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

Autor: Pietro Annovazzi, Fioravante Capone, Sofia Zywicki, Paola Cavalla, Claudio Gasperini, Roberta Fantozzi, Elisabetta Ferraro, Doriana Landi, Sebastiano Bucello, Maria Maddalena Filippi, Roberto Bergamaschi, Vincenzo Dattola, Luigi M.E. Grimaldi, Girolama Alessandra Marfia, Luca Prosperini, Paolo Ragonese, Paolo Manganotti, Cristina Zuliani, Marco Pisa, Maria Chiara Buscarinu, Giovanna Borriello, A. Bianchi, Massimiliano Mirabella, Antonio Cortese, Marta Altieri, Rosella Cavarretta, Valentina Liliana Adriana Torri-Clerici, Giovanna De Luca, Valentina Tomassini, Massimiliano Di Filippo, Graziella Callari, Massimo Filippi, Giulia Mallucci, Valeria Barcella, Mauro Zaffaroni, Marco Capobianco, Paola Perini, Margherita Russo, Sabrina Realmuto, Marianna Lo Re
Přispěvatelé: Bucello S., Annovazzi P., Ragonese P., Altieri M., Barcella V., Bergamaschi R., Bianchi A., Borriello G., Buscarinu M.C., Callari G., Capobianco M., Capone F., Cavalla P., Cavarretta R., Cortese A., De Luca G., Di Filippo M., Dattola V., Fantozzi R., Ferraro E., Filippi M.M., Gasperini C., Grimaldi L.M.E., Landi D., Re M.L., Mallucci G., Manganotti P., Marfia G.A., Mirabella M., Perini P., Pisa M., Realmuto S., Russo M., Tomassini V., Torri-Clerici V.L.A., Zaffaroni M., Zuliani C., Zywicki S., Filippi M., Prosperini L.
Rok vydání: 2021
Předmět:
Zdroj: Journal of neurology. 268(8)
ISSN: 1432-1459
Popis: 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 2.75years: ~ 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.
Databáze: OpenAIRE
Externí odkaz: