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Randomized Controlled Trial
. 2022 Jan 2;30(1):198-202.
doi: 10.1080/09273948.2020.1774906. Epub 2020 Aug 11.

Comparison of CD4 Counts with Mycophenolate Mofetil versus Methotrexate from the First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial

Christina L Kong  1 , Nicole K Kelly  1 , Miel Sundararajan  2 , S R Rathinam  3 , John A Gonzales  1   2 , Radhika Thundikandy  3 , Rajesh Vedhanayaki  3 , Anuradha Kanakath  4 , Bala Murugan  5 , Thuy Doan  1   2 , Debra Goldstein  6 , Hassan A Al-Dhibi  7 , Nisha R Acharya  1   2   8
Affiliations
Randomized Controlled Trial

Comparison of CD4 Counts with Mycophenolate Mofetil versus Methotrexate from the First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial

Christina L Kong et al. Ocul Immunol Inflamm. .

Abstract

Purpose: Sub-analysis of the FAST Trial comparing change in CD4 (∆CD4) from baseline through 12 months in uveitis patients treated with mycophenolate mofetil (MMF) and methotrexate (MTX).

Methods: Patients were randomly allocated to 1.5 g twice daily MMF or 25 mg weekly MTX. Individuals with CD4 counts at baseline, 6 months (or treatment failure prior), and 12 months (or treatment failure between 6 and 12 months) were included. The association between treatment and ∆CD4 (cells/μL) was analyzed using multivariable linear regression.

Results: There was no significant difference in ∆CD4 between MMF and MTX at 6 months (-31.7 cells/μL for MMF compared to MTX; 95% CI: -358.2 to 294.8, P = .85) and 12 months (-78.3 cells/μL for MMF compared to MTX; 95% CI: -468.0 to 311.3; P = .69).

Conclusion: There was no significant difference in ∆CD4 between MMF and MTX from baseline to 12 months, suggesting that MMF does not confer additional risk of CD4 lymphopenia in uveitic patients.ClinicalTrials.gov Identifier: NCT01829295.

Keywords: CD4; antimetabolite; methotrexate; mycophenolate mofetil; uveitis.

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Conflict of interest statement

DECLARATION OF INTEREST

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper. This study was funded by the National Eye Institute (NEI) (grant U10 EY021125).

Figures

Figure 1.
Figure 1.
Distribution of the change in CD4+ T-cell count from baseline to the primary endpoint by treatment group
See this image and copyright information in PMC

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