Health- and Vision-Related Quality of Life in a Randomized Controlled Trial Comparing Methotrexate and Mycophenolate Mofetil for Uveitis

To evaluate changes in health-related and vision-related quality of life (VRQoL) among patients with noninfectious uveitis who were treated with antimetabolites. Secondary analysis of a randomized controlled trial. Patients with noninfectious uveitis from India, the United States, Australia, Saudi A...

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Published in:	Ophthalmology (Rochester, Minn.) Vol. 128; no. 9; pp. 1337 - 1345
Main Authors:	Kelly, Nicole K., Chattopadhyay, Aheli, Rathinam, S.R., Thundikandy, Radhika, Kanakath, Anuradha, Murugan, S. Bala, Vedhanayaki, R., Cugley, Dean, Lim, Lyndell L., Suhler, Eric B., Al-Dhibi, Hassan A., Ebert, Caleb D., Berlinberg, Elyse J., Porco, Travis C., Acharya, Nisha R., Jeyakohila, G., Evangelin, Gracy, Azhagupandi, A.M., Praba, C.V., Bharati, S., Gomathi, S., Nirmaladevi, N.J., Siddiq, Mohammed, Saravanan, V.R., Srija, R., Dhanalakshmi, S., Sakthimari, R.R., Mallika, A.M., Vasanthi, C., Mariselvi, P.B., Pandeeswari, P., Bala Murugan, S., Thilagavathi, R., Krishnakumari, Chitra, Nagarasi, S., Gnansi, Kiruba, Arellanes-Garcia, Lourdes, Concha del Rio, Luz Elena, Kalb, Rashel Cheja, Fernández, Nancy, Burgoa, Yoko, Hernández, Hilda, Cuello, Roberto Fabela, Martínez Garcia, Lorenzo Agustín, Rodríguez, Ricardo Montoya, Arreola, Andrea, Al-Shamrani, Mohammed, Al-Hommadi, Abdulrahman, Mashan, Eman, Al-Ghamdi, Mizher, Al-Tuwejri, Ayshah, Goldstein, Debra A., Castro-Malek, Anna Liza, Dela Rosa, Gemma, Skelly, Marriner, Suhler, Eric, Salek, Sherveen, Biggee, Kristin, Shifera, Amde, Kopplin, Laura, Mount, George, Giles, Tracy, Nolte, Susan, Lundquist, Ann, Liesegang, Teresa, Romo, Albert, Howell, Chris, Pickell, Scott, Steinkemp, Peter, Ryan, Dawn, Hui, Jocelyn, Ukachukwu, Chiedozie, Lim, Lyndell, Stawell, Richard, Troutbeck, Robyn, Fagan, Xavier, Bosco, Julian, Godfrey, Timothy, D’Sylva, Carly, Tonder, Tina-Marie van, Acharya, Nisha, Gonzales, John, Doan, Thuy, Lopez, Sarah, Rao, Maya, Browne, Erica, Hom, Betty, Lee, Salena, Lietman, Thomas, Nguyen, Hieu, Maguire, Maureen G., Barlow, William E., Yeh, Steven, Vitale, Albert T., Glover, Jaqueline J., Rao, Narsing A.
