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Return to: GILENYA (fingolimod, FTY720) |
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#Post#: 1682-------------------------------------------------- |
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(AAN abst.) Alternate dosing of fingolimod for MS |
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By: agate Date: May 16, 2017, 3:53 pm |
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Presented as a platform session at the AAN annual meeting in |
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Boston in April 2017: |
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[quote]Alternate dosing of fingolimod for multiple sclerosis |
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Ilya Kister1, Daniel Kantor2, Samia Khoury3, Marcus Rice4, Ellen |
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Lathi5, Ana Belen Caminero Rodriguez6, Siddharama Pawate7, |
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Michael Bradshaw, MD7, Keith Edwards8, Anne Cross9, Becky |
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Parks9, Jennifer Lynch10,Robert Archer11, William Meador12, |
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Regina Berkovich13, Bassem Yamout14, Maya Zeineddine14, Danita |
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VanderKodde15, Gloria Von Geldern16, Lily Ge17, Shira Russell18, |
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Tamar Bacon1, Erin Longbrake19 |
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1 |
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NYU School of Medicine, NY, 2 |
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Kantor Neurology, 3 |
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Nehme and Therese Tohme MS Center, 4 |
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MS Center of Tidewater, 5 |
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The MS Ctr/Dept of Neuro, 6 |
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C/ Fuentes Claras #1, 7 |
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Vanderbilt University Medical Center, 8 |
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MS Center of Northeastern NY - Empire Neurology, P.C., 9 |
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Washington University School of Medicine, 10 CoxHealth, |
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11 University of Arkansas for Medical Sciences, 12 The |
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University of Alabama at Birmingham, 13 Keck School of Medicine |
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of USC, 14 American University of Beirut, 15 Spectrum Health |
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Medical Group, 16 University of Wisconsin |
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Medical Center, 17 NYU School of Medicine, 18 BarnabasRWJ, 19 |
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Yale University |
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Objective: |
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To document efficacy, tolerability and safety of alternate |
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(non-daily) dosing of fingolimod for MS. |
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Background: |
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Fingolimod 0.5 mg is approved for daily oral administration in |
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MS. It has a half-life of 6 days and many clinicians utilize |
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less frequent dosing (typically qod or tiw), especially for |
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patients who develop liver enzyme elevations, severe lymphopenia |
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or infections on standard daily dosing. Data on efficacy of |
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alternate dosing is scarce. |
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Design/Methods: |
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Multi-center retrospective chart and MRI review. |
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Results: |
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We identified 129 MS patients in 15 neurology clinics in the US, |
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Spain, and Lebanon who received fingolimod at alternate doses |
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(alt-dose) for >1 month. To date, chart review was completed for |
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42 patients (83% female, average age 43.0 +/-10.9 yrs, average |
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disease duration 13.0 +/- 7.6 yrs). |
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All patients initially received daily fingolimod for (average) |
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of 14.5 months (range 1.0 - 53.2 months) and later switched to |
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alt-dose for (average) of 17.6 months (range 1.0 � 63.4 months). |
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On daily dose, 5% of patients experienced ≥1 relapse and |
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31% had MRI activity, while on alt-dose, 12% experienced |
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≥1 relapse and 35% of patients had MRI activity. |
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Adverse events were recorded for 45% patients on daily dose and |
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12% of patients on alt-dose. |
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62% [of the] patients remained on alt-dose at last follow-up, 4 |
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(10%) went back to daily dose and 11 (26%) were switched to a |
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different therapy. Updated data on full cohort will be |
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presented. |
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Conclusions: |
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These observational data on MS patients treated with alternate |
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dosing of fingolimod offers preliminary support for the use of |
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this regimen, especially in patients who are not able to |
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tolerate daily dosing. Alternate day dosing of fingolimod |
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appears to be associated with less adverse effects (lower |
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incidence of LFT [liver function test] abnormalities and severe |
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lymphopenia) and is highly cost-effective. A prospective |
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randomized non-inferiority trial of alternate day v. daily |
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fingolimod 0.5 mg is warranted. [/quote] |
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