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-HeReport as inadecuate




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-He - Download this document for free, or read online. Document in PDF available to download.

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.



Author: Georgios Tsivgoulis , Aristeidis H. Katsanos, Dimitris Mavridis, Nikolaos Grigoriadis, Efthymios Dardiotis, Ioannis Heliopoulos,

Source: http://plos.srce.hr/



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