TY - JOUR
T1 - Dimethyl fumarate vs Teriflunomide
T2 - an Italian time-to-event data analysis
AU - ITALIAN-DIME-TERI group
AU - D’Amico, Emanuele
AU - Zanghì, Aurora
AU - Sciandra, Mariangela
AU - Lanzillo, Roberta
AU - Callari, Graziella
AU - Cortese, Antonio
AU - Lus, Giacomo
AU - Lucchini, Matteo
AU - Buccafusca, Maria
AU - Bonavita, Simona
AU - Gallo, Antonio
AU - Curti, Erica
AU - Gajofatto, Alberto
AU - Signoriello, Elisabetta
AU - Bisecco, Alvino
AU - Gobbin, Francesca
AU - Ferrò, Maria Teresa
AU - Ferrazzano, Gina
AU - Sparaco, Maddalena
AU - Valentino, Paola
AU - Mirabella, Massimiliano
AU - Granella, Franco
AU - Bresciamorra, Vincenzo
AU - Grimaldi, Luigi Maria Edoardo
AU - Patti, Francesco
AU - Borriello, Giovanna
AU - Grossi, Paola
AU - Carotenuto, Antonio
AU - Siena, Ernesto
AU - Tsantes, Elena
AU - Giugno, Alessia
AU - Abbadessa, Gian Marco
AU - Chisari, Clara Grazia
N1 - Funding Information:
Dr Emanuele D’Amico has received personal fees from Biogen and Sanofi. He also received travel funding from Bayer Biogen and Merck. Dr Aurora Zanghì received travel funding from Bayer-Schering and Sanofi Genzyme outside of the described work. Dr Mariangela Sciandra has nothing to disclose. Dr Roberta Lanzillo has received personal fees for public speaking or consultancy from Merck, Novartis, Biogen, Genzyme, Teva, Roche and Almirall. Dr Graziella Callari has received personal fees from Biogen and Sanofi. She also received travel funding from Bayer Biogen and Merck. Dr Antonio Cortese has received speaker honoraria from Biogen, Sanofi Genzyme, and Teva, and travel grants from Biogen, Merck, Sanofi Genzyme, and Teva. He also received advisory board member honoraria from Biogen, Merck, Novartis, and Teva. Dr Giacomo Lus has nothing to disclose related to this manuscript. Dr Matteo Lucchini has received travel grants from Almirall, Biogen, Sanofi-Genzyme and Roche, speaker honoraria from Biogen and consulting fees from Merck Serono, Almirall and Novartis. Dr Maria Buccafusca has nothing to disclose related to this manuscript. Dr Simona Bonavita has nothing to disclose related to this manuscript. Dr Antonio Gallo has nothing to disclose related to this manuscript. Dr Erica Curti has nothing to disclose related to this manuscript. Dr Alberto Gajofatto has nothing to disclose related to this manuscript. Dr Elisabetta Signoriello has nothing to disclose related to this manuscript. Dr Alvino Bisecco has nothing to disclose related to this manuscript. Dr Francesca Gobbin has nothing to disclose related to this manuscript. Dr Maria Teresa Ferrò has nothing to disclose related to this manuscript. De Gina Ferrazzano has nothing to disclose related to this manuscript. Dr Maddalena Sparaco has nothing to disclose related to this manuscript. Dr Paola Valentino has nothing to disclose related to this manuscript. Dr Massimiliano Mirabella has received honoraria for speaking, serving on the advisory board and consulting for Biogen, Novartis, Merck Serono, Roche, Almirall and Sanofi Genzyme. He has received reimbursement for congress attendance and travel costs from Biogen, Novartis, Sanofi Genzyme, Roche, Merck Serono and Teva. He was also a principal investigator for clinical trials for Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, Teva and Ultragenix. Dr Franco Granella has nothing to disclose related to this manuscript. Dr Vincenzo Brescia Morra has nothing to disclose related to this manuscript. Dr Luigi Maria Edoardo Grimaldi has served on the advisory boards of Bayer, Biogen Celgene, Merck, Novartis, Roche, Sanofi and Teva. He has also received personal fees for speaking activities at congresses or sponsored symposia. Dr Francesco Patti has served on the advisory boards of Bayer, Biogen Celgene, Merck, Novartis, Roche, Sanofi, Teva and Almirall. He has also received personal fees for speaking activities at congresses or sponsored symposia.
