AI Article Synopsis
- Natalizumab (NTZ) is effective for treating relapsing multiple sclerosis (RMS) but poses a risk of progressive multifocal leukoencephalopathy (PML) for patients with antibodies to the John Cunningham virus (JCV).
- The study evaluated the safety and effectiveness of quickly transitioning RMS patients from NTZ to teriflunomide (TFM), monitoring relapse-free status over 24 months.
- Results showed that 77% of patients were relapse-free at 24 months, with no incidence of PML, indicating that the transition was both efficacious and safe for at-risk patients.
Article 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.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8689625 | PMC |
| http://dx.doi.org/10.1177/20552173211066588 | DOI Listing |
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