BACKGROUND:Black adults are disproportionately affected by asthma and are often considered a homogeneous group in research studies despite cultural and ancestral differences. OBJECTIVE:We sought to determine if asthma morbidity differs across adults in Black ethnic subgroups. METHODS:Adults with moderate-severe asthma were recruited across the continental United States and Puerto Rico for the PREPARE (PeRson EmPowered Asthma RElief) trial. Using self-identifications, we categorized multiethnic Black (ME/B) participants (n = 226) as Black Latinx participants (n = 146) or Caribbean, continental African, or other Black participants (n = 80). African American (AA/B) participants (n = 518) were categorized as Black participants who identified their ethnicity as being American. Baseline characteristics and retrospective asthma morbidity measures (self-reported exacerbations requiring systemic corticosteroids [SCs], emergency department/urgent care [ED/UC] visits, hospitalizations) were compared across subgroups using multivariable regression. RESULTS:Compared with AA/B participants, ME/B participants were more likely to be younger, residing in the US Northeast, and Spanish speaking and to have lower body mass index, health literacy, and <1 comorbidity, but higher blood eosinophil counts. In a multivariable analysis, ME/B participants were significantly more likely to have ED/UC visits (incidence rate ratio [IRR] = 1.34, 95% CI = 1.04-1.72) and SC use (IRR = 1.27, 95% CI = 1.00-1.62) for asthma than AA/B participants. Of the ME/B subgroups, Puerto Rican Black Latinx participants (n = 120) were significantly more likely to have ED/UC visits (IRR = 1.64, 95% CI = 1.22-2.21) and SC use for asthma (IRR = 1.43, 95% CI = 1.06-1.92) than AA/B participants. There were no significant differences in hospitalizations for asthma among subgroups. CONCLUSIONS:ME/B adults, specifically Puerto Rican Black Latinx adults, have higher risk of ED/UC visits and SC use for asthma than other Black subgroups.

Mask-wearing, social distancing, and vaccination are recommended behaviors to prevent Covid19 infection. We surveyed participants in the PREPARE clinical trial to assess the relationship between preventative behaviors and Covid19 infection. Between January and April 2022, PREPARE participants, African-American/Black (AA/B) and Hispanic/Latinx (H/L) adults 18 to 75 years, completed a brief (< 10 minute) survey online or by telephone interview regarding behaviors relating to Covid19 prevention and diagnosis. We assessed the association of demographics, comorbidity, asthma severity, and preventative behaviors with the risk for Covid19 infection using t-test and Chi-square test. 84% (856/1022) participants completed the survey and 48% (413) avoided indoor gatherings. The 44% (373) who wore a mask "all of the time" and the 87% (747) with at least one dose of Covid19 vaccination were more likely to be H/L (respectively: 55% vs. 45%, p = 0.04; 53% vs. 47%, p = 0.001). 321 (38%) participants had Covid19 infection, and the risk was significantly lower in those who reported mask-wearing "all of the time" compared to some of the time or rarely/never (32% vs 67%; p = 0.007), and in those who had been vaccinated (36% vs 50%; p = 0.006). Avoiding large gatherings did not reduce the risk for Covid19 infection. A significant proportion of AA/B and H/L adults with high-risk asthma reported preventative behavioral changes in response to the Covid19 pandemic. Compared to AA/B, H/L were more likely to wear masks and pursue Covid19 vaccination and these behaviors may prevent Covid19 infection.

