Real world experience with teriflunomide in multiple sclerosis: the TER-Italy study

Sebastiano Bucello, Pietro Annovazzi, Paolo Ragonese, Marta Altieri, Valeria Barcella, Roberto Bergamaschi, Alessia Bianchi, Giovanna Borriello, Maria Chiara Buscarinu, Graziella Callari, Marco Capobianco, Fioravante Capone, Paola Cavalla, Rosella Cavarretta, Antonio Cortese, Giovanna De Luca, Massimiliano Di Filippo, Vincenzo Dattola, Roberta Fantozzi, Elisabetta FerraroMaria Maddalena Filippi, Claudio Gasperini, Luigi Maria Edoardo Grimaldi, Doriana Landi, Marianna Lo Re, Giulia Mallucci, Paolo Manganotti, Girolama Alessandra Marfia, Massimiliano Mirabella, Paola Perini, Marco Pisa, Sabrina Realmuto, Margherita Russo, Valentina Tomassini, Valentina Liliana Adriana Torri-Clerici, Mauro Zaffaroni, Cristina Zuliani, Sofia Zywicki, Massimo Filippi, Luca Prosperini

Research output: Contribution to journalArticlepeer-review

Abstract

OBJECTIVE: To identify baseline factors associated with disease activity in patients with relapsing-remitting multiple sclerosis (RRMS) under teriflunomide treatment.

METHODS: This was an independent, multi-centre, retrospective post-marketing study. We analysed data of 1,507 patients who started teriflunomide since October 2014 and were regularly followed in 28 Centres in Italy. We reported the proportions of patients who discontinued treatment (after excluding 32 lost to follow-up) and who experienced clinical disease activity, i.e., relapse(s) and/or confirmed disability worsening, as assessed by the Expanded Disability Status Scale (EDSS). Decision tree-based analysis was performed to identify baseline factors associated with clinical disease activity during teriflunomide treatment.

RESULTS: At database lock (September 2020), approximately 29% of patients (430 out of 1,475) discontinued teriflunomide because of disease activity (~ 46%), adverse events (~ 37%), poor tolerability (~ 15%), pregnancy planning (~ 2%). Approximately 28% of patients experienced disease activity over a median follow-up of 2.75 years: ~ 9% had relapses but not disability worsening; ~ 13% had isolated disability worsening; ~ 6% had both relapses and disability worsening. The most important baseline factor associated with disease activity (especially disability worsening) was an EDSS > 4.0 (p < 0.001). In patients with moderate disability level (EDSS 2.0-4.0), disease activity occurred more frequently in case of ≥ 1 pre-treatment relapses (p = 0.025). In patients with milder disability level (EDSS < 2.0), disease activity occurred more frequently after previous exposure to ≥ 2 disease-modifying treatments (p = 0.007).

CONCLUSIONS: Our study suggests a place-in-therapy for teriflunomide in naïve patients with mild disability level or in those who switched their initial treatment for poor tolerability. Adverse events related with teriflunomide were consistent with literature data, without any new safety concern.

Original languageEnglish
JournalJ. Neurol.
DOIs
Publication statusE-pub ahead of print - Feb 22 2021

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