Evidence map›Paper›PMID 38457005›Full record

SynthesisActa neurologica Belgica2024

Safety and efficacy of extended versus standard interval dosing of natalizumab in multiple sclerosis patients: a systematic review and meta-analysis.

Eslam Mohammed Rabea, Mohamed Mohamed Belal, Abdelrahman H Hafez, Ashraf Hassan Elbanna, Mahmoud Ahmed Khalifa, Anas Zakarya Nourelden, Nada H Mahmoud, Mohamed Sayed Zaazouee

Open access · hybridAbstract readMeta-AnalysisSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Acta neurologica Belgica, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 8% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. 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 · 2026
    Pooled it
  2. 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 · 2026
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Eslam Mohammed RabeaFaculty of Medicine, Alexandria University, Alexandria, Egypt.
Mohamed Mohamed BelalFaculty of Medicine, Alexandria University, Alexandria, Egypt.
Abdelrahman H HafezFaculty of Medicine, Al-Azhar University, Cairo, Egypt.
Ashraf Hassan ElbannaFaculty of Medicine, Alexandria University, Alexandria, Egypt.
Mahmoud Ahmed KhalifaFaculty of Medicine, Alexandria University, Alexandria, Egypt.
Anas Zakarya NoureldenFaculty of Medicine, Al-Azhar University, Cairo, Egypt.
Nada H MahmoudFaculty of Medicine, Alexandria University, Alexandria, Egypt.
Mohamed Sayed ZaazoueeFaculty of Medicine, Al-Azhar University, Assiut, Egypt. MohamedZaazouee.stu.6.44@azhar.edu.eg.ORCID http://orcid.org/0000-0003-0904-9153
Alexandria University · EGAl-Azhar University · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMultiple sclerosis (MS) is a chronic inflammatory, immune-mediated disease affecting the central nervous system. Natalizumab, an FDA-approved monoclonal antibody for MS, has been explored for its off-label extended interval dosing (EID), suggesting a potential reduction in the risk of progressive multifocal leukoencephalopathy (PML) compared to standard interval dosing (SID). Our objective was to assess the efficacy and safety of EID in comparison to SID for natalizumab treatment in patients with MS.

methodsWe searched PubMed, Embase, WOS, Scopus, Ovid, Science Direct, Clinical trials.gov, and Cochrane Library. Our assessed outcomes were clinical relapses, MRI activity, change in expanded disability status scale [EDSS], and the risk of PML. The EID group was defined as 5 to 8 weeks [EID (Q5-8W)]. The analysis was conducted using RevMan ver. 5.4. The effect estimates were presented as a risk ratio [RR] or mean difference with 95% confidence intervals [CI] using SID group as the reference for comparisons.

resultsFourteen studies met our inclusion criteria: 2 RCTs, 1 switched single-arm trial, and 12 observational studies. No significant differences were found in all efficacy outcomes of interest. Risk of clinical relapses [RR = 0.90, (95%CI 0.80, 1.02)], risk of new or newly enlarging T2 hyperintense MRI lesions [RR = 0.78, (95%CI 0.59, 1.04)], risk gadolinium enhancing lesions [RR = 1.30, (95%CI 0.98, 1.72)], change in EDSS [MD = 0.09 (95%CI - 0.57, 0.76)], risk of PML [RR = 1.09, 95%CI (0.24, 4.94)].

conclusionIn summary, our meta-analysis indicates that natalizumab maintains its effectiveness under extended interval dosing [up to 8 weeks], presenting comparable risks for clinical relapses, MRI lesions, EDSS, and PML. Caution is advised given study limitations and heterogeneity. Robust conclusions necessitate well-designed high-quality prospective studies.

Indexed as

Immunologic FactorsMultiple SclerosisNatalizumabHumansLeukoencephalopathy, Progressive MultifocalTreatment OutcomeImmunologic FactorsNatalizumabEIDExtended interval dosingMeta-analysisMultiple sclerosisNatalizumabSIDStandard interval dosing

Identifiers

PMID38457005
PMCPMC10965735
OpenAlexW4392595161

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.