IntroductionThe objective of this analysis was to compare the Asthma Control Test (ACT) and the Asthma APGAR asthma control assessment tools in African-Ancestry/Black (AA/B) and Hispanic/Latinx (H/L) adults with moderate to severe asthma.MethodsThis pre-planned sub-study of the PREPARE clinical trial compares the baseline ACT and Asthma APGAR scores for the PREPARE populations using correlation coefficients, generalized linear modeling and receiver operating curve (ROC) analyses. Correlations were also assessed for both control tests and the Asthma Symptom Utility Index (ASUI).ResultsAmong the 1201 adults (603 AA/B and 598 H/L) with moderate to severe asthma, most had uncontrolled asthma by both the ACT and the Asthma APGAR. Correlation coefficients between the ACT, Asthma APGAR and ASUI were strong and did not differ significantly by race/ethnicity. The ACT consistently assessed more patients as uncontrolled compared with the Asthma APGAR. The differences in ACT and Asthma APGAR scores did not differ by age, gender, race/ethnicity, self-reported health literacy or medication adherence but did differ by education level. Both the ACT and Asthma APGAR had similar ROCs for predicting an asthma exacerbation in the next 3 months.ConclusionsBoth the ACT and the Asthma APGAR can be used for asthma control assessment in AA/B and H/L populations with moderate to severe asthma, providing comparable rates of uncontrolled asthma and similar limited ability to predict exacerbations. Further work is required to better understand the basis and clinical implications of the higher rates of uncontrolled asthma identified using the ACT.

Patients frequently use non-standard terms for asthma inhalers. Such use is easy to determine. Whether such terms are associated with clinically important patient characteristics is unknown. African-American/Black and Hispanic/Latinx adults with moderate-severe asthma were recruited from U.S. clinics for the ongoing PeRson EmPowered Asthma RElief (PREPARE) trial. Preferred terms for asthma controller and reliever inhalers were collected from 1,150 participants for reference in monthly trial surveys. Terms based on brand name or inhaler type (i.e., "reliever ") were categorized as "standard." Other terms (e.g., color, device type) were categorized as "non-standard." Clinical characteristics were compared by inhaler term category using Chi-square and student's t-tests. Adjudicated asthma outcomes included self-reported asthma exacerbations (utilizing oral/parenteral corticosteroids) in the year prior to enrollment, emergency department (ED)/urgent care (UC) visits, or hospitalizations. Multivariable regression models were adjusted by health literacy, language, race/ethnicity, education, region, age, gender, and BMI. Forty-four percent of participants used non-standard terms, which associated with an odds ratio (OR) of 1.30 (95% CI 1.04-1.62, p=0.020) of exacerbations, 1.38 OR (95% CI 1.11-1.73, p=0.004) of ED/UC visits, and 1.50 OR (95% CI 1.10-2.06, p=0.010) of hospitalizations compared to standard term use when adjusted for all the factors above. Patients who use non-standard terms for asthma inhalers are at greater odds of poor asthma outcomes independent of primary language, education, and health literacy. Asking patients to name their medications may allow caregivers to identify those at greater risk for poor asthma outcomes.

Efforts to reduce the disproportionate asthma morbidity in African American/Black (AA/B) and Hispanic/Latinx (H/L) patients have been mostly unsuccessful. In a pragmatic, randomized study, we tested a Patient-Activated Reliever-Triggered Inhaled Corticosteroid (ICS) Strategy (PARTICS) in 1201 AA/B and H/L patients with moderate-to-severe asthma. PREPARE compared the addition of PARTICS [concomitant use of study-provided ICS (beclomethasone dipropionate 80 mcg) with reliever] to usual care (UC) (PARTICS+UC) with UC in 603 AA/B and 598 H/L adults (18–75 years old) who had an Asthma Control Test (ACT) <20 or an exacerbation in the past year (NCT02995733). UC continued at physician discretion. The primary endpoint was verified severe asthma exacerbations. Patients had one instructional visit followed by 15 monthly questionnaires. PARTICS+UC reduced severe asthma exacerbations by 15.4% (p=0.048) which corresponded to a reduction of 13 exacerbations/100 patient-years. PARTICS+UC improved ACT scores by 3.37 vs. 2.53 points from baseline (p<0.0001). ACT scores improved by ≥3 points from baseline during 11.8% more study months for patients assigned to PARTICS+UC versus UC (p=0.006). Asthma Symptom Utility Index (ASUI) scores improved by 0.12 versus 0.08 points (p<0.0001). The annualized rate of days missed of work/school/usual activities was reduced by 3.33 days/year (p=0.013). The total additional ICS use in PARTICS+UC was 1.3 refills/year. A patient-centered, one-time instruction in PARTICS, resulting in minimal additional ICS use, substantially reduces asthma exacerbations and improves asthma control and quality of life in AA/B and H/L adults with poorly controlled asthma.

