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5. Treatment Tolerability in Patients with Immunoglobulin Light-Chain Amyloidosis

Author

Rizio, Avery A., White, Michelle K., McCausland, Kristen L., Quock, Tiffany P., Guthrie, Spencer D., Yokota, Miyo, and Bayliss, Martha S.

Subjects
Clinical
Abstract

Immunoglobulin light-chain amyloidosis (AL amyloidosis) is a rare and often fatal disease for which there is currently no treatment approved by the US Food and Drug Administration or the European Medicines Agency. Treatment options, which are typically based on therapies for multiple myeloma and are used off-label, are associated with substantial adverse events (AEs). Because the severity of AEs is often determined by clinicians, evaluations of treatment tolerability may not fully consider patients' own experience with treatment.To explore the prevalence of AEs and treatment tolerability problems as reported by patients who received therapies for AL amyloidosis, and to examine the effects of AEs on treatment continuation and on health-related quality of life (HRQOL).Patients with AL amyloidosis were recruited for this noninterventional, longitudinal, online survey. The patients responded to survey items regarding demographics, disease characteristics, most recent AL amyloidosis treatment, and HRQOL. The study analyses are based on data collected during the 6-month follow-up survey and are restricted to patients who completed the baseline and 6-month surveys and received treatment for AL amyloidosis within 6 months before the follow-up survey.A total of 100 patients met the inclusion criteria and were included in the study. The patients self-reported having a variety of AEs, which ranged in severity. Overall, 69.4% of patients had problems tolerating their treatment in the past 6 months, of whom 22% discontinued at least 1 therapy. In addition, approximately 33% of patients reduced their AL amyloidosis treatment because of AEs. Most often reported AEs included fatigue (83%), shortness of breath (53%), nausea (52%), and diarrhea (51%). Overall, 50% of the patients reported that their treatment was moderately well-tolerated and 41% said it was very well-tolerated. Those whose treatment was not well-tolerated had significantly worse HRQOL than patients whose treatment was well-tolerated.Patient-reported experiences should be considered by clinicians when making treatment-related decisions. More research is needed to explore additional factors that may contribute to treatment discontinuation in patients with AL amyloidosis.

Published
2018

6. Burden of hereditary transthyretin amyloidosis on quality of life

Author

Yarlas, Aaron, primary, Gertz, Morie A., additional, Dasgupta, Noel R., additional, Obici, Laura, additional, Pollock, Michael, additional, Ackermann, Elizabeth J., additional, Lovley, Andrew, additional, Kessler, Asia Sikora, additional, Patel, Pankaj A., additional, White, Michelle K., additional, and Guthrie, Spencer D., additional

Published
2019
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12. Psychometric validation of the SF-36 Health Survey in light chain amyloidosis: results from community-based and clinic-based samples

Author

White,Michelle K, McCausland,Kristen L, Sanchorawala,Vaishali, Guthrie,Spencer D, Bayliss,Martha S, White,Michelle K, McCausland,Kristen L, Sanchorawala,Vaishali, Guthrie,Spencer D, and Bayliss,Martha S

Abstract

Michelle K White,1 Kristen L McCausland,1 Vaishali Sanchorawala,2 Spencer D Guthrie,3 Martha S Bayliss1 1Optum, Johnston, RI, 2Department of Medicine, Section of Hematology/Oncology, Amyloidosis Center, Boston University School of Medicine, Boston, MA, 3Medical Affairs, Prothena Biosciences Inc, South San Francisco, CA, USA Background: Light chain (AL) amyloidosis, a rare and life-threatening protein misfolding disorder, causes organ damage and severely impacts health-related quality of life (HRQoL). No patient-reported outcome (PRO) HRQoL measure has been validated for use in an AL amyloidosis patient population, leaving a gap for researchers conducting observational studies and clinical trials for drug development. The SF-36 Health Survey (SF-36) has been the most frequently used PRO in AL amyloidosis studies to date, and early qualitative validation studies support its use in this population. The aim of this study was to assess the psychometric properties of the SF-36 among patients with AL amyloidosis. Methods: Data from community-based (n=341) and clinic-based (n=1,438) observational studies were used to document the psychometric properties of the SF-36 in this disease population. Reliability was estimated using internal consistency (Cronbach’s alpha) and test–retest reliability (intraclass correlation). Convergent validity, known-groups validity, and the ability to detect change were assessed with available criterion variables. Results: Scale reliability (Cronbach’s alpha  ≥0.780 for all scores) and test–retest reliability (intraclass correlation coefficients ≥0.731 for all) were acceptable. Scale convergent validity was supported by strong correlations with conceptually related measures. Mean SF-36 scores varied by response to treatment (P<0.05 for all scores) and a self-reported measure of disease severity (P<0.001 for all scores). Data indicate that the SF-36 is sensitive to chan

