BACKGROUND: Natalizumab has been recommended for the treatment of relapsing-remitting multiple sclerosis (RRMS) in patients with insufficient response to interferon-beta/glatiramer acetate (DMT) or aggressive MS. The pivotal trials were not conducted to investigate natalizumab monotherapy in this patient population. METHOD: Retrospective, multicenter study in Germany and Switzerland. Five major MS centers reported all RRMS patients who initiated natalizumab >or=12 months prior to study conduction. RESULTS: Ninety-seven RRMS patients were included [69% female, mean age 36.5 years, mean Expanded Disability Status Scale (EDSS) 3.4; 93.8% were pre-treated with DMT], mean treatment duration with natalizumab was 19.3 +/- 6.1 months. We found a reduction of the annualized relapse rate from 2.3 to 0.2, 80.4% were relapse free with natalizumab. EDSS improved in 12.4% and 89.7% were progression free (change of >or= 1 EDSS point). Eighty-six per cent of patients with highly active disease (>or= 2 relapses in the year and >or= 1 Gadolinium (Gd)+ lesion at study entry, n = 20) remained relapse free. The mean number of Gd enhancing lesions was reduced to 0.1 (0.8 at baseline). Discontinuation rate was 8.2% (4.1% for antibody-positivity). CONCLUSION: Natalizumab is effective after insufficient response to other DMT and also in patients with high disease activity.
BACKGROUND:Natalizumab has been recommended for the treatment of relapsing-remitting multiple sclerosis (RRMS) in patients with insufficient response to interferon-beta/glatiramer acetate (DMT) or aggressive MS. The pivotal trials were not conducted to investigate natalizumab monotherapy in this patient population. METHOD: Retrospective, multicenter study in Germany and Switzerland. Five major MS centers reported all RRMS patients who initiated natalizumab >or=12 months prior to study conduction. RESULTS: Ninety-seven RRMS patients were included [69% female, mean age 36.5 years, mean Expanded Disability Status Scale (EDSS) 3.4; 93.8% were pre-treated with DMT], mean treatment duration with natalizumab was 19.3 +/- 6.1 months. We found a reduction of the annualized relapse rate from 2.3 to 0.2, 80.4% were relapse free with natalizumab. EDSS improved in 12.4% and 89.7% were progression free (change of >or= 1 EDSS point). Eighty-six per cent of patients with highly active disease (>or= 2 relapses in the year and >or= 1 Gadolinium (Gd)+ lesion at study entry, n = 20) remained relapse free. The mean number of Gd enhancing lesions was reduced to 0.1 (0.8 at baseline). Discontinuation rate was 8.2% (4.1% for antibody-positivity). CONCLUSION:Natalizumab is effective after insufficient response to other DMT and also in patients with high disease activity.
Authors: Michael Kaufman; Bruce A C Cree; Jerome De Sèze; Robert J Fox; Ralf Gold; Hans-Peter Hartung; Douglas Jeffery; Ludwig Kappos; Xavier Montalbán; Bianca Weinstock-Guttman; Barry Ticho; Petra Duda; Amy Pace; Denise Campagnolo Journal: J Neurol Date: 2014-11-09 Impact factor: 4.849
Authors: Marita Zimmermann; Elizabeth Brouwer; Jeffrey A Tice; Matt Seidner; Anne M Loos; Shanshan Liu; Richard H Chapman; Varun Kumar; Josh J Carlson Journal: CNS Drugs Date: 2018-12 Impact factor: 5.749
Authors: Ludwig Kappos; Paul W O'Connor; Christopher H Polman; Patrick Vermersch; Heinz Wiendl; Amy Pace; Annie Zhang; Christophe Hotermans Journal: J Neurol Date: 2013-01-05 Impact factor: 4.849
Authors: Tamara Castillo-Trivino; Ellen M Mowry; Alberto Gajofatto; Dorothee Chabas; Elizabeth Crabtree-Hartman; Bruce A Cree; Douglas S Goodin; Ari J Green; Darin T Okuda; Daniel Pelletier; Scott S Zamvil; Eric Vittinghoff; Emmanuelle Waubant Journal: PLoS One Date: 2011-02-03 Impact factor: 3.240