ACT Scores Research Articles

Dupilumab's impact on nasal citology: Real life experience after 1 year of treatment

BackgroundBiologic agents are considered a new revolutionized therapy for severe and recurrent forms of CRSwNP which disease burden is not sufficiently controlled by conservative and/or surgical treatments. Recent Research has focused on evaluating their real-life efficacy in CRSwNP, as only limited reports on real-life data are available. However, in most studies, the response to treatment is evaluated in terms of improvement in Nasal Polyp Score (NPS) or in Sino-Nasal Outcome test (SNOT-22) scores. However, both criteria do not consider nasal immunophlogosis, which can be easily assessed by nasal cytology.The aim of our study was to evaluate changings in the nasal inflammatory infiltrate of CRSwNP patients treated with Dupilumab for 12 months. Methods27 patients suffering from severe CRSwNP treated with Dupilumab were recruited. Nasal cytology findings, NPS, SNOT-22, ACT scores and blood eosinophil count at T0 (before treatment) and at T1 (after 1 year of treatment) were compared. ResultsAfter 1 year of biological therapy with Dupilumab, NPS, SNOT-22 and, among the 17 asthmatic patients, ACT scores improved significantly. At T1, a statistically significant percentage of patients showed negative citology. Moreover, a significant reduction in the mast cell-eosinophilic pattern and an increase of neutrophils and bacteria was reported. ConclusionsThe response to treatment can be considered both in the case of negative nasal cytology and in the case of the appearance of neutrophils and bacteria. In this context, eosinophils, the specific target of biological therapies, play a crucial role in regulating tissue homeostasis and, consequently, the nasal immunophlogosis.

Real-world clinical remission of severe asthma with benralizumab in Spanish adults with severe asthma

Objective Patients with severe eosinophilic asthma experience high risk of exacerbations and reduced quality of life. Benralizumab, a monoclonal antibody binding to IL-5 receptor α subunit, is an approved drug for its treatment. The objective was to describe clinical remission after benralizumab prescription in routine clinical practice. Methods Retrospective multicenter study with data from four hospitals in Valencian Community (Spain) with asthma units between 2019 and 2020. Data was gathered at baseline and after 12 months. We considered clinical remission after 1 year if the patient remained without exacerbations and use of systemic corticosteroids and with good clinical control and normal lung function. Results Data from 139 patients was gathered. At the 12-month follow-up, 44.1% were in clinical remission, since 84.0%, 77.5%, 51.0% and 95.5% of patients did not experience exacerbations, had total asthma control test score of ≥20, prebronchodilator FEV1 of ≥80% and did not use systemic corticosteroids. A significant reduction of long-acting muscarinic antagonists (p = 0.0001), leukotriene receptor antagonists (p = 0.0326), oral corticosteroids (p < 0.0001) and short-acting beta agonists (p = 0.0499) was observed. Baseline factors with greatest individual influence on clinical remission were employment situation, tobacco use, comorbidity number, eosinophil value, number of exacerbations, FEV1, emergency visit number, and ACT, MiniAQLQ and TAI scores. Final analysis of multiple logistic regression indicated that having baseline FEV1 value below 80% increases remission chance 9.7 times a year compared to FEV1 >80%. Conclusion Clinical remission after treatment with benralizumab is achievable in a high percentage of patients with severe asthma eosinophilia not controlled in real life.

Are nighttime respiratory symptoms assessed by asthma control test affected by comorbidities?

Objective Nocturnal symptoms are common in the asthmatic population, reflecting an exaggerated airway narrowing overnight due to several factors; it is questioned to what extent the awakenings documented in the clinical assessment of asthma control are due to the disease itself or to comorbidities. To answer this question, we aimed to evaluate to what proportion rhinitis, gastroesophageal reflux and the likelihood of being affected by OSAS were related to poor asthma control, by means of ACT evaluation. Methods Asthmatics attending the outpatient clinic were enrolled and administered the following questionnaires: ACT, Total 5 Symptom Score, GERD Impact Scale, Pittsburgh Sleep Quality Index and the Sleep Disorders Questionnaire. Results One-hundred consecutive patients (M/F: 42/58, mean age 52 ± 15 years) were recruited. According to the ACT findings, 14 asthmatics resulted as fully controlled (FC, ACT equal to 25), 55 partially controlled (PC, 25 < ACT >19) and 31 as uncontrolled (UC, ACT <19). GERD was not associated with the ACT score neither did rhinitic symptomatology. On the other hand, the PSQI scores appeared to significantly increase with the lack of symptom control: FC, 2.0 (1–4); PC, 3.5 (2–5); UC, 6.6 (4–8) (p = 0.002). The SA-SDQ questionnaire results significantly increased with the loss of asthma control: FC, 11.0 (9–12); PC, 12.5 (10–14); UC, 15.1 (14–16) (p = 0.005). Conclusions These results confirm and extend previous findings showing that there is a higher likelihood that underlying unknown sleep disturbances worsen asthma control, suggesting that a more comprehensive assessment is necessary to clarify the cause of nocturnal symptoms in asthma.

