Long-term clinical outcomes in patients with multiple sclerosis who are initiating disease-modifying therapy with natalizumab compared with BRACETD first-line therapies
Status PubMed-not-MEDLINE Language English Country England, Great Britain Media electronic-ecollection
Document type Journal Article
PubMed
38414723
PubMed Central
PMC10898303
DOI
10.1177/17562864231221331
PII: 10.1177_17562864231221331
Knihovny.cz E-resources
- Keywords
- multiple sclerosis, natalizumab, real-world evidence,
- Publication type
- Journal Article MeSH
BACKGROUND: Aggressive disease control soon after multiple sclerosis (MS) diagnosis may prevent irreversible neurological damage, and therefore early initiation of a high-efficacy disease-modifying therapy (DMT) is of clinical relevance. OBJECTIVES: Evaluate long-term clinical outcomes in patients with MS who initiated treatment with either natalizumab or a BRACETD therapy (interferon beta, glatiramer acetate, teriflunomide, or dimethyl fumarate). DESIGN: This retrospective analysis utilized data from MSBase to create a matched population allowing comparison of first-line natalizumab to first-line BRACETD. METHODS: This study included patients who initiated treatment either with natalizumab or a BRACETD DMT within 1 year of MS diagnosis and continued treatment for ⩾6 months, after which patients could switch DMTs or discontinue treatment. Patients had a minimum follow-up time of ⩾60 months from initiation. A subgroup analysis compared the natalizumab group to patients in the BRACETD group who escalated therapy after 6 months. Outcomes included unadjusted annualized relapse rates (ARRs), time-to-first relapse, time-to-first confirmed disability improvement (CDI), and time-to-first confirmed disability worsening (CDW). RESULTS: After 1:1 propensity score matching, 355 BRACETD patients were matched to 355 natalizumab patients. Patients initiating natalizumab were less likely to experience a relapse over the duration of follow-up, with ARRs [95% confidence interval (CI)] of 0.080 (0.070-0.092) for natalizumab patients and 0.191 (0.178-0.205) for BRACETD patients (p < 0.0001). A Cox regression model of time-to-first relapse showed a reduced risk of relapse for natalizumab patients [hazard ratio (95% CI) of 0.52 (0.42-0.65); p < 0.001] and a more favorable time-to-first CDI. The risk of CDW was similar between groups. The subgroup analysis showed an increased relapse risk as well as a significantly higher risk of CDW for BRACETD patients. CONCLUSION: Early initiation of natalizumab produced long-term benefits in relapse outcomes in comparison with BRACETD, regardless of a subsequent escalation in therapy.
Biogen Cambridge MA USA at the time of this analysis
Burnet Institute Melbourne VIC Australia
CHUM and Universite de Montreal Montreal QC Canada
Department of Neurology Box Hill Hospital Melbourne VIC Australia
Department of Neurology Box Hill Hospital Monash University Box Hill VIC Australia
Department of Neurology Hospital Universitario Virgen Macarena Sevilla Spain
Department of Neurology Jacobs MS Center for Treatment and Research Buffalo NY USA
Department of Neurology The Alfred Hospital Melbourne VIC Australia
Division of Neurology Department of Medicine Amiri Hospital Sharq Kuwait
Flinders University Adelaide SA Australia
Neuroimmunology Centre Department of Neurology The Royal Melbourne Hospital Melbourne VIC Australia
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