Title
The results of a 24-month controlled, prospective study of relapsing multiple sclerosis patients at risk for progressive multifocal encephalopathy, who switched from prolonged use of natalizumab to teriflunomide.
Document Type
Article
Publication Date
10-1-2021
Publication Title
Mult Scler J Exp Transl Clin
Keywords
washington; seattle; swedish
Abstract
Background: Natalizumab (NTZ) is a highly effective disease modifying treatment for relapsing multiple sclerosis (RMS), but it increases risk of progressive multifocal leukoencephalopathy (PML) in patients with serum anti- John Cunningham virus (JCV) antibodies.
Objective: To assess the safety and efficacy of rapid transition, from NTZ to teriflunomide (TFM) in RMS patients.
Methods: Clinically stable NTZ-treated, anti-JCV antibody positive RMS patients were switched to TFM 28 ± 7 days after their last dose of NTZ. The primary endpoint was proportion of relapse free patients at 24 months.
Results: Median [IQR] age of the 55 enrolled patients was 47 [40.7, 56.3] years, 76% were female. The median [IQR] number of prior NTZ treatments was 34 [18, 64]. annualized relapse rate (ARR) was 0.07 and 77% of the patients were relapse free at 24 months. Mean time to first GAD + lesion was 19.6 months, and to new/enlarging T2 lesion was 19.2 months. Mean time to 3 month sustained disability worsening (SDW) was 22 months and proportion free of 3-month SDW was 0.87. There were no cases of PML.
Conclusions: The washout-free transition of NTZ to TFM was an efficacious and safe strategy for patients at risk of developing PML.ClinicalTrials.gov Identifier: NCT01970410.
Clinical Institute
Neurosciences (Brain & Spine)
Department
Neurosciences
Recommended Citation
Cohan, Stanley; Gervasi-Follmar, Tiffany; Kamath, Aneesh; Kamath, Vineetha; Chen, Chiayi; Smoot, Kyle; Baraban, Elizabeth; and Edwards, Keith, "The results of a 24-month controlled, prospective study of relapsing multiple sclerosis patients at risk for progressive multifocal encephalopathy, who switched from prolonged use of natalizumab to teriflunomide." (2021). Articles, Abstracts, and Reports. 5592.
https://digitalcommons.providence.org/publications/5592