Metacognitive Exam Preparation Assignments in an Introductory Biology Course Improve Exam Scores for Lower ACT Students Compared with Assignments that Focus on Terms.

Preparing for exams in introductory biology classrooms is a complex metacognitive task. Focusing on lower achieving students (those with entering ACT scores below the median at our institution), we compared the effect of two different assignments distributed ahead of exams by dividing classes in half to receive either terms to define or open-ended metacognitive questions. Completing metacognitive assignments resulted in moderately higher exam scores for students on the second and third exams. Metacognitive assignments also improved accuracy (difference between predicted and actual exam scores) for the second and third exam in lower ACT students, but that improvement was driven largely by higher exam scores in the metacognitive group. Thus, despite the fact that the metacognitive assignments specifically asked students to reflect on their previous exam performance, their previous estimates and predict how well they expected to perform on the exam they were preparing for, there was little evidence that these assignments influenced lower achieving students' confidence levels any more than assignments where students defined terms. While understanding relevant terms was certainly important in this course, these results highlight that open-ended metacognitive prompts may improve exam scores in some students in introductory biology classrooms.

FERPA and coaches 1

A college registrar recently posted on a professional discussion listserv that he had just found out a staff member had added a coach and the athletic director as academic advisors to student athletes in the college's student information system. The registrar was concerned that this meant that these two individuals would have “constant access” to the student athletes’ records which included updates on their current classes, grades, and ACT scores, plus most of the information the college had collected about the students from the time they submitted their college applications. So, the registrar wanted to know if other colleges allowed similar access for their coaches and athletics departments.

Clinical characteristics of complete responders versus non-complete responders to omalizumab, benralizumab and mepolizumab in patients with severe asthma: a long-term retrospective analysis

Background Some patients with severe asthma may benefit from treatment with biologics, but evidence has been mostly collected from randomized controlled trials (RCTs), in which patients’ characteristics are different from those encountered in asthma patients in the real-world setting. The aim of this study was to describe the clinical features of complete responders versus non-complete responders to long-term treatment with biologics in patients with severe asthma attended in routine daily practice. Methods Data of a cohort of 90 patients with severe asthma who were treated with biologics (omalizumab, benralizumab, and mepolizumab) for at least 12 months and were followed up to March 2022. Data recorded included clinical characteristics and effectiveness of treatment (exacerbation, Asthma Control Test [ACT] score, lung function, use of maintenance oral corticosteroids [mOCS]), FeNO, and blood eosinophils at baseline, at 12 months, and at the end of follow-up. Complete response is considered if, in addition to not presenting exacerbations or the use of mOCS, the ACT score was >20 and, the FEV1 >80% predicted. Results An improvement in all asthma control parameters was observed after 12 months of treatment and a mean follow-up of 55 months. After 12 months of treatment 27.2% of patients met the criteria of complete response and this percentage even increased to 35.3% at the end of follow-up. Long-term complete response was associated to better lung function with mepolizumab and omalizumab treatment and to less previous exacerbations in the benralizumab group. The main cause of not achieving a complete response was the persistence of an airflow obstructive pattern. Conclusions This study shows that omalizumab, benralizumab, and mepolizumab improved the clinical outcomes of patients with severe asthma in a clinic environment with similar effect sizes to RCTs in the long term follow-up. Airflow obstruction, however, was a predictor of a non-complete response to biologics.

Anti-IL-5 and anti-IL-5R biologics for severe asthma. Are there any differences in their effects?

