Health- and Vision-Related Quality of Life in a Randomized Controlled Trial Comparing Methotrexate and Mycophenolate Mofetil for Uveitis
Copyright © 2021 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved..
PURPOSE: To evaluate changes in health-related and vision-related quality of life (VRQoL) among patients with noninfectious uveitis who were treated with antimetabolites.
DESIGN: Secondary analysis of a randomized controlled trial.
PARTICIPANTS: Patients with noninfectious uveitis from India, the United States, Australia, Saudi Arabia, and Mexico.
METHODS: From 2013 through 2017, 216 participants were randomized to receive 25 mg weekly oral methotrexate or 1.5 g twice daily oral mycophenolate mofetil. Median changes in quality of life (QoL) were measured using Wilcoxon signed-rank tests, and differences between treatment groups were measured using linear mixed models, adjusting for baseline QoL score, age, gender, and site. Among Indian patients, VRQoL scores from a general scale (the National Eye Institute Visual Function Questionnaire [NEI-VFQ]) and a culturally specific scale (the Indian Visual Function Questionnaire [IND-VFQ]) were compared using Pearson correlation tests.
MAIN OUTCOME MEASURES: Vision-related QoL (NEI-VFQ and IND-VFQ) and health-related QoL (HRQoL; physical component score [PCS] and mental component score [MCS] of the Medical Outcomes Study 36-Item Short Form Survey [SF-36v2]) were measured at baseline, the primary end point (6 months or treatment failure before 6 months), and the secondary end point (12 months or treatment failure between 6 and 12 months).
RESULTS: Among 193 participants who reached the primary end point, VRQoL increased from baseline by a median of 12.0 points (interquartile range [IQR], 1.0-26.1, NEI-VFQ scale), physical HRQoL increased by a median of 3.6 points (IQR, -1.4 to 14.9, PCS SF-36v2), and mental HRQoL increased by a median of 3.0 points (IQR, -3.7 to 11.9, MCS SF-36v2). These improvements in NEI-VFQ, SF-36v2 PCS, and SF-36v2 MCS scores all were significant (P < 0.01). The linear mixed models showed that QoL did not differ between treatment groups for each QoL assessment (NEI-VFQ, IND-VFQ, PCS SF-36v2, and MCS SF-36v2; P > 0.05 for all). The NEI-VFQ and IND-VFQ scores for Indian participants were correlated highly at baseline and the primary and secondary end points (correlation coefficients, 0.87, 0.80, and 0.90, respectively).
CONCLUSIONS: Among patients treated with methotrexate or mycophenolate mofetil for uveitis, VRQoL and HRQoL improved significantly over the course of 1 year and did not differ by treatment allocation. These findings suggest that antimetabolites could improve overall patient well-being and daily functioning.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:128 |
|---|---|
| Enthalten in: |
Ophthalmology - 128(2021), 9 vom: 15. Sept., Seite 1337-1345 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kelly, Nicole K [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 22.11.2021 Date Revised 02.09.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.ophtha.2021.02.024 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM322331021 |
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| 100 | 1 | |a Kelly, Nicole K |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Health- and Vision-Related Quality of Life in a Randomized Controlled Trial Comparing Methotrexate and Mycophenolate Mofetil for Uveitis |
| 264 | 1 | |c 2021 | |
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| 500 | |a Date Completed 22.11.2021 | ||
| 500 | |a Date Revised 02.09.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2021 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a PURPOSE: To evaluate changes in health-related and vision-related quality of life (VRQoL) among patients with noninfectious uveitis who were treated with antimetabolites | ||
| 520 | |a DESIGN: Secondary analysis of a randomized controlled trial | ||
| 520 | |a PARTICIPANTS: Patients with noninfectious uveitis from India, the United States, Australia, Saudi Arabia, and Mexico | ||
