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

Extended interval dosing Intravenous Multiple sclerosis NOVA Natalizumab Patient preference Subcutaneous

Journal

Neurology and therapy
ISSN: 2193-8253
Titre abrégé: Neurol Ther
Pays: New Zealand
ID NLM: 101637818

Informations de publication

Date de publication:
24 Jul 2024
Historique:
received: 03 04 2024
accepted: 04 07 2024
medline: 24 7 2024
pubmed: 24 7 2024
entrez: 24 7 2024
Statut: aheadofprint

Résumé

Following 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. In part 2, participants received natalizumab (Tysabri A 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. In NOVA (part 2), most participants on Q6W dosing of natalizumab preferred SC administration versus IV administration. GOV: NCT03689972. INFOGRAPHIC.

Identifiants

pubmed: 39046635
doi: 10.1007/s40120-024-00647-0
pii: 10.1007/s40120-024-00647-0
doi:

Banques de données

ClinicalTrials.gov
['NCT03689972']

Types de publication

Journal Article

Langues

eng

Informations de copyright

© 2024. The Author(s).

Références

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Auteurs

Heinz Wiendl (H)

Department of Neurology with Institute of Translational Neurology, University of Münster, Albert-Schweitzer-Campus 1, Building A1, 48149, Münster, Germany. heinz.wiendl@ukmuenster.de.

John Foley (J)

Rocky Mountain MS Clinic, Salt Lake City, UT, USA.

Gilles Defer (G)

Centre Hospitalier Universitaire de Caen, Caen, France.

Lana Zhovtis Ryerson (L)

Hackensack Meridian Health Jersey Shore University Medical Center, Neptune City, NJ, USA.

Jeffrey A Cohen (JA)

Cleveland Clinic, Cleveland, OH, USA.

Douglas L Arnold (DL)

Montreal Neurological Institute and Hospital, McGill University, Montreal, Canada.

Helmut Butzkueven (H)

Central Clinic School, Monash University, Melbourne, Australia.

Gary R Cutter (GR)

University of Alabama, Birmingham, AL, USA.

Gavin Giovannoni (G)

Blizard Institute, London, UK.

Joep Killestein (J)

MS Centre Amsterdam, Amsterdam, The Netherlands.

Rose Domingo-Horne (R)

Biogen, Cambridge, MA, USA.

Marie Toukam (M)

Biogen, Cambridge, MA, USA.

Aimie Nunn (A)

Cytel, London, UK.

Amir-Hadi Maghzi (AH)

Biogen, Cambridge, MA, USA.

Robert Kuhelj (R)

, Biogen, Baar, Switzerland.

Tyler Lasky (T)

Biogen, Cambridge, MA, USA.

Classifications MeSH