Related Experiment Video
Updated: Nov 10, 2025
10:46
A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data
Published on: December 9, 2015
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A randomized study of natalizumab dosing regimens for relapsing-remitting multiple sclerosis
Maria Trojano1, Lluís Ramió-Torrentà2, Luigi Me Grimaldi3
1Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro," Bari, Italy.
Multiple Sclerosis (Houndmills, Basingstoke, England)
|April 6, 2021
Summary
Subcutaneous natalizumab every 4 weeks (Q4W) demonstrated comparable efficacy, safety, and pharmacodynamics to intravenous dosing in relapsing-remitting multiple sclerosis (RRMS) patients. Less frequent dosing (Q12W) was associated with increased disease activity.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- The REFINE study investigated novel dosing regimens for natalizumab in relapsing-remitting multiple sclerosis (RRMS).
- Previous treatment involved 300 mg intravenous natalizumab for at least 12 months.
- Patients were clinically stable prior to randomization.
Purpose of the Study:
- To evaluate the efficacy, safety, and tolerability of various natalizumab administration schedules.
- To compare intravenous and subcutaneous routes of administration.
- To determine optimal dosing frequency for natalizumab in RRMS.
Main Methods:
- A prospective, randomized, dose-ranging study (REFINE) involving 290 RRMS patients.
- Six natalizumab regimens were tested over 60 weeks: 300 mg IV/SC Q4W, 300 mg IV/SC Q12W, and 150 mg IV/SC Q12W.
- The primary endpoint was the cumulative number of active MRI lesions at week 60.
Main Results:
- All Q12W dosing arms showed increased disease activity and were closed early.
- 300 mg subcutaneous Q4W and 300 mg intravenous Q4W arms showed low lesion activity (0.02 and 0.23, respectively) and relapse rates (0.07 and 0.08, respectively).
- Pharmacokinetics and pharmacodynamics were comparable between 300 mg IV and SC Q4W regimens.
Conclusions:
- Natalizumab 300 mg subcutaneous Q4W is a viable alternative to intravenous dosing.
- Subcutaneous administration offers comparable efficacy, safety, and pharmacodynamics.
- Less frequent Q12W dosing is not effective for maintaining disease control in RRMS.
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