Drug updated on 9/4/2024
| Dosage Form | Injection (intravenous; 300 mg/15 mL [20 mg/mL]) |
| Drug Class | Integrin receptor antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated 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.
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Summary
- Tysabri (natalizumab) is indicated for the treatment of relapsing forms of multiple sclerosis, including 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, the expected benefit should be considered to offset this risk. It is also 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.
- This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
- No significant difference was observed in the risk of clinical relapses between extended interval dosing (EID) and standard interval dosing (SID) of natalizumab (RR = 0.90, 95% CI 0.80, 1.02). However, natalizumab demonstrated high efficacy in reducing relapse frequency in RRMS, with a relative risk (RR) of 0.56 (95% CI 0.47 to 0.66).
- Disability progression showed no significant difference in the change in Expanded Disability Status Scale (EDSS) between EID and SID of natalizumab (MD = 0.09, 95% CI -0.57, 0.76). Natalizumab, alongside alemtuzumab and ocrelizumab, was highly effective in reducing 3-month confirmed disability progression (3mCDP).
- MRI outcomes were improved consistently across various DMTs, with specific DMTs like dimethyl fumarate and ocrelizumab showing superiority. However, IFN-beta-1b and siponimod outperformed others, with natalizumab performing best on the 9-Hole Peg Test (9HPT).
- No significant difference in the risk of progressive multifocal leukoencephalopathy (PML) between extended interval dosing (EID) and standard interval dosing (SID) of natalizumab (RR = 1.09, 95% CI 0.24, 4.94).
- Rituximab had an increased risk of common infections compared to natalizumab (OR 1.58, 95% CI 1.08 to 2.32).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Tysabri (natalizumab) Prescribing Information. | 2023 | Biogen Inc., Cambridge, MA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Monoclonal antibodies in pregnancy and breastfeeding in patients with multiple sclerosis: a review and an updated clinical guide. | 2023 | Pharmaceuticals |
| AGA clinical practice guidelines on the medical management of moderate to severe luminal and perianal fistulizing Crohn’s disease. | 2021 | American Gastroenterological Association: Gastroenterology |