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

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

KEYWORDS:

• CD4
• mycophenolate mofetil
• methotrexate
• antimetabolite
• uveitis

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).

Additional information

Funding

This work was supported by the National Eye Institute (NEI) under grant U10 EY021125 to Dr. Acharya. The Department of Ophthalmology at the University of California, San Francisco is supported by a core grant from the NEI (EY06190), an unrestricted grant from the Research to Prevent Blindness Foundation, and That Man May See Foundation.