Format:	Journal Article
Language:	English
Published:	United States Elsevier Inc 01-09-2021
Subjects:	Antimetabolites Quality of life uveitis PCS CI IND-VFQ IQR uveitis Antimetabolites Quality of life QoL VRQoL SF-36v2 MCID NEI-VFQ HRQoL FAST MCS
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Summary:	To evaluate changes in health-related and vision-related quality of life (VRQoL) among patients with noninfectious uveitis who were treated with antimetabolites. Secondary analysis of a randomized controlled trial. Patients with noninfectious uveitis from India, the United States, Australia, Saudi Arabia, and Mexico. 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. 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). 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). 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.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 ObjectType-News-3 content type line 23 Coordinating Center, University of California, San Francisco, CA: Nisha Acharya, MD, MS; Travis Porco, PhD, MPH; Thomas Lietman, MD; Jeremy Keenan, MD, MPH; Eric Kim, MA; Hieu Nguyen, MS; Caleb Ebert, MPH; Former members: Maya Rao, MPH; Elyse Berlinberg, BS; Erica Browne, MS; Andrew Hirst, MS, Rachel Weinrib, MPH National Eye Institute Program Director for Collaborative Clinical Research: Donald F. Everett, MA Data and Safety Monitoring Committee:Voting members: Maureen G. Maguire, PhD (Chair); William E. Barlow, PhD; Steven Yeh, MD; Albert T. Vitale, MD; Jaqueline J. Glover, PhD; Narsing A. Rao, MD; Former member. Debra A. Goldstein, MD Resource Centers Credit Roster for the FAST Research Group Aravind Eye Hospital, Coimbatore, India: Anuradha Kanakath, MD (Director); V.R. Saravanan, MD; Upendra Babu, MD; R. Srija; S. Dhanalakshmi; R.R. Sakthimari; P.S. Keerthana; Mallika A.M.; C. Vasanthi; P.B. Mariselvi; P. Pandeeswari; S.M. Sudarvanitha; Prema Asociación Para Evitar la Ceguera, Mexico City, Mexico: Lourdes Arellanes-Garcia, MD (Director); Luz Elena Concha del Rio, MD; Rashel Cheja Kalb, MD; Nancy Fernández, MD; Yoko Burgoa; Hilda Hernández; Roberto Fabela Cuello; Lorenzo Agustín Martínez Garcia; Ricardo Montoya Rodríguez; Maria del Carmen Preciado; Andrea Arreola Royal Victorian Eye & Ear Hospital, East Melbourne, Australia: Lyndell Lim, MD (Director); Richard Stawell, MD; Robyn Troutbeck, MD; Cecilia Ling, MD; Xavier Fagan, MD; Julian Bosco, MD; Timothy Godfrey, MD; Tanya Pejnovic; Carly D’Sylva; Sutha Sanmugasundram; Tina-Marie van Tonder; Maria Kolic University of California, San Francisco, CA: Nisha Acharya, MD, MS (Director); John Gonzales, MD; Thuy Doan, MD, PhD; Sarah Lopez, OD; Maya Rao, MPH; Erica Browne, MS; Betty Hom; Mary Lew, COT; Salena Lee, OD Northwestern University, Chicago, IL: Debra A. Goldstein, MD (Director); Anna Liza Castro-Malek; Gemma Dela Rosa; Marriner Skelly Aravind Eye Hospital, Pondicherry, India: S. Bala Murugan, MD (Director); Prabu Baskaran, MD; Madanagopalan, MD; Chokkahalli K. Nagesha, MD; R. Thilagavathi, Chitra; Krishnakumari; Irudhaya Raj P; S. Saravanan; Grace Mary, Nagarasi; Kiruba Gnansi Aravind Eye Hospital, Madurai, India: S.R. Rathinam, MD, PhD (Director); Radhika Thundikandy, MD; R. Vedhanayaki, MD; AL. Sivarama Subramanian; G. Jeyakohila; Gracy Evangelin; A.M. Azhagupandi; CV Praba; S. Bharati; Gomathi; N. J. Nirmaladevi; Mohammed Siddiq; B. Vijayakumar; S.R. Devi King Khaled Eye Specialist Hospital, Riyadh, Saudi Arabia: Hassan A. Al-Dhibi, MD (Director); Donald Stone, MD; Mohammed Al-Shamrani, MD; Sara Al-Nuwaysir; Abdulrahman Al-Hommadi; Abdullah Al-Omran; Saleh Al-Nasser; Gahram Al-Zahrani; Eman Mashan; Mizher Al-Ghamdi; Ayshah Al-Tuwejri Oregon Health and Science University, Portland, OR: Eric Suhler, MD, MPH (Director); James Rosenbaum, MD; Phoebe Lin, MD, PhD; Sherveen Salek, MD; Kristin Biggee, MD; Amde Shifera, MD, PhD; Laura Kopplin, MD, PhD; George Mount, MD; Tracy Giles; Susan Nolte; Ann Lundquist; Teresa Liesegang; Albert Romo; Chris Howell; Scott Pickell; Peter Steinkemp; Dawn Ryan; Jordan Barth, Jocelyn Hui, Chiedozie Ukachukwu
ISSN:	0161-6420 1549-4713
DOI:	10.1016/j.ophtha.2021.02.024