The natalizumab wearing-off effect: End of natalizumab cycle, recurrence of MS symptoms.


Journal

Neurology
ISSN: 1526-632X
Titre abrégé: Neurology
Pays: United States
ID NLM: 0401060

Informations de publication

Date de publication:
22 10 2019
Historique:
received: 03 12 2018
accepted: 21 05 2019
pubmed: 26 9 2019
medline: 7 2 2020
entrez: 26 9 2019
Statut: ppublish

Résumé

Natalizumab is effective in treating relapsing-remitting multiple sclerosis (RRMS). However, many patients report an increase of multiple sclerosis symptoms at the end of the natalizumab cycle: a wearing-off effect. The objective of this study was to evaluate the prevalence of the wearing-off effect in patients with standard and extended intervals and to study possible associations with pharmacokinetic/dynamic measurements and patient characteristics in a prospective, monocenter, cross-sectional cohort study. Patients with RRMS, with a minimum of 6 natalizumab infusions, were asked to complete 3 questionnaires: the Multiple Sclerosis Impact Scale, the 36-Item Short Form Health Survey, and a general questionnaire regarding the wearing-off effect. Natalizumab concentration and α4-integrin receptor saturation were measured before redosing. Ninety-three patients were included. A total of 54% experienced a wearing-off effect during natalizumab treatment and 32% experienced a current wearing-off effect at time of measurement. The self-reported wearing-off effect was not associated with natalizumab concentration nor with α4-integrin receptor saturation. The wearing-off effect was more frequently reported in the standard interval group (39%) than in the extended interval group (19%); the duration of symptoms was comparable between both groups. The wearing-off effect was not associated with number of infusions, disease duration, age, or sex. The wearing-off effect is a frequently reported phenomenon but is unlikely to reflect a nonoptimal pharmacokinetic/dynamic state. We did not find risk factors predicting the wearing-off effect.

Identifiants

pubmed: 31551258
pii: WNL.0000000000008357
doi: 10.1212/WNL.0000000000008357
doi:

Substances chimiques

Immunologic Factors 0
Natalizumab 0
Integrin alpha4 143198-26-9

Types de publication

Clinical Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e1579-e1586

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2019 American Academy of Neurology.

Auteurs

Zoé L E van Kempen (ZLE)

From the Amsterdam UMC (Z.L.E.v.K., D.D., I.D., B.I.L.-W., J.K.), Vrije Universiteit Amsterdam; Departments of Neurology (Z.L.E.v.K., D.D., I.D., J.K.) and Radiology & Nuclear Medicine (I.D.), MS Center Amsterdam, Amsterdam Neuroscience; and Departments of Epidemiology and Biostatistics (B.I.L.-W.) and Immunology (A.d.V., I.A.C., A.t.B., T.R.), Landsteiner Laboratory Sanquin Research, Amsterdam, the Netherlands. z.vankempen@amsterdamumc.nl.

Djoeke Doesburg (D)

From the Amsterdam UMC (Z.L.E.v.K., D.D., I.D., B.I.L.-W., J.K.), Vrije Universiteit Amsterdam; Departments of Neurology (Z.L.E.v.K., D.D., I.D., J.K.) and Radiology & Nuclear Medicine (I.D.), MS Center Amsterdam, Amsterdam Neuroscience; and Departments of Epidemiology and Biostatistics (B.I.L.-W.) and Immunology (A.d.V., I.A.C., A.t.B., T.R.), Landsteiner Laboratory Sanquin Research, Amsterdam, the Netherlands.

Iris Dekker (I)

From the Amsterdam UMC (Z.L.E.v.K., D.D., I.D., B.I.L.-W., J.K.), Vrije Universiteit Amsterdam; Departments of Neurology (Z.L.E.v.K., D.D., I.D., J.K.) and Radiology & Nuclear Medicine (I.D.), MS Center Amsterdam, Amsterdam Neuroscience; and Departments of Epidemiology and Biostatistics (B.I.L.-W.) and Immunology (A.d.V., I.A.C., A.t.B., T.R.), Landsteiner Laboratory Sanquin Research, Amsterdam, the Netherlands.

