Trial Conduct, Baseline Characteristics, and Symptom Burden of Patients in the ARISE Study
Introduction ARISE was a global clinical trial designed to generate evidence demonstrating the utility of the patient-reported outcome instruments Quality of Life–Bronchiectasis (QOL-B) [Respiratory Domain (RD) only] and Patient-Reported Outcomes Measurement Information System Short Form v1.0-Fatigu...
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| Vydáno v: | Pulmonary therapy Ročník 11; číslo 2; s. 269 - 283 |
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Cheshire
Springer Healthcare
01.06.2025
Springer Nature B.V Adis, Springer Healthcare |
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| Abstract | Introduction
ARISE was a global clinical trial designed to generate evidence demonstrating the utility of the patient-reported outcome instruments Quality of Life–Bronchiectasis (QOL-B) [Respiratory Domain (RD) only] and Patient-Reported Outcomes Measurement Information System Short Form v1.0-Fatigue 7a (PROMIS F SF-7a) in patients with newly diagnosed or recurrent
Mycobacterium avium
complex lung disease (MACLD). Here, we describe trial conduct, patient characteristics, and patient-reported symptoms at baseline among patients enrolled in ARISE.
Methods
Adult patients with newly diagnosed or recurrent non-cavitary MACLD who had not initiated antibiotic treatment for their current MAC infection were enrolled; data including comorbidities and prior MACLD history were collected during screening. Symptom burden was assessed using QOL-B, PROMIS F SF-7a, and Functional Assessment of Chronic Illness Therapy (FACIT) questionnaires.
Results
Of 99 patients from 12 countries enrolled in ARISE, the median age was 69.0 years; most were white (80.8%) and female (77.8%). This was the first diagnosis of MACLD for 72.7% of patients. Patients frequently reported having a comorbid respiratory disorder: bronchiectasis (49.5%), asthma (21.2%), and chronic obstructive pulmonary disease (16.2%). At baseline, mean (± SD) and median QOL-B RD scores were 65.0 (± 15.3) and 66.7; PROMIS F SF-7a T-scores were 53.8 (± 8.2) and 55.1; and FACIT-Fatigue scores were 35.0 (± 9.6) and 37.0.
Conclusions
Patients in ARISE were representative of a real-world patient population with MACLD. Comorbid chronic respiratory diseases were common in patients with new or recurrent MACLD, and substantial disease burden at the time physicians initiated MACLD treatment was evidenced by impairment across measures of fatigue and QOL-B domains.
ClinicalTrials.gov Identifier
NCT04677543.
Graphical Abstract
Plain Language Summary
People with a disease called
Mycobacterium avium
complex lung disease (MACLD) experience many symptoms, including cough, fatigue, and shortness of breath, which can impact their quality of life. It is not clear what symptoms people with new or repeating MACLD may have before they start antibiotic treatment for their disease. This publication describes the design of a study called ARISE, characteristics of people with MACLD who participated, and the symptoms they reported when they started the study. Overall, 99 people with a first, second, or third diagnosis of MACLD, who had not started taking antibiotics, participated in the study. People in the study were on average 69 years old and most were female (78%). This was the first diagnosis of MACLD for more than 70% of people who participated in ARISE. In addition to MACLD, many people also had other respiratory diseases, including bronchiectasis, asthma, and chronic obstructive pulmonary disease. At the start of the study, people completed three questionnaires that measured their symptoms, quality of life, and the severity and frequency of fatigue in their daily life. In these questionnaires, people with MACLD reported that, before starting treatment, they had a high burden of symptoms that impacted their daily lives and quality of life. They also reported more fatigue than people without MACLD. The results from this study were similar to those seen in people with MACLD from registries and other clinical studies. The results also showed that people with MACLD have a large symptom burden before starting treatment. |
