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Improved clinical outcomes in patients treated with natalizumab for at least 11 years - real-world data from a swedish national post-marketing surveillance study (IMSE 1)
Karolinska Institutet, Department of Clinical Neuroscience, Stockholm, Sweden.
Karolinska Institutet, Department of Clinical Neuroscience, Stockholm, Sweden.
Karolinska Institutet, Department of Clinical Neuroscience, Stockholm, Sweden.
Lund University, Department of Neurology, Lund, Sweden.
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2022 (English)In: Multiple Sclerosis Journal, ISSN 1352-4585, E-ISSN 1477-0970, Vol. 28, no Suppl. 3, p. 352-353, article id P324Article in journal, Meeting abstract (Other academic) Published
Abstract [en]

Introduction: Natalizumab (NTZ) is a highly effective disease modulatory treatment for relapsing-remitting multiple sclerosis (RRMS). Post-marketing surveillance is important for evaluation of long-term safety and effectiveness in a real-world setting. To this end the “Immunomodulation and Multiple Sclerosis Epidemiology Study” (IMSE 1) was initiated upon NTZ launch in Sweden (Aug 2006).

Objectives/Aims: To follow-up  the  long-term  effectiveness  and  safety of NTZ in a real-world setting.

Methods: Adverse  events  (AEs),  Serious  AEs  (SAEs),  John  Cunningham  virus status  (JCV)  and  clinical  effectiveness  measures; Extended Disability Status Scale (EDSS), Multiple Sclerosis Severity  Scale  (MSSS),  Symbol  Digit  Modalities Test  (SDMT)  and Multiple Sclerosis Impact Scale (MSIS-29) data is collected from  the nationwide Swedish Neuro Registry (NeuroReg). Effectiveness measures were assessed using the Wilcoxon Signed Rank Test.

Results: A total of 3622 NTZ patients were included in the IMSE 1 study from August 2006 until March 2022 (72% female; mean age  36  years;  80%  RRMS; mean  treatment  duration  49  months)  and  186  had  been  treated  for  at  east  132  months.  Of  the  132-month cohort, 73% were female, the mean age was 36 years, 88% had  RRMS,  and  the  mean  treatment  duration  was  155 months.  The majority were treated with interferons and glatiramer acetate prior NTZ  (64%).  25%  (47/186)  discontinued  NTZ  treatment  of  which 47% (n=22) discontinued due to JCV positive (JCV+). In total,  30%  (55/186)  of  these patients  were  JCV+  with  a  mean  JCV index of 1.2±1.0 (2% missing data). Relapses before treatment were reduced from 380/1000 patient years to 43/1000 during treatment,  71%  were  relapse-free  and  18%  had  1  relapse  during  the entire  treatment  period  (15%  missing  data).  Most  clinical  effectiveness measures, MSSS, MSIS-29 and SDMT showed statistically  significant  improvement between  baseline  and  132  months (p<0.05). Over the entire observation time, 125 SAEs had been reported to the Swedish MPA including 9 cases (2 fatal) of progressive  multifocal  leukoencephalopathy  (PML)  of  which  8  occurred between 2008 and 2012, and one in 2018.

Conclusions: NTZ  is  generally  well  tolerated  with  sustained  effectiveness regarding  cognitive,  physical  and  psychological  measures, as well as relapse-control. Introduction of JCV testing has  led  to  fewer  treated  JCV+  patients, which  likely  explains  a  drastic drop in number of reported cases of PML.

Place, publisher, year, edition, pages
Sage Publications, 2022. Vol. 28, no Suppl. 3, p. 352-353, article id P324
National Category
Neurology
Identifiers
URN: urn:nbn:se:oru:diva-102590ISI: 000866540801320OAI: oai:DiVA.org:oru-102590DiVA, id: diva2:1717326
Conference
38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2022), Amsterdam, the Netherlands, October 26-28, 2022
Available from: 2022-12-08 Created: 2022-12-08 Last updated: 2022-12-08Bibliographically approved

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