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#Post#: 1682--------------------------------------------------
(AAN abst.) Alternate dosing of fingolimod for MS
By: agate Date: May 16, 2017, 3:53 pm
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Presented as a platform session at the AAN annual meeting in
Boston in April 2017:
[quote]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. [/quote]
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