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| AbstractList | ARISE was a global clinical trial designed to generate evidence demonstrating the utility of the patient-reported outcome instruments Quality of Life-Bronchiectasis (QOL-B) [Respiratory Domain (RD) only] and Patient-Reported Outcomes Measurement Information System Short Form v1.0-Fatigue 7a (PROMIS F SF-7a) in patients with newly diagnosed or recurrent Mycobacterium avium complex lung disease (MACLD). Here, we describe trial conduct, patient characteristics, and patient-reported symptoms at baseline among patients enrolled in ARISE.INTRODUCTIONARISE was a global clinical trial designed to generate evidence demonstrating the utility of the patient-reported outcome instruments Quality of Life-Bronchiectasis (QOL-B) [Respiratory Domain (RD) only] and Patient-Reported Outcomes Measurement Information System Short Form v1.0-Fatigue 7a (PROMIS F SF-7a) in patients with newly diagnosed or recurrent Mycobacterium avium complex lung disease (MACLD). Here, we describe trial conduct, patient characteristics, and patient-reported symptoms at baseline among patients enrolled in ARISE.Adult patients with newly diagnosed or recurrent non-cavitary MACLD who had not initiated antibiotic treatment for their current MAC infection were enrolled; data including comorbidities and prior MACLD history were collected during screening. Symptom burden was assessed using QOL-B, PROMIS F SF-7a, and Functional Assessment of Chronic Illness Therapy (FACIT) questionnaires.METHODSAdult patients with newly diagnosed or recurrent non-cavitary MACLD who had not initiated antibiotic treatment for their current MAC infection were enrolled; data including comorbidities and prior MACLD history were collected during screening. Symptom burden was assessed using QOL-B, PROMIS F SF-7a, and Functional Assessment of Chronic Illness Therapy (FACIT) questionnaires.Of 99 patients from 12 countries enrolled in ARISE, the median age was 69.0 years; most were white (80.8%) and female (77.8%). This was the first diagnosis of MACLD for 72.7% of patients. Patients frequently reported having a comorbid respiratory disorder: bronchiectasis (49.5%), asthma (21.2%), and chronic obstructive pulmonary disease (16.2%). At baseline, mean (± SD) and median QOL-B RD scores were 65.0 (± 15.3) and 66.7; PROMIS F SF-7a T-scores were 53.8 (± 8.2) and 55.1; and FACIT-Fatigue scores were 35.0 (± 9.6) and 37.0.RESULTSOf 99 patients from 12 countries enrolled in ARISE, the median age was 69.0 years; most were white (80.8%) and female (77.8%). This was the first diagnosis of MACLD for 72.7% of patients. Patients frequently reported having a comorbid respiratory disorder: bronchiectasis (49.5%), asthma (21.2%), and chronic obstructive pulmonary disease (16.2%). At baseline, mean (± SD) and median QOL-B RD scores were 65.0 (± 15.3) and 66.7; PROMIS F SF-7a T-scores were 53.8 (± 8.2) and 55.1; and FACIT-Fatigue scores were 35.0 (± 9.6) and 37.0.Patients in ARISE were representative of a real-world patient population with MACLD. Comorbid chronic respiratory diseases were common in patients with new or recurrent MACLD, and substantial disease burden at the time physicians initiated MACLD treatment was evidenced by impairment across measures of fatigue and QOL-B domains.CONCLUSIONSPatients in ARISE were representative of a real-world patient population with MACLD. Comorbid chronic respiratory diseases were common in patients with new or recurrent MACLD, and substantial disease burden at the time physicians initiated MACLD treatment was evidenced by impairment across measures of fatigue and QOL-B domains.NCT04677543.GOV IDENTIFIERNCT04677543. Abstract Introduction ARISE was a global clinical trial designed to generate evidence demonstrating the utility of the patient-reported outcome instruments Quality of Life–Bronchiectasis (QOL-B) [Respiratory Domain (RD) only] and Patient-Reported Outcomes Measurement Information System Short Form v1.0-Fatigue 7a (PROMIS F SF-7a) in patients with newly diagnosed or recurrent Mycobacterium avium complex lung disease (MACLD). Here, we describe trial conduct, patient characteristics, and patient-reported symptoms at baseline among patients enrolled in ARISE. Methods Adult patients with newly diagnosed or recurrent non-cavitary MACLD who had not initiated antibiotic treatment for their current MAC infection were enrolled; data including comorbidities and prior MACLD history were collected during screening. Symptom burden was assessed using QOL-B, PROMIS F SF-7a, and Functional Assessment of Chronic Illness Therapy (FACIT) questionnaires. Results Of 99 patients from 12 countries enrolled in ARISE, the median age was 69.0 years; most were white (80.8%) and female (77.8%). This was the first diagnosis of MACLD for 72.7% of patients. Patients frequently reported having a comorbid respiratory disorder: bronchiectasis (49.5%), asthma (21.2%), and chronic obstructive pulmonary disease (16.2%). At baseline, mean (± SD) and median QOL-B RD scores were 65.0 (± 15.3) and 66.7; PROMIS F SF-7a T-scores were 53.8 (± 8.2) and 55.1; and FACIT-Fatigue scores were 35.0 (± 9.6) and 37.0. Conclusions Patients in ARISE were representative of a real-world patient population with MACLD. Comorbid chronic respiratory diseases were common in patients with new or recurrent MACLD, and substantial disease burden at the time physicians initiated MACLD treatment was evidenced by impairment across