Observational Studies Poster Presentation

P0858 - Comparative effectiveness of dimethyl fumarate versus other disease-modifying therapies in Multiple Sclerosis: a large population-based cohort study (ID 778)

Speakers
  • P. Bosco-Lévy
Authors
  • P. Bosco-Lévy
  • P. Blin
  • S. Lignot-Maleyran
  • R. Lassalle
  • A. Abouelfath
  • P. Diez-Andreu
  • M. Debouverie
  • B. Brochet
  • F. Guillemin
  • N. Moore
  • D. Cécile
Presentation Number
P0858
Presentation Topic
Observational Studies

Abstract

Background

Previous real-world comparative research of Multiple Sclerosis (MS) disease modifying therapies (DMTs) provided conflicting results on the effectiveness of the dimethyl fumarate (DMF) in comparison to the injectable immunomodulatory drugs (IID), and the two other oral drugs, fingolimod (FTY) and teriflunomide (TERI), in reducing relapses.

Objectives

To assess the effectiveness of DMF on annual rate of relapse (ARR) in MS compared to IID, TERI and FTY, in real life setting.

Methods

This cohort study included all patients identified in the French national claims-based database (SNDS) initiating IID, TERI, FTY or DMF from the 2015/07/01 to the 2017/12/31, with at least 4.5-year history and with 1 to 3.5 years of follow-up. The index date was the date of first DMT fill. The primary endpoint was the ARR, identified by a validated algorithm including MS hospitalizations and dispensing of corticosteroids on high dose (Positive Predictive Value: 95.2%). DMF patients were high dimensional Propensity Score 1:1 matched to IID, TERI or FTY based on data collected in the pre-index period. A negative binomial regression model and a regression logistic model were used to estimate the relative risk (RR ± [95% CI]) of ARR and the Odds Ratio (OR ± [95% CI]) of disability progression, respectively.

Results

We identified 9 304 subjects in the SNDS: 29.0% initiated DMF, 33.2% TERI, 5.6% FTY and 32.2% an IID. Overall, 72.8% were female with a mean age of 39.9 years (from 37.5 years for IID to 43.1 years for TERI) and a mean Charlson Comorbidity Index score of 0.58 (from 0.52 for DMF to 0.65 for TERI). In each treatment group, the 1:1 matched cohorts consisted in 1779 DMF-IID patients, 1679 DMF-TERI patients, and 376 DMF-FTY patients. During the index treatment exposure, DMF significantly reduced ARR compared to IID (RR 0.72, 95%CI [0.61 - 0.86]) and TERI (RR 0.81, 95%CI [0.68 - 0.96]). No significant difference on ARR was found between DMF and FTY patients (RR 1.38, 95%CI [0.95 - 1.99]), but the specific indication of FTY for the treatment of MS patients with high activity of the disease makes the comparison between both groups difficult.

Conclusions

Based on real-life data, DMF offers an effective treatment option to reduce the risk of relapse for patients with RRMS compared to other commonly used agents for RRMS including another oral drug, TERI.

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