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The Efficacy of Natalizumab versus Fingolimod for Patients with Relapsing-Remitting Multiple Sclerosis: A Systematic Review, Indirect Evidence from Randomized Placebo-Controlled Trials and Meta-Analysis of Observational Head-to-Head Trials

Author

Listed:
  • Georgios Tsivgoulis
  • Aristeidis H Katsanos
  • Dimitris Mavridis
  • Nikolaos Grigoriadis
  • Efthymios Dardiotis
  • Ioannis Heliopoulos
  • Panagiotis Papathanasopoulos
  • Theodoros Karapanayiotides
  • Constantinos Kilidireas
  • Georgios M Hadjigeorgiou
  • Konstantinos Voumvourakis
  • HELANI (Hellenic Academy of Neuroimmunology)

Abstract

Background: Although Fingolimod (FGD) and Natalizumab (NTZ) appear to be effective in relapsing-remitting multiple sclerosis (RRMS), they have never been directly compared in a randomized clinical trial (RCT). Methods and Findings: We evaluated the comparative efficacy of FGD vs. NTZ using a meta-analytical approach. Data from placebo-controlled RCTs was used for indirect comparisons and observational data was utilized for head-to-head comparisons. We identified 3 RCTs (2498 patients) and 5 observational studies (2576 patients). NTZ was associated with a greater reduction in the 2-year annualized relapse rate (ARR; SMDindirect = -0.24;95% CI: from -0.44 to -0.04; p = 0.005) and with the probability of no disease activity at 2 years (ORindirect:1.82, 95% CI: from 1.05 to 3.15) compared to FGD, while no differences between the two therapies were found in the proportion of patients who remained relapse-free (ORindirect = 1.20;95% CI: from 0.84 to 1.71) and those with disability progression (ORindirect = 0.76;95% CI: from 0.48 to 1.21) at 2 years. In the analysis of observational data, we found no significant differences between NTZ and FGD in the 2-year ARR (SMD = -0.05; 95% CI: from -0.26 to 0.16), and 2-year disability progression (OR:1.08;95% CI: from 0.77 to 1.52). However, NTZ-treated patients were more likely to remain relapse-free at 2-years compared to FGD (OR: 2.19;95% CI: from 1.15 to 4.18; p = z0.020). Conclusions: Indirect analyses of RCT data and head-to-head comparisons of observational findings indicate that NTZ may be more effective than FGD in terms of disease activity reduction in patients with RRMS. However, head-to-head RCTs are required to independently confirm this preliminary observation.

Suggested Citation

  • Georgios Tsivgoulis & Aristeidis H Katsanos & Dimitris Mavridis & Nikolaos Grigoriadis & Efthymios Dardiotis & Ioannis Heliopoulos & Panagiotis Papathanasopoulos & Theodoros Karapanayiotides & Constan, 2016. "The Efficacy of Natalizumab versus Fingolimod for Patients with Relapsing-Remitting Multiple Sclerosis: A Systematic Review, Indirect Evidence from Randomized Placebo-Controlled Trials and Meta-Analys," PLOS ONE, Public Library of Science, vol. 11(9), pages 1-14, September.
    • Handle: RePEc:plo:pone00:0163296
    DOI: 10.1371/journal.pone.0163296
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    References listed on IDEAS

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    1. Christian Röver & Richard Nicholas & Sebastian Straube & Tim Friede, 2015. "Changing EDSS Progression in Placebo Cohorts in Relapsing MS: A Systematic Review and Meta-Regression," PLOS ONE, Public Library of Science, vol. 10(9), pages 1-10, September.
    2. Georgios Tsivgoulis & Aristeidis H Katsanos & Nikolaos Grigoriadis & Georgios M Hadjigeorgiou & Ioannis Heliopoulos & Panagiotis Papathanasopoulos & Constantinos Kilidireas & Konstantinos Voumvourakis, 2015. "The Effect of Disease Modifying Therapies on Disease Progression in Patients with Relapsing-Remitting Multiple Sclerosis: A Systematic Review and Meta-Analysis," PLOS ONE, Public Library of Science, vol. 10(12), pages 1-12, December.
    3. Alessandro Liberati & Douglas G Altman & Jennifer Tetzlaff & Cynthia Mulrow & Peter C Gøtzsche & John P A Ioannidis & Mike Clarke & P J Devereaux & Jos Kleijnen & David Moher, 2009. "The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration," PLOS Medicine, Public Library of Science, vol. 6(7), pages 1-28, July.
    4. Ray Gani & Gavin Giovannoni & David Bates & Belinda Kemball & Steve Hughes & John Kerrigan, 2008. "Cost-Effectiveness Analyses of Natalizumab (Tysabri®) Compared with Other Disease-Modifying Therapies for People with Highly Active Relapsing-Remitting Multiple Sclerosis in the UK," PharmacoEconomics, Springer, vol. 26(7), pages 617-627, July.
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