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Open Access 19-04-2023 | Multiple Sclerosis | Original Communication

Real-world use of natalizumab in Austria: data from the Austrian Multiple Sclerosis Treatment Registry (AMSTR)

Authors: Tobias Monschein, Sarinah Dekany, Tobias Zrzavy, Markus Ponleitner, Patrick Altmann, Gabriel Bsteh, Barbara Kornek, Paulus Rommer, Christian Enzinger, Franziska Di Pauli, Jörg Kraus, Thomas Berger, Fritz Leutmezer, Michael Guger, the Austrian MS Treatment Registry (AMSTR)

Published in: Journal of Neurology | Issue 8/2023

Abstract

Introduction

With the approval of natalizumab in Europe in 2006, the Austrian Multiple Sclerosis Therapy Registry (AMSTR) was established. Here, we present data from this registry about effectiveness and safety of natalizumab in patients treated up to 14 years.

Patients/methods

Data retrieved from the AMSTR contained baseline characteristics and biannual documentation of annualised relapse rate (ARR) and Expanded Disability Status Scale (EDSS) score as well as adverse events and reasons for discontinuation on follow-up visits.

Results

A total of 1596 natalizumab patients (71% women, n = 1133) were included in the analysis and the observed treatment duration ranged from 0 to 164 months (13.6 years). The mean ARR was 2.0 (SD = 1.13) at baseline, decreasing to 0.16 after 1 year and 0.01 after 10 years. A total of 325 patients (21.6%) converted to secondary progressive multiple sclerosis (SPMS) during the observational period. Of 1502 patients, 1297 (86.4%) reported no adverse events (AE) during follow-up visits. The most common reported AEs were infections and infusion-related reactions. John Cunningham virus (JCV) seropositivity was the most common specified reason for treatment discontinuation (53.7%, n = 607). There were five confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) with 1 death.

Conclusion

The effectiveness of natalizumab in patients with active relapsing–remitting multiple sclerosis (RRMS) could be confirmed in our real-world cohort even after follow-up of up to 14 years, though after year 10, there were less than 100 remaining patients. A low number of AE were reported in this nationwide registry study, establishing Natalizumab’s favourable safety profile during long-term use.

Tintore M, Vidal-Jordana A, Sastre-Garriga J (2019) Treatment of multiple sclerosis — success from bench to bedside. Nat Rev Neurol 15:53–58CrossRefPubMed

Guger M, Enzinger C, Leutmezer F, Kraus J, Kalcher S, Kvas E et al (2018) Real-life clinical use of natalizumab and fingolimod in Austria. Acta Neurol Scand 137(2):181–187CrossRefPubMed

Salhofer-Polanyi S, Cetin H, Leutmezer F, Baumgartner A, Blechinger S, Dal-Bianco A et al (2017) Epidemiology of multiple sclerosis in Austria. Neuroepidemiology 49(1–2):40–44CrossRefPubMed

Kappos L, Bates D, Hartung HP, Havrdova E, Miller D, Polman CH et al (2007) Natalizumab treatment for multiple sclerosis: recommendations for patient selection and monitoring. Lancet Neurol 6:431–441CrossRefPubMed

Polman CH, O’Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH et al (2006) A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 354(9):899–910CrossRefPubMed

Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue E-W et al (2006) Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med 354(9):911–923CrossRefPubMed

Butzkueven H, Kappos L, Wiendl H, Trojano M, Spelman T, Spelman T et al (2020) Long-term safety and effectiveness of natalizumab treatment in clinical practice: 10 years of real-world data from the Tysabri Observational Program (TOP). J Neurol Neurosurg Psychiatry 91(6):660–668CrossRefPubMed

Lorscheider J, Buzzard K, Jokubaitis V, Spelman T, Havrdova E, Horakova D et al (2016) Defining secondary progressive multiple sclerosis. Brain 139(9):2395–2405CrossRefPubMed

Guger M, Enzinger C, Leutmezer F, Di Pauli F, Kraus J, Kalcher S et al (2021) Long-term outcome and predictors of long-term disease activity in natalizumab-treated patients with multiple sclerosis: real life data from the Austrian MS Treatment Registry. J Neurol 268(11):4303–4310CrossRefPubMedPubMedCentral

10.

He A, Merkel B, Brown JWL, Zhovits Ryerson L, Kister I, Malpas CB et al (2020) Timing of high-efficacy therapy for multiple sclerosis: a retrospective observational cohort study. Lancet Neurol 19(4):307–316CrossRefPubMed

11.

O’Connor P, Goodman A, Kappos L, Lublin F, Polman C, Rudick RA et al (2014) Long-term safety and effectiveness of natalizumab redosing and treatment in the STRATA MS study. Neurology 83(1):78–86CrossRefPubMedPubMedCentral

12.

Foley J, Carrillo-Infante C, Smith J, Evans K, Ho PR, Lee L et al (2020) The 5-year Tysabri global observational program in safety (TYGRIS) study confirms the long-term safety profile of natalizumab treatment in multiple sclerosis. Mult Scler Relat Disord 39:101863CrossRefPubMed

13.

Campagnolo DI, Ho P-R, Patel R, Chang I, Subramanyam M, Koendgen H et al (2016) Four-year longitudinal index stability data from STRATIFY-2 support the clinical utility of index for risk stratification of natalizumab-associated progressive multifocal leukoencephalopathy. Neurology 87(2):e25

14.

Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sørensen PS, Thompson AJ et al (2014) Defining the clinical course of multiple sclerosis: The 2013 revisions. Neurology 83:278–286CrossRefPubMedPubMedCentral

15.

Tremlett H, Zhao Y, Devonshire V (2008) Natural history of secondary-progressive multiple sclerosis. Mult Scler 14(3):314–324CrossRefPubMed

16.

Confavreux C, Vukusic S (2006) Natural history of multiple sclerosis: a unifying concept. Brain 129(3):606–616CrossRefPubMed

Title: Real-world use of natalizumab in Austria: data from the Austrian Multiple Sclerosis Treatment Registry (AMSTR)
Authors: Tobias Monschein
Sarinah Dekany
Tobias Zrzavy
Markus Ponleitner
Patrick Altmann
Gabriel Bsteh
Barbara Kornek
Paulus Rommer
Christian Enzinger
Franziska Di Pauli
Jörg Kraus
Thomas Berger
Fritz Leutmezer
Michael Guger
the Austrian MS Treatment Registry (AMSTR)
Publication date: 19-04-2023
Publisher: Springer Berlin Heidelberg
Keywords: Multiple Sclerosis
Natalizumab
Published in: Journal of Neurology / Issue 8/2023
Print ISSN: 0340-5354
Electronic ISSN: 1432-1459
DOI: https://doi.org/10.1007/s00415-023-11686-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Real-world use of natalizumab in Austria: data from the Austrian Multiple Sclerosis Treatment Registry (AMSTR)

Abstract

Introduction

Patients/methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Patients/methods

Results

Conclusion

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