Drug updated on 4/16/2024
| Dosage Form | Injection (intravenous; 300 mg/15 mL [20 mg/mL]) |
| Drug Class | Integrin receptor antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
- 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
- Natalizumab (Tysabri) is used for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.
- This drug is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to or are unable to tolerate conventional CD therapies and inhibitors of TNF-α.
- Two systematic reviews/meta-analyses were reviewed which compared natalizumab (Tysabri) among other Disease Modifying Therapies (DMTs) for treating Relapsing Multiple Sclerosis(RMS).
- According to a network meta-analysis study on DMTs efficacy against RMS, natalizumab was found as one of the three most efficacious treatments versus placebo when considering 6-month confirmed disability progression outcome.
- Another study comparing up-to-date DMTs' efficacy showed that natalizumab along with alemtuzumab and ocrelizumabin demonstrated superior effectiveness and compliance in treating Remitting-Relapsing MS patients.
- The same research concluded that these drugs did not significantly increase patient incompliance compared to placebo while reducing risk factors associated with RRMS effectively.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Tysabri (natalizumab) Prescribing Information. | 2023 | Biogen Inc., Cambridge, MA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Comparative efficacy of therapies for relapsing multiple sclerosis: a systematic review and network meta-analysis. | 2023 | Journal of Comparative Effectiveness Research |
| Disease modifying therapies in relapsing-remitting multiple sclerosis: a systematic review and network meta-analysis. | 2021 | Autoimmunity Reviews |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| AGA clinical practice guidelines on the medical management of moderate to severe luminal and perianal fistulizing Crohn’s disease. | 2021 | American Gastroenterological Association: Gastroenterology |
| Practice guideline recommendations summary: disease-modifying therapies for adults with multiple sclerosis; report of the guideline development, dissemination, and implementation subcommittee of the American Academy of Neurology. | 2018 | American Academy of Neurology |
| ACG clinical guideline: management of Crohn's disease in adults. | 2018 | The American Journal of Gastroenterology |