Objective The aim of this retrospective multicentre study is to describe the clinical characteristics of patients diagnosed with severe eosinophilic asthma receiving anti-IL-5/anti-IL-5Rα therapies and to compare their effectiveness. Methods We collected and analysed results separately for anti-IL-5 and anti-IL-5Rα therapies from January 2016 until December 2021 in multidisciplinary severe asthma units. We collected demographic and clinical data, treatment with previous anti-IgE and/or anti-IL-5 agents, and comorbidities. We compared the number of exacerbations and admissions to the hospital, daily oral corticosteroid intake, pulmonary function tests, and Asthma Control Test scores before and after 12 months of therapy. 261 patients were included: 176 patients in the anti-IL-5 group and 85 in the anti-IL-5Rα group. Results Both groups led to statistically significant reductions in asthma exacerbations, hospital admissions, and visits to the Emergency Room. Although both groups showed a significant reduction in blood eosinophiliccount, we found a difference, although not significant, in the magnitude of reduction as benralizumab was able to decrease eosinophil counts to zero. Patients in the anti-IL-5 group achieved higher ACT scores after treatment, although this improvement was seen in both treatment groups. Conclusion The anti-IL-5 and anti-IL-5Rα biologics have shown similar effectiveness despite having different mechanisms of action. The anti-IL-5 group appeared to be better than benralizumab at improving ACT scores and FEV1/FVC and at reducing the number of inhalers. Although these differences were not statistically significant, it is not clear whether they may have clinical relevance and they might highlight the need for further head-to-head studies comparing these treatments.

Features of severe asthma response to anti-IL5/IL5r therapies: identikit of clinical remission.

Clinical remission (CliR) achievement has been recognized as a new potential outcome in severe asthma. Nevertheless, we still lack a detailed profile of what features could better identify patients undergoing clinical remission. In this study, we aim to address this issue, tracing a possible identikit of patients fulfilling remission criteria. We enrolled 266 patients with severe eosinophilic asthma (SEA) treated with a 12-month course of anti-IL5/IL5 receptor (IL5r) monoclonal antibodies. Patients with no exacerbation, OCS withdrawal, ACT ≥ 20 and FEV1 ≥ 80% after 1 year of biologic treatment were classified as in clinical remission. 30.5% of the enrolled patients achieved remission after biologic administration. CliR group showed a lower number of baseline asthma exacerbations and better lung function parameters, with a trend for higher ACT scores and a less frequent history of a positive skin prick test. CliR achievement was unlikely in presence of a higher BMI, a positive skin prick test, an increased number of asthma exacerbations before biologic treatment, anti-muscarinic administration, and a previous diagnosis of EGPA, bronchiectasis or osteoporosis. In contrast, a better lung function, an increased blood eosinophilic count, the presence of chronic rhinosinusitis with nasal polyps and a more frequent use of reliever therapy predicts remission development. Changes in exacerbations number, OCS use, ACT scores and FEV1% between remittent and non-remittent patients arise at specific follow up timepoints and are positively associated with CliR achievement. anti-IL5/IL5r biologics can induce CliR in a proportion of patients with SEA. Patients achieving remission demonstrate specific clinical, functional and inflammatory features, as well as a specific moment of improvement in all the CliR items.

Predictors of Early and Late Lung Function Improvement in Severe Eosinophilic Asthma on Type2-Biologics in the PRISM Study.

The determinants linked to the short- and long-term improvement in lung function in patients with severe eosinophilic asthma (SEA) on biological treatment (BioT) remain elusive. We sought to identify the predictors of early and late lung function improvement in patients with SEA after BioT. 140 adult patients with SEA who received mepolizumab, dupilumab, or reslizumab were followed up for 6months to evaluate improvement in forced expiratory volume in one second (FEV1). Logistic regression was used to determine the association between potential prognostic factors and improved lung function at 1 and 6months of treatment. More than a third of patients with SEA using BioT showed early and sustained improvements in FEV1 after 1month. A significant association was found between low baseline FEV1 and high blood eosinophil count and sustained FEV1 improvement after 1month (0.54 [0.37-0.79] and 1.88 [1.28-2.97] odds ratios and 95% confidence interval, respectively). Meanwhile, among patients who did not experience FEV1 improvement after 1month, 39% exhibited improvement at 6months follow-up. A high ACT score measured at this visit was the most reliable predictor of late response after 6months of treatment (OR and 95% CI 1.75 [1.09-2.98]). Factors predicting the efficacy of biological agents that improve lung function in SEA vary according to the stage of response.

