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. 2017 Aug 24;3(3):2055217317715485.
doi: 10.1177/2055217317715485. eCollection 2017 Jul-Sep.

Comparative efficacy and discontinuation of dimethyl fumarate and fingolimod in clinical practice at 24-month follow-up

Carrie M Hersh  1 , Thomas E Love  2 , Anasua Bandyopadhyay  3 , Samuel Cohn  4 , Claire Hara-Cleaver  5 , Robert A Bermel  5 , Robert J Fox  5 , Jeffrey A Cohen  5 , Daniel Ontaneda  5
Affiliations

Comparative efficacy and discontinuation of dimethyl fumarate and fingolimod in clinical practice at 24-month follow-up

Carrie M Hersh et al. Mult Scler J Exp Transl Clin. .

Abstract

Background: Dimethyl fumarate and fingolimod are oral disease-modifying therapies approved to treat relapsing multiple sclerosis. Prior observational studies and our previous 12-month investigation showed comparable clinical efficacy.

Objective: The purpose of this study was to assess real-world efficacy and discontinuation of dimethyl fumarate and fingolimod over 24 months in patients with multiple sclerosis.

Methods: Patients treated with dimethyl fumarate (n = 395) or fingolimod (n = 264) completed 24-month follow-up in a large academic multiple sclerosis center. Discontinuation rates and measures of disease activity were compared after propensity score weighting. The primary outcome was on-treatment annualized relapse rate ratio. Other measures included rate of drug discontinuation and brain magnetic resonance imaging activity defined as new T2 and/or gadolinium-enhancing lesions.

Results: Propensity score weighting showed excellent covariate balance. At 24 months, dimethyl fumarate demonstrated comparable annualized relapse rate (rate ratio = 1.45, 95% confidence interval 0.53-3.99) and brain magnetic resonance imaging activity (odds ratio = 1.38, 95% confidence interval 0.83-2.32). Dimethyl fumarate patients discontinued therapy earlier compared to fingolimod (hazard ratio = 1.40, 95% confidence interval 1.11-1.77) and were more likely to discontinue therapy due to intolerability (odds ratio = 1.98, 95% confidence interval 1.18-3.23).

Conclusion: Dimethyl fumarate and fingolimod had similar reductions in annualized relapse rate in clinical trials, and our real-world experience supports this observation. Dimethyl fumarate-treated patients had higher likelihood of early discontinuation, and this was mostly due to intolerability.

Keywords: Dimethyl fumarate; comparative efficacy; discontinuation; fingolimod; multiple sclerosis; propensity score analysis.

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Figures

Figure 1.
Figure 1.
Density plot of propensity scores (propensity for dimethyl fumarate (DMF)) showing adequate overlap of propensity scores between DMF and fingolimod. MRI: magnetic resonance imaging; FTY: fingolimod.
Figure 2.
Figure 2.
Absolute standardized difference plot comparing baseline covariates between dimethyl fumarate (DMF) and fingolimod (FTY) before and after average treatment effect on the treated (ATT) weighting using the linear propensity score. Positive values represent higher standardized effect sizes for dimethyl fumarate (DMF). DMT: disease-modifying therapy; EQ5D: European Quality of Life-5 Dimensions; GA: glatiramer acetate; GdE: gadolinium-enhancing; IFN: interferon; intol: intolerability; IS: immunosuppressive therapy; IVMP: intravenous methylprednisolone; linps: linear propensity score; MRI: magnetic resonance imaging; MS: multiple sclerosis; MSPS: Multiple Sclerosis Performance Scale; NTZ: natalizumab; PHQ9: Patient Health Questionnaire-9; PS: propensity score; T25FW: timed 25-foot walk.
Figure 3.
Figure 3.
(a) Kaplan-Meier plot of relapse-free status through 24-month follow-up. (b) Kaplan-Meier plot of disease-modifying therapy (DMT) discontinuation through 24-month follow-up. CI: confidence interval; DMF: dimethyl fumarate; FTY: fingolimod; HR: hazard ratio.
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