Abstract
Background: Natalizumab (NTZ) and fingolimod (FTY) are second-line disease modifying treatments (DMTs) approved for Relapsing – Remitting Multiple Sclerosis (RRMS). Few studies are available on a direct comparison between NTZ and FTY, based on post-marketing experience, with conflicting results and reporting relatively short follow-up period.Aim: We hereby report real-world experience of a MS Center with respect to NTZ vs. FTY comparison in terms of efficacy and safety, referencing long-term follow-up.Methods: We used retrospective data for all patients that received 2nd-line treatment NTZ (since May 2007) or FTY (since September 2011). Primary endpoints were, among others, annual EDSS score (mean change from baseline), time to disability worsening or improvement, Annualized Relapse Rate (ARR) after 12 and 24 months and upon total treatment duration, time to first relapse and time to radiological progression.Results: A total of 138 unmatched patients, 84 treated with NTZ and 54 treated with FTY were included. Following Propensity Score (PS) matching, 31 patients in each group were retained. Mean follow-up period for NTZ- and FTY-treated patients was 4.43 ± 0.29 and 3.59 ± 0.32 years (p = 0.057), respectively. In the matched analysis, time to disability improvement and time to disability worsening was comparable between groups. A higher proportion of patients remained free of relapse under NTZ, compared to FTY (Log Rank test p = 0.021, HR: 0.25, 95% CI: 0.08–0.8), as well as free of MRI activity (Log Rank test p = 0.006, HR: 0.26, 95% CI: 0.08–0.6). Treatment discontinuation due to MRI activity was significantly higher for FTY-treated patients compared to NTZ (Log Rank test p = 0.019, HR: 0.12, 95% CI: 0.05–0.76).Conclusion: Our results indicate toward NTZ superiority with respect to relapse and MRI activity outcomes. The fact that NTZ-treated patients may achieve long-standing clinical and radiological remission points toward the need for long follow-up data.
Highlights
Natalizumab (NTZ) and fingolimod (FTY) are second-line disease-modifying treatments (DMTs), European Medicines Agency (EMA) approved for Relapsing–Remitting Multiple Sclerosis (RRMS) [1, 2], a classification based on the safety profile of these agents
There is no consensus on the definition for highly active Relapsing – Remitting Multiple Sclerosis (RRMS) [3], NTZ and FTY are indicated in patients with RRMS for whom at least one DMT has previously proven ineffective and/or exhibit rapidly evolving severe RRMS defined by two or more disabling relapses in 1 year, one or more Gd(+) lesions on brain Magnetic Resonance Imaging (MRI), or a significant increase in T2 lesion load as compared to a previous recent MRI [1, 2]
The use of NTZ has significantly been affected by the occurrence of Progressive multifocal leukoencephalopathy (PML), a rare but severe adverse event linked to anti-JCV (John Cunningham virus) Ab seropositivity, prior use of immunosuppressants, and prolonged (>2 years) exposure to NTZ [4]
Summary
Natalizumab (NTZ) and fingolimod (FTY) are second-line disease-modifying treatments (DMTs), European Medicines Agency (EMA) approved for Relapsing–Remitting Multiple Sclerosis (RRMS) [1, 2], a classification based on the safety profile of these agents. Both treatments were shown to be effective in controlling clinical and MRI activity in patients with RRMS with highly active disease at diagnosis. PML risk stratification has further been implemented in clinical practice according to EMA guidelines and based on the anti-JCV Ab index as well as the duration of exposure to NTZ [5]. Few studies are available on a direct comparison between NTZ and FTY, based on post-marketing experience, with conflicting results and reporting relatively short follow-up period
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