Fingolimod vs dimethyl fumarate in multiple sclerosis: A real-world propensity score-matched study

Luca Prosperini, Matteo Lucchini, Shalom Haggiag, Paolo Bellantonio, Assunta Bianco, Maria Chiara Buscarinu, Fabio Buttari, Diego Centonze, Antonio Cortese, Laura De Giglio, Roberta Fantozzi, Elisabetta Ferraro, Arianna Fornasiero, Ada Francia, Simonetta Galgani, Claudio Gasperini, Girolama Alessandra Marfia, Enrico Millefiorini, Viviana Nociti, Simona PontecorvoCarlo Pozzilli, Serena Ruggieri, Marco Salvetti, Eleonora Sgarlata, Massimiliano Mirabella

Research output: Contribution to journalArticle

Abstract

OBJECTIVE: To directly compare fingolimod (FNG) and dimethyl fumarate (DMF) on no evident disease activity (NEDA) status in patients with relapsing-remitting multiple sclerosis (RRMS) from 7 multiple sclerosis outpatient clinics in Central Italy.

METHODS: We analyzed data of patients with RRMS who started an oral agent, namely DMF or FNG, either as first treatment (naives) or after switching from self-injectable drugs (switchers). We performed a propensity score (PS)-based nearest-neighbor matching within a caliper of 0.05 to select patients with homogeneous baseline characteristics. Pairwise censoring was adopted to adjust for difference in length of follow-up between the 2 treatment groups. Comparisons were then conducted in matched samples with Cox models (stratified by center) with NEDA-3 as the main outcome. NEDA-3 was defined as no relapses, no disability worsening, and no MRI activity.

RESULTS: Overall, 483 and 456 patients eligible for analysis started on FNG and DMF, respectively. The PS-matching procedure retained a total of 550 patients (275 per group). After a median on-study follow-up of 18 months, the proportions of patients with NEDA-3 were similar (FNG 73%, DMF 70%; hazard ratio [HR] 0.74, p = 0.078). Subgroup analyses showed a comparable effectiveness of the 2 drugs in naives (n = 170, HR 1.15, p = 0.689), whereas FNG was superior to DMF in the achievement of NEDA-3 status among switchers (n = 380, HR 0.57, p = 0.007).

CONCLUSION: We found no significant difference between FNG and DMF on NEDA-3 status, while subgroup analyses suggest the superiority of FNG over DMF in patients switching from self-injectable drugs.

CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that for patients with RRMS, DMF and FNG have comparable efficacy in treatment-naive patients and that FNG is superior to DMF in patients switching from self-injectable drugs.

Original languageEnglish
Pages (from-to)e153-e161
JournalNeurology
Volume91
Issue number2
DOIs
Publication statusPublished - Jul 10 2018

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Propensity Score
Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
Pharmaceutical Preparations
Injections
Fingolimod Hydrochloride
Dimethyl Fumarate
Ambulatory Care Facilities
Proportional Hazards Models
Italy
Recurrence

Cite this

Prosperini, L., Lucchini, M., Haggiag, S., Bellantonio, P., Bianco, A., Buscarinu, M. C., ... Mirabella, M. (2018). Fingolimod vs dimethyl fumarate in multiple sclerosis: A real-world propensity score-matched study. Neurology, 91(2), e153-e161. https://doi.org/10.1212/WNL.0000000000005772

Fingolimod vs dimethyl fumarate in multiple sclerosis : A real-world propensity score-matched study. / Prosperini, Luca; Lucchini, Matteo; Haggiag, Shalom; Bellantonio, Paolo; Bianco, Assunta; Buscarinu, Maria Chiara; Buttari, Fabio; Centonze, Diego; Cortese, Antonio; De Giglio, Laura; Fantozzi, Roberta; Ferraro, Elisabetta; Fornasiero, Arianna; Francia, Ada; Galgani, Simonetta; Gasperini, Claudio; Marfia, Girolama Alessandra; Millefiorini, Enrico; Nociti, Viviana; Pontecorvo, Simona; Pozzilli, Carlo; Ruggieri, Serena; Salvetti, Marco; Sgarlata, Eleonora; Mirabella, Massimiliano.

In: Neurology, Vol. 91, No. 2, 10.07.2018, p. e153-e161.

Research output: Contribution to journalArticle

Prosperini, L, Lucchini, M, Haggiag, S, Bellantonio, P, Bianco, A, Buscarinu, MC, Buttari, F, Centonze, D, Cortese, A, De Giglio, L, Fantozzi, R, Ferraro, E, Fornasiero, A, Francia, A, Galgani, S, Gasperini, C, Marfia, GA, Millefiorini, E, Nociti, V, Pontecorvo, S, Pozzilli, C, Ruggieri, S, Salvetti, M, Sgarlata, E & Mirabella, M 2018, 'Fingolimod vs dimethyl fumarate in multiple sclerosis: A real-world propensity score-matched study', Neurology, vol. 91, no. 2, pp. e153-e161. https://doi.org/10.1212/WNL.0000000000005772
Prosperini L, Lucchini M, Haggiag S, Bellantonio P, Bianco A, Buscarinu MC et al. Fingolimod vs dimethyl fumarate in multiple sclerosis: A real-world propensity score-matched study. Neurology. 2018 Jul 10;91(2):e153-e161. https://doi.org/10.1212/WNL.0000000000005772
Prosperini, Luca ; Lucchini, Matteo ; Haggiag, Shalom ; Bellantonio, Paolo ; Bianco, Assunta ; Buscarinu, Maria Chiara ; Buttari, Fabio ; Centonze, Diego ; Cortese, Antonio ; De Giglio, Laura ; Fantozzi, Roberta ; Ferraro, Elisabetta ; Fornasiero, Arianna ; Francia, Ada ; Galgani, Simonetta ; Gasperini, Claudio ; Marfia, Girolama Alessandra ; Millefiorini, Enrico ; Nociti, Viviana ; Pontecorvo, Simona ; Pozzilli, Carlo ; Ruggieri, Serena ; Salvetti, Marco ; Sgarlata, Eleonora ; Mirabella, Massimiliano. / Fingolimod vs dimethyl fumarate in multiple sclerosis : A real-world propensity score-matched study. In: Neurology. 2018 ; Vol. 91, No. 2. pp. e153-e161.
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T1 - Fingolimod vs dimethyl fumarate in multiple sclerosis