PURPOSE: Asthma disproportionately affect African American/Black (AA/B) and Hispanic/Latinx (H/L) individuals; but the extent to which socioeconomic status (SES) affects asthma morbidity within these racial/ethnic groups is limited.Our purpose was to determine whether SES associates with asthma morbidity measures among AA/B and H/L. METHODS:The PCORI-funded PeRson EmPowered Asthma RElief (PREPARE) study is a randomized, open-label, pragmatic clinical trial of AA/B and H/L adults with moderate to severe asthma.This ancillary study analyzed data collected at trial enrollment (n¼1201) to assess associations between SES and morbidity measures (self-reported steroid bursts, emergency room (ER) visits, hospitalization, and asthma control scores).Structural equation models were fit to test direct and indirect effects of SES on six different asthma morbidity measures.Indirect relationships between asthma and morbidity were tested via health literacy, stress, and discrimination scores.All models were adjusted by age, gender, body mass index, race/ethnicity, and medical comorbidity count.RESULTS: SES was found to have a direct positive association with asthma hospitalizations and worse asthma control scores.Stress was a mediator between SES and several outcomes (ER visits, and asthma control scores), with lower SES (lower income, unemployment, and less education) correlating with higher stress and worse asthma morbidity measures.Health literacy and discrimination did not mediate any associations between SES and asthma morbidity measures; however, a direct effect of discrimination on steroid bursts and APGAR scores was observed.CONCLUSIONS: Lower SES is directly associated with more asthma hospitalizations and worse asthma control in AA/B and H/L patients.Stress partially mediates the association between SES and morbidity measures, with more significant stress leading to more ER visits and worse asthma symptoms scores.CLINICAL IMPLICATIONS: Lower SES is directly associated with more severe asthma morbidity outcomes, an effect partially mediated by stress.

TOPIC: Allergy and Airway TYPE: Original Investigations PURPOSE: Hispanic/Latinx (HL) ethnicity incorporates many subgroups from diverse racial and cultural backgrounds. Studies suggest that Puerto Ricans (PR) have a greater asthma prevalence and asthma-related morbidity relative to White and Mexican counterparts. However, these studies were in children or limited in clinical and phenotypic characterization. Our purpose was to determine whether clinical, phenotypic differences, and disparities in asthma-related morbidity exist across adult HL subgroups. Considering the shared heritage between PR and other Caribbean HL (Cubans and Dominicans, C&D), we hypothesized that Caribbean HL (CHL; PR and C&D) adults would have greater asthma morbidity compared to other HLs (OHL; Mexicans, Spaniards, Central/South Americans). METHODS: Adults with moderate-severe persistent asthma were recruited from primary care/specialty clinics across the United States, including Puerto Rico, for the PREPARE trial, an open-label pragmatic trial testing a patient directed treatment strategy compared to usual care in Black and HL adults. We examined baseline differences in self-reported clinical characteristics between CHL (n= 457) and OHL (n=141) and between CHL subgroups C&D (n=56) and PR (n=401). These were evaluated through Chi-square or t-tests. Differences in asthma morbidity measures (self-reported exacerbations requiring steroids, ER visits, hospitalizations) were tested with multivariate logistic and ordinal regression models, with adjustment for age, gender, BMI, controller therapy and poverty measure. RESULTS: CHL compared to OHL were more likely to be female (84% vs 77% p=0.04) and to be prescribed more asthma controller therapies (ICS + >2 controllers 50% vs 22% p<0.001) but were similar in age (48 vs 46 years p=0.16), BMI (33 vs 32 p=0.18), poverty measure (46% vs 43% p=0.14), blood eosinophils (263 vs 290 p=0.37) and FeNO (27 vs 31 ppb p=0.2). Relative to OHL, CHL had 7.9-fold greater odds of more asthma exacerbations (95%CI 2.4 to 26.6-fold