measures of fatigue and QOL-B domains. ClinicalTrials.gov Identifier NCT04677543. Graphical Abstract IntroductionARISE was a global clinical trial designed to generate evidence demonstrating the utility of the patient-reported outcome instruments Quality of Life–Bronchiectasis (QOL-B) [Respiratory Domain (RD) only] and Patient-Reported Outcomes Measurement Information System Short Form v1.0-Fatigue 7a (PROMIS F SF-7a) in patients with newly diagnosed or recurrent Mycobacterium avium complex lung disease (MACLD). Here, we describe trial conduct, patient characteristics, and patient-reported symptoms at baseline among patients enrolled in ARISE.MethodsAdult patients with newly diagnosed or recurrent non-cavitary MACLD who had not initiated antibiotic treatment for their current MAC infection were enrolled; data including comorbidities and prior MACLD history were collected during screening. Symptom burden was assessed using QOL-B, PROMIS F SF-7a, and Functional Assessment of Chronic Illness Therapy (FACIT) questionnaires.ResultsOf 99 patients from 12 countries enrolled in ARISE, the median age was 69.0 years; most were white (80.8%) and female (77.8%). This was the first diagnosis of MACLD for 72.7% of patients. Patients frequently reported having a comorbid respiratory disorder: bronchiectasis (49.5%), asthma (21.2%), and chronic obstructive pulmonary disease (16.2%). At baseline, mean (± SD) and median QOL-B RD scores were 65.0 (± 15.3) and 66.7; PROMIS F SF-7a T-scores were 53.8 (± 8.2) and 55.1; and FACIT-Fatigue scores were 35.0 (± 9.6) and 37.0.ConclusionsPatients in ARISE were representative of a real-world patient population with MACLD. Comorbid chronic respiratory diseases were common in patients with new or recurrent MACLD, and substantial disease burden at the time physicians initiated MACLD treatment was evidenced by impairment across measures of fatigue and QOL-B domains.ClinicalTrials.gov IdentifierNCT04677543.Plain Language SummaryPeople with a disease called Mycobacterium avium complex lung disease (MACLD) experience many symptoms, including cough, fatigue, and shortness of breath, which can impact their quality of life. It is not clear what symptoms people with new or repeating MACLD may have before they start antibiotic treatment for their disease. This publication describes the design of a study called ARISE, characteristics of people with MACLD who participated, and the symptoms they reported when they started the study. Overall, 99 people with a first, second, or third diagnosis of MACLD, who had not started taking antibiotics, participated in the study. People in the study were on average 69 years old and most were female (78%). This was the first diagnosis of MACLD for more than 70% of people who participated in ARISE. In addition to MACLD, many people also had other respiratory diseases, including bronchiectasis, asthma, and chronic obstructive pulmonary disease. At the start of the study, people completed three questionnaires that measured their symptoms, quality of life, and the severity and frequency of fatigue in their daily life. In these questionnaires, people with MACLD reported that, before starting treatment, they had a high burden of symptoms that impacted their daily lives and quality of life. They also reported more fatigue than people without MACLD. The results from this study were similar to those seen in people with MACLD from registries and other clinical studies. The results also showed that people with MACLD have a large symptom burden before starting treatment. People with a disease called Mycobacterium avium complex lung disease (MACLD) experience many symptoms, including cough, fatigue, and shortness of breath, which can impact their quality of life. It is not clear what symptoms people with new or repeating MACLD may have before they start antibiotic treatment for their disease. This publication describes the design of a study called ARISE, characteristics of people with MACLD who participated, and the symptoms they reported when they started the study. Overall, 99 people with a first, second, or third diagnosis of MACLD, who had not started taking antibiotics, participated in the study. People in the study were on average 69 years old and most were female (78%). This was the first diagnosis of MACLD for more than 70% of people who participated in ARISE. In addition to MACLD, many people also had other respiratory diseases, including bronchiectasis, asthma, and chronic obstructive pulmonary disease. At the start of the study, people completed three questionnaires that measured their symptoms, quality of life, and the severity and frequency of fatigue in their daily life. In these questionnaires, people with MACLD reported that, before starting treatment, they had a high burden of symptoms that impacted their daily lives