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: NCT 01829295
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).