Abstract
BackgroundComparative effectiveness of natalizumab and fingolimod over a follow-up longer than 2 years has been not addressed yet.ObjectivesTo compare the effect on no evidence of disease activity (NEDA-3) in relapsing-remitting multiple sclerosis (RRMS) patients treated with natalizumab or fingolimod for at least 4 years.MethodsWe included RRMS patients switched from first-line agents to natalizumab or fingolimod. Patients were propensity score (PS)-matched on a 1-to-1 basis. Percentages of patients reaching NEDA-3 status at 2 and 4 years of follow-up were compared using the chi-square test. The risk of not achieving NEDA-3 at 4 years was explored in matched samples by Cox regression models.ResultsWe evaluated 174 PS-matched patients. Patients receiving natalizumab reached a NEDA-3 status at 2 and 4 years more frequently than those exposed to fingolimod (63% vs 44%, p=0.037; 45.7% vs 25.8%, p=0.015, respectively). Patients receiving natalizumab were at a significant lower risk of not achieving the NEDA-3 status at 4 years compared to those exposed to fingolimod (hazard ratio (95% confidence interval): 0.54 (0.36–0.80), p=0.002).ConclusionsAlthough both medications were effective in patients non-responding to first-line agents, natalizumab seems to be superior to fingolimod in RRMS in obtaining NEDA-3 status at 4 years.
Highlights
First-line disease-modifying therapies (DMTs), both injectables and orals significantly reduce relapse rate and short-term disability worsening in multiple sclerosis (MS) [1,2,3,4,5,6].In spite of this, a considerable number of patients treated with first-line agents continue to experience disease activity, which is associated with accumulation of disability [7, 8]
The results of this study confirm that NTZ is more effective than FIN in patients who do not respond to first-line agents, as already suggested in previous observational studies
NTZ and FIN have been both used as the first option in patients with rapidly worsening MS or in patients who do not respond to first-line DMTs
Summary
First-line disease-modifying therapies (DMTs), both injectables (interferon beta-1b, interferon beta-1a, glatiramer acetate) and orals (teriflunomide and dimethyl-fumarate) significantly reduce relapse rate and short-term disability worsening in multiple sclerosis (MS) [1,2,3,4,5,6].In spite of this, a considerable number of patients treated with first-line agents continue to experience disease activity, which is associated with accumulation of disability [7, 8]. Based on the evidence from randomized clinical trials (RCTs), escalation to second-line DMTs (natalizumab (NTZ) or fingolimod (FIN)) after treatment failure of first-line BRACE (Betaferon®, Betaseron®, Rebif®, Avonex®, Copaxone®, or Extavia®), treatment therapies are more effective than the so-called lateral switch in reducing clinical and MRI disease activity [9]. This approach has been based on the perceived superior efficacy of these drugs in comparison to the injectable first-line agents [10, 11]. Comparative effectiveness of natalizumab and fingolimod over a follow-up longer than 2 years has been not addressed yet
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