Comparable Efficacy and Safety of Teriflunomide versus Dimethyl Fumarate for the Treatment of Relapsing-Remitting Multiple Sclerosis.

Nasim Nehzat,Mahdi Barzegar,Omid Mirmosayyeb,Vahid Shaygannejad,Reza Vosoughi,Erfane Fazeli,Jeff Bronstein

doi:10.1155/2021/6679197

Nasim Nehzat, Mahdi Barzegar + Show 5 more

Open Access

https://doi.org/10.1155/2021/6679197

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Abstract

Background The aim of this observational study is to investigate the efficacy and safety of two approved oral disease-modifying therapies (DMTs) in patients with remitting-relapsing multiple sclerosis (RRMS): dimethyl fumarate (DMF) vs. teriflunomide (TRF). Methods A total of 159 RRMS patients (82 on TRF and 77 on DMF) were included. The expanded disability status scale (EDSS), confirmed disability improvement (CDI), confirmed disability progression (CDP), and annualized relapse rate (ARR) were evaluated for the two-year period prior to enrollment in our study. The drug-associated adverse effects (AEs) were recorded. We conducted propensity matching score to compare the efficacy between TRF and DMF. Results After matching for the confounders, TRF- and DMF-treated groups were not different in terms of EDSS (P value = 0.54), CDI (P value = 0.80), CDP (P value = 0.39), and ARR (P value >0.05). TRF discontinuation occurred in 2 patients (2.43%) due to mediastinitis and liver dysfunction, while a patient (1.29%) discontinued DMF due to depression. Incidence rate of AEs in the TRF-treated group was 81.4%: hair thinning (hair loss) (62.9%), nail loss (20.9%), and elevated aminotransferase (14.8%) were the most common AEs; in DMF-treated patients, AEs were 88.2% with predominance of flushing (73.2%), pruritus (16.9%), and abdominal pain (16.9%). Conclusion Based on our findings, DMF is as efficacious and safe as TRF for the treatment of RRMS in our Iranian study population. Multicentric studies need to corroborate these findings in other populations.

Highlights

Over the past 20 years, the outcome of patients with multiple sclerosis (MS) has significantly improved with earlier diagnosis by magnetic resonance imaging (MRI) and earlier administration of disease-modifying therapies (DMTs) [1]
Study Population. e current observational study has been conducted on adults with remitting-relapsing multiple sclerosis diagnosed with relapsing-remitting MS, fulfilling the 2017 McDonald diagnostic criteria [16], who were referred to the outpatient Multiple Sclerosis Clinic of Kashani Hospital, affiliated with Isfahan University of Medical Sciences
We aimed to compare TRF with dimethyl fumarate (DMF) in a real-life setting in a cohort of Iranian remitting-relapsing MS (RRMS) patients followed up for 2 years. e data were collected through a standardized method and analyzed using propensity score matching. e primary outcomes of this report included a comparison of confirmed disability progression (CDP) of the patients under treatment of either TRF or DMF

Summary

Introduction

Over the past 20 years, the outcome of patients with multiple sclerosis (MS) has significantly improved with earlier diagnosis by magnetic resonance imaging (MRI) and earlier administration of disease-modifying therapies (DMTs) [1]. An 8-year study of Interferon-Beta use in 394 cases with remitting-relapsing MS (RRMS) or secondary-progressive MS (SPMS) patients revealed 14% of treatment discontinuation due to AEs including flu-like syndrome, injection-site reaction, depression, and fatigue [7]. Another 5-year study on 122 Interferon-Beta-treated RRMS patients reported 23% treatment discontinuation due to either clinical AEs such as local injection-site reaction and flu-like syndrome or Neurology Research International laboratory AEs including leukopenia and elevated liver enzymes [8]. Despite having the convenience of oral administration as opposed to platform injectable DMTs, AEs such as gastrointestinal irritability and elevated liver enzymes result in nonadherence or treatment discontinuation [10, 12, 13]

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