Observational studyNeurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics2020
Extending the Interval of Natalizumab Dosing: Is Efficacy Preserved?
Observational study in Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 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
28 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Efficacy and safety of extended-interval dosing of natalizumab in multiple sclerosis: a systematic review and meta-analysis with subgroup evaluation.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026Pooled it
- Drug-Induced Progressive Multifocal Leukoencephalopathy (PML): A Systematic Review and Meta-Analysis.Drug safety · 2024Pooled 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
- Pro-Inflammatory c-MetAnnals of neurology · 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
- Low natalizumab trough concentrations are associated with reduced seroconversion of the John Cunningham virus in natalizumab-treated patients with multiple sclerosis.Journal of neurology, neurosurgery, and psychiatry · 2025Article
- Comparative Efficacy and Safety of Extended Versus Standard Interval Dosing of Natalizumab in Relapsing-Remitting Multiple Sclerosis Patients: A Multicenter Analysis.CNS neuroscience & therapeutics · 2025Article
- Patient Preference for Subcutaneous Versus Intravenous Administration with Every-6-Week Natalizumab (TysabriNeurology and therapy · 2024Article
- High levels of endothelial ICAM-1 prohibit natalizumab mediated abrogation of CD4Journal of neuroinflammation · 2023Article
- Real-World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort.Neurology and therapy · 2023Article
- Switch to ocrelizumab in MS patients treated with natalizumab in extended interval dosing at high risk of PML: A 96-week follow-up pilot study.Frontiers in immunology · 2023Observational
- 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
- Multiple Sclerosis Management During the COVID-19 Pandemic.Current neurology and neuroscience reports · 2022Review
- [Clinical and radiological effectiveness of natalizumab extended dosage interval in patients with relapsing multiple sclerosis].Revista de neurologia · 2022Observational
- Monoclonal Antibodies in the Treatment of Relapsing Multiple Sclerosis: an Overview with Emphasis on Pregnancy, Vaccination, and Risk Management.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022Review
- Erythropoietin therapy in a case of neonatal anemia after exposure to natalizumab throughout pregnancy.Italian journal of pediatrics · 2021Article
- Does Extended Interval Dosing Natalizumab Preserve Effectiveness in Multiple Sclerosis? A 7 Year-Retrospective Observational Study.Frontiers in immunology · 2021Observational
- No evidence for loss of natalizumab effectiveness with every-6-week dosing: a propensity score-matched comparison with every-4-week dosing in patients enrolled in the Tysabri Observational Program (TOP).Therapeutic advances in neurological disorders · 2021Article
- The Dimethyl Fumarate Experience: A Handy Drug With Broad Clinical Utility.Frontiers in neurology · 2021Article
- Using Monoclonal Antibody Therapies for Multiple Sclerosis: A Review.Biologics : targets & therapy · 2021Review
Corrections and comments
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Authors and funding
28 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Extending the natalizumab interval after the 24th administration could reduce the risk of progressive multifocal leukoencephalopathy (PML). The objective is to evaluate the noninferiority of the efficacy of an extended interval dosing (EID) compared with the standard interval dosing (SID) of natalizumab. It is an observational, multicenter (14 Italian centers), retrospective cohort study, starting from the 24th natalizumab infusion to the loss of follow-up or 2 years after baseline. Patients were grouped in 2 categories according to the mean number of weeks between doses: < 5 weeks, SID; ≥ 5 weeks, EID. Three hundred and sixty patients were enrolled. Median dose interval (MDI) following 24th infusion was 4.7 weeks, with a bimodal distribution (modes at 4 and 6 weeks). Two hundred and sixteen patients were in the SID group (MDI = 4.3 weeks) and 144 in the EID group (MDI 6.2 weeks). Annualized relapse rate was 0.060 (95% CI = 0.033-0.087) in the SID group and 0.039 (95% CI = 0.017-0.063) in the EID group. The non-inferiority of EID versus SID was satisfied. In conclusion, there is no evidence of a reduced efficacy of natalizumab in an EID setting. This observation confirms previous results and together with the emerging evidence of a reduced risk of PML associated to an EID, supports the need of a randomized study to assess the need to change the standard of the natalizumab dosing schedule.
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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.