Natalizumab for multiple sclerosis.

Area of Science:

• Neurology
• Immunology
• Pharmacology

Background:

• Natalizumab (NTZ) is a key treatment for highly active relapsing-remitting multiple sclerosis (RRMS).
• Recent research has expanded the understanding of NTZ's efficacy and safety since its approval.

Purpose of the Study:

• To systematically evaluate the benefits and harms of natalizumab (NTZ) in patients with multiple sclerosis (MS).
• To compare NTZ alone or in combination with other treatments against control groups or alternative therapies.

Main Methods:

• Conducted a systematic review of randomized controlled trials (RCTs) including adults with any MS subtype.
• Searched multiple databases (CENTRAL, PubMed, Embase) and trial registries up to February 2024.
• Assessed outcomes including relapse, disability worsening, serious adverse events (SAEs), quality of life (QoL), MRI activity, and treatment discontinuation.

Main Results:

• For RRMS vs. placebo: NTZ significantly reduced relapses (high-certainty) and disability progression (high-certainty), with slight QoL improvements and reduced MRI activity.
• NTZ likely had little difference in SAEs and discontinuation due to AEs compared to placebo (moderate-certainty).
• For RRMS vs. biosimilar-NTZ: Evidence (low-to-moderate certainty) suggests comparable effects on SAEs, MRI activity, and discontinuation.
• For SPMS vs. placebo: Low-to-moderate certainty evidence indicates potential relapse reduction but little difference in disability, SAEs, QoL, or discontinuation.

Conclusions:

• NTZ is effective in reducing relapses and disability in RRMS compared to placebo, with high-certainty evidence.
• NTZ appears comparable to biosimilar NTZ for RRMS, though evidence is less certain.
• Evidence for NTZ in SPMS is limited, suggesting potential relapse reduction but no significant impact on disability or safety compared to placebo.