Efficacy of natalizumab in multiple sclerosis patients with high disease activity: a Danish nationwide study

A B Oturai, N Koch-Henriksen, T Petersen, P E H Jensen, F Sellebjerg, P S Sorensen

80 Citations (Scopus)

Abstract

INTRODUCTION: Previous studies of natalizumab (Tysabri) in relapsing multiple sclerosis (MS) patients have included patients with moderate disease activity. We studied a patient population with high disease activity.

PATIENTS AND METHODS: We analyzed data from 234 consecutive, natalizumab-treated patients, followed for at least 3 months. Three groups of patients were eligible for natalizumab therapy: patients with two or more documented relapses or sustained increase of 2 EDSS points on disease modifying therapy (DMT) in the previous year; patients switching from mitoxantrone; and patients with very active MS as de novo therapy.

RESULTS: During a median observation time of 11.3 months (range 3.0-21.5) the annualized relapse rate decreased to 0.68 from a pre-treatment rate of 2.53 (73% reduction). We assessed the annualized relapse rate in three subgroups: (i) 0.83 in 14 (6.0%) de novo treated patients; (ii) 0.71 in 175 (74.8%) patients with >or=2 relapses or sustained increase in EDSS of >or=2 points on a first-line DMT; and (iii) 0.56 in 45 (19.2%) patients switching from mitoxantrone. Nine anaphylactoid reactions, two severe, were reported. Out of 215 patients 7 (3%) were persistently positive for antibodies to natalizumab.

CONCLUSIONS: Tysabri appears to be effective in MS patients with high disease activity, but the relapse rate was higher than in the pivotal study after the first treatment year. This is likely to reflect differences in disease activity before the initiation of natalizumab treatment.

Original languageEnglish
JournalEuropean Journal of Neurology
Volume16
Issue number3
Pages (from-to)420-3
Number of pages4
ISSN1351-5101
DOIs
Publication statusPublished - Mar 2009
Externally publishedYes

Keywords

  • Adolescent
  • Adult
  • Anaphylaxis/chemically induced
  • Antibodies, Monoclonal/adverse effects
  • Antibodies, Monoclonal, Humanized
  • Denmark
  • Disease Progression
  • Enzyme-Linked Immunosorbent Assay
  • Humans
  • Middle Aged
  • Mitoxantrone/therapeutic use
  • Multiple Sclerosis, Relapsing-Remitting/drug therapy
  • Natalizumab
  • Neuroprotective Agents/adverse effects
  • Recurrence
  • Severity of Illness Index
  • Treatment Outcome
  • Young Adult

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