Published
2017

15. Impact of NEOD001 on Neuropathy in Patients With Light Chain Amyloidosis and Persistent Organ Dysfunction: Results From the Expansion Phase of a Phase 1/2 Study (S5.001)

Author

Liedtke, Michaela, primary, Comenzo, Raymond L., additional, Landau, Heather, additional, Sanchorawala, Vaishali, additional, Weiss, Brendan M., additional, Zonder, Jeffrey, additional, Walling, Jackie, additional, Kinney, Gene G., additional, Koller, Martin, additional, Schenk, Dale B., additional, Guthrie, Spencer D., additional, Liu, Enchi, additional, and Gertz, Morie A., additional

Published
2017
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16. Organ Biomarker Responses in Patients With Light Chain Amyloidosis Treated With NEOD001 Are Independent of Previous Hematologic Response

Author

Gertz, Morie A., primary, Comenzo, Raymond L., additional, Landau, Heather, additional, Sanchorawala, Vaishali, additional, Weiss, Brendan M., additional, Zonder, Jeffrey A., additional, Walling, Jackie, additional, Kinney, Gene G., additional, Koller, Martin, additional, Schenk, Dale B., additional, Guthrie, Spencer D., additional, Liu, Enchi, additional, and Liedtke, Michaela, additional

Published
2017
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17. NEOD001 Demonstrates Organ Biomarker Responses in Patients With Light Chain Amyloidosis and Persistent Organ Dysfunction: Results From a Phase 1/2 Study

Author

Gertz, Morie A., primary, Comenzo, Raymond L., additional, Landau, Heather, additional, Sanchorawala, Vaishali, additional, Weiss, Brendan M., additional, Zonder, Jeffrey A., additional, Walling, Jackie, additional, Kinney, Gene G., additional, Koller, Martin, additional, Schenk, Dale B., additional, Guthrie, Spencer D., additional, Liu, Enchi, additional, and Liedtke, Michaela, additional

Published
2017
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19. Organ Biomarker Responses in Patients with Light Chain Amyloidosis Treated with NEOD001 Are Independent of Previous Hematologic Response

Author

Liedtke, Michaela, primary, Comenzo, Raymond L., additional, Landau, Heather, additional, Sanchorawala, Vaishali, additional, Weiss, Brendan M., additional, Zonder, Jeffrey A., additional, Walling, Jackie, additional, Kinney, Gene G., additional, Koller, Martin, additional, Schenk, Dale B., additional, Guthrie, Spencer D., additional, Liu, Enchi, additional, and Gertz, Morie A., additional

Published
2016
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25. NEOD001 Demonstrates Organ Biomarker Responses in Patients with Light Chain Amyloidosis and Persistent Organ Dysfunction: Results from the Expansion Cohort of a Phase 1/2 Study

Author

Gertz, Morie A., primary, Comenzo, Raymond L., additional, Landau, Heather, additional, Sanchorawala, Vaishali, additional, Weiss, Brendan M., additional, Zonder, Jeffrey A., additional, Walling, Jackie, additional, Kinney, Gene G., additional, Koller, Martin, additional, Schenk, Dale B., additional, Guthrie, Spencer D., additional, Liu, Enchi, additional, and Liedtke, Michaela, additional

Published
2016
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26. Cardiac biomarkers and health‐related quality of life in patients with light chain (AL) amyloidosis.

