Evidence map›Paper›PMID 39046635›Full record

ArticleNeurology and therapy2024

Patient Preference for Subcutaneous Versus Intravenous Administration with Every-6-Week Natalizumab (Tysabri

Heinz Wiendl, John Foley, Gilles Defer, Lana Zhovtis Ryerson, Jeffrey A Cohen, Douglas L Arnold, Helmut Butzkueven, Gary R Cutter, Gavin Giovannoni, Joep Killestein and 6 more

Registry-linked trialAbstract read
In one paragraph

Article in Neurology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03689972 (A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT03689972 phase3completednot on this map

A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration

TypeinterventionalSponsorBiogenRan2018 to 2023Enrolled585ConditionsMultiple Sclerosis, Relapsing-RemittingArmsNatalizumab
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Natalizumab for multiple sclerosis.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Review
  3. Observational
  4. Article
  5. Observational
  6. Article
  7. Article
  8. The Present and Future of Monoclonal Antibody Therapies for Multiple Sclerosis.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
  9. Article
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

16 authors.

Heinz WiendlDepartment of Neurology with Institute of Translational Neurology, University of Münster, Albert-Schweitzer-Campus 1, Building A1, 48149, Münster, Germany. heinz.wiendl@ukmuenster.de.
John FoleyRocky Mountain MS Clinic, Salt Lake City, UT, USA.
Gilles DeferCentre Hospitalier Universitaire de Caen, Caen, France.
Lana Zhovtis RyersonHackensack Meridian Health Jersey Shore University Medical Center, Neptune City, NJ, USA.
Jeffrey A CohenCleveland Clinic, Cleveland, OH, USA.
Douglas L ArnoldMontreal Neurological Institute and Hospital, McGill University, Montreal, Canada.
Helmut ButzkuevenCentral Clinic School, Monash University, Melbourne, Australia.
Gary R CutterUniversity of Alabama, Birmingham, AL, USA.
Gavin GiovannoniBlizard Institute, London, UK.
Joep KillesteinMS Centre Amsterdam, Amsterdam, The Netherlands.
Rose Domingo-HorneBiogen, Cambridge, MA, USA.
Marie ToukamBiogen, Cambridge, MA, USA.
Aimie NunnCytel, London, UK.
Amir-Hadi MaghziBiogen, Cambridge, MA, USA.
Robert Kuhelj, Biogen, Baar, Switzerland.
Tyler LaskyBiogen, Cambridge, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFollowing NOVA (part 1) and the approval of the subcutaneous (SC) route of administration of natalizumab by the European Medicines Agency, an extension phase of the NOVA phase IIIb study (part 2) was initiated to collect patient preference data for SC versus intravenous (IV) dosing in patients receiving every-6-week (Q6W) dosing of natalizumab. This study was performed to evaluate patient preference for SC versus IV natalizumab administration and explore the efficacy, safety, and pharmacology characteristics of both routes of administration.

methodsIn part 2, participants received natalizumab (Tysabri

resultsA total of 153 participants were randomized in NOVA part 2. Of 123 with patient preference data, 108 (87.8%) preferred the SC route of administration for natalizumab over the IV route; 102 (82.9%) specified "requires less time in the clinic" as the reason for the SC preference.

conclusionIn NOVA (part 2), most participants on Q6W dosing of natalizumab preferred SC administration versus IV administration. CLINICALTRIALS: GOV: NCT03689972. INFOGRAPHIC.

Indexed as

Extended interval dosingIntravenousMultiple sclerosisNatalizumabNOVAPatient preferenceSubcutaneous

Identifiers

PMID39046635
PMCPMC11393236

What OpenQuestion holds

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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.