Trial reportNeurology2017
Reversibility of the effects of natalizumab on peripheral immune cell dynamics in MS patients.
Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph
Trial report in Neurology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04048577 (The Impact of a Planned 12-week Dosing Interruption of Natalizumab on Immune Cell Trafficking, Pharmacokinetic), which is not on this map. Cited by 45 papers.
0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed
6.7field-weighted citation impact, top 2% of its field
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.
The Impact of a Planned 12-week Dosing Interruption of Natalizumab on Immune Cell Trafficking, Pharmacokinetic (PK)/Pharmacodynamic (PD) Parameters, and Multiple Sclerosis (MS) Disease Stability.
Who cites it
45 citing papers in PubMed, 89 citations in OpenAlex.
- Pharmacokinetics and Pharmacodynamics of Natalizumab 6-Week Dosing vs Continued 4-Week Dosing for Relapsing-Remitting Multiple Sclerosis.Neurology(R) neuroimmunology & neuroinflammation · 2024Trial
- A randomized study of natalizumab dosing regimens for relapsing-remitting multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2021Trial
- Outcome Predictors in Progressive Multifocal Leukoencephalopathy Associated With Multiple Sclerosis Treatments: A Multicenter Cohort Study.Neurology(R) neuroimmunology & neuroinflammation · 2026Article
- Annual 12-Week Dosing Gap of Natalizumab: Clinical Efficacy, Blood Biomarkers, and CSF Cell Composition.Annals of clinical and translational neurology · 2026Observational
- Clinical implications of natalizumab Fab-arm exchange in patients with multiple sclerosis.Frontiers in immunology · 2026Article
- T cell-mediated immunodysregulation in multiple sclerosis: from pathogenic subsets to therapeutic advances.Frontiers in immunology · 2026Review
- 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
- Predictors of Radiological and Clinical Disease Reactivation in Multiple Sclerosis Patients After Cessation of Natalizumab (Tysabri).Brain and behavior · 2025Article
- Carotid intima media thickness, neutrophil to lymphocyte ratio, and platelet to lymphocyte ratio in multiple sclerosis.Scientific reports · 2025Article
- Choosing initial MS therapy; personal, disease, and medication factors.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025Review
- Pharmacokinetic Model-Informed Precision Dosing of Natalizumab in Multiple Sclerosis.CPT: pharmacometrics & systems pharmacology · 2025Article
- Natalizumab and fumarate treatment differentially modulate CD4+ T cell and B cell subtypes in multiple sclerosis patients without impacting durable COVID-19 vaccine responses.Frontiers in immunology · 2025Observational
- Twenty years of natalizumab in multiple sclerosis: lessons learned and future outlook.Therapeutic advances in neurological disorders · 2025Review
- Disease activity and neonatal outcomes after exposure to natalizumab throughout pregnancy.Journal of neurology, neurosurgery, and psychiatry · 2024Observational
- Long-lasting severe anemia following treatment with natalizumab for relapsing-remitting multiple sclerosis: a case report.Journal of medical case reports · 2024Article
- Vedolizumab Efficacy Is Associated With Decreased Intracolonic Dendritic Cells, Not Memory T Cells.Inflammatory bowel diseases · 2024Article
- No increase of serum neurofilament light in relapsing-remitting multiple sclerosis patients switching from standard to extended-interval dosing of natalizumab.Multiple sclerosis (Houndmills, Basingstoke, England) · 2022Article
- Disease Reactivation After Cessation of Disease-Modifying Therapy in Patients With Relapsing-Remitting Multiple Sclerosis.Neurology · 2022Observational
- Article
- Natural killer cell homing and trafficking in tissues and tumors: from biology to application.Signal transduction and targeted therapy · 2022Review
Corrections and comments
- Erratum issued
Authors and funding
21 authors at 1 institution in 1 country.
Tatiana PlavinaFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.). Tatiana.plavina@biogen.com.
Kumar Kandadi MuralidharanFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Geoffrey KuestersFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Daniel MikolFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Karleyton EvansFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Meena SubramanyamFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Ivan NestorovFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Yi ChenFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Qunming DongFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Pei-Ran HoFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Diogo AmaranteFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Alison AdamsFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Jerome De SèzeFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Robert FoxFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Ralf GoldFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Douglas JefferyFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Ludwig KapposFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Xavier MontalbanFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Bianca Weinstock-GuttmanFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Hans-Peter HartungFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
Bruce A C CreeFrom Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).
St. Josef-Hospital · DE
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo characterize the reversibility of natalizumab-mediated changes in pharmacokinetics/pharmacodynamics in patients with multiple sclerosis (MS) following therapy interruption.
methodsPharmacokinetic/pharmacodynamic data were collected in the Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis (AFFIRM) (every 12 weeks for 116 weeks) and Randomized Treatment Interruption of Natalizumab (RESTORE) (every 4 weeks for 28 weeks) studies. Serum natalizumab and soluble vascular cell adhesion molecule-1 (sVCAM-1) were measured using immunoassays. Lymphocyte subsets, α4-integrin expression/saturation, and vascular cell adhesion molecule-1 (VCAM-1) binding were assessed using flow cytometry.
resultsBlood lymphocyte counts (cells/L) in natalizumab-treated patients increased from 2.1 × 10
conclusionsNatalizumab's effects on peripheral immune cells and pharmacodynamic markers were reversible, with changes starting 8 weeks post last natalizumab dose; levels returned to those observed/expected in untreated patients ≈16 weeks post last dose. This reversibility differentiates natalizumab from MS treatments that require longer reconstitution times. Characterization of the time course of natalizumab's biological effects may help clinicians make treatment sequencing decisions. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that the pharmacodynamic markers of natalizumab are reversed ≈16 weeks after stopping natalizumab.
Indexed as
AdultDouble-Blind MethodFemaleFollow-Up StudiesHumansImmunologic FactorsIntegrin alpha4Lymphocyte CountLymphocyte SubsetsMaleMiddle AgedMultiple SclerosisNatalizumabRetrospective StudiesSecondary PreventionTreatment OutcomeImmunologic FactorsIntegrin alpha4NatalizumabVascular Cell Adhesion Molecule-1
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Registered trials
NCT04048577ClinicalTrials.gov
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