Author

McCausland, Kristen L., Quock, Tiffany P., Rizio, Avery A., Bayliss, Martha S., White, Michelle K., Guthrie, Spencer D., and Sanchorawala, Vaishali

Subjects
CARDIAC amyloidosis, QUALITY of life, BIOMARKERS, CLINICAL trial registries
Abstract

The article focuses on a study which examines cardiac biomarkers as well as the health-related quality of life in patients with light chain (AL) amyloidosis, which is a rare and often fatal disease caused by misfolded light chains, that form soluble toxic aggregates that deposit as fibrils in tissue and organs. Information about disease progression and cardiac response to treatment is presented.

Published
2019
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27. NEOD001 Demonstrates Cardiac Responses in Patients with Light Chain Amyloidosis and Persistent Organ Dysfunction in a Phase 1/2 Study Expansion

Author

Liedtke, Michaela, primary, Comenzo, Raymond L., additional, Landau, Heather, additional, Sanchorawala, Vaishali, additional, Weiss, Brendan, additional, Zonder, Jeffrey, additional, Walling, Jackie, additional, Kinney, Gene G., additional, Koller, Martin, additional, Schenk, Dale B., additional, Guthrie, Spencer D., additional, Liu, Enchi, additional, and Gertz, Morie A., additional

Published
2016
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28. The PRONTO amyloidosis study: A randomized, double-blind, placebo-controlled, global, phase 2b study of NEOD001 in previously treated subjects with light chain amyloidosis and persistent cardiac dysfunction.

Author

Merlini, Giampaolo, primary, Liedtke, Michaela, additional, Landau, Heather Jolie, additional, Comenzo, Raymond L., additional, Sanchorawala, Vaishali, additional, Weiss, Brendan M., additional, Zonder, Jeffrey A., additional, Schönland, Stefan, additional, Guthrie, Spencer D., additional, Walling, Jackie, additional, Kinney, Gene G., additional, Koller, Martin, additional, and Gertz, Morie A., additional

Published
2016
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29. First-in-Human Phase I/II Study of NEOD001 in Patients With Light Chain Amyloidosis and Persistent Organ Dysfunction

Author

Gertz, Morie A., primary, Landau, Heather, additional, Comenzo, Raymond L., additional, Seldin, David, additional, Weiss, Brendan, additional, Zonder, Jeffrey, additional, Merlini, Giampaolo, additional, Schönland, Stefan, additional, Walling, Jackie, additional, Kinney, Gene G., additional, Koller, Martin, additional, Schenk, Dale B., additional, Guthrie, Spencer D., additional, and Liedtke, Michaela, additional

Published
2016
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33. Epidemiology of AL Amyloidosis in a US Commercially Insured Population

Author

Quock, Tiffany P., Yan, Jessie T., Chang, Eunice, Guthrie, Spencer D, and Broder, Michael S.

Abstract

Introduction:Amyloid light chain (AL) amyloidosis is a rare, progressive, and typically fatal disease caused by extracellular deposition of misfolded immunoglobulin light chains. There is a paucity of epidemiological studies of AL amyloidosis, and many existing studies are not recent. The objective of the current study was to provide an up-to-date estimate of the prevalence and incidence of AL amyloidosis in the US.

Published
2017
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34. Associations between Socioeconomic Status and Health-Related Quality of Life in Patients with AL Amyloidosis

Author

McCausland, Kristen L., White, Michelle K, Yokota, Miyo, Quock, Tiffany P., Guthrie, Spencer D, Bayliss, Martha S, and Sanchorawala, Vaishali

Abstract

Introduction:Socioeconomic status (SES) can affect health-related quality of life (HRQoL) through a variety of mechanisms, including poor access to healthcare, physical and mental health comorbidities, low levels of health literacy or health activation, and consequent negative health behaviors. The impact of low SES on HRQoL of patients with AL amyloidosis, however, has not been well described. AL amyloidosis is a rare, complex disease associated with significant organ dysfunction, disability, and death. Although patients with AL amyloidosis report significant HRQoL impairments, it is likely that patients in lower SES groups report even greater deficits. The aim of this study was to assess the impact of SES on HRQoL in AL amyloidosis patients.

