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Comparison of Long-term Response and Remission to Omalizumab and Anti-IL-5/IL-5R Using Different Criteria in a Real-life Cohort of Severe Asthma Patients

BackgroundEvaluation of biologic therapy response is vital to monitor its effectiveness. Authors have proposed various response criteria including good responder, super-responder, non-responder, and clinical remission. ObjectivesTo ascertain the prevalence of response and clinical remission after long-term treatment (>6 months) of anti-IgE and anti-IL-5/IL-5Rα biologics, compare these results with existing criteria, and identify predictors for non-responders and clinical remission. MethodsA multicenter, real-life study involving severe asthma patients in Spain. Various outcomes were assessed to gauge response and clinical remission against established criteria. ResultsThe study included 429 patients, 209 (48.7%) omalizumab, 112 (26.1%) mepolizumab, 19 (4.4%) reslizumab and 89 (20.7%) benralizumab, with a mean treatment duration of 55.3±38.8 months. In the final year of treatment, 218 (50.8%) were super-responders, 173 (40.3%) responders, 38 (8.9%) non-responders, and clinical remission in 116 (27%), without differences among biologics. The short-term non-responders (<6 months) were 25/545 (4.6%). Substantial variations in response and clinical remission were observed when applying different published criteria. Predictors of non-response included higher BMI (OR:1.14; 95% CI:1.06–1.23; p<0.001), admissions at ICU (2.69; 1.30–5.56; p=0.01), high count of SAE (1.21; 1.03–1.42; p=0.02) before biologic treatment. High FEV1% (0.96; 0.95–0.98; p<0.001), a high ACT score (0.93; 0.88–0.99; p=0.01) before biologic treatment or NSAID-ERD (0.52; 0.29–0.91; p=0.02) showed strong associations with achieving clinical remission. ConclusionA substantial proportion of severe asthma patients treated long-term with omalizumab or anti-IL5/IL-5Rα achieved a good response. Differences in response criteria highlight the need for harmonization in defining response and clinical remission in biologic therapy to enable meaningful cross-study comparisons.

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Exploring the impact of inflammatory endotypes on olfactory function and quality of life in chronic rhinosinusitis patients

ObjectivesThe aim of this observational cross-sectional study was to determine the endotypic inflammatory pattern of a sample of patients with CRS in Brazil, correlate it with olfactory function, and evaluate the clinical severity of the disease. MethodsIn this cross-sectional study, 73 CRS patients were recruited. Patients were classified into type 2 and non-type 2 endotypic patterns based on IgE and eosinophilia levels. All subjects performed the University of Pennsylvania Smell Identification Test (UPSIT®) and responded to the Sino-Nasal Outcome Test (SNOT-22). ResultsThe majority of patients had type 2 CRS (n=57, 78.1%). Patients with type 2 CRS compared to non-type 2 CRS had a higher prevalence of nasal polyps (93% vs. 12.5%), asthma (40.3% vs. 12.5%), and non-steroidal anti-inflammatory drug exacerbated respiratory disease (NERD, 17.5% vs. 0%). Type 2 patients also had significantly lower UPSIT® and higher SNOT-22, Lund-Kennedy, and Lund-Mackay scores. ConclusionOur study provides evidence that type 2 CRS is associated with a higher prevalence of nasal polyps, asthma, and NERD, as well as decreased olfactory function and worse quality of life scores. These data will contribute to the body of knowledge on CRS and the development of treatments for this disease in Brazil. Level of evidence3.

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Patient Insights into the Diagnosis of Smell and Taste Disorders in the United States.

Diagnosis of smell/taste dysfunction is necessary for appropriate medical care. This study examines factors affecting testing and diagnosis of smell/taste disorders . The online USA Smell and Taste Patient Survey was made available to US patients with smell/taste disorders between April 6-20, 2022. 4,728 respondents were included. 1,791 (38%) patients reported a documented diagnosis. Patients most often saw family practitioners (34%), otolaryngologists (20%), and Taste/Smell clinics (6%) for smell/taste dysfunction. 64% of patients who went to Taste/Smell clinics received smell testing, followed by 39% of patients who saw otolaryngologists, and 31% of patients who saw family practitioners. Factors associated with increased odds of diagnosis included age (25-39 years (OR 2.97, 95% CI [2.25, 3.95]), 40-60 (OR 3.3, 95% CI [2.56, 4.52]), and >60 (OR 4.25, 95% CI [3.21, 5.67]) vs. 18-24 years), male gender (OR 1.26, 95% CI [1.07, 1.48]), insurance status (private (OR 1.61, 95% CI [1.15, 2.30]) or public (OR 2.03, 95% CI [1.42, 2.95]) vs. uninsured), perception of their family practitioner to be knowledgeable (OR 2.12, 95% CI [1.16, 3.90]), otolaryngologic evaluation (OR 6.17, 95% CI [5.16, 7.38]), and psychophysical smell testing (OR 1.77, 95% CI [1.42, 2.22]). Psychophysical testing, otolaryngologic evaluation, patient assessment of family practitioner knowledge level, insurance, age, and gender are significant factors in obtaining smell/taste dysfunction diagnosis. This study identifies barriers to diagnosis including lack of insurance or access to specialist evaluation and highlights the importance of educating family practitioners in diagnosis and management of patients with smell/taste disorders.