Birgit I Lissenberg-Witte (BI)

From the Amsterdam UMC (Z.L.E.v.K., D.D., I.D., B.I.L.-W., J.K.), Vrije Universiteit Amsterdam; Departments of Neurology (Z.L.E.v.K., D.D., I.D., J.K.) and Radiology & Nuclear Medicine (I.D.), MS Center Amsterdam, Amsterdam Neuroscience; and Departments of Epidemiology and Biostatistics (B.I.L.-W.) and Immunology (A.d.V., I.A.C., A.t.B., T.R.), Landsteiner Laboratory Sanquin Research, Amsterdam, the Netherlands.

Annick de Vries (A)

From the Amsterdam UMC (Z.L.E.v.K., D.D., I.D., B.I.L.-W., J.K.), Vrije Universiteit Amsterdam; Departments of Neurology (Z.L.E.v.K., D.D., I.D., J.K.) and Radiology & Nuclear Medicine (I.D.), MS Center Amsterdam, Amsterdam Neuroscience; and Departments of Epidemiology and Biostatistics (B.I.L.-W.) and Immunology (A.d.V., I.A.C., A.t.B., T.R.), Landsteiner Laboratory Sanquin Research, Amsterdam, the Netherlands.

Iris A Claessen (IA)

From the Amsterdam UMC (Z.L.E.v.K., D.D., I.D., B.I.L.-W., J.K.), Vrije Universiteit Amsterdam; Departments of Neurology (Z.L.E.v.K., D.D., I.D., J.K.) and Radiology & Nuclear Medicine (I.D.), MS Center Amsterdam, Amsterdam Neuroscience; and Departments of Epidemiology and Biostatistics (B.I.L.-W.) and Immunology (A.d.V., I.A.C., A.t.B., T.R.), Landsteiner Laboratory Sanquin Research, Amsterdam, the Netherlands.

Anja Ten Brinke (AT)

From the Amsterdam UMC (Z.L.E.v.K., D.D., I.D., B.I.L.-W., J.K.), Vrije Universiteit Amsterdam; Departments of Neurology (Z.L.E.v.K., D.D., I.D., J.K.) and Radiology & Nuclear Medicine (I.D.), MS Center Amsterdam, Amsterdam Neuroscience; and Departments of Epidemiology and Biostatistics (B.I.L.-W.) and Immunology (A.d.V., I.A.C., A.t.B., T.R.), Landsteiner Laboratory Sanquin Research, Amsterdam, the Netherlands.

Theo Rispens (T)

From the Amsterdam UMC (Z.L.E.v.K., D.D., I.D., B.I.L.-W., J.K.), Vrije Universiteit Amsterdam; Departments of Neurology (Z.L.E.v.K., D.D., I.D., J.K.) and Radiology & Nuclear Medicine (I.D.), MS Center Amsterdam, Amsterdam Neuroscience; and Departments of Epidemiology and Biostatistics (B.I.L.-W.) and Immunology (A.d.V., I.A.C., A.t.B., T.R.), Landsteiner Laboratory Sanquin Research, Amsterdam, the Netherlands.

Joep Killestein (J)

From the Amsterdam UMC (Z.L.E.v.K., D.D., I.D., B.I.L.-W., J.K.), Vrije Universiteit Amsterdam; Departments of Neurology (Z.L.E.v.K., D.D., I.D., J.K.) and Radiology & Nuclear Medicine (I.D.), MS Center Amsterdam, Amsterdam Neuroscience; and Departments of Epidemiology and Biostatistics (B.I.L.-W.) and Immunology (A.d.V., I.A.C., A.t.B., T.R.), Landsteiner Laboratory Sanquin Research, Amsterdam, the Netherlands.

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