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

Abstract

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