2.46[1.50, 4.05]). A history of multiple exacerbations and current asthma control as measured by AIRQ® is strongly and independently associated with future exacerbations. Additional assessments do not significantly enhance the ability of AIRQ® to predict exacerbations.

Background: US Black and Hispanic patients (pts) suffer disproportionate asthma morbidity compared to White pts. Aim: Assess AIRQ performance in Black or Hispanic pts vs White pts. Methods: Panel-recruited adults with self-identified asthma completed a web survey consisting of sociodemographic and medical histories, AIRQ, and Asthma Control Test (ACT). AIRQ performance was assessed against corticosteroid and rescue therapy use and ACT score (general linear models and Chi-square analyses). Results: 1129 pts were included: mean[SD] age 49[15] yrs; 60% female; 15% Black, 13% Hispanic, 72% White; AIRQ categories: 36% Well-controlled (WC), 33% Not Well-controlled (NWC), 31% Very Poorly Controlled (VPC). A greater proportion of Black or Hispanic pts vs White pts reported >1 OCS course or >1 steroid injection in the past year or inhaled/nebulized rescue therapy use >2 times/week (p <0.001) (Figure). A lower proportion of Black or Hispanic pts were WC and more were VPC vs White pts (p <0.001). Worse AIRQ control for Black or Hispanic pts was supported by higher proportions of both groups vs White pts reporting these steroid and rescue use frequencies (p <0.001). For each cohort, as AIRQ control worsened, the proportion of pts with these morbidity indices increased and ACT scores decreased (p <0.001). Conclusion: AIRQ demonstrates the ability to assess asthma control in diverse US adult populations and reflects known disparities.