학술논문

Health- and Vision-Related Quality of Life in a Randomized Controlled Trial Comparing Methotrexate and Mycophenolate Mofetil for Uveitis
Document Type
article
Author
Kelly, Nicole KChattopadhyay, AheliRathinam, SRGonzales, John AThundikandy, RadhikaKanakath, AnuradhaMurugan, S BalaVedhanayaki, RCugley, DeanLim, Lyndell LSuhler, Eric BAl-Dhibi, Hassan AEbert, Caleb DBerlinberg, Elyse JPorco, Travis CAcharya, Nisha RSubramanian, AL SivaramaJeyakohila, GEvangelin, GracyAzhagupandi, AMPraba, CVBharati, SGomathi, SNirmaladevi, NJSiddiq, MohammedVijayakumar, BDevi, SRSaravanan, VRBabu, UpendraSrija, RDhanalakshmi, SSakthimari, RRKeerthana, PSMallika, AMVasanthi, CMariselvi, PBPandeeswari, PSudarvanitha, SMPrema, RBaskaran, PrabuMadanagopalan, SNagesha, Chokkahalli KThilagavathi, RKrishnakumari, ChitraP, Irudhaya RajSaravanan, SMary, GraceNagarasi, SGnansi, KirubaArellanes-Garcia, Lourdesdel Rio, Luz Elena ConchaKalb, Rashel ChejaFernández, NancyBurgoa, YokoHernández, HildaCuello, Roberto FabelaGarcia, Lorenzo Agustín MartínezRodríguez, Ricardo Montoyadel Carmen Preciado, MariaArreola, AndreaStone, DonaldAl-Shamrani, MohammedAl-Nuwaysir, SaraAl-Hommadi, AbdulrahmanAl-Omran, AbdullahAl-Nasser, SalehAl-Zahrani, GahramMashan, EmanAl-Ghamdi, MizherAl-Tuwejri, AyshahGoldstein, Debra ACastro-Malek, Anna LizaDela Rosa, GemmaSkelly, MarrinerSuhler, EricRosenbaum, JamesLin, PhoebeSalek, SherveenBiggee, KristinShifera, AmdeKopplin, LauraMount, GeorgeGiles, TracyNolte, SusanLundquist, AnnLiesegang, TeresaRomo, AlbertHowell, ChrisPickell, ScottSteinkemp, PeterRyan, DawnBarth, JordanHui, JocelynUkachukwu, Chiedozie
Source
Ophthalmology. 128(9)
Subject
Biomedical and Clinical Sciences
Ophthalmology and Optometry
Clinical Research
Eye Disease and Disorders of Vision
Clinical Trials and Supportive Activities
6.1 Pharmaceuticals
Evaluation of treatments and therapeutic interventions
Good Health and Well Being
Administration
Oral
Adult
Aged
Enzyme Inhibitors
Female
Health
Health Status
Humans
Immunosuppressive Agents
Male
Methotrexate
Middle Aged
Mycophenolic Acid
Prospective Studies
Quality of Life
Sickness Impact Profile
Surveys and Questionnaires
Uveitis
Vision
Ocular
Antimetabolites
uveitis
Quality of life
FAST Research Group
Clinical Sciences
Opthalmology and Optometry
Public Health and Health Services
Ophthalmology & Optometry
Ophthalmology and optometry
Language
Abstract
PurposeTo evaluate changes in health-related and vision-related quality of life (VRQoL) among patients with noninfectious uveitis who were treated with antimetabolites.DesignSecondary analysis of a randomized controlled trial.ParticipantsPatients with noninfectious uveitis from India, the United States, Australia, Saudi Arabia, and Mexico.MethodsFrom 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 measuresVision-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).ResultsAmong 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).ConclusionsAmong 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.