Description of Baseline Characteristics of Pediatric Allergic Asthma Patients Including those Initiated on Omalizumab

Background Indication of omalizumab in the United States was recently extended to include pediatric (6–11 years) uncontrolled moderate-to-severe allergic asthma patients. Objective The purpose of this study was to describe baseline characteristics of this population from a real-world dataset. Methods Allergic asthma patients and uncontrolled moderate-to-severe allergic asthma patients, aged 6–11 years, were identified in the Allergy Partners Network Electronic Medical Records (2007–2016). The index date for allergic asthma patients was the latest between the second asthma-related visit and the allergic status confirmation. Uncontrolled moderate-to-severe allergic asthma patients were stratified into omalizumab-exposed (index date) or omalizumab-unexposed (index date randomly generated) groups. Characteristics were evaluated during the 12-month preindex period. Results A total of 5806 allergic asthma, 37 omalizumab-exposed, and 2620 omalizumab-unexposed patients were selected (mean age approximately 9 years). Allergic asthma and omalizumab-unexposed patients were predominantly white (70.2% and 61.2%) whereas the majority of omalizumab-exposed were African Americans (62.2%). Mean immunoglobulin E was 782.0 IU/ml in allergic asthma patients (available in 2.2%), 1134.4 IU/ml in omalizumab-exposed (available in 100.0%), and 746.1 IU/ml in omalizumab-unexposed (available in 3.1%). Allergic asthma patients were less severe than omalizumab-exposed and omalizumab-unexposed based on the forced expiratory volume in 1 s as a percentage of predicted value (FEV1% predicted) and the Childhood Asthma Control Test (C-ACT). FEV1% predicted was below normal (<80%) in 42.4% of omalizumab-exposed and 39.1% of omalizumab-unexposed patients, also 63.6% of omalizumab-exposed and 46.7% of omalizumab-unexposed had uncontrolled asthma (C-ACT score <20). In African American omalizumab-exposed patients, FEV1% predicted was below normal in 47.6% and 55.0% had uncontrolled asthma. Conclusions In a real-world setting, pediatric patients with uncontrolled moderate-to-severe allergic asthma have a significant disease burden as shown by high rates of poor lung function, disease control, and symptoms. Currently available treatments could help improve disease management in this population.

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Demographic and Comorbidity Characteristics of Newly Diagnosed Multiple Myeloma Patients in the United States: A Real World Data Analysis

Blood ◽

10.1182/blood.v124.21.1301.1301 ◽

2014 ◽

Vol 124 (21) ◽

pp. 1301-1301 ◽

Cited By ~ 3

Author(s):

Yaozhu J Chen ◽

Ajita P De ◽

Ze Cong ◽

Sanjay K Aggarwal ◽

Rolin L Wade

Keyword(s):