Publisher Copyright:
© 2020, Springer-Verlag GmbH Germany, part of Springer Nature.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/10/1
Y1 - 2020/10/1
N2 - Background: The introduction of oral disease-modifying therapies (DMTs) for relapsing–remitting multiple sclerosis (RRMS) changed algorithms of RRMS treatment. Objectives: To compare the effectiveness of treatment with dimethyl fumarate (DMF) and teriflunomide (TRF) in a large multicentre Italian cohort of RRMS patients. Materials and Methods: Patients with RRMS who received treatment with DMF and TRF between January 1st, 2012 and December 31st, 2018 from twelve MS centers were identified. The events investigated were “time-to-first-relapse”, “time-to-Magnetic-Resonance-Imaging (MRI)-activity” and “time-to-disability-progression”. Results: 1445 patients were enrolled (1039 on DMF, 406 on TRF) and followed for a median of 34 months. Patients on TRF were older (43.5 ± 8.6 vs 38.8 ± 9.2 years), with a predominance of men and higher level of disability (p < 0.001 for all). Patients on DMF had a higher number of relapses and radiological activity (p <.05) at baseline. Time-varying Cox-model for the event “time-to-first relapse” revealed that no differences were found between the two groups in the first 38 months of treatment (HRt < 38DMF = 0.73, CI = 0.52 to 1.03, p = 0.079). When the time-on-therapy exceeds 38 months patients on DMF had an approximately 0.3 times lower relapse hazard risk than those who took TRF (HRt>38DMF = 3.83, CI = 1.11 to 13.23, p = 0.033). Both DMTs controlled similarly MRI activity and disability progression. Conclusions: Patients on DMF had higher relapse-free survival time than TRF group after the first 38 months ontherapy.
AB - Background: The introduction of oral disease-modifying therapies (DMTs) for relapsing–remitting multiple sclerosis (RRMS) changed algorithms of RRMS treatment. Objectives: To compare the effectiveness of treatment with dimethyl fumarate (DMF) and teriflunomide (TRF) in a large multicentre Italian cohort of RRMS patients. Materials and Methods: Patients with RRMS who received treatment with DMF and TRF between January 1st, 2012 and December 31st, 2018 from twelve MS centers were identified. The events investigated were “time-to-first-relapse”, “time-to-Magnetic-Resonance-Imaging (MRI)-activity” and “time-to-disability-progression”. Results: 1445 patients were enrolled (1039 on DMF, 406 on TRF) and followed for a median of 34 months. Patients on TRF were older (43.5 ± 8.6 vs 38.8 ± 9.2 years), with a predominance of men and higher level of disability (p < 0.001 for all). Patients on DMF had a higher number of relapses and radiological activity (p <.05) at baseline. Time-varying Cox-model for the event “time-to-first relapse” revealed that no differences were found between the two groups in the first 38 months of treatment (HRt < 38DMF = 0.73, CI = 0.52 to 1.03, p = 0.079). When the time-on-therapy exceeds 38 months patients on DMF had an approximately 0.3 times lower relapse hazard risk than those who took TRF (HRt>38DMF = 3.83, CI = 1.11 to 13.23, p = 0.033). Both DMTs controlled similarly MRI activity and disability progression. Conclusions: Patients on DMF had higher relapse-free survival time than TRF group after the first 38 months ontherapy.
KW - Dimethyl fumarate
KW - Efficacy
KW - Multiple sclerosis
KW - Safety
KW - Teriflunomide
UR - http://www.scopus.com/inward/record.url?scp=85086091841&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85086091841&partnerID=8YFLogxK
U2 - 10.1007/s00415-020-09959-1
DO - 10.1007/s00415-020-09959-1
M3 - Article
C2 - 32506391
AN - SCOPUS:85086091841
VL - 267
SP - 3008
EP - 3020
JO - Journal of Neurology
JF - Journal of Neurology
SN - 0340-5354
IS - 10
ER -