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Personalized extended interval dosing of natalizumab in MS: A prospective multicenter trial.
Personalized extended interval dosing of natalizumab in MS: A prospective multicenter trial.
- Source :
-
Neurology [Neurology] 2020 Aug 11; Vol. 95 (6), pp. e745-e754. Date of Electronic Publication: 2020 Jul 20. - Publication Year :
- 2020
-
Abstract
- Objective: To determine whether natalizumab efficacy is maintained when switching to personalized extended interval dosing based on individual natalizumab trough concentrations in patients with relapsing-remitting multiple sclerosis (RRMS).<br />Methods: This was a prospective multicenter single-arm trial with 1 year follow-up and a 1-year extension phase. Participants were adult persons with RRMS treated with natalizumab without disease activity in the year prior to enrollment. The natalizumab treatment interval was based on longitudinal natalizumab trough concentrations. Patients received 3 monthly MRI scans, relapse assessments, and disability scoring during follow-up. The primary endpoint was the occurrence of gadolinium-enhancing lesions on MRI. Secondary endpoints were new/enlarging T2 lesions on MRI and relapses and progression on the Expanded Disability Status Scale (EDSS) during follow-up and extension phase.<br />Results: Sixty-one patients were included. Eighty-four percent extended the interval from a 4-week interval to a 5- to 7-week interval. No patient developed gadolinium-enhancing lesions (95% confidence interval [CI] 0%-7.4%) during follow-up. No new/enlarging T2 lesions (95% CI 0%-7.4%) or relapses (95% CI 0%-7.4%) were reported during follow-up and in the extension phase. Median EDSS was comparable at baseline (3.0, interquartile range [IQR] 2.0-5.0) and after follow-up (3.0, IQR 2.0-5.0).<br />Conclusion: Personalized extended interval dosing did not induce recurrence of MS disease activity. Natalizumab efficacy was maintained in stable patients with RRMS receiving personalized extended interval dosing based on individual natalizumab concentrations.<br />Classification of Evidence: This study provides Class IV evidence that personalized extended interval dosing of natalizumab does not result in recurrence of disease activity in stable patients with RRMS.<br /> (© 2020 American Academy of Neurology.)
- Subjects :
- Adult
Disability Evaluation
Drug Administration Schedule
Drug Monitoring
Female
Follow-Up Studies
Humans
Integrin alpha4beta1 antagonists & inhibitors
Integrin alpha4beta1 immunology
Magnetic Resonance Imaging
Male
Middle Aged
Multiple Sclerosis blood
Multiple Sclerosis diagnostic imaging
Natalizumab blood
Natalizumab therapeutic use
Netherlands
Neuroimaging
Precision Medicine
Prospective Studies
Severity of Illness Index
Multiple Sclerosis drug therapy
Natalizumab administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1526-632X
- Volume :
- 95
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Neurology
- Publication Type :
- Academic Journal
- Accession number :
- 32690785
- Full Text :
- https://doi.org/10.1212/WNL.0000000000009995