Real World ◽

Research Funding ◽

Index Date ◽

The United States ◽

Newly Diagnosed ◽

Real World Evidence ◽

The Us ◽

Skeletal Related Events ◽

Baseline Characteristics ◽

Baseline Demographic

Abstract Background Multiple myeloma (MM) remains an incurable plasma cell neoplasm with >20,000 new cases diagnosed annually in the United States (US). The presentation of MM is diverse and the management is guided by disease- and patient- related factors. Real world evidence regarding disease presentation is sparse for newly diagnosed MM (NDMM) patients. The goal of this study was to describe the baseline demographic and clinical characteristics of NDMM patients by linking multiple large claims databases in the US. Methods A retrospective cohort study was conducted by linking the records between 01/01/2006-12/31/2013 from three longitudinal IMS databases (Medical Claims, Pharmacy Prescriptions, and Hospital Charge Master), to reflect a complete treatment continuum for patients in all ages and by all payer types across healthcare settings. Included patients met the following criteria: ≥2 claims with a diagnosis of MM (ICD-9-CM 203.0x) at least 30 days apart between 01/01/2007-12/31/2012 (first MM diagnosis date = index date); provider stability for at least 6 months before and 3 months after index date; aged 18+ as of index date. NDMM patients were identified as those with no MM diagnosis in the 6 months pre-index. Patient baseline characteristics were assessed using data at index for age, gender, geographic region and payer type; 6-month pre-index plus index day data for Charlson Comorbidity Index (CCI); 6-month pre-index data for 32 comorbidities (e.g., cardiac arrhythmia, cerebrovascular disease, chronic kidney disease, diabetes, hypertension, among others); and 5 comorbidity categories (cardiovascular, renal, metabolic, skeletal-related events, and other). Autologous stem cell transplant (ASCT) status was also assessed based on the available follow-up data after initial diagnosis. Patient baseline characteristics were compared between the patients with versus without ASCT after MM diagnosis. Chi-square tests for categorical variables and t-tests for continuous variables (alpha=0.05) were conducted. Results The study cohort of 8,239 NDMM patients had a mean (SD) age of 66.2 (11.3) years at diagnosis, with 56.7% aged 65+; 51.8% were female; and the majority were with commercial (43.3%) or Medicare (42.8%) as payer. Patients with post-index ASCT (n=1,429; 17.3%) were distinctly different from those without (n=6,810; 82.7%): they were younger with a mean (SD) age of 58.1 (8.7) vs. 67.9 (11.1) years, fewer aged 65+, 24.1% vs. 63.5%; fewer female, 47.6% vs. 52.6% (all p<0.001); and the majority (67.5%) of patients who later had ASCT were covered by commercial plans, compared to Medicare as the biggest payer (48.2%) for those who did not have post-index ASCT. NDMM patients had an overall mean (SD) CCI score of 3.1 (1.6). Patients who later received ASCT were healthier than those who did not, with mean (SD) CCI scores of 2.7 (1.4) vs. 3.2 (1.6) (p<0.001). Close to half (47.9%) of all NDMM patients had >1 type of comorbidities at baseline. Figure 1 depicts the baseline comorbidity categories among all NDMM patients as well as the two subsets (with versus without post-index ASCT). Comorbidities were prevalent even before MM diagnosis: 43.9% of patients presented with metabolic comorbidities, 21.4% with cardiovascular diseases, 11.5% with renal conditions, 5.9% with skeletal-related events, and 45.0% with other comorbidities. The patient subset with post-index ASCT had lower comorbidity occurrences compared to those without: 10.5% vs. 23.6% in cardiovascular diseases, 5.9% vs. 12.7% in renal conditions, 32.7% vs. 46.3% in metabolic diseases (all p<0.001), consistent with literature showing that ASCT candidates tend to be younger and have less severe comorbidities. Conclusions This study provided baseline demographic and comorbidity profiles of NDMM patients and showed that the NDMM patient population presented with various comorbidities prior to the first MM diagnosis, suggesting the needs for efficacious, tolerable and safe treatment options for a heterogeneous patient population with complex disease profiles. As expected, patients who had ASCT after initial diagnosis were younger and healthier than those who did not have ASCT. The study findings portray a clearer picture of NDMM patients in the US, and provide clinicians with valuable real world evidence to identify appropriate treatment strategies for these patients. Figure 1 Figure 1. Disclosures Chen: Onyx Pharmaceuticals: Research Funding. De:Onyx Pharmaceuticals: Research Funding. Cong:Onyz Pharmaceuticals: Employment. Aggarwal:Onyx Pharmaceuticals: Employment. Wade:Onyx Pharmaceuticals: Research Funding.

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Real-World Data Evaluation Of Total IgE, Specific IgE And Omalizumab Therapy In A Cohort Of Allergic Asthma Patients Treated In A Community-Based Practice

Journal of Immunology and Allergy ◽

10.37191/mapsci-2582-6549-1(3)-016 ◽

2020 ◽

Author(s):

Fortune O Alabi

Keyword(s):

Allergic Asthma ◽

Specific Ige ◽

Forced Expiratory Volume ◽

Act Scores ◽

Asthma Control Test ◽

Real World Data ◽

Total Ige ◽

Prick Test ◽

Negative Results ◽

Asthma Patients

Objective: In this study, we: (1) evaluated the correlation between total IgE and the presence of specific IgE; (2) compared the characteristics of patients with positive specific IgE to those with negative specific IgE; and, (3) analyzed the allergic testing results of patients on omalizumab and reported the effect of omalizumab on forced expiratory volume (FEV1) and asthma control test (ACT) results. Methods: Data from patients diagnosed with allergic asthma and seen at Florida Lung, Asthma & Sleep Specialists (FLASS) between January 2016 and June 2019 were analyzed. Parameters evaluated were total IgE, and levels of specific IgE to antigens in the ImmunoCAP test and skin prick test (SPT). Additional parameters for patients on omalizumab therapy for at least 6 months were FEV1, % predicted FEV1 and ACT results. Results: A total of 475 patients (114 males, 361 females) met the inclusion criteria. The mean age was 53 years (range: 17 to 89 years). Of these, 36 patients were not included in the analysis due to incomplete data. Mean total IgE was higher in patients with positive ImmunoCAP results compared to those with negative results (396 KU/L vs. 81.3 KU/L). There was a significant positive correlation between total IgE and levels of positive specific IgE in the ImmunoCAP test (p<0.0001, r=0.36, n=213 patients). The correlation between total IgE and levels of positive allergens in SPT was not significant (p=0.15, n=44 patients) Two positive reactions to allergens were seen in 22% of ImmunoCAP tests and 13% of SPT tests. There was no statistically significant improvement in FEV1 (p=0.097, CI -0.17 to 0.02) and % predicted FEV1 (p=0.109, CI -6.63 to 0.70) in patients who used omalizumab for at least 6 months. There was a statistically significant improvement in ACT scores (p=0.031, CI -4.21 to -0.21) in patients who used omalizumab for at least 6 months. Conclusion: Allergic asthma could be seen in patients who had an absence of specific IgE in ImmunoCAP and a negative reaction to SPT. The benefit of omalizumab therapy is not limited to allergic asthma patients with positive specific IgE.

