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

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

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
Pages (from-to)2922-2932
Number of pages11
JournalJournal of Neurology
Volume268
Publication statusPublished - 2021

All Science Journal Classification (ASJC) codes

  • Neurology
  • Clinical Neurology

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