| 520 | |a METHODS: From 2013 through 2017, 216 participants were randomized to receive 25 mg weekly oral methotrexate or 1.5 g twice daily oral mycophenolate mofetil. Median changes in quality of life (QoL) were measured using Wilcoxon signed-rank tests, and differences between treatment groups were measured using linear mixed models, adjusting for baseline QoL score, age, gender, and site. Among Indian patients, VRQoL scores from a general scale (the National Eye Institute Visual Function Questionnaire [NEI-VFQ]) and a culturally specific scale (the Indian Visual Function Questionnaire [IND-VFQ]) were compared using Pearson correlation tests | ||
| 520 | |a MAIN OUTCOME MEASURES: Vision-related QoL (NEI-VFQ and IND-VFQ) and health-related QoL (HRQoL; physical component score [PCS] and mental component score [MCS] of the Medical Outcomes Study 36-Item Short Form Survey [SF-36v2]) were measured at baseline, the primary end point (6 months or treatment failure before 6 months), and the secondary end point (12 months or treatment failure between 6 and 12 months) | ||
| 520 | |a RESULTS: Among 193 participants who reached the primary end point, VRQoL increased from baseline by a median of 12.0 points (interquartile range [IQR], 1.0-26.1, NEI-VFQ scale), physical HRQoL increased by a median of 3.6 points (IQR, -1.4 to 14.9, PCS SF-36v2), and mental HRQoL increased by a median of 3.0 points (IQR, -3.7 to 11.9, MCS SF-36v2). These improvements in NEI-VFQ, SF-36v2 PCS, and SF-36v2 MCS scores all were significant (P < 0.01). The linear mixed models showed that QoL did not differ between treatment groups for each QoL assessment (NEI-VFQ, IND-VFQ, PCS SF-36v2, and MCS SF-36v2; P > 0.05 for all). The NEI-VFQ and IND-VFQ scores for Indian participants were correlated highly at baseline and the primary and secondary end points (correlation coefficients, 0.87, 0.80, and 0.90, respectively) | ||
| 520 | |a CONCLUSIONS: Among patients treated with methotrexate or mycophenolate mofetil for uveitis, VRQoL and HRQoL improved significantly over the course of 1 year and did not differ by treatment allocation. These findings suggest that antimetabolites could improve overall patient well-being and daily functioning | ||
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Antimetabolites | |
| 650 | 4 | |a Quality of life | |
| 650 | 4 | |a uveitis | |
| 650 | 7 | |a Enzyme Inhibitors |2 NLM | |
| 650 | 7 | |a Immunosuppressive Agents |2 NLM | |
| 650 | 7 | |a Mycophenolic Acid |2 NLM | |
| 650 | 7 | |a HU9DX48N0T |2 NLM | |
| 650 | 7 | |a Methotrexate |2 NLM | |
| 650 | 7 | |a YL5FZ2Y5U1 |2 NLM | |
| 700 | 1 | |a Chattopadhyay, Aheli |e verfasserin |4 aut | |
| 700 | 1 | |a Rathinam, S R |e verfasserin |4 aut | |
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| 700 | 1 | |a Thundikandy, Radhika |e verfasserin |4 aut | |
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| 700 | 1 | |a Murugan, S Bala |e verfasserin |4 aut | |
| 700 | 1 | |a Vedhanayaki, R |e verfasserin |4 aut | |
| 700 | 1 | |a Cugley, Dean |e verfasserin |4 aut | |
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| 700 | 1 | |a Porco, Travis C |e verfasserin |4 aut | |
| 700 | 1 | |a Acharya, Nisha R |e verfasserin |4 aut | |
| 700 | 0 | |a FAST Research Group |e verfasserin |4 aut | |
| 700 | 1 | |a Rathinam, S R |e investigator |4 oth | |
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| 700 | 1 | |a Sivarama Subramanian, A L |e investigator |4 oth | |
| 700 | 1 | |a Jeyakohila, G |e investigator |4 oth | |
| 700 | 1 | |a Evangelin, Gracy |e investigator |4 oth | |
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| 700 | 1 | |a Nirmaladevi, N J |e investigator |4 oth | |
| 700 | 1 | |a Siddiq, Mohammed |e investigator |4 oth | |
| 700 | 1 | |a Vijayakumar, B |e investigator |4 oth | |
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| 700 | 1 | |a Kanakath, Anuradha |e investigator |4 oth | |
| 700 | 1 | |a Saravanan, V R |e investigator |4 oth | |
| 700 | 1 | |a Babu, Upendra |e investigator |4 oth | |
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