Impact of Breathing exercise and Inhalation Technique on patient’s Quality of Life among Asthma and COPD patients

Around 4 million deaths each year are caused by respiratory disorders worldwide. These diseases are a persistent threat to India as well; the number of people in India who suffer from COPD and asthma has been estimated to be 14.84 million and 17.23 million, respectively.In the present prospective and observational study, a total of 120 patients were enrolled, among 38 patients were diagnosed with Asthma and 82 were COPD patients. All the patients were trained with breathing exercises and inhalation techniques. The patients who have been prescribed with DPI and MDI inhalation devices were checked for their correct usage. The checklist score (DPI and MDI) for Asthma patients, before trainingwas 2.9 and after training was 8.1(&lt;0.001***) and checklist score for COPD patients, before training was 2.8 and after training was 8.5(&lt;0.001***).The results indicate that there is a significant increase (&lt;0.001***) in correct usage after training session, which influences the inspiratory flow rate on Respirometer. Asthma Patient’s QoLwas measured by using ACT score, before training was 9.3 and after training was 19.7(&lt;0.001***) and AQLQ score before training was 35.6 and after training was 74.1 (&lt;0.001***). For COPD Patient’s QoLwas measured by using CAT score, before training was 33.2 and after training was 12.1(&lt;0.001***) and MMRC score before training was 3.6 and after training was 1.4(&lt;0.001***). In the present study breathing exercises increases inhalation capacity and hands on training for inhalation techniques improves the efficacy of drugs, together influences the patient’s Quality of Life (QoL) which reduces the number of days of hospitalization and socio-economic burden.

Level of asthma control in children and adolescents before and during the COVID-19 pandemic.

During the COVID-19 pandemic, national lockdowns were implemented worldwide. Asthma control was reported to have improved. However, some patients lost follow-up from the clinic because they intended to avoid crowds at the hospital. To evaluate the level of asthma control during the COVID-19 pandemic and explore factors influencing asthma outcomes. Subjects 8-18 years old from our previous study in 2019 were recruited. The data during the pandemic period were collected between June 2021 - May 2023. The level of asthma control was compared before and during the pandemic. We also evaluated inhaled corticosteroid (ICS) adherence and factors related to poor asthma control during the COVID-19 pandemic. One hundred and three subjects were enrolled. Asthma control levels remained relatively stable during the pandemic. However, an asthma exacerbation was significantly decreased from 36 (36.3%) in 2019 to 19 (19.2%)and 15 (15.1%) in 2021 and 2022 (p = 0.012, p < 0.001), respectively. Spirometry results demonstrated improved pre-bronchodilator FEV1 (89.91 ± 11.02 vs. 101.91 ± 14.11, p < 0.001). The factors related to the poor asthma outcome were not wearing a face mask (aOR = 8.52, 95%CI 1.26-57.79) and previously poor-controlled by the ACT score (aOR = 2.55, 95%CI 1.41-4.63). The median adherence rate during the pandemic was 85%. The main reasons for poor adherence were hectic lifestyle and misunderstandings of disease. Asthma exacerbation was significantly decreased during the lockdown. Not wearing a face mask and previously poorly controlled by the ACT score are related to poor asthma outcomes.

Presence of sputum IgG against eosinophilic inflammatory proteins in asthma.

Sputum immunoglobulin G (Sp-IgG) has been discovered to induce cytolytic extracellular trap cell death in eosinophils, suggesting a potential autoimmune mechanism contributing to asthma. This study aimed to explore the potential origin of Sp-IgG and identify clinically relevant subtypes of Sp-IgG that may indicate autoimmune events in asthma. This study included 165 asthmatic patients and 38 healthy volunteers. We measured Sp-IgG and its five subtypes against eosinophil inflammatory proteins (Sp-IgGEPs), including eosinophil peroxidase, eosinophil major basic protein, eosinophil-derived neurotoxin, eosinophil cationic protein, and Charcot-Leyden Crystal protein in varying asthma severity. Clinical and Mendelian randomization (MR) analyses were conducted. A positive Sp-IgGEPs signature (Sp-IgGEPs+) was defined when any of the five Sp-IgGEPs values exceeded the predefined cutoff thresholds, calculated as the mean values of healthy controls plus twice the standard deviation. The levels of Sp-IgG and Sp-IgGEPs were significantly elevated in moderate/severe asthma than those in mild asthma/healthy groups (all p < 0.05). Sp-IgG levels were positively correlated with airway eosinophil and Sp-IgGEPs. MR analysis showed causality between eosinophil and IgG (OR = 1.02, 95%CI = 1.00-1.04, p = 0.020), and elevated IgG was a risk factor for asthma (OR = 2.05, 95%CI = 1.00-4.17, p = 0.049). Subjects with Sp-IgGEPs+ exhibited worse disease severity and served as an independent risk factor contributing to severe asthma (adjusted-OR = 5.818, adjusted-95% CI = 2.193-15.431, adjusted-p < 0.001). Receiver operating characteristic curve analysis demonstrated that the combination of Sp-IgGEPs+ with non-allergic status, an ACT score < 15, and age ≥ 45 years, effectively predicted severe asthma (AUC = 0.84, sensitivity = 86.20%, specificity = 67.80%). This study identifies a significant association between airway eosinophilic inflammation, Sp-IgG, and asthma severity. The Sp-IgGEPs panel potentially serves as the specific biomarker reflecting airway autoimmune events in asthma.