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Effects of Omalizumab Treatment on Some Biomarkers in Severe Allergic Asthma Patients

Eurasian Journal of Pulmonology ◽

10.5152/ejp.2017.64935 ◽

2017 ◽

Vol 19 (2) ◽

pp. 84-90

Author(s):

Seda Tural Onur ◽

Arzu Didem Yalcin ◽

Saadet Gumuslu ◽

Gizem Esra Genc ◽

Kemal Kiraz ◽

...

Keyword(s):

Allergic Asthma ◽

Severe Allergic Asthma ◽

Asthma Patients

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Endotypes of severe allergic asthma patients who clinically benefit from anti-IgE therapy

Clinical & Experimental Allergy ◽

10.1111/cea.13248 ◽

2018 ◽

Vol 49 (1) ◽

pp. 44-53 ◽

Cited By ~ 13

Author(s):

Yu-Chen Huang ◽

Chih-Ming Weng ◽

Meng-Jung Lee ◽

Shu-Min Lin ◽

Chun-Hua Wang ◽

...

Keyword(s):

Allergic Asthma ◽

Severe Allergic Asthma ◽

Asthma Patients

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Effectiveness and Safety Studies of Omalizumab in Children and Adolescents With Moderate-To-Severe Asthma

Journal of Pharmacy Practice ◽

10.1177/08971900211038251 ◽

2021 ◽

pp. 089719002110382

Author(s):

Lu Cheng ◽

Tianrui Yang ◽

Xiang Ma ◽

Yuling Han ◽

Yongtai Wang

Keyword(s):

Children And Adolescents ◽

Allergic Asthma ◽

Severe Asthma ◽

Fixed Effects ◽

Vital Capacity ◽

Immunoglobulin E ◽

Meta Analysis ◽

Fixed Effects Model ◽

Significant Difference ◽

Severe Allergic Asthma

Background Omalizumab is currently approved for the treatment of moderate-to-severe allergic asthma in patients 6 years and older. Objective To assess the effectiveness and safety of subcutaneous omalizumab as an add-on therapy option for moderate–severe allergic asthma in patients aged 6—20 years old. Methods The studies published from July, 1970 to May, 2021 were searched from the electronic databases which followed keywords: (“anti-IgE” OR “anti-immunoglobulin E” OR “anti-IgE antibody” OR “omalizumab” OR “rhuMAb-E25” OR “Xolair”) AND “asthma” AND (“child” OR “children” OR “adolescents” OR “youth” OR “teenager” OR “kids” OR “pediatric”). Thirteen studies were pooled to determine the effectiveness and safety of omalizumab. Efficacy endpoints were evaluated using a fixed-effects model or a random-effects model depending on heterogeneity. Safety endpoints were evaluated by odds ratio. Results Thirteen studies were included. In this meta-analysis, our results showed that fractional exhaled nitric oxide and asthma control test scores were significantly improved with omalizumab treatment. Serum immunoglobulin E was also decreased in children with moderate-to-severe asthma after treatment with omalizumab. The analysis found that there was no significant difference between pre-and post-treatment in forced expiratory volume in one second/ forced vital capacity ratio, forced expiratory flow between 25 and 75% of vital capacity, or FEV1. Overall, more adverse events occurred with omalizumab compared to placebo. However, the degree was mild to moderate. Conclusion This meta-analysis indicates that omalizumab is safe and effective to treat children and adolescents with moderate-to-severe asthma.

