Overview of COA Measures in SLE Clinical Trials and Label Claims
Само за регистроване кориснике
2023
Конференцијски прилог (Објављена верзија)
,
Elsevier
Метаподаци
Приказ свих података о документуАпстракт
Background
Systematic lupus erythematosus (SLE) is a condition linked with high symptom burden and severe quality of life (QoL) impacts. The FDA and EMA SLE guidance recommends inclusion of clinical outcome assessments (COAs), such as those assessing disease activity, fatigue, and quality of life in SLE clinical trials. The objective of this review is to review the landscape of COAs that were included in SLE clinical trials and FDA and EMA drug labels.
Methods
The PROLABELS database was reviewed to identify COA-related label claims for approved SLE products (FDA and EMA). The data base was searched for all results relating to “Lupus erythematosus, systemic”; results were not limited to a single timeframe. A review of the Clinicaltrials.gov website was also performed to identify COAs used in SLE clinical trials in the past 10 years. Search criteria for “SLE” and “systemic lupus erythematosus” were used; the review was limited to trials that met the following limits: (1) complet...ed, (2) interventional, (3) Phase III, and (4) conducted in the past ten years.
Results
Three drug approvals with COAs included in the label were identified via the PROLABELs database. Two approvals were granted by the EMA (Benlysta, 2011 and Saphnelo, 2022) and one was also approved by the FDA (Benlysta, 2011). Fatigue was the only PRO , while the rest included ClinROs assessing flares and disease activity. A total of eleven clinical trials meeting the criteria were identified. Five included PROs and nine included ClinROs used to support primary and secondary endpoints. The most frequently utilized PROs (primary and secondary endpoints) in clinical trials were the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) (n=3), and Lupus Quality of Life Questionnaire (LupusQoL) (n=2). The majority of ClinROs used supported primary composite endpoints for disease activity.
Conclusions
The review of labels for approved SLE drugs indicated only a single drug that included a PRO in the label. PROs in SLE trials were not consistently used and unlikely assessed all meaningful outcomes. Future SLE drug development should focus on improving meaningful outcomes for patients, especially those relating to QoL impacts.
Кључне речи:
clinical outcome assessment / systematic lupus erythematosus / drugs / quality of lifeИзвор:
Value in Health, 2023, 26, 12, s28-Издавач:
- Elsevier
Институција/група
Psihologija / PsychologyTY - CONF AU - Suminski, Naomi AU - Zupan, Zorana AU - Rudell, Katja PY - 2023 UR - http://reff.f.bg.ac.rs/handle/123456789/6013 AB - Background Systematic lupus erythematosus (SLE) is a condition linked with high symptom burden and severe quality of life (QoL) impacts. The FDA and EMA SLE guidance recommends inclusion of clinical outcome assessments (COAs), such as those assessing disease activity, fatigue, and quality of life in SLE clinical trials. The objective of this review is to review the landscape of COAs that were included in SLE clinical trials and FDA and EMA drug labels. Methods The PROLABELS database was reviewed to identify COA-related label claims for approved SLE products (FDA and EMA). The data base was searched for all results relating to “Lupus erythematosus, systemic”; results were not limited to a single timeframe. A review of the Clinicaltrials.gov website was also performed to identify COAs used in SLE clinical trials in the past 10 years. Search criteria for “SLE” and “systemic lupus erythematosus” were used; the review was limited to trials that met the following limits: (1) completed, (2) interventional, (3) Phase III, and (4) conducted in the past ten years. Results Three drug approvals with COAs included in the label were identified via the PROLABELs database. Two approvals were granted by the EMA (Benlysta, 2011 and Saphnelo, 2022) and one was also approved by the FDA (Benlysta, 2011). Fatigue was the only PRO , while the rest included ClinROs assessing flares and disease activity. A total of eleven clinical trials meeting the criteria were identified. Five included PROs and nine included ClinROs used to support primary and secondary endpoints. The most frequently utilized PROs (primary and secondary endpoints) in clinical trials were the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) (n=3), and Lupus Quality of Life Questionnaire (LupusQoL) (n=2). The majority of ClinROs used supported primary composite endpoints for disease activity. Conclusions The review of labels for approved SLE drugs indicated only a single drug that included a PRO in the label. PROs in SLE trials were not consistently used and unlikely assessed all meaningful outcomes. Future SLE drug development should focus on improving meaningful outcomes for patients, especially those relating to QoL impacts. PB - Elsevier C3 - Value in Health T1 - Overview of COA Measures in SLE Clinical Trials and Label Claims IS - 12 SP - s28 VL - 26 DO - https://doi.org/10.1016/j.jval.2023.09.145 ER -
@conference{ author = "Suminski, Naomi and Zupan, Zorana and Rudell, Katja", year = "2023", abstract = "Background Systematic lupus erythematosus (SLE) is a condition linked with high symptom burden and severe quality of life (QoL) impacts. The FDA and EMA SLE guidance recommends inclusion of clinical outcome assessments (COAs), such as those assessing disease activity, fatigue, and quality of life in SLE clinical trials. The objective of this review is to review the landscape of COAs that were included in SLE clinical trials and FDA and EMA drug labels. Methods The PROLABELS database was reviewed to identify COA-related label claims for approved SLE products (FDA and EMA). The data base was searched for all results relating to “Lupus erythematosus, systemic”; results were not limited to a single timeframe. A review of the Clinicaltrials.gov website was also performed to identify COAs used in SLE clinical trials in the past 10 years. Search criteria for “SLE” and “systemic lupus erythematosus” were used; the review was limited to trials that met the following limits: (1) completed, (2) interventional, (3) Phase III, and (4) conducted in the past ten years. Results Three drug approvals with COAs included in the label were identified via the PROLABELs database. Two approvals were granted by the EMA (Benlysta, 2011 and Saphnelo, 2022) and one was also approved by the FDA (Benlysta, 2011). Fatigue was the only PRO , while the rest included ClinROs assessing flares and disease activity. A total of eleven clinical trials meeting the criteria were identified. Five included PROs and nine included ClinROs used to support primary and secondary endpoints. The most frequently utilized PROs (primary and secondary endpoints) in clinical trials were the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) (n=3), and Lupus Quality of Life Questionnaire (LupusQoL) (n=2). The majority of ClinROs used supported primary composite endpoints for disease activity. Conclusions The review of labels for approved SLE drugs indicated only a single drug that included a PRO in the label. PROs in SLE trials were not consistently used and unlikely assessed all meaningful outcomes. Future SLE drug development should focus on improving meaningful outcomes for patients, especially those relating to QoL impacts.", publisher = "Elsevier", journal = "Value in Health", title = "Overview of COA Measures in SLE Clinical Trials and Label Claims", number = "12", pages = "s28", volume = "26", doi = "https://doi.org/10.1016/j.jval.2023.09.145" }
Suminski, N., Zupan, Z.,& Rudell, K.. (2023). Overview of COA Measures in SLE Clinical Trials and Label Claims. in Value in Health Elsevier., 26(12), s28. https://doi.org/https://doi.org/10.1016/j.jval.2023.09.145
Suminski N, Zupan Z, Rudell K. Overview of COA Measures in SLE Clinical Trials and Label Claims. in Value in Health. 2023;26(12):s28. doi:https://doi.org/10.1016/j.jval.2023.09.145 .
Suminski, Naomi, Zupan, Zorana, Rudell, Katja, "Overview of COA Measures in SLE Clinical Trials and Label Claims" in Value in Health, 26, no. 12 (2023):s28, https://doi.org/https://doi.org/10.1016/j.jval.2023.09.145 . .