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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).
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.
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).
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.
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.
Glossary
- 9HPT=
- 9-hole peg test;
- AUMC=
- Amsterdam University Medical Center;
- CI=
- confidence interval;
- DSMB=
- data safety monitoring board;
- EDSS=
- Expanded Disability Status Scale;
- FLAIR=
- fluid-attenuated inversion recovery;
- Gd+=
- gadolinium-enhancing;
- IQR=
- interquartile range;
- JCV=
- John Cunningham virus;
- MFI=
- mean fluorescence intensity;
- MS=
- multiple sclerosis;
- MSFC=
- Multiple Sclerosis Functional Composite;
- MSIS-29=
- 29-item Multiple Sclerosis Impact Scale;
- NfL=
- neurofilament light;
- PASAT=
- paced auditory serial addition test;
- PML=
- progressive multifocal leukoencephalopathy;
- RRMS=
- relapsing-remitting multiple sclerosis;
- SF-36=
- 36-item Short Form Health Survey;
- T25FW=
- timed 25-foot walk
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Class of Evidence: NPub.org/coe
- Received October 10, 2019.
- Accepted in final form March 6, 2020.
- © 2020 American Academy of Neurology
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