What are the results of Rituximab (rituximab) trials in neurology?

From the Guidelines

Rituximab is a viable treatment option for certain neurological conditions, including neuromyelitis optica spectrum disorders (NMOSD), multiple sclerosis (MS), myasthenia gravis, and autoimmune encephalitis, due to its ability to deplete CD20+ B cells and reduce inflammatory processes. When considering rituximab for these conditions, it's essential to weigh the potential benefits against the risks, including infusion reactions, infections, and rare but potentially fatal complications like progressive multifocal leukoencephalopathy 1. Key considerations for rituximab treatment in neurology include:

• Dosing regimens: typically 375 mg/m² weekly for four weeks or two 1000 mg infusions separated by two weeks, followed by maintenance dosing every 6 months for NMOSD, and similar regimens for MS and myasthenia gravis 1.
• Monitoring: treatment response is often monitored through CD19/CD20 B-cell counts, with retreatment considered when levels begin to recover 1.
• Side effects: common side effects include infusion reactions, infections, and potential progressive multifocal leukoencephalopathy in rare cases, emphasizing the need for premedication with acetaminophen, diphenhydramine, and sometimes corticosteroids to minimize infusion reactions 1.
• Patient selection: rituximab may be particularly beneficial for patients with refractory disease or those who have failed other treatments, as seen in the Rituximab in Myositis study, which showed a favorable response in 83% of patients throughout the 44-week trial 1. Given the potential benefits and risks, rituximab should be considered as a treatment option for patients with neurological conditions who have failed other therapies or have refractory disease, under close monitoring and with careful consideration of the potential side effects.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Rituximab Trials in Neurology

• Rituximab is a monoclonal anti-CD20 chimeric antibody that inhibits B cell activity, and has been used as a treatment for various neuroinflammatory conditions, including neuromyelitis optica spectrum disorder (NMOSD) and multiple sclerosis (MS) 2, 3, 4, 5, 6.
• Studies have shown that rituximab can reduce the frequency of relapses and neurological disability in patients with NMOSD 2, 5.
• A systematic review and meta-analysis of 46 studies involving 438 patients with NMOSD found that rituximab therapy resulted in a significant reduction in the annualized relapse rate ratio and Expanded Disability Status Scale score 5.
• Adverse effects of rituximab treatment have been reported, including infusion-related reactions, infections, and persistent leukopenia 5, 6.
• A study of 56 patients with MS or NMOSD treated with rituximab found that the treatment was well-tolerated, with infusion-related reactions and infections being the most common adverse events 6.
• The majority of patients (almost 80%) benefited at least partially from rituximab treatment, with a quarter of patients experiencing a full treatment response 6.

Efficacy of Rituximab in NMOSD

• A retrospective observational study of 37 patients with NMOSD treated with rituximab found that the annualized relapse rate (ARR) was significantly lower during treatment than before treatment 2.
• The study also found that there was a significant reduction in ARR for the seropositive subgroup, but not for the seronegative subgroup 2.
• Significant improvement in Modified Rankin Scores (mRS) was seen post-treatment, indicating a reduction in disability 2.

Safety Profile of Rituximab

• Adverse effects of rituximab treatment have been reported, including infusion-related reactions, infections, and persistent leukopenia 5, 6.
• A study of 56 patients with MS or NMOSD treated with rituximab found that infusion-related reactions were the most common adverse event, reported in four patients 6.
• Infections were seen in three patients, with two patients being hospitalized for urinary tract infection and urosepsis 6.
• All patients recovered from infection, and no unexpected side effects were seen 6.