Reduced Dose Methotrexate and Mycophenolate Mofetil in Noninfectious Uveitis: A Sub-Analysis from the First-Line Antimetabolites as Steroid Sparing Therapy (FAST) Trial

Ocul Immunol Inflamm. 2024 Aug;32(6):955-960. doi: 10.1080/09273948.2023.2165949. Epub 2023 Jan 26.

Abstract

Purpose: Some patients taking methotrexate (MTX) or mycophenolate mofetil (MMF) experience intolerable side effects at full doses. We evaluated whether dose reduction affected treatment outcomes in uveitis patients.

Methods: Subanalysis of the First-line Antimetabolites as Steroid-sparing Treatment (FAST) uveitis trial. Patients were randomized to receive MTX (25 mg weekly) or MMF (3 g daily). A pre-specified dose reduction protocol could be employed for intolerable side effects. Primary analysis was performed at 6 months.

Results: 43/194 patients (22%) required dose reduction. 88/151 patients (58%) on maximum doses and 32/43 patients (74%) on reduced doses were deemed treatment successes at 6 months. The odds ratio point estimate (1.60, 95% CI 0.72-3.74) favored dose-reduction but this was not significant. Following reduction, adverse events improved at the subsequent study visit (79 events reduced to 63 events).

Conclusion: Dose reduction of antimetabolites was not associated with worse outcomes in this subanalysis of a uveitis trial.

Keywords: Antimetabolite; dosing; methotrexate; mycophenolate mofetil; uveitis.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study

MeSH terms

  • Adult
  • Dose-Response Relationship, Drug*
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Glucocorticoids / administration & dosage
  • Glucocorticoids / therapeutic use
  • Humans
  • Immunosuppressive Agents* / administration & dosage
  • Immunosuppressive Agents* / therapeutic use
  • Male
  • Methotrexate* / administration & dosage
  • Methotrexate* / therapeutic use
  • Middle Aged
  • Mycophenolic Acid* / administration & dosage
  • Mycophenolic Acid* / therapeutic use
  • Treatment Outcome
  • Uveitis* / diagnosis
  • Uveitis* / drug therapy
  • Visual Acuity

Substances

  • Methotrexate
  • Mycophenolic Acid
  • Immunosuppressive Agents
  • Glucocorticoids