TY - JOUR
T1 - Real world experience with teriflunomide in multiple sclerosis
T2 - the TER-Italy study
AU - Bucello, Sebastiano
AU - Annovazzi, Pietro
AU - Ragonese, Paolo
AU - Altieri, Marta
AU - Barcella, Valeria
AU - Bergamaschi, Roberto
AU - Bianchi, Alessia
AU - Borriello, Giovanna
AU - Buscarinu, Maria Chiara
AU - Callari, Graziella
AU - Capobianco, Marco
AU - Capone, Fioravante
AU - Cavalla, Paola
AU - Cavarretta, Rosella
AU - Cortese, Antonio
AU - De Luca, Giovanna
AU - Di Filippo, Massimiliano
AU - Dattola, Vincenzo
AU - Fantozzi, Roberta
AU - Ferraro, Elisabetta
AU - Filippi, Maria Maddalena
AU - Gasperini, Claudio
AU - Grimaldi, Luigi Maria Edoardo
AU - Landi, Doriana
AU - Re, Marianna Lo
AU - Mallucci, Giulia
AU - Manganotti, Paolo
AU - Marfia, Girolama Alessandra
AU - Mirabella, Massimiliano
AU - Perini, Paola
AU - Pisa, Marco
AU - Realmuto, Sabrina
AU - Russo, Margherita
AU - Tomassini, Valentina
AU - Torri-Clerici, Valentina Liliana Adriana
AU - Zaffaroni, Mauro
AU - Zuliani, Cristina
AU - Zywicki, Sofia
AU - Filippi, Massimo
AU - Prosperini, Luca
PY - 2021/2/22
Y1 - 2021/2/22
N2 - 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.
AB - 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.
U2 - 10.1007/s00415-021-10455-3
DO - 10.1007/s00415-021-10455-3
M3 - Article
C2 - 33616742
JO - J. Neurol.
JF - J. Neurol.
SN - 1432-1459
ER -