Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2021
A randomized study of natalizumab dosing regimens for relapsing-remitting multiple sclerosis.
Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
34 citing papers in PubMed, 3 syntheses or guidelines pooled it, 59 citations in OpenAlex.
- Natalizumab and Tyruko (natalizumab biosimilar) for treating highly active relapsing-remitting multiple sclerosis after at least one disease-modifying therapy: a systematic review and economic model.Health technology assessment (Winchester, England) · 2026Pooled it
- Natalizumab for multiple sclerosis.The Cochrane database of systematic reviews · 2025Pooled it
- Safety and efficacy of extended versus standard interval dosing of natalizumab in multiple sclerosis patients: a systematic review and meta-analysis.Acta neurologica Belgica · 2024Pooled it
- Digital signatures of fatigue and wearing-off symptoms in patients with multiple sclerosis under natalizumab.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026Article
- Biosimilars: A Virtuous Cycle of Sustainability and Innovation.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Serum biomarkers remain stable after transitioning from intravenous to subcutaneous natalizumab in multiple sclerosis.Journal of neurology · 2026Article
- Time and Motion Study to Quantify Time for Tysabri (Natalizumab) Intravenous Versus Subcutaneous to Treat Relapsing-Remitting Multiple Sclerosis in France, Spain, and the United Kingdom.Neurology and therapy · 2026Article
- Clinical implications of natalizumab Fab-arm exchange in patients with multiple sclerosis.Frontiers in immunology · 2026Article
- Biological and clinical stability after switching from intravenous to subcutaneous natalizumab in RRMS under standard and extended dosing.Frontiers in immunology · 2026Observational
- Patient SAtisfaction with the TYSabri SC Formulation - A Swiss multi-centriC, prospective non-intervenTIONal study: the SATYSFACTION study.Therapeutic advances in neurological disorders · 2026Article
- Use of subcutaneous natalizumab in routine care - Final results of a non-interventional, observational study (SISTER) in Germany and Austria.Therapeutic advances in neurological disorders · 2026Article
- Serum neurofilament light chain as a biomarker of disease control in multiple sclerosis: a real-world cross-sectional analysis of therapeutic regimens.Journal of neurology · 2025Article
- Cost-Consequence Analysis of Natalizumab Compared with Other High-Efficacy Treatments in Patients with Relapsing-Remitting Multiple Sclerosis.PharmacoEconomics · 2025Article
- Cost-consequence analysis of early vs. delayed natalizumab use in highly active relapsing-remitting multiple sclerosis: a simulation study.Journal of neurology · 2025Article
- Article
- Access, satisfaction, adherence and safety to subcutaneous natalizumab compared to intravenous natalizumab in multiple sclerosis in a real-life cohort: first report from Latin America.Therapeutic advances in neurological disorders · 2025Article
- Cost-Minimization Analysis and Budget Impact Analysis About Subcutaneous Natalizumab in Relapsing-Remitting Multiple Sclerosis in Italy.ClinicoEconomics and outcomes research : CEOR · 2025Article
- Patient Preference and Time Allocation Associated with Transition from Intravenous to Subcutaneous Administration of Natalizumab (Tysabri) in Patients with Relapsing Remitting MS - A Questionnaire Study.Patient preference and adherence · 2025Article
- Twenty years of natalizumab in multiple sclerosis: lessons learned and future outlook.Therapeutic advances in neurological disorders · 2025Review
- Patient Preference for Subcutaneous Versus Intravenous Administration with Every-6-Week Natalizumab (TysabriNeurology and therapy · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundREFINE was an exploratory, dose- and frequency-blinded, prospective, randomized, dose-ranging study in relapsing-remitting multiple sclerosis (RRMS) patients.
objectiveTo examine the efficacy, safety, and tolerability of natalizumab administered via various regimens in RRMS patients.
methodsClinically stable RRMS patients previously treated with 300 mg natalizumab intravenously for ⩾12 months were randomized to one of six natalizumab regimens over 60 weeks: 300 mg administered intravenously or subcutaneously every 4 weeks (Q4W), 300 mg intravenously or subcutaneously every 12 weeks (Q12W), or 150 mg intravenously or subcutaneously Q12W. The primary endpoint was the mean cumulative number of combined unique active magnetic resonance imaging (MRI) lesions at week 60.
resultsIn total, 290 patients were enrolled. All Q12W dosing arms were associated with increased clinical and MRI disease activity and closed early; ⩾39.5% of patients in each Q12W arm met rescue criteria. In the 300 mg intravenous and subcutaneous Q4 W arms, the mean cumulative number of combined unique active MRI lesions was 0.23 and 0.02, respectively; annualized relapse rates were 0.07 and 0.08, respectively; and trough natalizumab serum levels and α4-integrin saturation were comparable.
conclusionNatalizumab 300 mg subcutaneous Q4W was comparable to 300 mg intravenous Q4W dosing with respect to efficacy, pharmacokinetics/pharmacodynamics, and safety.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.