Abstract
Teriflunomide (TRF) and Dimethyl fumarate (DMF) are licensed drugs for relapsing-remitting Multiple Sclerosis (RRMS). We aimed to compare the rate and the time to discontinuation among persons with RRMS (pwRRMS), newly treated with TRF and DMF. A retrospective study on prospectively collected data was performed in nine tertiary MS centers, in Italy. The 24-month discontinuation rate in the two cohorts was the primary study outcome. We also assessed the time to discontinuation and reasons of therapy withdrawn. Discontinuation of TRF and DMF was defined as a gap of treatment ≥ 60 days. A cohort of 903 pwRRMS (316 on TRF and 587 on DMF) was analyzed. During 24 months of follow-up, pwRRMS on TRF and DMF showed similar discontinuation rates. The analysis of predictors with Cox regression model showed differences between the two groups (p for log-rank test = 0.007); male gender [HR 2.21 (1.00-4.90); p = 0.01] and the number of previous switches [HR 1.47 (1.16-1.86); p = 0.01] were associated with higher hazard of discontinuation in the DMF group. In a real-world setting, pwRRMS on TRF and DMF had similar discontinuation rates over 24 months. Male pwRRMS on DMF with a previous history of therapeutic failure are at more risk of discontinuation therapy.
Highlights
The current therapeutic approach for the relapsing remitting forms of multiple sclerosis (RRMS) is based on the early start of treatment with one of the licensed disease modifying therapies (DMTs) with the possibility to switch to another DMT in case of failure of efficacy or for raising safety alert(s) [1, 2]
316 persons with RRMS (pwRRMS) were on TRF and 587 on Dimethyl fumarate (DMF) and met the inclusion criteria to be included in the analyses (Fig. 1)
A higher number of pwRRMS on TRF was naïve to treatment than pwRRMS on DMF (p < 0.05)
Summary
The current therapeutic approach for the relapsing remitting forms of multiple sclerosis (RRMS) is based on the early start of treatment with one of the licensed disease modifying therapies (DMTs) with the possibility to switch to another DMT in case of failure of efficacy or for raising safety alert(s) [1, 2]. Studies comparing the discontinuation rates and time to discontinuation among oral drugs in RRMS are increasing [6,7,8,9,10,11], and a recent Italian study tracked and evaluated the post-market DMF profile in real-world setting [12]. We compared the discontinuation rates in two large groups of persons with RRMS (pwRRMS) treated with TRF and DMF, using a large Italian multicentre cohort. Objectives We aimed to compare the rate and the time to discontinuation among persons with RRMS (pwRRMS), newly treated with TRF and DMF. During 24 months of follow-up, pwRRMS on TRF and DMF showed similar discontinuation rates. Conclusions In a real-world setting, pwRRMS on TRF and DMF had similar discontinuation rates over 24 months. Male pwRRMS on DMF with a previous history of therapeutic failure are at more risk of discontinuation therapy
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