greater p<0.001), 10.3-fold greater odds of more ER visits (95%CI 3.1 to 34.1-fold greater p<0.001), and trended towards greater odds of hospitalizations (OR=5.4 p=0.08). While PR (n=401) exhibited similar morbidity measures relative to OHL, C&D (n=56) had greater odds of exacerbations than OHL (2.0, 95% 1.1 to 3.5-fold greater p=0.03) but not ER visits or hospitalizations. PR had greater odds of more ER visits than C&D but not exacerbations overall. CONCLUSIONS: CHL adults exhibit increased asthma morbidity relative to OHL. While both PR and C&D have more asthma exacerbations relative to OHL, PR have greater odds of ER visits relative to C&D. Geography, healthcare access, ancestry and culture may underlie these differences. CLINICAL IMPLICATIONS: Adult CHL have worse asthma morbidity relative to OHL. Further research is needed to understand and find interventions to address this disparity. DISCLOSURES: No relevant relationships by Paulina Arias Hernandez, source=Web Response No relevant relationships by ahmet baydur, source=Web Response Advisory Committee Member relationship with Genentech Please note: 1/2020-12/2020 Added 04/20/2021 by Juan Cardet, source=Web Response, value=Honoraria Advisory Committee Member relationship with AstraZeneca Please note: 01/2020-12/2020 Added 04/20/2021 by Juan Cardet, source=Web Response, value=Honoraria No relevant relationships by Jennifer Carroll, source=Web Response No relevant relationships by Jing Cui, source=Web Response No relevant relationships by Prajwal Dara, source=Web Response No relevant relationships by Brianna Ericson, source=Web Response No relevant relationships by Dr. Maureen Fagan, source=Web Response No relevant relationships by Victoria Forth, source=Web Response No relevant relationships by Anne Fuhlbrigge, source=Web Response No relevant relationships by Rohit Gupta, source=Web Response Advisory Committee Member relationship with Novartis Please note: 2020 - present Added 04/26/2021 by Mary Hart, source=Web Response, value=honoraria went to my employer Advisory Committee Member relationship with AZ Please note: 2019-2020 Added 04/26/2021 by Mary Hart, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Theravance Please note: 2019-2020 Added 04/26/2021 by Mary Hart, source=Web Response, value=Honoraria Employee relationship with Allergy & Asthma Network Please note: 2019-present Added 04/26/2021 by Mary Hart, source=Web Response, value=Salary No relevant relationships by Michelle Hernandez, source=Web Response Consultant relationship with 4D Pharma Please note: In the last 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Consulting Removed 04/27/2021 by Elliot Israel, source=Web Response Consultant relationship with AB Science Please note: In the past 2 years Added 04/27/2021 by Elliot Israel, source=Web Response, value=Consulting fee Consultant relationship with Amgen Please note: In the past 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Consulting fee Consultant relationship with AstraZeneca Please note: In the past 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Consulting fee Consultant relationship with Avillion Please note: In the past 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Consulting fee Consultant relationship with Biometry Please note: In the past 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Consulting fee Consultant relationship with Cowen Please note: In the past 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Consulting fee Consultant relationship with Equillium Please note: In the past 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Consulting fee Removed 04/27/2021 by Elliot Israel, source=Web Response Consultant relationship with Genentech Please note: In the past 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Consulting fee Removed 04/27/2021 by Elliot Israel, source=Web Response Consultant relationship with GlaxoSmithKline Please note: In the past 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Consulting fee Consultant relationship with Merck Please note: In the past 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Consulting fee