Original ArticleHealth- and Vision-Related Quality of Life in a Randomized Controlled Trial Comparing Methotrexate and Mycophenolate Mofetil for Uveitis
Section snippets
Study Design
The FAST Trial (ClinicalTrials.gov identifier, NCT01829295)10 was a randomized, observer-masked clinical trial that compared the effectiveness of 2 common corticosteroid-sparing antimetabolite treatments, methotrexate and mycophenolate mofetil, among patients with noninfectious intermediate uveitis, posterior uveitis, and panuveitis. From August 2013 through August 2017, we prospectively enrolled participants at 9 centers throughout India, the United States, Australia, Saudi Arabia, and Mexico.
Participant Inclusion and Baseline Demographics
Two hundred sixteen participants were randomized and enrolled from August 22, 2013, through August 16, 2017. Of the 216 participants, 193 (89.4%) reached the primary end point with complete QoL information and subsequently were included in this analysis (Fig 1). Baseline demographic and clinical characteristics are presented in Table 1 and were balanced between treatment groups, with the exception of sex. A higher proportion of participants randomized to methotrexate were women (72.9%) compared
Discussion
Clinically meaningful improvements in VRQoL and HRQoL were observed in patients treated with either methotrexate or mycophenolate mofetil. These findings are consistent with the trial’s primary outcome, that corticosteroid-sparing control of inflammation did not differ by use of methotrexate or mycophenolate mofetil.10 This secondary analysis also demonstrated how antimetabolites, along with a corticosteroid taper, can improve the overall physical and mental well-being of patients with
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Supplemental material available at www.aaojournal.org.
Disclosure(s): All authors have completed and submitted the ICMJE disclosures form.
The author(s) have made the following disclosure(s): A.K.: Nonfinancial support – F. I. Proctor Foundation. L.L.L.: Consultant – Allergan, Novotech; Advisory board – Allergan; Financial support – Bayer. E.B.S.: Financial support – AbbVie, Aldeyra, Clearside, Eyegate, Eyepoint, Gilead, Eyevensys
Supported by the National Eye Institute, National Institutes of Health, Bethesda, Maryland (grant nos.: U10 EY021125 and EY06190); Research to Prevent Blindness, Inc., New York, New York (unrestricted grant to the Department of Ophthalmology at UCSF); and That Man May See Foundation. The sponsors had no role in the design or conduct of this research.
HUMAN SUBJECTS: Human subjects were included in this study. Investigators obtained ethical approval from local institutional review boards (University of California San Francisco; Aravind Eye Hospital, India; Royal Victorian Eye and Ear Hospital, Melbourne, Australia; Oregon Health and Science University, Portland, Oregon; King Khaled Eye Specialist Hospital, Riyadh, Saudi Arabia), all participants provided written informed consent, and all research procedures adhered to the tenets of the Declaration of Helsinki.
No animal subjects were included in this study.
Author Contributions:
Conception and design: Kelly, Chattopadhyay, Rathinam, Gonzales, Thundikandy, Kanakath, Bala Murugan, Vedhanayaki, Cugley, Lim, Suhler, Al-Dhibi, Ebert, Berlinberg, Porco, Acharya
Analysis and interpretation: Kelly, Chattopadhyay, Rathinam, Gonzales, Thundikandy, Kanakath, Bala Murugan, Vedhanayaki, Cugley, Lim, Suhler, Al-Dhibi, Ebert, Berlinberg, Porco, Acharya
Data collection: Kelly, Chattopadhyay, Rathinam, Gonzales, Thundikandy, Kanakath, Bala Murugan, Vedhanayaki, Cugley, Lim, Suhler, Al-Dhibi, Ebert, Berlinberg, Porco, Acharya
Obtained funding: Lim, Suhler
Overall responsibility: Kelly, Chattopadhyay, Rathinam, Gonzales, Thundikandy, Kanakath, Bala Murugan, Vedhanayaki, Cugley, Lim, Suhler, Al-Dhibi, Ebert, Berlinberg, Porco, Acharya
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Members of the FAST Research Group available online (www.aaojournal.org).