T2 - A real-world propensity score-matched study

AU - Prosperini, Luca

AU - Lucchini, Matteo

AU - Haggiag, Shalom

AU - Bellantonio, Paolo

AU - Bianco, Assunta

AU - Buscarinu, Maria Chiara

AU - Buttari, Fabio

AU - Centonze, Diego

AU - Cortese, Antonio

AU - De Giglio, Laura

AU - Fantozzi, Roberta

AU - Ferraro, Elisabetta

AU - Fornasiero, Arianna

AU - Francia, Ada

AU - Galgani, Simonetta

AU - Gasperini, Claudio

AU - Marfia, Girolama Alessandra

AU - Millefiorini, Enrico

AU - Nociti, Viviana

AU - Pontecorvo, Simona

AU - Pozzilli, Carlo

AU - Ruggieri, Serena

AU - Salvetti, Marco

AU - Sgarlata, Eleonora

AU - Mirabella, Massimiliano

N1 - © 2018 American Academy of Neurology.

PY - 2018/7/10

Y1 - 2018/7/10

N2 - OBJECTIVE: To directly compare fingolimod (FNG) and dimethyl fumarate (DMF) on no evident disease activity (NEDA) status in patients with relapsing-remitting multiple sclerosis (RRMS) from 7 multiple sclerosis outpatient clinics in Central Italy.METHODS: We analyzed data of patients with RRMS who started an oral agent, namely DMF or FNG, either as first treatment (naives) or after switching from self-injectable drugs (switchers). We performed a propensity score (PS)-based nearest-neighbor matching within a caliper of 0.05 to select patients with homogeneous baseline characteristics. Pairwise censoring was adopted to adjust for difference in length of follow-up between the 2 treatment groups. Comparisons were then conducted in matched samples with Cox models (stratified by center) with NEDA-3 as the main outcome. NEDA-3 was defined as no relapses, no disability worsening, and no MRI activity.RESULTS: Overall, 483 and 456 patients eligible for analysis started on FNG and DMF, respectively. The PS-matching procedure retained a total of 550 patients (275 per group). After a median on-study follow-up of 18 months, the proportions of patients with NEDA-3 were similar (FNG 73%, DMF 70%; hazard ratio [HR] 0.74, p = 0.078). Subgroup analyses showed a comparable effectiveness of the 2 drugs in naives (n = 170, HR 1.15, p = 0.689), whereas FNG was superior to DMF in the achievement of NEDA-3 status among switchers (n = 380, HR 0.57, p = 0.007).CONCLUSION: We found no significant difference between FNG and DMF on NEDA-3 status, while subgroup analyses suggest the superiority of FNG over DMF in patients switching from self-injectable drugs.CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that for patients with RRMS, DMF and FNG have comparable efficacy in treatment-naive patients and that FNG is superior to DMF in patients switching from self-injectable drugs.

AB - OBJECTIVE: To directly compare fingolimod (FNG) and dimethyl fumarate (DMF) on no evident disease activity (NEDA) status in patients with relapsing-remitting multiple sclerosis (RRMS) from 7 multiple sclerosis outpatient clinics in Central Italy.METHODS: We analyzed data of patients with RRMS who started an oral agent, namely DMF or FNG, either as first treatment (naives) or after switching from self-injectable drugs (switchers). We performed a propensity score (PS)-based nearest-neighbor matching within a caliper of 0.05 to select patients with homogeneous baseline characteristics. Pairwise censoring was adopted to adjust for difference in length of follow-up between the 2 treatment groups. Comparisons were then conducted in matched samples with Cox models (stratified by center) with NEDA-3 as the main outcome. NEDA-3 was defined as no relapses, no disability worsening, and no MRI activity.RESULTS: Overall, 483 and 456 patients eligible for analysis started on FNG and DMF, respectively. The PS-matching procedure retained a total of 550 patients (275 per group). After a median on-study follow-up of 18 months, the proportions of patients with NEDA-3 were similar (FNG 73%, DMF 70%; hazard ratio [HR] 0.74, p = 0.078). Subgroup analyses showed a comparable effectiveness of the 2 drugs in naives (n = 170, HR 1.15, p = 0.689), whereas FNG was superior to DMF in the achievement of NEDA-3 status among switchers (n = 380, HR 0.57, p = 0.007).CONCLUSION: We found no significant difference between FNG and DMF on NEDA-3 status, while subgroup analyses suggest the superiority of FNG over DMF in patients switching from self-injectable drugs.CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that for patients with RRMS, DMF and FNG have comparable efficacy in treatment-naive patients and that FNG is superior to DMF in patients switching from self-injectable drugs.

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DO - 10.1212/WNL.0000000000005772

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JF - Neurology

SN - 0028-3878

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