Consultant relationship with Novartis Please note: In the past 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Consulting fee Consultant relationship with Pneuma Respiratory Please note: In the past 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Consulting fee Consultant relationship with PPS Health Please note: In the past 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Consulting fee Consultant relationship with Regeneron Pharmaceuticals Please note: In the past 2 years Added 04/26/2021 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by Elliot Israel, source=Web Response, value=non-financial support Clinical research grants relationship with AstraZeneca Please note: In the past 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Grant/Research Support Clinical research grants relationship with Avillion Please note: In the past 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Grant/Research Support Clinical research grants relationship with Genentech Please note: In the past 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Grant/Research Support Removed 04/27/2021 by Elliot Israel, source=Web Response Clinical research grants relationship with Gossamer Bio Please note: In the past 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Grant/Research Support Clinical research grants relationship with Novartis Please note: In the past 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Grant/Research Support Clinical research grants relationship with Sanofi Please note: In the past 2 years Added 04/26/2021 by Elliot Israel, source=Web Response, value=Grant/Research Support Removed 04/27/2021 by Elliot Israel, source=Web Response Consultant relationship with Arrowhead Pharmaceuticals Please note: 4/13/21 Added 04/27/2021 by Elliot Israel, source=Web Response, value=Consulting fee No relevant relationships by Nancy Maher, source=Web Response No relevant relationships by Victor Pinto-Plata, source=Web Response No relevant relationships by Janet Robles, source=Web Response No relevant relationships by Jacqueline Rodriguez-Louis, source=Web Response Advisory Committee Member relationship with Aztra Zeneca Please note: 4/2020 Added 04/27/2021 by Kartik Shenoy, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Gennetech Please note: 4/24/2021 Added 04/26/2021 by Kartik Shenoy, source=Web Response, value=Consulting fee No relevant relationships by Joel Shields, source=Web 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BACKGROUND:Generally, a short-acting beta-2 agonist (SABA) delivered via metered-dose inhaler (MDI) is recommended for quick relief of asthma symptoms. However, in the PeRson EmPowered Asthma RElief (PREPARE) pragmatic trial, 67% of patients reported having used a nebulizer for SABA administration. OBJECTIVE:To understand preferences, experiences, and decision making regarding the use of nebulizers in Black and Latinx adults with uncontrolled asthma. METHODS:We interviewed 40 of the 1,201 PREPARE patients employing a matrix analysis. Those interviewed were Black (n = 20) and Latinx (n = 20) adults with uncontrolled asthma seeking primary or specialty care in clinics throughout the United States. Data were analyzed used a Rapid Assessment Procedures qualitative methodology, informed by grounded theory. RESULTS:Substudy participants, on average, reported using a nebulizer 3.5 times/wk. Daily use was common, and frequency ranged from less than daily to up to 6 times daily. Nearly all participants reported a longstanding history of nebulizer use. Participants tended to use their nebulizer at home, and some shared it with others in the home. Many reported preferring a nebulizer over an MDI for relief of severe symptoms and to avoid emergency room visits or hospitalizations. The extent to which cost affected nebulizer use varied among participants. CONCLUSIONS:Despite asthma guideline recommendations that MDIs be used rather than nebulizers for SABA administration, nebulizer use was common among PREPARE study participants. Clinicians should explore patients' history and experiences with nebulizer use as part of evaluation of asthma control.

