Elsevier

Ophthalmology

Volume 128, Issue 9, September 2021, Pages 1337-1345
Ophthalmology

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

https://doi.org/10.1016/j.ophtha.2021.02.024Get rights and content

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.

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

References (39)

  • T. Tsirouki et al.

    A focus on the epidemiology of uveitis

    Ocul Immunol Inflamm

    (2018)
  • H. Harrabi et al.

    Visual difficulty and employment status in the world

    PloS One

    (2014)
  • A.C. Stolk-Vos et al.

    Outcomes in patients with chronic uveitis: which factors matter to patients? A qualitative study

    BMC Ophthalmol

    (2020)
  • M.O. Tallouzi et al.

    Outcomes important to patients with non-infectious posterior segment-involving uveitis: a qualitative study

    BMJ Open Ophthalmol

    (2020)
  • S.R. Rathinam et al.

    Effect of corticosteroid-sparing treatment with mycophenolate mofetil vs methotrexate on inflammation in patients with uveitis: a randomized clinical trial

    JAMA

    (2019)
  • A.K. Denniston et al.

    Heterogeneity of primary outcome measures used in clinical trials of treatments for intermediate, posterior, and panuveitis

    Orphanet J Rare Dis

    (2015)
  • S. Dean et al.

    “The patient is speaking”: discovering the patient voice in ophthalmology

    Br J Ophthalmol

    (2017)
  • J.E. Ware et al.

    The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection

    Med Care

    (1992)
  • C.M. Mangione et al.

    Development of the 25-item National Eye Institute Visual Function Questionnaire

    Arch Ophthalmol

    (2001)
  • Cited by (6)

    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

    Members of the FAST Research Group available online (www.aaojournal.org).

    View full text