Pierluigi Paggiaro, Gabriel Garcia, Nicolas Roche, Manish Verma, Maximilian Plank, Sean Oosterholt, Janna K. Duong, Anurita Majumdar, Oscar Della Pasqua
{"title":"中度重度哮喘患者的基线特征和维持疗法选择对症状控制、缓解剂使用和恶化风险的影响:临床建模与模拟研究》。","authors":"Pierluigi Paggiaro, Gabriel Garcia, Nicolas Roche, Manish Verma, Maximilian Plank, Sean Oosterholt, Janna K. Duong, Anurita Majumdar, Oscar Della Pasqua","doi":"10.1007/s12325-024-02962-2","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>Although some factors associated with asthma symptom deterioration and risk of exacerbation have been identified, these are not yet fully characterised. We conducted a clinical modelling and simulation study to understand baseline factors affecting symptom control, reliever use and exacerbation risk in patients with moderate–severe asthma during follow-up on regularly dosed inhaled corticosteroid (ICS) monotherapy, or ICS/long-acting beta<sub>2</sub>-agonist (LABA) combination therapy.</p><h3>Methods</h3><p>Individual patient data from randomised clinical trials (undertaken between 2001 and 2019) were used to model the time course of symptoms (<i>n</i> = 7593), patterns of reliever medication use (<i>n</i> = 3768) and time-to-first exacerbation (<i>n</i> = 6763), considering patient-specific and extrinsic factors, including treatment. Model validation used standard graphical and statistical criteria. Change in symptom control scores (Asthma Control Questionnaire 5 [ACQ-5]), reduction in reliever use and annualised exacerbation rate were then simulated in patient cohorts with different baseline characteristics and treatment settings.</p><h3>Results</h3><p>Being a smoker, having higher baseline ACQ-5 and body mass index affected symptom control scores, reliever use and exacerbation risk (<i>p</i> < 0.01). In addition, low forced expiratory volume in 1 s percent predicted, female sex, season and previous exacerbations were found to contribute to a further increase in exacerbation risk (<i>p</i> < 0.01), whereas long asthma history was associated with more frequent reliever use (<i>p</i> < 0.01). These effects were independent from the underlying maintenance therapy. In different scenarios, fluticasone furoate (FF)/vilanterol was associated with greater reductions in reliever use and exacerbation rates compared with FF or fluticasone propionate (FP) alone or budesonide/formoterol, independently from other factors (<i>p</i> < 0.01).</p><h3>Conclusions</h3><p>This study provided further insight into the effects of individual baseline characteristics on treatment response and highlighted significant differences in the performance of ICS/LABA combination therapy on symptom control, reliever use and exacerbation risk. These factors should be incorporated into clinical practice as the basis for tailored management of patients with moderate–severe asthma.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"41 11","pages":"4065 - 4088"},"PeriodicalIF":3.4000,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-024-02962-2.pdf","citationCount":"0","resultStr":"{\"title\":\"Baseline Characteristics and Maintenance Therapy Choice on Symptom Control, Reliever Use, Exacerbation Risk in Moderate–Severe Asthma: A Clinical Modelling and Simulation Study\",\"authors\":\"Pierluigi Paggiaro, Gabriel Garcia, Nicolas Roche, Manish Verma, Maximilian Plank, Sean Oosterholt, Janna K. Duong, Anurita Majumdar, Oscar Della Pasqua\",\"doi\":\"10.1007/s12325-024-02962-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>Although some factors associated with asthma symptom deterioration and risk of exacerbation have been identified, these are not yet fully characterised. We conducted a clinical modelling and simulation study to understand baseline factors affecting symptom control, reliever use and exacerbation risk in patients with moderate–severe asthma during follow-up on regularly dosed inhaled corticosteroid (ICS) monotherapy, or ICS/long-acting beta<sub>2</sub>-agonist (LABA) combination therapy.</p><h3>Methods</h3><p>Individual patient data from randomised clinical trials (undertaken between 2001 and 2019) were used to model the time course of symptoms (<i>n</i> = 7593), patterns of reliever medication use (<i>n</i> = 3768) and time-to-first exacerbation (<i>n</i> = 6763), considering patient-specific and extrinsic factors, including treatment. Model validation used standard graphical and statistical criteria. Change in symptom control scores (Asthma Control Questionnaire 5 [ACQ-5]), reduction in reliever use and annualised exacerbation rate were then simulated in patient cohorts with different baseline characteristics and treatment settings.</p><h3>Results</h3><p>Being a smoker, having higher baseline ACQ-5 and body mass index affected symptom control scores, reliever use and exacerbation risk (<i>p</i> < 0.01). In addition, low forced expiratory volume in 1 s percent predicted, female sex, season and previous exacerbations were found to contribute to a further increase in exacerbation risk (<i>p</i> < 0.01), whereas long asthma history was associated with more frequent reliever use (<i>p</i> < 0.01). These effects were independent from the underlying maintenance therapy. In different scenarios, fluticasone furoate (FF)/vilanterol was associated with greater reductions in reliever use and exacerbation rates compared with FF or fluticasone propionate (FP) alone or budesonide/formoterol, independently from other factors (<i>p</i> < 0.01).</p><h3>Conclusions</h3><p>This study provided further insight into the effects of individual baseline characteristics on treatment response and highlighted significant differences in the performance of ICS/LABA combination therapy on symptom control, reliever use and exacerbation risk. 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Baseline Characteristics and Maintenance Therapy Choice on Symptom Control, Reliever Use, Exacerbation Risk in Moderate–Severe Asthma: A Clinical Modelling and Simulation Study
Introduction
Although some factors associated with asthma symptom deterioration and risk of exacerbation have been identified, these are not yet fully characterised. We conducted a clinical modelling and simulation study to understand baseline factors affecting symptom control, reliever use and exacerbation risk in patients with moderate–severe asthma during follow-up on regularly dosed inhaled corticosteroid (ICS) monotherapy, or ICS/long-acting beta2-agonist (LABA) combination therapy.
Methods
Individual patient data from randomised clinical trials (undertaken between 2001 and 2019) were used to model the time course of symptoms (n = 7593), patterns of reliever medication use (n = 3768) and time-to-first exacerbation (n = 6763), considering patient-specific and extrinsic factors, including treatment. Model validation used standard graphical and statistical criteria. Change in symptom control scores (Asthma Control Questionnaire 5 [ACQ-5]), reduction in reliever use and annualised exacerbation rate were then simulated in patient cohorts with different baseline characteristics and treatment settings.
Results
Being a smoker, having higher baseline ACQ-5 and body mass index affected symptom control scores, reliever use and exacerbation risk (p < 0.01). In addition, low forced expiratory volume in 1 s percent predicted, female sex, season and previous exacerbations were found to contribute to a further increase in exacerbation risk (p < 0.01), whereas long asthma history was associated with more frequent reliever use (p < 0.01). These effects were independent from the underlying maintenance therapy. In different scenarios, fluticasone furoate (FF)/vilanterol was associated with greater reductions in reliever use and exacerbation rates compared with FF or fluticasone propionate (FP) alone or budesonide/formoterol, independently from other factors (p < 0.01).
Conclusions
This study provided further insight into the effects of individual baseline characteristics on treatment response and highlighted significant differences in the performance of ICS/LABA combination therapy on symptom control, reliever use and exacerbation risk. These factors should be incorporated into clinical practice as the basis for tailored management of patients with moderate–severe asthma.
期刊介绍:
Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.