Sustained Efficacy of Natalizumab in the Treatment of Relapsing-Remitting Multiple Sclerosis Independent of Disease Activity and Disability at Baseline: Real-Life Data From a Swiss Cohort

ObjectivesTherapy for relapsing-remitting multiple sclerosis with natalizumab (Tysabri; Biogen Idec) has been shown to be effective in the reduction of the clinical relapse rate and disability progression. However, real-life longitudinal data, including years before baseline, are rare. MethodsAn observational single-center study was carried out. We analyzed data from 64 consecutive patients with multiple sclerosis. ResultsAfter 1 year of treatment (n = 64), score on the Expanded Disability Status Scale (EDSS) decreased by 0.47 points (P = 0.047) and the annualized relapse rate (ARR) decreased by 82% (P < 0.001). After 2 years (n = 41), EDSS score was still reduced by 0.28 (not significant) and ARR was reduced by 69% (P < 0.001). After 3 years (n = 23), EDSS score was reduced by 0.26 (not significant), and ARR was reduced by 77% (P < 0.001). Reduction of EDSS score and ARR did not depend on baseline ARR (1–2 vs >2) or EDSS score and was not biased by exceptional high disease activity or relapses around baseline. ConclusionsThese real-life data reinforce that natalizumab is effective over years, reduces ARR, and stabilizes EDSS score independent of baseline ARR, baseline EDSS score, or baseline treatment.

[1]  H. Norton,et al.  Course of relapsing–remitting multiple sclerosis before, during and after natalizumab , 2011, Multiple sclerosis.

[2]  E. de Ramón,et al.  The efficacy of natalizumab in patients with multiple sclerosis according to level of disability: results of an observational study , 2011, Multiple sclerosis.

[3]  T. Olsson,et al.  A Swedish national post-marketing surveillance study of natalizumab treatment in multiple sclerosis , 2011, Multiple sclerosis.

[4]  N. Putzki,et al.  Natalizumab Reduces Clinical and MRI Activity in Multiple Sclerosis Patients with High Disease Activity: Results from a Multicenter Study in Switzerland , 2010, European Neurology.

[5]  P. Sørensen,et al.  Efficacy of natalizumab in multiple sclerosis patients with high disease activity: a Danish nationwide study , 2009, European journal of neurology.

[6]  C. Polman,et al.  Effect of natalizumab on clinical and radiological disease activity in multiple sclerosis: a retrospective analysis of the Natalizumab Safety and Efficacy in Relapsing-Remitting Multiple Sclerosis (AFFIRM) study , 2009, The Lancet Neurology.

[7]  Ludwig Kappos,et al.  A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. , 2006, The New England journal of medicine.

[8]  S. Reingold,et al.  Diagnostic criteria for multiple sclerosis: 2005 revisions to the “McDonald Criteria” , 2005, Annals of neurology.

[9]  Jessica M. Holm A Wellcome relief , 2004, The Lancet Neurology.

[10]  David H. Miller,et al.  A controlled trial of natalizumab for relapsing multiple sclerosis. , 2003, The New England journal of medicine.

[11]  C Confavreux,et al.  Relapses and progression of disability in multiple sclerosis. , 2000, The New England journal of medicine.

[12]  C. Pozzilli,et al.  Natalizumab treatment in multiple sclerosis: the experience of S. Andrea MS Centre in Rome , 2010, Neurological Sciences.