Comparable efficacy and safety of dimethyl fumarate and teriflunomide treatment in Relapsing-Remitting Multiple Sclerosis: an Italian real-word multicenter experience

D’Amico, Emanuele; Zanghì, Aurora; Callari, Graziella; Borriello, Giovanna; Gallo, Antonio; Graziano, Giusi; Valentino, Paola; Buccafusca, Maria; Cottone, Salvatore; Salemi, Giuseppe; Ragonese, Paolo; Bossio, Roberto Bruno; Docimo, Renato; Grimaldi, Luigi Maria Edoardo; Pozzilli, Carlo; Tedeschi, Gioacchino; Zappia, Mario; Patti, Francesco

doi:10.1177/1756286418796404

Cited by 33 publications

(32 citation statements)

References 22 publications

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“…Our indings are in line with previous studies reporting a similar discontinuation rate for TFN and DMF [32][33][34][35], but conlict with a recently published large post-marketing analysis conducted in France showing a higher rate of treatment discontinuation in TFN-treated patients due to lack of efectiveness, especially due to MRI activity [36]. This discrepancy might be explained not only by longer followup (2 years), but also by diferent characteristics of the two study populations.…”

Section: Discussionsupporting

confidence: 90%

Exit strategies for “needle fatigue” in multiple sclerosis: a propensity score-matched comparison study

et al. 2019

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Section: Discussionsupporting

confidence: 90%

Exit strategies for “needle fatigue” in multiple sclerosis: a propensity score-matched comparison study

et al. 2019

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“…Moreover, this analysis is based on RCTs where the patients were highly selected and weakly representative of the population of patients with MS, as seen in real-life practice. 24 The number of patients in the studies based on observational data 11,12 is lower than in our work, with a shorter follow-up, and they were not able to correct MS activity with MRI at baseline. Finally, they also used propensity matching for statistical analyses, which has proven limitations.…”

Section: Discussionmentioning

confidence: 54%

“…9,10 The last ones were based on observational databases from neurologists in Germany 11 and Italy. 12 In all these studies, save the Italian one, the authors reported on a superior efficacy of DMF over TRF in relapse prevention. However, it is difficult to compare our results with these studies.…”

Section: Discussionmentioning

confidence: 99%

“…Recent observational studies have reported inconsistent results regarding clinical MS activity at 1 year (annualized relapse rate, time to first relapse) but none has compared clinical efficacy, MRI disease activity, and treatment withdrawals at 1 and 2 years in a large population of patients. [8][9][10][11][12] Such a study has the advantage of being more representative of real-life practices and effects, even if the treated patients are often noncomparable directly due to indication biases. In this context, taking advantage of the French Multiple Sclerosis Registry (Observatoire Français de la Sclérose En Plaques [OFSEP]), we propose to compare the real-life effectiveness and tolerance of DMF and TRF, using weighted propensity scores to deal with possible confounders.…”

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confidence: 99%

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Comparative effectiveness of teriflunomide vs dimethyl fumarate in multiple sclerosis

Laplaud

Casey²,

Barbin³

et al. 2019

Neurology

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ObjectiveIn this study, we compared the effectiveness of teriflunomide (TRF) and dimethyl fumarate (DMF) on both clinical and MRI outcomes in patients followed prospectively in the Observatoire Français de la Sclérose en Plaques.MethodsA total of 1,770 patients with relapsing-remitting multiple sclerosis (RRMS) (713 on TRF and 1,057 on DMF) with an available baseline brain MRI were included in intention to treat. The 1- and 2-year postinitiation outcomes were relapses, increase of T2 lesions, increase in Expanded Disability Status Scale score, and reason for treatment discontinuation. Propensity scores (inverse probability weighting) and logistic regressions were estimated.ResultsThe confounder-adjusted proportions of patients were similar in TRF- compared to DMF-treated patients for relapses and disability progression after 1 and 2 years. However, the adjusted proportion of patients with at least one new T2 lesion after 2 years was lower in DMF compared to TRF (60.8% vs 72.2%, odds ratio [OR] 0.60, p < 0.001). Analyses of reasons for treatment withdrawal showed that lack of effectiveness was reported for 8.5% of DMF-treated patients vs 14.5% of TRF-treated patients (OR 0.54, p < 0.001), while adverse events accounted for 16% of TRF-treated patients and 21% of DMF-treated patients after 2 years (OR 1.39, p < 0.001).ConclusionsAfter 2 years of treatment, we found similar effectiveness of DMF and TRF in terms of clinical outcomes, but with better MRI-based outcomes for DMF-treated patients, resulting in a lower rate of treatment discontinuation due to lack of effectiveness.Classification of evidenceThis study provides Class III evidence that for patients with RRMS, TRF and DMF have similar clinical effectiveness after 2 years of treatment.

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“…Studies matching the clinical efficacy provided conflicting results [9][10][11][12][13][14][15][16][17][18][19][20]. These discrepancies ask for further investigations to confirm or rebut the published findings, especially by real-life experiences.…”

Section: Introductionmentioning

confidence: 98%

Oral therapies for treatment of relapsing–remitting multiple sclerosis in Austria: a 2-year comparison using an inverse probability weighting method

et al. 2020

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Objectives To compare the efficacies, frequencies and reasons for treatment interruption of fingolimod (FTY), dimethyl fumarate (DMF) or teriflunomide (TERI) in a nationwide observational cohort. Materials and methods Two cohorts of patients with relapsing–remitting multiple sclerosis (RRMS) having started treatment with FTY, DMF or TERI documented in the Austrian MS Treatment Registry (AMSTR) since 2014 and either staying on therapy for at least 24 months (24 m cohort) or with at least one follow-up visit after start of treatment (total cohort). The 24 m cohort included 629 RRMS patients: 295 in the FTY, 227 in the DMF and 107 in the TERI group. We used multinomial propensity scores for inverse probability weighting in generalized linear and Cox proportional hazards models to correct for the bias of this non-randomised registry study. Results Estimated mean annualized relapse rates (ARR) over 24 months were 0.13 for FTY, 0.09 for DMF and 0.11 for TERI treatment. For TERI in comparison with DMF, we observed higher probability for treatment interruption (p = 0.023) and reduced sustained EDSS regression for 12 (p = 0.016) and 24 weeks (p = 0.031) and, for the comparison of DMF versus FTY, a reduced sustained EDSS progression for 12 weeks (p = 0.02). Conclusions Relapse rates with treatment with FTY, DMF and TERI were similar. Patients treated with DMF showed less sustained disability progression for 12 weeks than FTY-treated patients. However, FTY and DMF treatment was associated with more likely EDSS regression for 12 and 24 weeks and a lower probability for treatment interruption as compared to TERI-treated patients.

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Comparable efficacy and safety of dimethyl fumarate and teriflunomide treatment in Relapsing-Remitting Multiple Sclerosis: an Italian real-word multicenter experience

Cited by 33 publications

References 22 publications

Exit strategies for “needle fatigue” in multiple sclerosis: a propensity score-matched comparison study

Exit strategies for “needle fatigue” in multiple sclerosis: a propensity score-matched comparison study

Comparative effectiveness of teriflunomide vs dimethyl fumarate in multiple sclerosis

Oral therapies for treatment of relapsing–remitting multiple sclerosis in Austria: a 2-year comparison using an inverse probability weighting method

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