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Assessment of disease control in patients with asthma

Medicina ◽

10.3390/medicina45120121 ◽

2009 ◽

Vol 45 (12) ◽

pp. 943 ◽

Cited By ~ 1

Author(s):

Guoda Pilkauskaitė ◽

Kęstutis Malakauskas ◽

Raimundas Sakalauskas

Keyword(s):

Lung Function ◽

Asthma Control ◽

Control Level ◽

Asthma Management ◽

Control Test ◽

Uncontrolled Asthma ◽

Asthma Control Test ◽

Inhaled Steroids ◽

Asthma Patients ◽

Β2 Agonists

International guidelines indicate that the main criterion of asthma management is asthma control level. The aim of this study was to assess asthma control and its relation with age, gender, and lung function. Material and methods. A total of 106 family physicians and 13 pulmonologists and allergists took part in this study. Each doctor had selected 10–15 asthma patients and had sent invitations to them by post. On the visit day, the patients themselves filled in the Asthma Control Test. The doctors interviewed the patients and filled in a special questionnaire. Pulmonologists and allergists also assessed lung function by performing spirometry. According to the results of the Asthma Control Test, the disease control level was indicated as “totally controlled” (25 points), “well controlled” (24–20 points), and “uncontrolled” (19 points or less). Results. A total of 876 asthma patients were examined. Uncontrolled asthma was diagnosed to 56.2% of the patients, 36.5% of patients had well controlled and 7.3% totally controlled asthma. There was no significant difference in asthma control level comparing men and women. A correlation between asthma control level and age was found revealing poorer asthma control in older patients. Ninety-five percent of patients were treated with inhaled steroids; most of them had used inhaled steroids in combination with long-acting β2 agonists. It was found that lung function correlated with clinical symptoms of asthma, the demand of shortacting β2 agonists, and asthma control level. Conclusion. The study showed that uncontrolled asthma was diagnosed to more than half of the patients, despite most of them used inhaled steroids. Asthma control was worsening with the age of patients with asthma and it correlated with lung function. We suggest that periodical assessment of asthma control should help to optimize asthma management.

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1782. Real-World HIV Diagnostic Testing Patterns in the United States

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz360.1645 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S656-S656

Author(s):

James Karichu ◽

Mindy Cheng ◽

Pedro Rodriguez ◽

Nicole Robinson ◽

Chakkarin Burudpakdee ◽

...

Keyword(s):

Real World ◽

Index Date ◽

Clinical Laboratory ◽

The United States ◽

Fourth Generation ◽

Test Results ◽

Confirmatory Testing ◽

Confirmatory Tests ◽

Testing Patterns ◽

Hiv 1

Abstract Background Current HIV diagnostic laboratory testing guidelines from the US Centers for Disease Control and Prevention (CDC) recommend a sequence of tests for detection, differentiation, and confirmation of HIV-1 and HIV-2 diagnosis. There is a gap in knowledge about real-world implementation of the testing algorithm. The aim of this study was to characterize the population that underwent HIV antibody differentiation and confirmatory testing and to describe subsequent testing patterns from a large US clinical laboratory database. Methods Patients who received one or more HIV-1/2 antibody differentiation test (BioRad Geenius™ HIV 1/2 Supplemental Assay [Geenius]) in the Quest Diagnostics laboratory database between January 1, 2017 and December 31, 2017 were selected into the study; earliest test date was index date. Geenius tests, HIV-1 qualitative RNA (Aptima HIV-1 RNA Qualitative Assay [Aptima]), and HIV-2 DNA/RNA confirmatory tests subsequent to index date were captured. Study measures included pt demographic characteristics, testing frequency and sequencing, and test results. For patients with >1 Geenius test in 2017, concordance between index and subsequent test results was assessed. Results There were 26,319 unique patients identified who received ≥1 HIV antibody differentiation result from the Geenius assay. Mean age was 40.7 ± 14.3 years, 66.4% were male, and 42.5% were from southern states. Among the study population, there were 28,954 Geenius, 7,234 Aptima, and 298 HIV-2 DNA/RNA confirmatory tests. 26.4% of Geenius test results were discordant with the initial positive fourth-generation HIV screening results and required subsequent confirmatory testing. In terms of sequencing, the CDC-recommended HIV diagnostic algorithm was followed 74% of the time after screening. 8.5% of patients had >1 Geenius test in 2017; 11.2% of the retests returned different results compared with the first test. Conclusion The CDC recommended algorithm for HIV diagnosis is complex for laboratories to implement and currently available assays do not support testing efficiency. To mitigate observed inefficiencies and reduce the laboratory burden of HIV testing, a more accurate and reliable approach for HIV differentiation and confirmatory testing is needed. Disclosures All authors: No reported disclosures.

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