Quality-of-Life Outcomes From a Randomized Clinical Trial Comparing Antimetabolites for Intermediate, Posterior, and Panuveitis

Katherine M Niemeyer; John A Gonzales; Sivakumar R Rathinam; Manohar Babu; Radhika Thundikandy; Anuradha Kanakath; Travis C Porco; Erica N Browne; Maya M Rao; Nisha R Acharya

doi:10.1016/j.ajo.2017.04.003

Quality-of-Life Outcomes From a Randomized Clinical Trial Comparing Antimetabolites for Intermediate, Posterior, and Panuveitis

Am J Ophthalmol. 2017 Jul:179:10-17. doi: 10.1016/j.ajo.2017.04.003. Epub 2017 Apr 14.

Affiliations

¹ F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California.
² F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California.
³ Aravind Eye Care System, Madurai, India.
⁴ Aravind Eye Care System, Coimbatore, India.
⁵ F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California; Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California.
⁶ F. I. Proctor Foundation, University of California, San Francisco, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California. Electronic address: nisha.acharya@ucsf.edu.

Abstract

Purpose: To evaluate the changes in quality of life in noninfectious uveitis patients treated with 2 of the most commonly prescribed antimetabolite treatments.

Design: Secondary analysis of a multicenter, block-randomized clinical trial.

Methods: Eighty patients at Aravind Eye Hospitals in Madurai and Coimbatore, India, with noninfectious intermediate, posterior, or panuveitis were randomized to receive oral methotrexate, 25 mg weekly, or oral mycophenolate mofetil, 1 g twice daily, and were followed up monthly for 6 months. Best-corrected visual acuity, Indian Vision Function Questionnaire (IND-VFQ), and Medical Outcomes Study 36-item Short Form Survey (SF-36) were obtained at enrollment and at 6 months (or prior, in the event of early treatment failure).

Results: IND-VFQ scores, on average, increased by 9.2 points from trial enrollment to 6 months (95% confidence interval [CI]: 4.9, 13.5, P = .0001). Although the SF-36 physical component summary score did not significantly differ over the course of the trial, the mental component summary score decreased by 2.3 points (95% CI: -4.4, -0.1, P = .04) and the vitality subscale decreased by 3.5 points (95% CI: -5.6, -1.4, P = .001). Quality-of-life scores did not differ between treatment arms. Linear regression modeling showed a 3.2-point improvement in IND-VFQ score for every 5-letter improvement in visual acuity (95% CI: 1.9, 4.3; P < .001).

Conclusions: Although uveitis treatment was associated with increased vision and vision-related quality of life, patient-reported physical health did not change after 6 months of treatment, and mental health decreased. Despite improved visual outcomes, uveitis patients receiving systemic immunosuppressive therapy may experience a deterioration in mental health-related quality of life.

Trial registration: ClinicalTrials.gov NCT01232920.

Publication types

Multicenter Study
Randomized Controlled Trial

MeSH terms

Administration, Oral
Adult
Antimetabolites / administration & dosage*
Dose-Response Relationship, Drug
Female
Follow-Up Studies
Health Status*
Humans
Male
Panuveitis / drug therapy*
Panuveitis / psychology
Quality of Life*
Surveys and Questionnaires*
Treatment Outcome
Uveitis, Posterior / drug therapy*
Uveitis, Posterior / psychology
Visual Acuity*

Substances

Antimetabolites

Associated data

ClinicalTrials.gov/NCT01232920

Grants and funding

U10 EY021125/EY/NEI NIH HHS/United States