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. 2021 Aug;268(8):2922-2932.
doi: 10.1007/s00415-021-10455-3. Epub 2021 Feb 22.

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

Sebastiano Bucello  1 , Pietro Annovazzi  2 , Paolo Ragonese  3 , Marta Altieri  4 , Valeria Barcella  5 , Roberto Bergamaschi  6 , Alessia Bianchi  3 , Giovanna Borriello  7 , Maria Chiara Buscarinu  8 , Graziella Callari  9 , Marco Capobianco  10 , Fioravante Capone  11 , Paola Cavalla  12 , Rosella Cavarretta  13 , Antonio Cortese  4   14 , Giovanna De Luca  15 , Massimiliano Di Filippo  16 , Vincenzo Dattola  17 , Roberta Fantozzi  18 , Elisabetta Ferraro  14 , Maria Maddalena Filippi  19 , Claudio Gasperini  20 , Luigi Maria Edoardo Grimaldi  9 , Doriana Landi  21 , Marianna Lo Re  10 , Giulia Mallucci  6 , Paolo Manganotti  22 , Girolama Alessandra Marfia  18   21 , Massimiliano Mirabella  23 , Paola Perini  24 , Marco Pisa  25 , Sabrina Realmuto  26 , Margherita Russo  27 , Valentina Tomassini  15   28 , Valentina Liliana Adriana Torri-Clerici  29 , Mauro Zaffaroni  2 , Cristina Zuliani  30 , Sofia Zywicki  24 , Massimo Filippi  25   31   32 , Luca Prosperini  33
Affiliations

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

Sebastiano Bucello et al. J Neurol. 2021 Aug.

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.

Keywords: Multiple sclerosis; Oral drugs; Teriflunomide.

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