Comparison of fingolimod and dimethyl fumarate in the treatment of multiple sclerosis: one year experience
Author(s): ,
B.L. Vollmer
Affiliations:
Department of Neurology, University of Colorado Denver School of Medicine
,
K. Nair
Affiliations:
Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Denver, Aurora, CO, United States
,
S.H. Sillau
Affiliations:
Department of Neurology, University of Colorado Denver School of Medicine
,
M. Strobel
Affiliations:
Department of Neurology, University of Colorado Denver School of Medicine
,
L. Robinson
Affiliations:
Department of Neurology, University of Colorado Denver School of Medicine
,
J. Corboy
Affiliations:
Department of Neurology, University of Colorado Denver School of Medicine
,
T. Vollmer
Affiliations:
Department of Neurology, University of Colorado Denver School of Medicine
E. Alvarez
Affiliations:
Department of Neurology, University of Colorado Denver School of Medicine
ECTRIMS Online Library. Vollmer B. 10/09/15; 115882; 1273
Brandi Vollmer
Brandi Vollmer
Contributions
Abstract
Abstract: P1049

Type: Poster

Abstract Category: Immunomodulation / Immunosuppression

Objective: To compare the first year experience of fingolimod(FTY) and dimethyl fumarate(DMF) including discontinuation rates, efficacy, and tolerability.

Background: FTY and DMF are the two most common MS oral treatments becoming available in 2010 and 2013, respectively. There is limited comparative effectiveness data after one year of treatment.

Methods: Patients prescribed FTY or DMF at the Rocky Mountain MS Center at Anschutz Medical Campus (University of Colorado) prior to April 2014 were identified. Clinician-reported data including relapse history, adverse events, medications, MRI outcomes, disease history and patient characteristics were retrospectively collected. Primary outcome was the probability of discontinuing drug by the end of year one. Reasons for discontinuation were also evaluated. Simple logistic regression, propensity matching with 1:1 greedy matching without replacement and 1:3 nearest neighbor matching were used for data analysis controlling for age, disease duration, type of MS, previous natalizumab use, gender, and disease burden at baseline (missing, mild, moderate, severe) to estimate differences in the primary outcome.

Results: A total of 317 and 492 patients initiated FTY and DMF and were followed for one year. Patients had a mean age of 45.4 (FTY) and 47.3 (DMF) years; were predominantly female (72.6% FTY; 70.7% DMF); and had a mean MS disease duration of 11 years for both groups. For the entire study cohort, 21(6.30%) FTY patients had a clinical relapse compared to 31(6.62%) patients on DMF. At ≤12 months, 62(19.6%) and 124(25.2%) discontinued FTY and DMF respectively with an unadjusted odds ratio (OR) of 1.386(95%CI 0.982-1.956, p=0.063) and adjusted OR of 1.548(95%CI 1.000-2.394, p=0.050) with 3:1 matching with replacement. Primary reason for discontinuation was adverse events which was lower for FTY 39(12.3%) compared to DMF 80(16.3%)(OR 1.384, 95%CI 0.917-2.090, p=0.122). New Disease activity (relapses and/or new MRI lesions) had discontinuation in 12(3.8%)of FTY and 32(6.5%) of DMF patients(unadjusted OR 1.768, 95%CI 0.896-3.488, p=0.100). Median time to discontinuation was 5 and 4 months for FTY and DMF, respectively.

Conclusions: There was a trend towards fewer discontinuations with FTY over DMF. Discontinuation rates in the first year were driven by tolerability issues, and two year data needs to be examined to better evaluate effect on disease activity. Preliminary two year data also will be presented.

Disclosure:

Brandi Vollmer: nothing to disclose

Kavita Nair: Astellas, Eli Lilly, Gilead, Genentech, Biogen Idec,

Stefan H. Sillau: nothing to disclose

Molly Strobel: nothing to disclose

Lorraina Robinson: nothing to disclose

John Corboy:

  • PI for clinical trial: NIH, Novartis, Sun Pharma, Celgene Therapeutics, National Multiple Sclerosis Society (NMSS)
  • Research grants: Juvenile Diabetes Research Foundation (Biomarker in MS), NMSS (MS Tissue Bank), Diogenix (adjudicator for diagnosis of MS)
  • Consultant: Novartis (to design clinical trials and safety information processing), Celgene Therapeutics (to design clinical trials), Teva Neurosciences (advisory board), Biogen Idec (to answer a survey to identify consensus treatment statements in MS)
  • Honoraria to give talk:Pro CE, Rocky Mountain MS Center, via Genzyme, Grand Rounds at multiple academic institutions

  • Other:Medical-legal work, Editor, Neurology: Clinical Practice,

    Board Member on NMSS Colorado-Wyoming Chapter
Timothy Vollmer:

  • Consulting: Acorda, Biogen Idec, Consortium of MS Centers (CME presentation), DeltaQuest, Genentech, Novartis, Novartis Canada, Novartis, Japan, Teva, Teva Canada, Xenoport, Mylan, Medscape

  • Clinical Research:Accelerated Cure Project, Acorda, Avanir, Biogen Idec, EMD Serono, Genzyme, Jensen Research, MedImmune, NIH, Novartis Pharmaceuticals, Ono Pharmaceuticals, Rky Mnt MS Center, Teva, Neuroscience, Vaccinex, Roche
Enrique Alvarez:

  • Consulting: Teva Neuroscience, Genzyme, and Biogen IDEC.
  • Clinical Research: Novartis, Biogen Idec, Rocky Mountain MS Center

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