Comparative effectiveness of initial Treatment Choices for Multiple Sclerosis: a multicentre study
SYNOPSIS AND RESULTS
Data start
Data end
2018-04-16
2022-05-26
PARTICIPATING CENTERS
Francesco Patti, MD
Aurora Zanghì, MD
OUTCOME
Introduction and aims Multiple sclerosis (MS) therapies have changed considerably over the last several decades, with the approval of oral disease modifying therapies (DMTs) following the demonstration of efficacy and safety for the treatment of the relapsing forms of MS (RRMS). This multicenter, observational, retrospectively acquired, and propensity adjusted cohort study utilized RRMS-naïve patients from the Italian MS Register who started either injectable or oral first-line DMTs between January 1, 2010, and December 31, 2017, to evaluate the impact on disability outcomes in patients.
Results Enrolled patients were divided into two groups, namely the injectable group (IG) and the oral group (OG). Of a cohort of 11,416 patients, 4,602 were enrolled (3919 in the IG and 683 in the OG). The IG had a higher rate of women (67.3% vs 63.4%, p < 0.05) and a lower mean age (36.1 ± 10.9 vs 38.9 ± 11.8, p < 0.001). The event time to first relapse demonstrated a lower risk in the OG (HR = 0.58; CI 95% 0.48–0.72, p < 0.001). However, no differences were found between the two groups with respect to the risk of CDP (HR = 0.94; CI 95% 0.76–1.29, p = 0.941), while a lower risk of DMT was found in the OG (HR = 0.72; CI 95% 0.58–0.88, p = 0.002) for the event time to discontinuation.
Conclusions Real-world data from the Italian MS Register suggests that first-line oral DMTs are associated with a lower risk of experiencing a new relapse and of therapy discontinuation compared to injectable DMTs. From this project derived three scientific publications, focusing on first line DMT’s comparison.
Pubblicazioni e Comunicazioni a Congressi/ Publications and Congress Presentations D'Amico E, Zanghì A, Romeo M, et al. Injectable Versus Oral First-Line Disease-Modifying Therapies: Results from the Italian MS Register. Neurotherapeutics. 2021;18(2):905-919. doi:10.1007/s13311-020-01001-6 Zanghì A, Avolio C, Amato MP, et al. First-line therapies in late-onset multiple sclerosis: An Italian registry study. Eur J Neurol. 2021;28(12):4117-4123. doi:10.1111/ene.15006 Zanghì A, Avolio C, Amato MP, et al. Real world comparison of teriflunomide and dimethyl fumarate in naïve relapsing multiple sclerosis patients: Evidence from the Italian MS register. Mult Scler Relat Disord. 2022;58:103489. doi:10.1016/j.msard.2022.103489
PUBLICATIONS
D'Amico E, Zanghì A, Romeo M, et al. Injectable Versus Oral First-Line Disease-Modifying Therapies: Results from the Italian MS Register. Neurotherapeutics. 2021;18(2):905-919. doi:10.1007/s13311-020-01001-6
Zanghì, A, Avolio, C, Amato, MP, et al. First-line therapies in late-onset multiple sclerosis: An Italian registry study. Eur J Neurol. 2021; 28: 4117– 4123. https://doi.org/10.1111/ene.15006
Zanghì A, Avolio C, Amato MP, et al. Real world comparison of teriflunomide and dimethyl fumarate in naïve relapsing multiple sclerosis patients: Evidence from the Italian MS register [published online ahead of print, 2022 Jan 2]. Mult Scler Relat Disord. 2022;58:103489. doi:10.1016/j.msard.2022.103489
Fondazione Italiana Sclerosi Multipla – FISM – Ente del Terzo Settore/ETS e, in forma abbreviata, FISM ETS. Iscrizione al RUNTS Rep. N° 89695 - Fondazione con Riconoscimento di Personalità Giuridica - C.F. 95051730109
Comparative effectiveness of initial Treatment Choices for Multiple Sclerosis: a multicentre study
Francesco Patti, MD
Aurora Zanghì, MD
Introduction and aims
Multiple sclerosis (MS) therapies have changed considerably over the last several decades, with the approval of oral disease modifying therapies (DMTs) following the demonstration of efficacy and safety for the treatment of the relapsing forms of MS (RRMS).
This multicenter, observational, retrospectively acquired, and propensity adjusted cohort study utilized RRMS-naïve patients from the Italian MS Register who started either injectable or oral first-line DMTs between January 1, 2010, and December 31, 2017, to evaluate the impact on disability outcomes in patients.
Results
Enrolled patients were divided into two groups, namely the injectable group (IG) and the oral group (OG).
Of a cohort of 11,416 patients, 4,602 were enrolled (3919 in the IG and 683 in the OG). The IG had a higher rate of women (67.3% vs 63.4%, p < 0.05) and a lower mean age (36.1 ± 10.9 vs 38.9 ± 11.8, p < 0.001). The event time to first relapse demonstrated a lower risk in the OG (HR = 0.58; CI 95% 0.48–0.72, p < 0.001). However, no differences were found between the two groups with respect to the risk of CDP (HR = 0.94; CI 95% 0.76–1.29, p = 0.941), while a lower risk of DMT was found in the OG (HR = 0.72; CI 95% 0.58–0.88, p = 0.002) for the event time to discontinuation.
Conclusions
Real-world data from the Italian MS Register suggests that first-line oral DMTs are associated with a lower risk of experiencing a new relapse and of therapy discontinuation compared to injectable DMTs. From this project derived three scientific publications, focusing on first line DMT’s comparison.
Pubblicazioni e Comunicazioni a Congressi/ Publications and Congress Presentations
D'Amico E, Zanghì A, Romeo M, et al. Injectable Versus Oral First-Line Disease-Modifying Therapies: Results from the Italian MS Register. Neurotherapeutics. 2021;18(2):905-919. doi:10.1007/s13311-020-01001-6
Zanghì A, Avolio C, Amato MP, et al. First-line therapies in late-onset multiple sclerosis: An Italian registry study. Eur J Neurol. 2021;28(12):4117-4123. doi:10.1111/ene.15006
Zanghì A, Avolio C, Amato MP, et al. Real world comparison of teriflunomide and dimethyl fumarate in naïve relapsing multiple sclerosis patients: Evidence from the Italian MS register. Mult Scler Relat Disord. 2022;58:103489. doi:10.1016/j.msard.2022.103489
D'Amico E, Zanghì A, Romeo M, et al. Injectable Versus Oral First-Line Disease-Modifying Therapies: Results from the Italian MS Register. Neurotherapeutics. 2021;18(2):905-919. doi:10.1007/s13311-020-01001-6
Zanghì, A, Avolio, C, Amato, MP, et al. First-line therapies in late-onset multiple sclerosis: An Italian registry study. Eur J Neurol. 2021; 28: 4117– 4123.
https://doi.org/10.1111/ene.15006
Zanghì A, Avolio C, Amato MP, et al. Real world comparison of teriflunomide and dimethyl fumarate in naïve relapsing multiple sclerosis patients: Evidence from the Italian MS register [published online ahead of print, 2022 Jan 2]. Mult Scler Relat Disord. 2022;58:103489. doi:10.1016/j.msard.2022.103489