Natalizumab

(Tysabri®)

Tysabri®

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Drug updated on 5/17/2024

Dosage FormInjection (intravenous; 300 mg/15 mL [20 mg/mL])
Drug ClassIntegrin receptor antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TYSABRI increases the risk of PML. When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk.
  • Indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α.

Summary
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  • Natalizumab (Tysabri) is recommended for the management of relapsing forms of multiple sclerosis and Crohn's disease in adults who have not responded adequately to, or cannot tolerate, standard therapies. It remains effective with extended interval dosing of up to 8 weeks.
  • The information was derived from nine systematic reviews and meta-analyses, which focused on different population types, subgroup considerations, and comparisons with other therapies in terms of safety and effectiveness.
  • Compared to other Disease-Modifying Therapies (DMTs) for Progressive MS (PMS), natalizumab is highly effective at preventing disability progression over three months. In the case of Relapsing Remitting Multiple Sclerosis (RRMS), it demonstrates a positive impact on preventing disability worsening and on rates of withdrawal due to adverse events over a 24-month period.
  • A significant risk of natalizumab use is the development of progressive multifocal leukoencephalopathy (PML). Risk factors strongly associated with this include the duration of treatment and the presence of the John Cunningham virus before treatment.
  • Network meta-analysis identifies natalizumab as one of the top efficacious treatments for reducing the annualized relapse rate and confirmed disability progression when compared to newer therapies like ozanimod and ponesimod.
  • Subgroup considerations are critical in determining its appropriateness; particularly effective results were observed in RRMS patients, with a reduction in relapse frequency and a delay in disability progression.

Product Monograph / Prescribing Information

Document TitleYearSource
Tysabri (natalizumab) Prescribing Information.2023Biogen Inc., Cambridge, MA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines