Drug updated on 12/11/2024
| Dosage Form | Injection (intravenous; 300 mg/15 mL [20 mg/mL]) |
| Drug Class | Integrin receptor antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
- Indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohns disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-.
Latest News
Summary
- This summary is based on the review of 27 systematic review(s)/meta-analysis(es). [1-26]
- Brain Volume Loss (BVL) in relapsing multiple sclerosis (RMS): Natalizumab was less effective in reducing brain volume loss compared to other disease-modifying treatments (DMTs), including fingolimod, ozanimod, teriflunomide, alemtuzumab, and ponesimod.
- Relapses and Disability Progression in progressive multiple sclerosis (PMS): Natalizumab did not provide moderate or high certainty evidence in reducing relapses or disability progression compared to placebo over 12, 24, and 36 months. However, in highly active relapsing-remitting multiple sclerosis (HA RRMS), natalizumab showed lower relapse rates and improved disease activity outcomes in sub-optimally treated patients.
- Extended Interval Dosing (EID): Natalizumab demonstrated similar effectiveness under extended interval dosing (up to 8 weeks) as standard interval dosing for clinical relapses, MRI lesions, and Expanded Disability Status Scale (EDSS) scores.
- Annualized Relapse Rate (ARR) and Disability Progression in RRMS: Natalizumab achieved substantial relapse reduction at 12 and 24 months compared to placebo, comparable to cladribine and alemtuzumab, and showed moderate-certainty evidence in reducing disability worsening at 24 months.
- Serious Adverse Events (SAEs) and Treatment Discontinuation: Natalizumab and other DMTs, including interferon beta-1a, rituximab, and fingolimod, showed moderate-certainty evidence for increased treatment discontinuation due to adverse events. In some instances, natalizumab demonstrated a safer SAE profile than placebo.
- EID Safety: Natalizumab under EID showed comparable risks for clinical relapses, MRI lesions, EDSS, and progressive multifocal leukoencephalopathy (PML) compared to standard interval dosing (SID).
- Cancer Risk and Immunogenicity: The pooled cancer prevalence in natalizumab-treated MS patients was 2%, primarily basal cell carcinoma. Additionally, natalizumab exhibited a 16% pooled rate of anti-drug antibodies (ADA), with lower ADA positivity when combined with immunomodulators.
- Specific populations analyzed include sub-optimally treated HA RRMS patients, where natalizumab demonstrated effectiveness in reducing relapse rates; pregnant women, where natalizumab use was linked to a risk of mild hematological abnormalities in newborns and potential disease relapse; secondary progressive MS (SPMS) patients, where natalizumab showed superior functional performance in tests like the 9-Hole Peg Test; and gender bias was identified in clinical trials, highlighting the need for more balanced sex-specific analyses.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Tysabri (natalizumab) Prescribing Information. | 2023 | Biogen, Cambridge, MA |