Fingolimod treatment in multiple sclerosis leads to increased macular volume

Neurology. 2013 Jan 8;80(2):139-44. doi: 10.1212/WNL.0b013e31827b9132. Epub 2012 Dec 5.


Objective: To determine whether fingolimod, an oral sphingosine-1-phosphate receptor modulator approved for treatment of multiple sclerosis (MS), generally leads to increased retinal tissue volume.

Methods: In this longitudinal observational study, we compared changes in macular volume on spectral-domain optical coherence tomography (OCT) between consecutive patients with MS who initiated fingolimod and a matched reference cohort of patients with MS never exposed to the drug. The primary reference cohort was matched based on time interval between OCT examinations. A secondary reference cohort was matched based on age and disease duration. Change in macular volume within each group was analyzed using the paired t test. Change in macular volume between groups was examined using multiple linear regression.

Results: Macular volume increased by a mean of 0.025 mm3 (95% confidence interval [CI] +0.017 to +0.033, p < 0.001) in the 30 patients with MS who initiated fingolimod over a mean follow-up time of 5 months (SD 3). Macular volume did not significantly change over a mean follow-up time of 6 months (SD 4) in a comparison group of 30 patients with MS never treated with fingolimod (mean change of -0.003 mm3, 95% CI -0.009 to +0.004, p = 0.47). Overall, 74% of eyes in the fingolimod-treated group exhibited an increase in macular volume vs. 37% of eyes in the comparison group.

Conclusion: Initiation of fingolimod in MS is associated with a modest, relatively rapid increase in macular volume.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Female
  • Fingolimod Hydrochloride
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Linear Models
  • Longitudinal Studies
  • Macula Lutea / pathology*
  • Male
  • Multiple Sclerosis / drug therapy*
  • Multiple Sclerosis / pathology
  • Propylene Glycols / therapeutic use*
  • Receptors, Lysosphingolipid / antagonists & inhibitors
  • Retinal Neurons / pathology
  • Sphingosine / analogs & derivatives*
  • Sphingosine / therapeutic use
  • Tomography, Optical Coherence


  • Immunosuppressive Agents
  • Propylene Glycols
  • Receptors, Lysosphingolipid
  • Fingolimod Hydrochloride
  • Sphingosine