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SARS-CoV-2 infection and long COVID among California farmworkers.

The purpose of this cross-sectional study was to determine the prevalence of long COVID and identify its clinical manifestations among farmworkers in California. We collected data on sociodemographic characteristics, anthropometrics, clinical chemistries and anti-SARS-CoV-2 immunoglobulin G antibodies, self-reported SARS-CoV-2 infection history, and standardized health tests and scales from 297 farmworkers in California between February and July 2022. Most participants were born in Mexico or Central America, had less than a high school diploma, and were overweight or obese. The prevalence of long COVID (defined as self-reported SARS-CoV-2 infection with symptoms >28 days) among farmworkers with a suspected or test-confirmed infection was 61.8%. Participants with long COVID had higher mean [95% CI] body mass index (32.9 [31.6-34.1]) and high-sensitivity C-reactive protein levels (4.8 [3.7, 6.0]) than those with no COVID-19 history (30.5 [29.3-31.7], and 3.3 [2.2, 4.3], respectively). Farmworkers with long COVID also reported greater fatigue, dyspnea, taste and smell problems, and overall poorer mental and physical health, than those with no COVID-19 history. Farmworkers with long COVID had increased odds of functional limitations compared to those with a self-reported SARS-CoV-2 infection with symptoms ≤28 days (OR [95% CI]: 7.46 [3.26, 17.09]). A significant proportion of farmworkers experience long COVID with persistent symptoms that limit their ability to perform their work. A comprehensive approach that addresses the unique needs and challenges of farmworkers is warranted given this population's high prevalence of long COVID and the essential nature of their work.

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The Multiscent-20: A Digital Odour Identification Test Developed with Item Response Theory

Abstract Although validated and reliable psychophysical tests of olfactory function are available, an easy-to-use and feasible test has yet to be developed. This study aimed to design a digital odour identification test, evaluate its validity, establish a normative curve, and explore the impact of demographic factors. The odour identification test was presented with the Multiscent-20, a hand-held, tablet-like digital scent device that features an integrated odour digital delivery system. The identification performance on the 20 odours was assessed using item response theory (IRT). The normative curve was established by administering the test to a large sample of participants (n = 1,299). The mean identification score was 17.5 (SD = 2.1). The two-parameter logistic IRT model provided the best fit, revealing variation in item discrimination and difficulty parameters. Educational attainment influenced performance, with primary education associated with lower scores. Sex was marginally associated with performance, suggesting that men scored slightly lower than women. This study provides initial evidence supporting the validity of use of the Multiscent-20 as a digital odour identification test. The test's automation and portability enable the standardized delivery of olfactory stimuli and efficient automatic recording and scoring of responses.

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A Supervised Learning Regression method for the analysis of oral sensitivity of healthy subjects and patients with chemosensory loss

Abstract The gustatory, olfactory, and trigeminal systems are anatomically separated. However, they interact cognitively to give rise to oral perception, which can significantly affect health and quality of life. We built a Supervised Learning (SL) regression model that, exploiting subjects’ features, was capable of automatically analyzing with high precision the self-ratings of oral sensitivity of healthy participants and patients with chemosensory loss, determining the contribution of its three components: gustatory, olfactory, and trigeminal. CatBoost regressor provided predicted values of the self-rated oral sensitivity close to experimental values. Patients showed lower predicted values of oral sensitivity, lower scores for measured taste, spiciness, astringency, and smell sensitivity, higher BMI, and lower levels of well-being. CatBoost regressor defined the impact of the single components of oral perception in the two groups. The trigeminal component was the most significant, though astringency and spiciness provided similar contributions in controls, while astringency was most important in patients. Taste was more important in controls while smell was the least important in both groups. Identification of the significance of the oral perception components and the differences found between the two groups provide important information to allow for more targeted examinations supporting both patients and healthcare professionals in clinical practice.

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