Rituxumab is a monoclonal antibody that interferes with the growth and spread of leukemia and lymphoma cancer cells. It works by targeting CD20 antigens on the surface of certain immune cells called B-cells. Rituximab binds to the antigen on the cell surface which activates B-cell death. Because B-cells contribute to myelin damage in multiple sclerosis, rituximab may be helpful for treating the disease.
Studies involving rituximab for RRMS
Early studies of rituximab in people with neuromyelitis optica (NCT00501748) tested the drug’s safety. Although preliminary results from a group of eight people with neuromyelitis optica showed that B-cell depletion may enhance neurological recovery from attacks, there is still no published data from this study.
A Phase 2 study (NCT00097188) evaluated the safety and effectiveness of rituximab in adults with remitting-relapsing multiple sclerosis (RRMS). Participants showed reduced numbers of new brain lesions and a 50% reduction in relapses.
A Phase 2/3 study (NCT00087529) evaluated the safety and effectiveness of rituximab in adults with primary progressive multiple sclerosis (PPMS). This trial compared rituximab to a placebo. Though rituximab did not prove effective, it was safe for people with PPMS.
A study (NCT01212094) involving people with secondary progressive multiple sclerosis (SPMS) was terminated because cerebrospinal fluid biomarkers failed to reach the criteria for continuation. This trial included 27 people with SPMS who received rituximab injections intrathecally (into the spine).
There are no Phase 3 trials currently planned for rituximab in MS, though the drug is licensed for other diseases and is currently used off-label for MS. Off-label use of rituximab for MS has received positive response — the observed annualized relapse rate and MRI disease activity were low during rituximab treatment, providing evidence that it is a safe and effective treatment for MS for up to 2 years.
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