MS Speaks

Alternate dosing of fingolimod for multiple sclerosis

Ilya Kister1, Daniel Kantor2, Samia Khoury3, Marcus Rice4, Ellen Lathi5, Ana Belen Caminero Rodriguez6, Siddharama Pawate7, Michael Bradshaw, MD7, Keith Edwards8, Anne Cross9, Becky Parks9, Jennifer Lynch10,Robert Archer11, William Meador12, Regina Berkovich13, Bassem Yamout14, Maya Zeineddine14, Danita
VanderKodde15, Gloria Von Geldern16, Lily Ge17, Shira Russell18, Tamar Bacon1, Erin Longbrake19

1
NYU School of Medicine, NY, 2
Kantor Neurology, 3
Nehme and Therese Tohme MS Center, 4
MS Center of Tidewater, 5
The MS Ctr/Dept of Neuro, 6
C/ Fuentes Claras #1, 7
Vanderbilt University Medical Center, 8
MS Center of Northeastern NY - Empire Neurology, P.C., 9
Washington University School of Medicine, 10 CoxHealth,
11 University of Arkansas for Medical Sciences, 12 The University of Alabama at Birmingham, 13 Keck School of Medicine of USC, 14 American University of Beirut, 15 Spectrum Health Medical Group, 16 University of Wisconsin
Medical Center, 17 NYU School of Medicine, 18 BarnabasRWJ, 19 Yale University

Objective:

To document efficacy, tolerability and safety of alternate (non-daily) dosing of fingolimod for MS.

Background:

Fingolimod 0.5 mg is approved for daily oral administration in MS. It has a half-life of 6 days and many clinicians utilize less frequent dosing (typically qod or tiw), especially for patients who develop liver enzyme elevations, severe lymphopenia or infections on standard daily dosing. Data on efficacy of alternate dosing is scarce.

Design/Methods:

 Multi-center retrospective chart and MRI review.

Results:

We identified 129 MS patients in 15 neurology clinics in the US, Spain, and Lebanon who received fingolimod at alternate doses (alt-dose) for >1 month. To date, chart review was completed for 42 patients (83% female, average age 43.0 +/-10.9 yrs, average disease duration 13.0 +/- 7.6 yrs).

All patients initially received daily fingolimod for (average) of 14.5 months (range 1.0 - 53.2 months) and later switched to alt-dose for (average) of 17.6 months (range 1.0 – 63.4 months). On daily dose, 5% of patients experienced ≥1 relapse and 31% had MRI activity, while on alt-dose, 12% experienced ≥1 relapse and 35% of patients had MRI activity.

Adverse events were recorded for 45% patients on daily dose and 12% of patients on alt-dose.

 62% [of the] patients remained on alt-dose at last follow-up, 4 (10%) went back to daily dose and 11 (26%) were switched to a different therapy. Updated data on full cohort will be presented.

Conclusions:

These observational data on MS patients treated with alternate dosing of fingolimod offers preliminary support for the use of this regimen, especially in patients who are not able to tolerate daily dosing. Alternate day dosing of fingolimod appears to be associated with less adverse effects (lower incidence of LFT [liver function test] abnormalities and severe lymphopenia) and is highly cost-effective. A prospective randomized non-inferiority trial of alternate day v. daily fingolimod 0.5 mg is warranted.