Silent zone detection in asthma and its relation to T2 inflammation

Abstract Objective Study objectives are to detect small airways disease in asthma and to study T2 inflammatory markers (eosinophil count, IgE, phenotyping) in association with small airways disease. Methods and patients The retrospective study at OPC at Al Qassimi Hospital of EHS included 83 patients with confirmed asthma diagnosis. Based on their ACT scores, patients were divided into two groups. An assessment of demographic data, blood eosinophils, fractional exhaled nitric oxide, IgE, PFE25-75, FEV1%, R5-20, X5 and AX was carried out. Analyzing and collecting data. Results In this study, a significant correlation was found between the R5-20, X5, and AX values of the small airway and the asthma control test. Uncontrolled asthmatics had a higher fractional exhaled nitric oxide level and blood eosinophilic count. Conclusion In asthma management, small airways clinical impact should be investigated actively. Impulse oscillometry is an excellent marker for asthma control.

FERPA and coaches

A college registrar recently posted on a professional discussion listserv that he had just found out a staff member had added a coach and the athletic director as academic advisors to student‐athletes in the college's student information system. The registrar was concerned that this meant that these two individuals would have “constant access” to the student‐athletes’ records which included updates on their current classes, grades, and ACT scores, plus most of the information the college had collected about the students from the time they submitted their college applications. So, the registrar wanted to know whether other colleges allowed similar access for their coaches and athletics departments.

College Gap Time and Academic Outcomes for Women: Evidence from Missionaries

Abstract This study leverages a policy change in the missionary program of The Church of Jesus Christ of Latter-day Saints that exogenously influenced the likelihood that a woman took gap time during college to understand how gap time influences women's subsequent choice of major and academic outcomes. If structured gap time shapes educational outcomes, increasing the uptake of gap time by women may be a mechanism to ameliorate later wage gaps. Using administrative data from Brigham Young University (N = 17,402) and an instrumental variables estimation strategy, we find that women who take gap time for missionary service shift into majors with higher expected salaries and are more likely to be in limited-enrollment majors and majors with a higher concentration of men. However, gap time decreases the likelihood of graduating within eight years of entering college, creating tension between the costs and benefits. On average, net benefits of expected wages are close to zero. Gap time most clearly benefits women with relatively low ACT scores who are more likely to be accepted into limited enrollment programs following gap time. This research informs university administrators and students alike seeking to understand the academic implications of taking planned time off during postsecondary education.

Consider how FERPA applies to coaches, staff accessing student‐athletes’ academic records

A college registrar recently posted on a professional discussion listserv that he had just found out that a staff member had added a coach and the athletics director as academic advisors to student‐athletes in the college's student information system. The registrar was concerned that this meant that these two individuals would have “constant access” to the student‐athletes’ records, which included updates on their current classes. grades, and ACT scores, plus most of the information that the college had collected about the students from the time they submitted their college applications. So, the registrar wanted to know if other colleges allowed similar access for their coaches and athletics departments.

The role of ACT score in mepolizumab discontinuation

Background Mepolizumab is a therapy for severe asthma. We have little knowledge of the characteristics of people in the US that discontinue mepolizumab in clinical care. Objective To investigate the real-world efficacy and time to clinical discontinuation of mepolizumab, we evaluated individuals with asthma started on mepolizumab at the Cleveland Clinic. We hypothesized that individuals that discontinue mepolizumab have more severe and uncontrolled asthma at baseline. Methods Between 2016 and 2022, patients who started on mepolizumab consented to be assessed over 18 months. At baseline, a questionnaire including demographic and medical history was collected. Laboratory findings such as ACT score, FENO (Fractional Excretion of Nitric Oxide), and spirometry were recorded. At the conclusion of the observation period, the participants were divided into two categories: Group A and Group B. Results Group B [N = 28] discontinued mepolizumab (p < 0.05) at an average of 5.8 months (SD 4.2 months). Group A [N = 129] stayed on the therapy for at least 1 year. A participant with an ACT score less than 13 has an odds ratio of 6.64 (95% CI, 2.1 − 26.0) of discontinuing mepolizumab therapy. For a male, the odds of discontinuing mepolizumab therapy is 3.39 (95% CI, 1.1–11.2). Conclusion In this real-world study, we find that high eosinophil count may not be adequate in screening which individuals will benefit from mepolizumab. Up to 17% of patients fail therapy within 6 months, with male sex and low ACT score increasing risk of mepolizumab discontinuation at Cleveland Clinic.

