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Am J Ophthalmol. 2019 Jul 22. pii: S0002-9394(19)30331-9. doi: 10.1016/j.ajo.2019.07.008. [Epub ahead of print]

Comparison between Methotrexate and Mycophenolate Mofetil monotherapy for the control of Non- Infectious Ocular Inflammatory Diseases.

Author information

1
Vanderbilt Eye Institute, Nashville, TN; Laboratory of Immunology, National Eye Institute, National Institutes of Health, Bethesda, MD. Electronic address: sapna.gangaputra@vumc.org.
2
Department of Biostatistics, Epidemiology, and Informatics, the Perelman School of Medicine, the University of Pennsylvania, Philadelphia, PA.
3
Department of Ophthalmology, The Johns Hopkins School of Medicine, Baltimore, MD.
4
Department of Ophthalmology, The Perelman School of Medicine, The University of Pennsylvania, Philadelphia, PA; Massachusetts Eye Research and Surgery Institution, Waltham, MA; Department of Ophthalmology, Somdech Phra Pinkloa hospital, Royal Thai Navy, Bangkok, Thailand; Department of Ophthalmology, Chulalongkorn University, Bangkok, Thailand.
5
Department of Ophthalmology, The Perelman School of Medicine, The University of Pennsylvania, Philadelphia, PA; Massachusetts Eye Research and Surgery Institution, Waltham, MA; Siddharth Netralaya, Belgaum, Karnataka, India.
6
Department of Ophthalmology, The Perelman School of Medicine, The University of Pennsylvania, Philadelphia, PA.
7
Laboratory of Immunology, National Eye Institute, National Institutes of Health, Bethesda, MD.
8
Department of Ophthalmology, Oregon Health and Science University, Portland, OR; Portland Veteran's Affairs Medical Center, Portland, OR.
9
Department of Ophthalmology, The Johns Hopkins School of Medicine, Baltimore, MD; Department of Epidemiology, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.
10
Massachusetts Eye Research and Surgery Institution, Waltham, MA; Department of Ophthalmology, Harvard Medical School, Boston, MA.
11
Department of Epidemiology, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD; Departments of Ophthalmology and Medicine, The Icahn School of Medicine at Mount Sinai, New York, NY.
12
Department of Ophthalmology, Oregon Health and Science University, Portland, OR; Department of Medicine, Oregon Health and Science University, Portland, OR; Legacy Devers Eye Institute, Portland, OR.
13
The Tampa Bay Uveitis Center, St. Petersburg, FL.
14
Department of Ophthalmology, Harvard Medical School, Boston, MA; Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Boston, MA; MCM Eye Unit/Ophthalmology; MyungSung Christian Medical Center and MyungSung Medical School, Addis Ababa, Ethiopia.

Abstract

PURPOSE:

To compare mycophenolate mofetil (MMF) to methotrexate (MTX) as corticosteroid-sparing therapy for ocular inflammatory diseases.

DESIGN:

Retrospective analysis of cohort study data METHODS: Participants were identified from the Systemic Immunosuppressive Therapy for Eye Diseases Cohort Study. Demographic and clinical characteristics were obtained via medical record review. The study included 352 patients who were taking single agent immunosuppression with MTX or MMF at four tertiary uveitis clinics. Marginal structural models (MSM)-derived statistical weighting created a virtual population with covariates and censoring patterns balanced across alternative treatments. With this methodological approach, the results estimate what would have happened had none of the patients stopped their treatment. Survival analysis with stabilized MSM-derived weights simulated a clinical trial comparing MMF vs. MTX for non-infectious inflammatory eye disorders. The primary outcome was complete control of inflammation on prednisone ≤10 mg/day, sustained for ≥30 days.

RESULTS:

The time-to-success was shorter (more favorable) for MMF than MTX (HR=0.68, 95% confidence interval: 0.46-0.99). Adjusting for covariates, the proportion achieving success was higher at every point in time for MMF than MTX from 2-8m then converges at 9 months. The onset of corticosteroid-sparing success took more than three months for most patients in both groups. Outcomes of treatment (MMF vs. MTX) were similar across all anatomic sites of inflammation. The incidence of stopping therapy for toxicity was similar in both groups.

CONCLUSIONS:

Our results suggest that, on average, MMF may be faster than MTX in achieving corticosteroid-sparing success in ocular inflammatory diseases.

PMID:
31344346
DOI:
10.1016/j.ajo.2019.07.008

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