and quality of life. They also reported more fatigue than people without MACLD. The results from this study were similar to those seen in people with MACLD from registries and other clinical studies. The results also showed that people with MACLD have a large symptom burden before starting treatment. ARISE was a global clinical trial designed to generate evidence demonstrating the utility of the patient-reported outcome instruments Quality of Life-Bronchiectasis (QOL-B) [Respiratory Domain (RD) only] and Patient-Reported Outcomes Measurement Information System Short Form v1.0-Fatigue 7a (PROMIS F SF-7a) in patients with newly diagnosed or recurrent Mycobacterium avium complex lung disease (MACLD). Here, we describe trial conduct, patient characteristics, and patient-reported symptoms at baseline among patients enrolled in ARISE. Adult patients with newly diagnosed or recurrent non-cavitary MACLD who had not initiated antibiotic treatment for their current MAC infection were enrolled; data including comorbidities and prior MACLD history were collected during screening. Symptom burden was assessed using QOL-B, PROMIS F SF-7a, and Functional Assessment of Chronic Illness Therapy (FACIT) questionnaires. Of 99 patients from 12 countries enrolled in ARISE, the median age was 69.0 years; most were white (80.8%) and female (77.8%). This was the first diagnosis of MACLD for 72.7% of patients. Patients frequently reported having a comorbid respiratory disorder: bronchiectasis (49.5%), asthma (21.2%), and chronic obstructive pulmonary disease (16.2%). At baseline, mean (± SD) and median QOL-B RD scores were 65.0 (± 15.3) and 66.7; PROMIS F SF-7a T-scores were 53.8 (± 8.2) and 55.1; and FACIT-Fatigue scores were 35.0 (± 9.6) and 37.0. Patients in ARISE were representative of a real-world patient population with MACLD. Comorbid chronic respiratory diseases were common in patients with new or recurrent MACLD, and substantial disease burden at the time physicians initiated MACLD treatment was evidenced by impairment across measures of fatigue and QOL-B domains. NCT04677543. Introduction ARISE was a global clinical trial designed to generate evidence demonstrating the utility of the patient-reported outcome instruments Quality of Life–Bronchiectasis (QOL-B) [Respiratory Domain (RD) only] and Patient-Reported Outcomes Measurement Information System Short Form v1.0-Fatigue 7a (PROMIS F SF-7a) in patients with newly diagnosed or recurrent Mycobacterium avium complex lung disease (MACLD). Here, we describe trial conduct, patient characteristics, and patient-reported symptoms at baseline among patients enrolled in ARISE. Methods Adult patients with newly diagnosed or recurrent non-cavitary MACLD who had not initiated antibiotic treatment for their current MAC infection were enrolled; data including comorbidities and prior MACLD history were collected during screening. Symptom burden was assessed using QOL-B, PROMIS F SF-7a, and Functional Assessment of Chronic Illness Therapy (FACIT) questionnaires. Results Of 99 patients from 12 countries enrolled in ARISE, the median age was 69.0 years; most were white (80.8%) and female (77.8%). This was the first diagnosis of MACLD for 72.7% of patients. Patients frequently reported having a comorbid respiratory disorder: bronchiectasis (49.5%), asthma (21.2%), and chronic obstructive pulmonary disease (16.2%). At baseline, mean (± SD) and median QOL-B RD scores were 65.0 (± 15.3) and 66.7; PROMIS F SF-7a T-scores were 53.8 (± 8.2) and 55.1; and FACIT-Fatigue scores were 35.0 (± 9.6) and 37.0. Conclusions Patients in ARISE were representative of a real-world patient population with MACLD. Comorbid chronic respiratory diseases were common in patients with new or recurrent MACLD, and substantial disease burden at the time physicians initiated MACLD treatment was evidenced by impairment across measures of fatigue and QOL-B domains. ClinicalTrials.gov Identifier NCT04677543. Graphical Abstract Plain Language Summary People with a disease called Mycobacterium avium complex lung disease (MACLD) experience many symptoms, including cough, fatigue, and shortness of breath, which can impact their quality of life. It is not clear what symptoms people with new or repeating MACLD may have before they start antibiotic treatment for their disease. This publication describes the design of a study called ARISE, characteristics of people with MACLD who participated, and the symptoms they reported when they started the study. Overall, 99 people with a first, second, or third diagnosis of MACLD, who had not started taking antibiotics, participated in the study. People in the study were on average 69 years old and most were female (78%). This was the first diagnosis of MACLD for more than 70% of people who participated in ARISE. In addition to MACLD, many people also