Effectiveness of a Maintenance and Reliever Digihaler System in Asthma: 24-Week Randomized Study (CONNECT2)

BACKGROUNDDigital health tools have been shown to help address challenges in asthma control, including inhaler technique, treatment adherence and short-acting beta2-agonist overuse. The maintenance and reliever Digihaler System (DS) comprises two Digihaler inhalers (fluticasone propionate/salmeterol and albuterol) with an associated patient App and web-based Dashboard. Clinicians can review patients’ inhaler use and Digihaler inhalation parameter data to support clinical decision-making. OBJECTIVECONNECT2 evaluated asthma control in participants using the DS versus standard-of-care (SoC) maintenance and reliever inhalers. METHODSParticipants (≥13 years) with uncontrolled asthma (Asthma Control Test [ACT] score <19) were randomized 4:3 (open-label) to the DS (n = 210) or SoC (n = 181) for 24 weeks. The primary endpoint was the proportion of patients achieving well-controlled asthma (i.e., an ACT score ≥20 or increase from baseline of ≥3 units at Week 24). RESULTSThere was an 88.7% probability that participants using the DS would have greater odds of achieving improvement in asthma control compared with SoC after 24 weeks. Mean odds ratio (95% credible interval) for DS versus SoC was 1.35 (0.846–2.038), indicating a 35% higher odds of improved asthma control with the DS. The DS group had more clinician-participant interactions versus SoC, mainly addressing poor inhaler technique. DS participants’ maintenance treatment adherence was good (Month 1: 79.2%; Month 6: 68.6%); reliever use decreased by 38.2% versus baseline. App and Dashboard usability were rated ‘good’. CONCLUSIONThe positive results in asthma control in this study after 24 weeks demonstrate the effectiveness of the DS in asthma management.

Identification of biologic-responsive phenotypes in elderly people with eosinophilic asthma

Asthma in the elderly is not as well studied as in younger age groups. Age-related immunosenescence may result in diminished TH2 inflammation, which raises a question about whether asthma in elderly patients responds well to anti-TH2 asthma biologics. We sought to determine whether asthma in elderly people has different TH2 biomarkers and clinical features compared to nonelderly people, and if disease in the 2 age groups responds differently to anti-TH2 biologics. We also aimed to identify treatment-responsive phenotypes with clinical and biomarker features that could be used to predict best response to biologics. A retrospective chart review was conducted for 56 patients (30 elderly [age ≥62 years] and 26 nonelderly [ages 18-59 years] subjects) with severe asthma treated with dupilumab or benralizumab. Differences in baseline characteristics and response to treatment were analyzed. Ahierarchical cluster analysis was also performed to identify treatment-responsive phenotypes. Significance threshold was P= .05 for all analyses. Baseline characteristics and TH2 biomarkers (blood eosinophil level, total IgE, aeroallergen sensitivity) were similar between elderly and nonelderly subjects. The disease in both groups responded well to biologics (improvement in ACT scores, decreased exacerbations, decreased need for prednisone), but no significant response difference was found based on age groups. Cluster analysis identified 3 phenotypes, as follows: cluster 1, youngest age, moderate eosinophil levels, lowest total IgE, few environmental allergies, and least response to biologics; cluster 2, intermediate age, lowest eosinophil level, highest IgE level, many environmental allergies, and an intermediate response to biologics; and cluster 3, oldest ages, highest eosinophil levels, high total IgE, few environmental allergies, and best response to biologics. These results confirm trends seen in another study utilizing cluster analyses showing that subjects with highest levels of IgE and eosinophils responded better to biologic treatment for asthma. Elderly people with asthma should be considered for biologic therapy no differently than younger people. There may be subgroups of patients with different biologic responses based on age, allergenicity, IgE, and eosinophil levels that could be used to predict treatment response.

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.