Published
2017
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35. Healthcare Utilization and Costs in Commercially Insured Patients with AL Amyloidosis

Author

Quock, Tiffany P., Yan, Jessie T., Chang, Eunice, Guthrie, Spencer D, and Broder, Michael S.

Abstract

Objectives: Amyloid light chain (AL) amyloidosis is a rare, progressive, and typically fatal disease caused by extracellular deposition of misfolded immunoglobulin light chains (LCs). Soluble toxic aggregates and deposited fibrils (amyloid) lead to progressive failure of vital organs, including the heart, kidneys, and nervous system, causing significant morbidity and mortality. Its effects on resource utilization are poorly understood. The aim of this study was to estimate healthcare utilization and costs among patients with AL amyloidosis.

Published
2017
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36. Health Utility Analyses in AL Amyloidosis — Existing Mapping Algorithms May be Inadequate

Author

McCausland, Kristen L., Bjorner, Jakob, Quock, Tiffany P., Guthrie, Spencer D, White, Michelle K, and Bayliss, Martha S

Abstract

Introduction:Economic analyses in health research often needs outcomes assessed as a single number - a health utility score - defined by anchors of perfect health = 1 and death = 0. Two survey-based health utility measures are the EQ-5D and the SF-6D. The SF-6D is derived from responses to the SF-36® Health Survey (SF-36). Utility scores have been derived separately for each measure by analyses of preferences for different health states, but the two measures often give different results. For this reason, mapping algorithms have been developed to directly predict EQ-5D scores from the SF-36. We aimed to evaluate whether existing SF-36-to-EQ-5D mapping algorithms are appropriate for AL amyloidosis patients in clinical trials.

Published
2017
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37. Treatment Tolerability in Patients with Immunoglobulin Light-Chain Amyloidosis.

Author

Rizio AA, White MK, McCausland KL, Quock TP, Guthrie SD, Yokota M, and Bayliss MS

Abstract

Background: Immunoglobulin light-chain amyloidosis (AL amyloidosis) is a rare and often fatal disease for which there is currently no treatment approved by the US Food and Drug Administration or the European Medicines Agency. Treatment options, which are typically based on therapies for multiple myeloma and are used off-label, are associated with substantial adverse events (AEs). Because the severity of AEs is often determined by clinicians, evaluations of treatment tolerability may not fully consider patients' own experience with treatment., Objectives: To explore the prevalence of AEs and treatment tolerability problems as reported by patients who received therapies for AL amyloidosis, and to examine the effects of AEs on treatment continuation and on health-related quality of life (HRQOL)., Methods: Patients with AL amyloidosis were recruited for this noninterventional, longitudinal, online survey. The patients responded to survey items regarding demographics, disease characteristics, most recent AL amyloidosis treatment, and HRQOL. The study analyses are based on data collected during the 6-month follow-up survey and are restricted to patients who completed the baseline and 6-month surveys and received treatment for AL amyloidosis within 6 months before the follow-up survey., Results: A total of 100 patients met the inclusion criteria and were included in the study. The patients self-reported having a variety of AEs, which ranged in severity. Overall, 69.4% of patients had problems tolerating their treatment in the past 6 months, of whom 22% discontinued at least 1 therapy. In addition, approximately 33% of patients reduced their AL amyloidosis treatment because of AEs. Most often reported AEs included fatigue (83%), shortness of breath (53%), nausea (52%), and diarrhea (51%). Overall, 50% of the patients reported that their treatment was moderately well-tolerated and 41% said it was very well-tolerated. Those whose treatment was not well-tolerated had significantly worse HRQOL than patients whose treatment was well-tolerated., Conclusions: Patient-reported experiences should be considered by clinicians when making treatment-related decisions. More research is needed to explore additional factors that may contribute to treatment discontinuation in patients with AL amyloidosis.

Published
2018

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