OBJECTIVE:RA is associated with localized bone loss in the hands, as well as generalized osteoporosis. We evaluated the relationship between hand digital X-ray radiogrammetry BMD (DXR-BMD) and total hip and lumbar spine BMD.METHODS:We conducted a cross-sectional study of 138 post-menopausal women with RA. The DXR-BMD was calculated based on digitized hand radiographs. Measurements of the total hip and lumbar spine BMD were performed by a DXA-BMD (BMDa) scan. Patient and physician questionnaires and laboratory samples supplied information on relevant covariates. Separate multivariate linear regression models were constructed to determine the cross-sectional relationship between hand DXR-BMD (independent variable) and total hip or lumbar spine BMD (dependent variables).RESULTS:The cohort comprised women with a median age of 61 years and RA disease duration of 13 years. Seventy-six per cent were either RF and/or anti-cyclic citrullinated peptide (anti-CCP) positive and most had moderate disease activity [median disease activity score-28 joint count (DAS28) 3.7]. Hand DXR-BMD was significantly associated with total hip BMD (beta = 0.61; P < 0.0001) and lumbar spine BMD (beta = 0.62; P < 0.0008) in adjusted models.CONCLUSIONS:This study suggests that hand DXR-BMD is associated with both the total hip and lumbar spine BMD among post-menopausal women with RA. The relationship between bone loss in the hands and generalized osteoporosis should be further explored in longitudinal studies of patients with RA.

Robert M Plenge1–3, Chris Cotsapas1,3, Leela Davies1, Alkes L Price1,4, Paul I W de Bakker1,3,4, Julian Maller1,3, Itsik Pe’er5, Noel P Burtt1, Brendan Blumenstiel1, Matt DeFelice1, Melissa Parkin1, Rachel Barry1, Wendy Winslow1, Claire Healy1, Robert R Graham1,3, Benjamin M Neale1,3,6, Elena Izmailova7, Ronenn Roubenoff 7, Alexander N Parker7, Roberta Glass2, Elizabeth W Karlson2, Nancy Maher2, David A Hafler1,8, David M Lee2, Michael F Seldin9, Elaine F Remmers10, Annette T Lee11, Leonid Padyukov12, Lars Alfredsson13, Jonathan Coblyn2, Michael E Weinblatt2, Stacey B Gabriel1, Shaun Purcell1,3, Lars Klareskog12, Peter K Gregersen11, Nancy A Shadick2, Mark J Daly1,3 & David Altshuler1,3,4

OBJECTIVEWith the growth in patient registries in rheumatic disease research, it is important to validate the collected information. We examined the convergent validity of self-reported medication use for rheumatoid arthritis (RA).METHODSIn the setting of the Brigham Rheumatoid Arthritis Sequential Study (BRASS), a large registry of patients with RA, we examined the agreement between patients' self-report of current and past RA medication use and information from medical records. For a sample of patients in BRASS, these 2 sources of information were compared using the kappa statistic as well as the percent agreement.RESULTSThe 91 patients selected for assessment were typical of a prevalent RA cohort: >80% were women and the mean disease duration was 16 years. The agreement for current medication use was excellent, ranging from 0.71 for sulfasalazine to 0.96 for methotrexate. However, for past medication use agreement was lower, ranging from 0.13 for methotrexate to 0.74 for aurothioglucose. The weighted kappa for cumulative oral glucocorticoid dose was 0.67.CONCLUSIONSelf-report of current medication use and cumulative oral glucocorticoid dose appears to have moderate to excellent validity. However, self-report of past medication use may not be valid.

To identify susceptibility alleles associated with rheumatoid arthritis, we genotyped 397 individuals with rheumatoid arthritis for 116,204 SNPs and carried out an association analysis in comparison to publicly available genotype data for 1,211 related individuals from the Framingham Heart Study. After evaluating and adjusting for technical and population biases, we identified a SNP at 6q23 (rs10499194, approximately 150 kb from TNFAIP3 and OLIG3) that was reproducibly associated with rheumatoid arthritis both in the genome-wide association (GWA) scan and in 5,541 additional case-control samples (P = 10(-3), GWA scan; P < 10(-6), replication; P = 10(-9), combined). In a concurrent study, the Wellcome Trust Case Control Consortium (WTCCC) has reported strong association of rheumatoid arthritis susceptibility to a different SNP located 3.8 kb from rs10499194 (rs6920220; P = 5 x 10(-6) in WTCCC). We show that these two SNP associations are statistically independent, are each reproducible in the comparison of our data and WTCCC data, and define risk and protective haplotypes for rheumatoid arthritis at 6q23.