had other respiratory diseases, including bronchiectasis, asthma, and chronic obstructive pulmonary disease. At the start of the study, people completed three questionnaires that measured their symptoms, quality of life, and the severity and frequency of fatigue in their daily life. In these questionnaires, people with MACLD reported that, before starting treatment, they had a high burden of symptoms that impacted their daily lives and quality of life. They also reported more fatigue than people without MACLD. The results from this study were similar to those seen in people with MACLD from registries and other clinical studies. The results also showed that people with MACLD have a large symptom burden before starting treatment. |
| Author | Chalmers, James D. Nevoret, Marie-Laure Griffith, David E. Flume, Patrick A. Hasegawa, Naoki Andrisani, Dario Hassan, Mariam Avsar, Korkut Winthrop, Kevin L. Morimoto, Kozo Mange, Kevin Sheu, Chau-Chyun Daley, Charles L. Yuen, Dayton W. Codecasa, Luigi Ruffo |
| Author_xml | – sequence: 1 givenname: Charles L. surname: Daley fullname: Daley, Charles L. organization: National Jewish Health and the University of Colorado School of Medicine – sequence: 2 givenname: James D. surname: Chalmers fullname: Chalmers, James D. organization: Division of Respiratory Medicine and Gastroenterology, Ninewells Hospital and Medical School – sequence: 3 givenname: Patrick A. surname: Flume fullname: Flume, Patrick A. organization: Medical University of South Carolina – sequence: 4 givenname: David E. surname: Griffith fullname: Griffith, David E. organization: National Jewish Health and the University of Colorado School of Medicine – sequence: 5 givenname: Naoki surname: Hasegawa fullname: Hasegawa, Naoki organization: Keio University School of Medicine – sequence: 6 givenname: Kozo surname: Morimoto fullname: Morimoto, Kozo organization: Fukujūji Hospital, Japan Anti-Tuberculosis Association – sequence: 7 givenname: Kevin L. surname: Winthrop fullname: Winthrop, Kevin L. organization: OHSU-PSU School of Public Health – sequence: 8 givenname: Chau-Chyun surname: Sheu fullname: Sheu, Chau-Chyun organization: Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University – sequence: 9 givenname: Korkut surname: Avsar fullname: Avsar, Korkut organization: Lungenaerzte Am Rundfunkplatz – sequence: 10 givenname: Dario surname: Andrisani fullname: Andrisani, Dario organization: Respiratory Disease Unit, Azienda Policlinico di Modena, University of Modena and Reggio Emilia – sequence: 11 givenname: Luigi Ruffo surname: Codecasa fullname: Codecasa, Luigi Ruffo organization: TB Reference Centre and Lab, Villa Marelli Institute, Niguarda Hospital – sequence: 12 givenname: Dayton W. surname: Yuen fullname: Yuen, Dayton W. organization: Insmed Incorporated – sequence: 13 givenname: Mariam surname: Hassan fullname: Hassan, Mariam organization: Insmed Incorporated – sequence: 14 givenname: Marie-Laure surname: Nevoret fullname: Nevoret, Marie-Laure email: marielaure.nevoret@insmed.com organization: Insmed Incorporated – sequence: 15 givenname: Kevin surname: Mange fullname: Mange, Kevin organization: Insmed Incorporated |
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| Snippet | Introduction
ARISE was a global clinical trial designed to generate evidence demonstrating the utility of the patient-reported outcome instruments Quality of... ARISE was a global clinical trial designed to generate evidence demonstrating the utility of the patient-reported outcome instruments Quality of... IntroductionARISE was a global clinical trial designed to generate evidence demonstrating the utility of the patient-reported outcome instruments Quality of... People with a disease called Mycobacterium avium complex lung disease (MACLD) experience many symptoms, including cough, fatigue, and shortness of breath,... Abstract Introduction ARISE was a global clinical trial designed to generate evidence demonstrating the utility of the patient-reported outcome instruments... |
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| SubjectTerms | Amikacin liposome inhalation suspension Antibiotics Asthma Chronic illnesses Chronic obstructive pulmonary disease Clinical trial Comorbidity Family Medicine General Practice Internal Medicine Lung diseases Medicine Medicine & Public Health Mycobacterium avium complex lung disease Nontuberculous mycobacterial lung disease Original Research Patient-reported outcomes Patients Pharmacoeconomics and Health Outcomes Pharmacotherapy Pneumology/Respiratory System Quality of life Quality of Life Research Questionnaires Respiratory diseases |
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| Title | Trial Conduct, Baseline Characteristics, and Symptom Burden of Patients in the ARISE Study |
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