Abstract
The current study aims to compare injectable and oral first-line disease-modifying therapies (DMTs) for time to first relapse, time to confirmed disability progression (CDP), and time to discontinuation using a cohort of relapsing remitting multiple sclerosis (RRMS) patients, with data extracted from the Italian MS Register. 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. Enrolled patients were divided into two groups, namely the injectable group (IG) and the oral group (OG). Of a cohort of 11,416 patients, 4602 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. 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.
Highlights
Multiple sclerosis (MS) therapies have changed considerably over the last several decades, with the approval of oral diseasemodifying therapies (DMTs) following the demonstration of efficacy and safety for the treatment of the relapsing forms of MS (RRMS) [1].Prior to 2010, only DMTs administered by injection were available as an initial therapeutic option
Median disease duration was longer in the injectable group (IG) (66 months with a range of 23–249 compared to 70 months with a range of 21–277, p < 0.0001)
Observational, retrospectively acquired cohort study, starting oral first-line DMTs (DMF and TRF) was associated with a lower risk of first relapse occurrence and treatment discontinuation rate during the follow-up, in comparison to first-line injectable DMTs, but no significant difference was found in reaching confirmed disability progression (CDP)
Summary
Multiple sclerosis (MS) therapies have changed considerably over the last several decades, with the approval of oral diseasemodifying therapies (DMTs) following the demonstration of efficacy and safety for the treatment of the relapsing forms of MS (RRMS) [1].Prior to 2010, only DMTs administered by injection were available as an initial therapeutic option. Multiple sclerosis (MS) therapies have changed considerably over the last several decades, with the approval of oral diseasemodifying therapies (DMTs) following the demonstration of efficacy and safety for the treatment of the relapsing forms of MS (RRMS) [1]. Established efficacy evidence for reducing relapsing activity and disability progression is available for all licensed firstline DMTs, but the need for real data of comparison between the established and the newer first-line DMTs in unselected patient populations is still needed to define treatment sequences and to gather real-world data on long-term outcomes [8,9,10,11, 14,15,16,17,18,19]
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